MEDICINES AND ALLIED SUBSTANCES ACT: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
Medicines and Allied Substances (Agro-Veterinary Shops) Regulations
Medicines and Allied Substances (Dispensing Certificates) Regulations
Medicines and Allied Substances (Health Shops) Regulations
Medicines and Allied Substances (Fees) Regulations
Medicines and Allied Substances (Importation and Exportation) Regulations
Medicines and Allied Substances (Certificate of Registration) Regulations
Medicines and Allied Substances (Pharmaceutical Licence) Regulations
Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations
Medicines and Allied Substances (Expert Advisory Committee) Regulations
MEDICINES AND ALLIED SUBSTANCES (AGRO-VETERINARY SHOPS) REGULATIONS
[Section 29]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
AGRO-VETERINARY SHOP PERMIT
5. Rejection of application for permit
7. Application for renewal of permit
10. Application for duplicate permit
13. Location of agro-veterinary shop
14. Identity of agro-veterinary shop
15. Sale of veterinary medicines
16. Sale, supply and dispensing of veterinary medicines
17. Storage of veterinary medicines
PART III
GENERAL PROVISIONS
18. Register of agro-veterinary shop permits
SI 10 of 2016.
PART I
PRELIMINARY
These Regulations may be cited as the Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016.
In these Regulations, unless the context otherwise requires-
"authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act;
"insanitary conditions" means the conditions or circumstances that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health;
"permit" means an agro-veterinary shop permit issued under section 29 of the Act; and
"responsible person" means a person who has the control and management of an agro-veterinary shop.
PART II
AGRO-VETERINARY SHOP PERMIT
(1) A person shall apply to the Authority for a permit in Form I set out in the First Schedule.
(2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(3) A separate application shall be made and a separate permit issued in respect of each premises.
(4) The Authority may inspect the premises in respect of which an application for a permit is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority.
The Authority may request an applicant to submit information in relation to an application for a permit in Form II set out in the First Schedule.
5. Rejection of application for permit
(1) The Authority shall reject an application for a permit if-
(a) the applicant fails to meet the requirements of the Act and the guidelines issued by the Authority;
(b) the permit issued to the applicant was revoked by the Authority within a period of two years preceding the application; or
(c) the applicant is convicted of an offence under the Act or any other relevant written law.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the First Schedule.
(1) The Authority shall, where the applicant meets the requirements of the Act and the guidelines issued by the Authority, issue a permit in Form IV set out in the First Schedule.
(2) A permit shall be valid for two years from the date of issue.
(3) A permit may be issued in respect of the following classes of agro-veterinary shops-
(a) Class I, to stock for sell the veterinary medicines and allied substances specified in Part A of the Second Schedule;
(b) Class II, to stock for sale the veterinary medicines and allied substances as specified in Part B of the Second Schedule; and
(c) Class III, to stock for sale the veterinary medicines and allied substances specified in Part C of the Second Schedule.
(4) The classes of agro-veterinary shops shall be managed as follows-
(a) Class I, by a registered veterinary surgeon or pharmacist;
(b) Class II, by a registered veterinary para-professional under the supervision of a registered veterinary surgeon or pharmacist; and
(c) Class III, by a suitably qualified person as determined by the Authority.
7. Application for renewal of permit
(1) An application for the renewal of a permit shall be made to the Authority in Form V set out in the First Schedule.
(2) The Authority shall, within 14 days of receipt of an application for the renewal of a permit, grant the application if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the permit.
(3) A permit that is not renewed by the Authority lapses on its date of expiry.
(1) A permit shall be used solely by the holder and is not transferable to any other person without the prior approval of the Authority.
(2) An application for approval to transfer a permit shall be made to the Authority in Form VI set out in the First Schedule.
(3) The Authority shall, within 30 days of receipt of an application for the transfer of a permit, approve the transfer if the applicant meets the requirements of the Act and the guidelines issued by the Authority and issue the transferee with a new permit.
(4) The Authority shall reject an application for the transfer of a permit if the applicant fails to comply with the conditions for the grant of the permit, the provisions of the Act and the guidelines issued by the Authority.
(5) The Authority shall, where it rejects an application to transfer a permit under sub-regulation (4), inform the applicant in Form III set out in the First Schedule.
(1) The Authority may amend a permit where-
(a) some other person succeeds to the interest of the business of the holder;
(b) the name of the business changes; or
(c) there is a change in the employment of the responsible person.
(2) An application for the amendment of a permit shall be made in Form VII set out in the First Schedule.
(3) The Authority shall communicate its decision to the permit holder within 14 days of receipt of the application for amendment of the permit.
(4) The Authority shall, where it approves the amendment of a permit, issue the applicant with a new permit.
10. Application for duplicate permit
A person may, where a permit is lost, damaged or defaced, apply to the Authority for a duplicate permit in Form VIII set out in the First Schedule.
(1) The Authority shall suspend a permit if-
(a)the holder operates the agro-veterinary shop in respect of which it is issued under insanitary conditions;
(b) the holder or manager of the agro-veterinary shop in respect of which it is issued obtains or sells veterinary medicines from unauthorised suppliers or stocks and sells unauthorised products;
(c) the agro-veterinary shop in respect of which it was issued contravenes the prescribed standards or the provisions of the Act;
(d) the agro-veterinary shop is not managed or controlled by a responsible person determined by the Authority;
(e) the responsible person fails to maintain the required records on veterinary medicines and allied substances;
(f) the agro-veterinary shop stocks and sells medicines that are not on the prescribed list; or
(g) the holder contravenes the terms and conditions of the permit, the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a permit, give notice to the holder of the intention to suspend the permit and request the holder to show cause, within a specified period, why the permit should not be suspended.
(3) A notice of intention to suspend a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall suspend a permit if the holder of the permit fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of the suspension of a permit shall be in Form X set out in the First Schedule.
(6) The Authority shall, during the period of the suspension of the permit, quarantine any product affected by the suspension of the permit at the cost of the permit holder.
(1) The Authority shall revoke a permit if the holder-
(a) contravenes the provisions of the Act or any other relevant written law or breaches the terms or conditions of the permit;
(b) fails to take corrective measures following the suspension of the permit within the specified period;
(c) changes the agro-veterinary shop premises without authorisation; or
(d) obtained the permit by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a permit, give notice to the holder of the permit of the intention to revoke the permit and request the holder to show cause, within a specified period, why the permit should not be revoked.
(3) A notice of the intention to revoke a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall revoke a permit if the holder fails to take remedial measures during the period specified by the Authority.
(5) A notice of the revocation of a permit shall be in Form X set out in the First Schedule.
(6) Upon the revocation of a permit, the medicines and allied substances on the premises shall be quarantined and disposed of as directed by the Authority at the holder's cost.
13. Location of agro-veterinary shop
The Authority shall, in considering an application for a permit, give priority to submissions filed by the applicants in the following areas-
(a) rural areas and districts where access to medicines is limited; and
(b) peripheral areas of municipalities or cities, where access to medicines is limited.
14. Identity of agro-veterinary shop
An agro-veterinary shop shall fix a standard logo for purposes of identifying the agro-veterinary shop as specified in the guidelines issued by the Authority.
15. Sale of veterinary medicines
A holder of a permit shall sell the veterinary medicines prescribed in the Second Schedule.
16. Sale, supply and dispensing of veterinary medicines
Veterinary medicines shall be sold, supplied and dispensed in accordance with the guidelines issued by the Authority.
17. Storage of veterinary medicines
(1) The storage of veterinary medicines in an agro-veterinary shop shall be in the manufacturer's original container and under conditions stipulated by the manufacturer.
(2) Where veterinary medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines.
(3) The Authority shall, where it is established that the holder of a permit stocks veterinary medicines or products under insanitary conditions, direct the holder to dispose of the veterinary medicines or products at the holder's cost.
PART III
GENERAL PROVISIONS
18. Register of agro-veterinary shop permits
(1) The Authority shall keep and maintain a register of agro-veterinary permits in Form XI set out in the First Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of an inspection fee prescribed in the Third Schedule.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12]
PRESCRIBED FORMS
Form I
[Regulation 3(1)]
(To be completed in triplicate)
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Form II
[Regulation 4]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) |
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The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 |
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REQUEST FOR INFORMATION |
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To: ................................................................................................................................ |
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Address: ....................................................................................................................... |
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Application No.: ............................................................................................................. |
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You are requested to furnish the following information or documents in respect of your application for ................................................................................................................ |
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(a) ............................................................................................................................ |
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(b) ............................................................................................................................ |
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(c) ............................................................................................................................ |
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(d) ............................................................................................................................ |
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within ..................... days of this notice. |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. |
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Dated this ............ day of ......................... 20...... |
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.................................................. |
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Form III
[Regulations 5(2) and 8(5)]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF REJECTION OF APPLICATION |
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(1) Here insert the full names and address of the applicant |
To (1) ................................................................................................. |
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................................................................................................. |
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(2) Here insert the reference No. of the application |
IN THE MATTER OF (2) ........................................ you are notified that your application for (3) .................................................... has been rejected by the Authority on the following grounds: |
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(3) Here insert type of application |
(a) ....................................................................................... |
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(b) .......................................................................................... |
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(c) ............................................................................................ |
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(d) ........................................................................................... |
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Dated this .......... day of ........................, 20...... |
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................................................. |
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Form IV
[Regulation 6]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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AGRO-VETERINARY SHOP PERMIT |
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Registration No.: .................................................. AVS |
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Permit No.: AVS/........................................................ |
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This is to certify that (Name of agro-veterinary shop) ..................................................... |
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..................................................................................................................................... |
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of (Physical address) .................................................................................................... |
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.................................................................................................................................... |
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................................................................... is registered to operate an agro-veterinary shop. |
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Name of responsible person: ........................................................................................... |
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The conditions of the agro-veterinary shop permit are overleaf. |
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This permit is valid until ......................... 20..... |
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.................................................. |
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Conditions for agro-veterinary shop permit |
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1. Any change in the responsible person, name, location or condition of permit of the agro-veterinary shop shall be approved by the Authority. |
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2. The agro-veterinary shop shall only stock and sell medicinal products that are on the prescribed list. |
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3. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. |
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4. The agro-veterinary shop permit is not transferable without the written approval of the Authority. |
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5. The agro-veterinary shop permit shall, upon grant, be displayed conspicuously at the front shop in a place visible to the public. |
Form V
[Regulation 7(1)]
(To be completed in triplicate)
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Form VI
[Regulation 8(2)]
(To be completed in triplicate)
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Form VII
[Regulation 9]
(To be completed in triplicate)
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Form VIII
[Regulation 10]
(To be completed in triplicate)
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Form IX
[Regulations 11(3) and 12(3)]
(To be completed in triplicate)
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF INTENTION TO SUSPEND/REVOKE AGRO-VETERINARY SHOP PERMIT |
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(1) Here insert the full names and address of holder of permit |
To (1) ............................................................................................ |
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...................................................................................................... |
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..................................................................................................... |
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(2) Here insert the Permit No. |
IN THE MATTER OF (2) ....................... .... you are notified that the Authority intends to *suspend/revoke your permit on the following grounds: |
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(a) ............................................................................................... |
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(b) ............................................................................................... |
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(c) ............................................................................................... |
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(d) ............................................................................................... |
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(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your permit should not be *suspended/revoked and to take action to remedy the breaches set out in paragraphs ......................... (above) within (3) ............ days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/revocation of your permit. |
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Dated this ............. day of ......................... 20..... |
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(4) Signature of Director-General |
(4) ................................................ |
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Form X
[Regulations 11(5) and 12(5)]
(To be completed in triplicate)
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF SUSPENSION OR REVOCATION OF AGRO-VETERINARY SHOP PERMIT |
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(1) Here insert the full names and address of holder of permit |
To (1) ................................................................................ |
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.......................................................................................... |
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(2) Here insert the permit no. |
IN THE MATTER OF (2) ................................................. you are notified that your permit has been *suspended for a period of (3) .................... /*revoked on the following grounds: |
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(3) Here insert the period |
(a) ................................................................................ |
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(4) Signature of Director-General |
(b) ............................................................................... |
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(c) .............................................................................. |
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(d) .............................................................................. |
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Dated this ............. day of ......................... 20..... |
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(4) ................................................ |
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Form XI
[Regulation 18]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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REGISTER OF AGRO-VETERINARY SHOP PERMITS |
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No. |
Name and address of business |
Permit No. |
Class of permit |
Registration number |
Date of issue |
Expiry date |
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1. |
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2. |
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3. |
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4. |
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5. |
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6. |
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7. |
[Regulations 16(3) and 15(1)]
VETERINARY PRODUCTS FOR AGRO-VETERINARY SHOPS
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A. Agro-Veterinary Shop Class I |
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1. All prescription-only veterinary medicine (POM-V) with marketing authorisation |
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2. All pharmacy (P-V) veterinary medicines with market authorisation |
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3. All general sales (GS-V) veterinary medicines and allied substances |
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4. All medicines that have been imported with special authorisation |
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5. Medicines and allied substances added by guidelines issued by the Authority on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
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B. Agro-Veterinary Shops Class II |
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Part A |
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No. |
Item |
Dosage Form |
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Analgesics- non-steroidal anti-inflammatories |
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1 |
Acetaminophen |
Tablets or powder |
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2 |
Carprofen |
Tablets |
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3 |
Diclofenac |
Tablets or gel |
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4 |
Dimethyl sulfoxide (DMSO) |
Tablets, or cream or ointment |
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5 |
Dipyrone |
Injection |
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6 |
Flunixin meglumine |
Injection |
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7 |
Ketoprofen |
Tablets or powder |
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8 |
Meloxicam |
Tablets or powder |
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Antiprotozoa |
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1 |
Amprolium |
Injectable solutions |
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2 |
Amprolium |
Soluble powders |
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3 |
Parvaquone |
Injectable solutions |
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4 |
Burparvaquone |
Injectable solutions |
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5 |
Diminazene aceturate |
Injectable solutions |
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6 |
Diminazene aceturate |
Injectable solutions granules |
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7 |
Imidocarb dipropionate |
Injectable solutions |
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8 |
Isometamidium chloride |
Injectable solutions |
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9 |
Parvarquone |
Injectable solutions powder |
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10 |
Quinapyramine sulphate/chloride |
Injectable solutions |
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Antifungals |
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1 |
Fluconazole |
Tablets or powder |
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2 |
Griseofulvin |
Tablets or capsules |
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3 |
Ketoconazole |
Tablets, capsules, lotions, shampoo |
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Antihistamines |
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1 |
Chlorpheniramine |
Tablets |
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2 |
Cimetidine |
Tablets |
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3 |
Diphenhydramine |
Tablets |
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4 |
Cetirizine |
Tablets |
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Antimicrobials |
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1 |
Amikacin |
Tablets |
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2 |
Amoxicillin |
Tablets, capsules or injection |
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3 |
Ampicillin |
Tablets, capsules or injection |
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4 |
Doxycycline |
Tablets, capsules or injection |
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5 |
Neomycin |
Pessaries, ointment or creams |
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6 |
Oxytetracycline injectable solutions |
All concentrations and dosage forms |
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7 |
Oxytetracycline soluble powder |
All concentrations and dosage forms |
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8 |
Oxytetracycline soluble powder with vitamins |
All concentrations and dosage forms |
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9 |
Penicillin |
Injection |
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10 |
Penicillin-streptomycin |
Injection |
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11 |
Sulfadimidine |
Injectable solutions 33% w/v, 33.3% |
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12 |
Sulfadimidine |
Powder |
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13 |
Tetracycline |
Ointment or spray |
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14 |
Tetracycline |
Powder |
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15 |
Tiamulin |
Powder |
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Autonomic drugs |
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1 |
Atropine |
Injection |
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2 |
Bethanechol |
Injection |
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3 |
Glycopyrrolate |
Injection |
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Electrolytes/Nutritional |
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1 |
Calcium |
Injection and powder |
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2 |
Iron |
Injection or oral liquid |
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3 |
Methionine, D-L |
Powder |
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4 |
Multivitamin |
Injectable solution |
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5 |
Multivitamin |
Soluble powder |
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6 |
Potassium |
Injection |
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7 |
Selenium/Vitamin E |
Injection |
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8 |
Taurine |
Injection |
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9 |
Vitamin A & D |
Injection |
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10 |
Vitamin B complex |
Injection |
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11 |
Vitamin C |
Tablets or powder |
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12 |
Vitamin D |
Injection |
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13 |
Vitamin K |
Injection |
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14 |
Sodium chloride 0.9% (N-Saline) |
Solution |
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15 |
Dextrose 5%, 10%, 50% |
Solution |
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16 |
Ringers lactate |
Solution |
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Gastrointestinal agents |
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1 |
Metoclopramide |
Tablets |
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2 |
Sucralfate |
Tablets |
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Hormones |
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1 |
Dexamethasone |
Injection |
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2 |
Dinoprost |
Injection |
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3 |
Estradiol cypionate |
Injection |
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4 |
Gonadorelin |
Injection |
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5 |
Oxytocin |
Injection |
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6 |
Progesterone |
Injection |
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7 |
Stilboestral dipropionate |
Injection |
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8 |
Triamcinolone |
Injection |
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Respiratory |
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1 |
Aminophyline |
Tablet or injection |
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2 |
Dextromethorphan |
Injection |
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3 |
Doxapram |
Injection |
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Sedatives |
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1 |
Acepromazine |
Tablet |
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Miscellaneous |
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1 |
Methimazole |
Tablet |
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2 |
Propylene glycol |
Liquid |
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3 |
Protamine sulfate |
Powder |
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Allied substances (Acaricides) |
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1 |
Chlorfenvinphos |
Concentrate |
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2 |
Dichlorvos |
Concentrate |
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Anthelmintics |
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1 |
Albendazole |
Bolus up to 2.5 g |
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2 |
Albendazole |
Suspensions 2.5% w/v,10% w/v |
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3 |
Clorsulon |
Injection |
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4 |
Closantel |
Injection or drench |
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5 |
Febantel |
Drench, bolus or injection |
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6 |
Fenbendazole |
Drench, bolus or injection |
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7 |
Haloxon |
Drench |
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8 |
Hexachloroethane |
Drench |
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9 |
Hexachloroparaxylene |
Drench |
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10 |
Hexachlorophene |
Drench |
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11 |
Ivermectin |
Bolus or powder |
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12 |
Ivermectin |
Injectable solutions |
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13 |
Levamisole |
Bolus or powder |
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14 |
Levamisole hydrochloride |
Drench, powder or injection |
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15 |
Levamisole phosphate injection |
Injection |
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16 |
Mebendazole |
Drench, tablets, bolus |
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17 |
Niclosamide |
Drench or bolus |
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18 |
Nitoxynil |
Drench or bolus |
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19 |
Oxfendazole |
Drench or bolus |
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20 |
Oxibendazole |
Drench or bolus |
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21 |
Oxyclozanide |
Drench or bolus |
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22 |
Oxyclozanide |
Drench or bolus |
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23 |
Parbendazole |
Drench or bolus |
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24 |
Piperazine citrate |
Soluble powders |
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25 |
Piperazine citrate |
Tablets |
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26 |
Praziquantel |
Tablets |
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27 |
Pyrantel |
Tablets or oral liquid |
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28 |
Rafoxanide |
Drench or bolus |
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29 |
Tetramisole |
Drench or bolus |
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30 |
Thiabendazole |
Drench or bolus |
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31 |
Thiophanate |
Drench or bolus |
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32 |
Trichlorfon |
Drench or bolus |
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33 |
Triclabendazole |
Drench or bolus |
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34 |
Ivermectin/clorsulon |
Injection |
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35 |
Levamisole/oxyclozanide |
Drench or bolus |
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36 |
Piperazine citrate/pyrantel parmoate |
Tablets or oral liquid |
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37 |
Levamisole/piperazine dihydrochloride |
Powder |
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Biologicals: |
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Poultry vaccines |
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1 |
Anticoccidial vaccines |
All dosage forms |
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2 |
Chicken anaemia virus vaccines |
All dosage forms |
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3 |
Fowl cholera vaccines |
All dosage forms |
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4 |
Fowl pox vaccines |
All dosage forms |
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5 |
Fowl typhoid vaccines |
All dosage forms |
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6 |
Infectious bronchitis vaccines |
All dosage forms |
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7 |
Infectious bronchitis/newcastle disease/egg drop syndrome baccines |
All dosage forms |
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8 |
Infectious bronchitis/newcastle inactivated vaccines |
All dosage forms |
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9 |
Infectious bursal disease vaccines |
All dosage forms |
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10 |
Infectious coryza vaccines |
All dosage forms |
|
11 |
Infectious laryngotracheitis vaccines |
All dosage forms |
|
12 |
Newcastle cloned vaccines |
All dosage forms |
|
13 |
Newcastle disease live vaccine |
All dosage forms |
|
14 |
Newcastle disease inactivated vaccines |
All dosage forms |
|
15 |
Newcastle disease thermostable vaccines |
All dosage forms |
|
16 |
Salmonella vaccines for avians |
All dosage forms |
|
17 |
Egg drop syndrome vaccines |
All dosage forms |
|
Ruminant vaccines |
||
|
1 |
Anaplasmosis vaccines |
All dosage forms |
|
2 |
Anthrax vaccines |
All dosage forms |
|
3 |
Avian & bovine tuberculin kit |
Injectible |
|
4 |
Black leg-clostridium chauvoei vaccines |
All dosage forms |
|
5 |
Blackleg/anthrax vaccines |
All dosage forms |
|
6 |
Blue tongue vaccines |
All dosage forms |
|
7 |
Botulism vaccines |
All dosage forms |
|
8 |
Botulism/anthrax vaccines |
All dosage forms |
|
9 |
Anthrax/black quarter/botulism vaccines |
All dosage forms |
|
10 |
Bovine ephemeral fever vaccines |
All dosage forms |
|
11 |
Brucella vaccines |
All dosage forms |
|
12 |
Calf paratyphoid live and killed vaccines |
All dosage forms |
|
13 |
Enzootic abortion vaccines |
All dosage forms |
|
14 |
Clostridial/pasteurella vaccines |
All dosage forms |
|
15 |
Infectious bovine rhinotracheitis/parainfluenza/bovine respiratory syncitial virus/bovine viral diarrhoea (combination) vaccines, both live and killed |
All dosage forms |
|
16 |
Leptospirosis vaccines |
All dosage forms |
|
17 |
Lumpy skin disease vaccines |
All dosage forms |
|
18 |
Milk ring test antigen |
All dosage forms |
|
19 |
Multiclostridials vaccines |
All dosage forms |
|
20 |
Pasturella vaccines |
All dosage forms |
|
21 |
Pulpy kidney vaccines |
All dosage forms |
|
22 |
Rift valley fever vaccines, live and inactivated |
All dosage forms |
|
23 |
Rota/corona/E.coli vaccine for cattle |
All dosage forms |
|
24 |
Rift valley fever inactivated vaccine for cattle |
All dosage forms |
|
25 |
Rift valley fever live vaccine for sheep |
All dosage forms |
|
26 |
Bovine rota/coronavirus vaccine/clostridium perfringens type C/escherichia coli bacterin/toxoid Injectable vaccine/toxoid |
All dosage forms |
|
27 |
Sheep multiclostridial vaccines |
All dosage forms |
|
28 |
Tetanus vaccines |
All dosage forms |
|
29 |
Tetanus toxoid |
All dosage forms |
|
30 |
Bovine ephemeral fever vaccines |
All dosage forms |
|
31 |
Vibriosis vaccines |
All dosage forms |
|
Pig vaccines |
||
|
1 |
Parvovirus killed vaccine/erysipelothrix/leptospira bacterin vaccine/toxoid |
All dosage forms |
|
2 |
Boar-taint vaccines |
All dosage forms |
|
3 |
E. coli/clostridium perfringens type C beta toxoid |
All dosage forms |
|
Vaccines for companion animals |
||
|
1 |
Equine influenza virus vaccines |
All dosage forms |
|
2 |
Feline viral rhinotracheitis/feline calicivirus/feline panleukopenia vaccines |
All dosage forms |
|
3 |
Canine parvovirus vaccines |
All dosage forms |
|
4 |
Horse sickness polyvalent vaccine |
All dosage forms |
|
5 |
Canine distemper/adenovirus type 2/ parainfluenza/parvovirus modified live virus vaccine/ leptospira bacterin vaccine/toxoid |
All dosage forms |
|
6 |
Rabies vaccines |
All dosage forms |
|
Intra-Uterine infusion drugs |
||
|
1 |
Intrauterine pessaries |
Pessaries |
|
Intramammary infusion drugs |
||
|
1 |
Mastitis intramammary infusion |
Ointments |
|
Ophthalmologic drug |
||
|
1 |
Cloxacillin eye ointment 16.7% w/w |
Ointments |
|
2 |
Dexamethasone ointment or drops |
Ointments or drops |
|
3 |
Doxycycline |
Eye powder |
|
4 |
Neomycin |
Ointment or drops |
|
5 |
Oxytetracycline |
Powder or ointment |
|
Antiseptics |
||
|
1 |
Povidone iodine |
Concentrate |
|
Part B |
||
|
1. All general sales (GSV) veterinary medicines and allied substances |
||
|
2. Medicines and allied substances added by guidelines issued by the Authority on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
||
|
Agro-Veterinary Shop Class III |
||
|
Part A |
|
No. |
Item |
Dosage Form |
|
Analgesics-non-steroidal anti-inflammatories |
||
|
1 |
Diclofenac |
Tablets or gel |
|
2 |
Dipyrone |
Injection |
|
Antiprotozoa |
||
|
1 |
Amprolium |
Soluble powders |
|
Diminazene aceturate |
Injectable solutions |
|
|
Antihistamines |
||
|
1 |
Chlorpheniramine |
Tablets |
|
Antimicrobials |
||
|
1 |
Oxytetracycline injectable solutions |
All concentrations and dosage forms |
|
2 |
Oxytetracycline soluble powder |
All concentrations and dosage forms |
|
3 |
Oxytetracycline soluble powder with vitamins |
All concentrations and dosage forms |
|
4 |
Tetracycline |
Ointment or spray |
|
5 |
Tetracycline |
Powder |
|
Electrolytes/Nutritional |
||
|
1 |
Multivitamin |
Soluble powder |
|
2 |
Potassium |
Injection |
|
3 |
Vitamin C |
Tablets or powder |
|
Allied substances (Acaricides) |
||
|
1 |
Chlorfenvinphos |
Concentrate |
|
Anthelmintics |
||
|
1 |
Albendazole |
Bolus up to 2.5 g |
|
2 |
Albendazole |
Suspensions 2.5% w/v,10% w/v |
|
3 |
Closantel |
Injection or drench |
|
4 |
Ivermectin |
Bolus or powder |
|
5 |
Levamisole |
Bolus or powder |
|
6 |
Oxfendazole |
Drench or bolus |
|
7 |
Oxyclozanide |
Drench or bolus |
|
8 |
Parbendazole |
Drench or bolus |
|
9 |
Piperazine citrate |
Soluble powders |
|
10 |
Piperazine citrate |
Tablets |
|
11 |
Praziquantel |
Tablets |
|
12 |
Pyrantel |
Tablets or oral liquid |
|
Biologicals: |
|
|
|
Poultry vaccines |
||
|
1 |
Newcastle disease |
Thermostable vaccines |
|
Ophthalmologic drug |
||
|
1 |
Cloxacillin eye ointment 16.7% w/w |
Ointments |
|
2 |
Doxycycline |
Eye powder |
|
3 |
Neomycin |
Ointment or drops |
|
4 |
Oxytetracycline |
Power or ointment |
|
|
||
|
Part B |
||
|
1. All general sales (GSV) veterinary medicines and allied substances |
||
|
2. Medicines and allied substances added by guidelines issued by the Authority, and are categorised for distribution in Class 3 agro-veterinary shops, on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
||
|
Note: All medicines with marketing authorisation for use in humans, if prescribed for use in animals, shall only be accessed from registered pharmacies on prescription from a registered veterinary surgeon. |
MEDICINES AND ALLIED SUBSTANCES (DISPENSING CERTIFICATES) REGULATIONS
[Section 28]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
DISPENSING CERTIFICATE
3. Application for certificate
5. Rejection of application for certificate
7. Application for renewal of certificate
10. Application for duplicate certificate
PART III
GENERAL PROVISIONS
15. Register of dispensing certificates
SI 11 of 2016.
PART I
PRELIMINARY
These Regulations may be cited as the Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016.
In these Regulations, unless the context otherwise requires-
"authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act; and
"certificate" means the dispensing certificate issued under section 28 of the Act.
PART II
DISPENSING CERTIFICATE
3. Application for certificate
(1) A person shall apply to the Authority for a certificate in Form I set out in the Schedule.
(2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(3) A separate application shall be made and a separate certificate issued in respect of each health facility.
(4) The Authority may inspect the health facility in respect of which an application for a certificate is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority.
(5) The Authority shall consider the following matters in determining an application for a certificate-
(a) the number of health facilities in the area;
(b) the classification of the health facility; and
(c) the competence of the health practitioners responsible for dispensing the medicines.
The Authority may request an applicant to submit information in relation to an application for a certificate in Form II set out in the Schedule.
5. Rejection of application for certificate
(1) The Authority shall reject an application for a certificate if-
(a) the applicant fails to meet the requirements of the Act and the guidelines issued by the Authority;
(b) the certificate issued to the applicant was revoked by the Authority within the preceding two years before the date of the application;
(c) the applicant's practising certificate is withdrawn by the relevant professional body; or
(d) the applicant is convicted of an offence under the Act or any other relevant written law.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the Schedule.
(1) The Authority shall, where the applicant meets the requirements of the Act and the guidelines issued by the Authority, issue a certificate in Form IV set out in the Schedule.
(2) A certificate shall be valid for two years from the date of issue.
7. Application for renewal of certificate
(1) An application for the renewal of a certificate shall be made to the Authority in Form V set out in the Schedule.
(2) The Authority shall, within 14 days of the application for a certificate, renew the certificate if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the certificate.
(3) A certificate that is not renewed by the Authority lapses on its date of expiry.
A certificate shall be used solely by the holder and is not transferable to any other person.
(1) The Authority may amend a certificate where the name of the business changes.
(2) An application for the amendment of a certificate shall be made in Form VI set out in the Schedule.
(3) The Authority shall, where it approves an application for the amendment of a certificate, issue the applicant with a new certificate.
10. Application for duplicate certificate
A person may, where a certificate is lost, damaged or defaced, apply to the Authority for a duplicate certificate in Form VII set out in the Schedule.
(1) The Authority shall suspend a certificate if-
(a)the holder dispenses medicine under insanitary conditions;
(b) the holder or manager of the health facility in respect of which it is issued obtains or sells medicines from unauthorised suppliers or stocks and sells unauthorised products;
(c) the health facility does not comply with good dispensing practices determined by the Authority;
(d) the holder fails to maintain the required records on medicines and allied substances; or
(e) the holder contravenes the terms and conditions of the certificate or the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a certificate, give notice to the holder of the intention to suspend the certificate and request the holder to show cause, within a specified period, why the certificate should not be suspended.
(3) A notice of intention to suspend a certificate shall be in Form VIII set out in the Schedule.
(4) The Authority shall suspend a certificate if the holder of the certificate fails to take remedial measures within the period specified in the notice issued under sub-regulation (3).
(5) A notice of the suspension of a certificate shall be in Form IX set out in the Schedule.
(6) During the period of the suspension of the certificate-
(a) the product affected by the suspension of the certificate shall be quarantined and disposed of at the cost of the certificate holder; and
(b) the health facility to which it relates shall not dispense medicines, except for emergency cases.
(7) The Authority shall lift the suspension of a certificate where the holder complies with the terms and conditions of the suspension.
(1) The Authority shall revoke a certificate if the holder-
(a) contravenes the provisions of the Act or breaches the terms or conditions of the certificate;
(b) fails to take corrective measures following the suspension of the certificate within the specified period;
(c) obtained the certificate by fraud or deliberate or negligent submission of false information or statements; or
(d) fails to comply with any other relevant written law.
(2) The Authority shall, before revoking a certificate, give notice to the holder of the certificate of the intention to revoke the certificate and request the holder to show cause, within a specified period, why the certificate should not be revoked.
(3) A notice of the intention to revoke a certificate shall be in Form VIII set out in the First Schedule.
(4) The Authority shall revoke a certificate if the holder fails to take remedial measures during the period specified by the Authority.
(5) A notice of the revocation of a certificate shall be in Form IX set out in the Schedule.
(6) Upon the revocation of a certificate, the products in the health facility shall be quarantined or disposed of as directed by the Authority at the holder's cost.
(1) Medicines in a health facility shall be dispensed in accordance with the guidelines issued by the Authority.
(2) A holder of a dispensing certificate who undertakes dispensing activities shall stock medicines of the required quality, safety and efficacy.
(3) A patient may request a medical practitioner for a written prescription to enable the patient obtain medicines from any other health facility of their choice.
(1) The storage of medicines in a health facility shall be in the manufacturer's original container and under conditions stipulated by the manufacturer.
(2) The Authority shall, where it determines that the holder of a certificate stocks medicines or products under insanitary conditions, direct the holder to dispose of the medicines or products at the holder's cost.
(3) Where medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines.
PART III
GENERAL PROVISIONS
15. Register of dispensing certificates
(1) The Authority shall keep and maintain a register of dispensing certificates in Form X set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of a prescribed inspection fee.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 15]
PRESCRIBED FORMS
Form I
[Regulation 3(1)]
(To be completed in triplicate)
|
|
Form II
[Regulation 4]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
REQUEST FOR INFORMATION |
|
To: ...................................................................................................................... |
|
Address: .............................................................................................................. |
|
Application No.: .................................................................................................... |
|
You are requested to furnish the following information in respect of your application for ................................................ within ..................................... days of this Notice: |
|
(a) .................................................................................................................. |
|
(b) .................................................................................................................. |
|
(c) .................................................................................................................. |
|
(d) .................................................................................................................. |
|
If you fail to furnish the requested information within the stipulated period, your application |
|
Dated this ............. day of ............................. 20.... |
|
................................... |
|
|
Form III
[Regulation 5(2)]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
|
NOTICE OF REJECTION OF APPLICATION |
|
|
(1) Here insert the full names and address of the applicant |
To (1) ............................................................................................................ |
|
..................................................................................................................... |
|
|
(2) Here insert the reference No. of the application |
IN THE MATTER OF (2) ................................................. you are notified that your application for (3) .............................................................. has been rejected by the Authority on the following grounds: |
|
(3) Here insert type of application |
(a) ............................................................................................................ |
|
(b) ............................................................................................................ |
|
|
(c) ............................................................................................................ |
|
|
(d) ............................................................................................................ |
|
|
Dated this ............. day of .............................., 20..... |
|
|
................................... |
|
|
|
Form IV
[Regulation 6]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
DISPENSING CERTIFICATE |
|
Registration No.: ..................................... DC |
|
Certificate No.: DC/................................... |
|
This is to certify that ......................................................................................................... |
|
....................................................................................................................................... |
|
of (Physical address) ....................................................................................................... |
|
....................................................................................................................................... |
|
.............................................................................................. may dispense medicines at |
|
....................................................................................................................................... |
|
Name of Health Facility: ................................................................................................... |
|
This Certificate is valid until ................................... 20.... |
|
The conditions of the Dispensing Certificate are overleaf. |
|
..................................... |
|
|
|
Conditions for Dispensing Certificate |
|
1. The holder shall inform the Authority of any change in the details of the Dispensing Certificate. |
|
2. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. |
|
3. The Dispensing Certificate is not transferable to any other person. |
|
4. The Dispensing Certificate shall, upon grant, be displayed conspicuously at the health facility in a place visible to the public. |
Form V
[Regulation 7(1)]
(To be completed in triplicate)
|
|
Form VI
[Regulation 9(2)]
(To be completed in triplicate)
|
|
Form VII
[Regulation 10]
(To be completed in triplicate)
|
|
Form VIII
[Regulations 11(3) and 12(3)]
|
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
|
NOTICE OF INTENTION TO SUSPEND/REVOKE DISPENSING CERTIFICATE |
|
|
(1) Here insert the full names and address of holder of certificate |
To (1) ................................................................................................... |
|
............................................................................................................ |
|
|
............................................................................................................ |
|
|
(2) Here insert the Certificate No. |
IN THE MATTER OF (2) ...................................................... you are notified that the Authority intends to *suspend/revoke your certificate on the following grounds: |
|
|
(a) ................................................................................................ |
|
|
(b) ................................................................................................ |
|
|
(c) ................................................................................................ |
|
|
(d) ................................................................................................ |
|
(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your certificate should not be suspended/revoked and to take action to remedy the breaches set out in paragraphs ................................... (above) within (3) .................... days of receiving this notice. Failure to remedy the specified breaches shall result in the *suspension/revocation of your certificate. |
|
Dated this ............... day of ................................... 20...... |
|
|
................................... |
|
|
|
Form IX
[Regulations 11(5) and 12(5)]
|
|
|||
|
The Medicines and Allied Substances Act, 2013 |
|||
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|||
|
NOTICE OF SUSPENSION/REVOCATION OF DISPENSING CERTIFICATE |
|||
|
(1) Here insert the full names and address of holder of certificate |
To (1) ................................................................................................................. |
||
|
.......................................................................................................................... |
|||
|
|
|||
|
(2) Here insert the Registration No. |
(2) ..................................................................................................................... |
||
|
(3) Here insert the Certificate No. |
IN THE MATTER OF (3) ..................................................... you are notified that your certificate has been |
(4) Here insert the period |
........................................................................................................................... |
|
........................................................................................................................... |
|||
|
........................................................................................................................... |
|||
|
........................................................................................................................... |
|||
|
|
|
||
|
Dated this ........... day of ...................... 20...... |
|||
|
..................................... |
|||
|
{mprestriction ids="2,3,5"} |
|
Form X
[Regulation 15(1)]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
REGISTER OF DISPENSING CERTIFICATES |
|
No. |
Name of Certificate Holder |
Name and Address of Business |
Registration Number |
Date of Issue |
Expiry Date |
|
1. |
|||||
|
2. |
|||||
|
3. |
|||||
|
4. |
|||||
|
5. |
|||||
|
6. |
|||||
|
7. |
MEDICINES AND ALLIED SUBSTANCES (HEALTH SHOPS) REGULATIONS
[Section 30]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
HEALTH SHOP PERMIT
5. Rejection of application for permit
7. Application for renewal of permit
10. Application for duplicate permit
16. Dispensing of medicines in health shop
PART III
GENERAL PROVISIONS
18. Register of health shop permits
SI 12 of 2016.
PART I
PRELIMINARY
These Regulations may be cited as the Medicines and Allied Substances (Health Shops) Regulations, 2016.
In these Regulations, unless the context otherwise requires-
"authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act;
"health shop dispenser" means a person responsible for managing the health shop and has undergone training approved by the Authority;
"patient pack" means a quantity of medicines sufficient to treat a single patient for a specified condition;
"permit" means a health shop permit issued under section 30 of the Act;
"re-packing of medicines" means the act of removing a preparation from its original primary container and placing it into a patient pack, but does not include the act of cutting of a blister pack;
"responsible person" means a pharmacist or pharmacy technologist; and
"supervising pharmacist" means a pharmacist providing supervisory services to a health shop.
PART II
HEALTH SHOP PERMIT
(1) A person shall apply to the Authority for a permit in Form I set out in the First Schedule.
(2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(3) A separate application shall be made and a separate permit issued in respect of each premises.
(4) The Authority may inspect the premises in respect of which an application for a permit is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority.
The Authority may request an applicant to submit information in relation to an application in Form II set out in the First Schedule.
5. Rejection of application for permit
(1) The Authority shall reject an application for a permit if-
(a) the applicant fails to comply with any condition precedent to the issue of the permit;
(b) the permit issued to the applicant was revoked by the Authority within a period of two years preceding the date of the application; or
(c) the applicant is convicted of an offence under the Act or any other relevant written law.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the First Schedule.
(1) The Authority shall, where the applicant meets the requirements of the guidelines issued by the Authority and the Act, issue a permit in Form IV set out in the First Schedule.
(2) A permit shall be valid for two years from the date of issue.
(3) A health shop shall be managed by a health shop dispenser under the supervision of a responsible person.
7. Application for renewal of permit
(1) An application for the renewal of a permit shall be made to the Authority in Form V set out in the First Schedule.
(2) The Authority shall, within 14 days of the receipt of an application for the renewal of a permit, grant the application for the renewal of the permit if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the permit.
(3) The Authority shall, where it renews a permit, issue a new permit to the applicant.
(4) A permit that is not renewed by the Authority lapses on its date of expiry.
(1) A permit shall be used solely by the holder and is not transferable to any other person without the prior approval of the Authority.
(2) An application for approval to transfer a permit shall be made to the Authority in Form VI set out in the First Schedule.
(3) The Authority shall, within 30 days of receipt of an application for the transfer of a permit, approve the transfer if the applicant meets the requirements of the Act, and issue the transferee with a permit.
(4) The Authority shall reject an application for the transfer of a permit if the applicant fails to comply with the conditions for the grant of the permit, the provisions of the Act and the guidelines issued by the Authority.
(5) The Authority shall, where it rejects an application to transfer a permit under sub-regulation (4)-
(a) inform the applicant in Form III set out in the First Schedule; and
(b) suspend or revoke the permit.
(1) The Authority may amend a permit where-
(a) some other person succeeds to the interest in the business belonging to the holder of the permit; or
(b) the name of the business changes.
(2) An application for the amendment of a permit shall be made in Form VII set out in the First Schedule.
(3) The Authority shall communicate its decision to the permit holder within 14 days of receipt of the application for the permit.
(4) The Authority shall, where it approves the amendment of a permit, issue the applicant with a new permit.
10. Application for duplicate permit
A person shall, where that person's permit is lost, damaged or defaced, apply to the Authority for a duplicate permit in Form VIII set out in the First Schedule.
(1) The Authority shall suspend a permit if-
(a) the holder operates the health shop under insanitary conditions;
(b) the holder obtains or sells medicine from unauthorised suppliers or stocks and sells unauthorised products;
(c) the health shop in respect of which it was issued contravenes the prescribed standards;
(d) the health shop is not managed or controlled by a responsible person determined by the Authority;
(e) the responsible person fails to maintain the required records on medicines;
(f) the health shop stocks and sells medicines that are not on the prescribed list; or
(g) the holder contravenes the terms and conditions of the permit, the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a permit, give notice to the holder of the intention to suspend the permit and request the holder to show cause, within a specified period, why the permit should not be suspended.
(3) A notice of intention to suspend a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall suspend a permit if the holder of the permit fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of the suspension of a permit shall be in Form X set out in the First Schedule.
(6) The product affected by the suspension of the permit shall be quarantined at the cost of the permit holder during the period of the suspension of the permit.
(1) The Authority shall revoke a permit if the holder-
(a) contravenes the provisions of the Act or any other relevant written law or breaches the terms or conditions of the permit;
(b) fails to take corrective measures following the suspension of the permit within the specified period;
(c) changes the health shop premises without authorisation; or
(d) obtained the permit by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a permit, give notice to the holder of the permit of the intention to revoke the permit and request the holder to show cause, within a specified period, why the permit should not be revoked.
(3) A notice of the intention to revoke a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall revoke a permit if the holder fails to take remedial measures during the period specified by the Authority.
(5) A notice of the revocation of a permit shall be in Form X set out in the First Schedule.
(6) The Authority shall, where it determines that the holder stocks medicines in the health shop under insanitary conditions, direct the holder to dispose of the medicine.
(7) A holder of a permit shall, where the permit is revoked, quarantine the products on the premises and dispose of the products as directed by the Authority at the holder's cost.
(1) The Authority shall, in considering an application for a permit, prioritise the submissions filed by applicants in the following areas-
(a) rural areas and districts where access by the members of the public to medicines is limited; and
(b) peripheral areas of big towns or cities, where access to medicines is limited.
(2) The Authority shall, when considering the grant of a permit, take into account the availability of dispensing facilities in the area with respect to which the permit relates.
(1) A holder of a permit shall only sell the medicines prescribed in the Second Schedule.
(2) A health shop shall not stock for sale prescription only medicines and pharmacy sale medicines which are not specified in the prescribed list for health shops.
A health shop shall affix a standard logo for purposes of identifying the health shop as specified in the guidelines issued by the Authority.
16. Dispensing of medicines in health shop
Dispensing of medicines in a health shop shall be in accordance with the guidelines for dispensing of medicines in a health shop issued by the Authority.
The storage of medicines in a health shop shall be in the patient pack size and under conditions stipulated by the manufacturer.
PART III
GENERAL PROVISIONS
18. Register of health shop permits
(1) The Authority shall keep and maintain a register of health shop permits in Form XI set out in the First Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of an inspection fee as prescribed in the Medicines and Allied Substances (Fees) Regulations, 2015.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12]
Form I
[Regulation 3(1)]
(To be completed in triplicate)
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form II
[Regulation 4]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
REQUEST FOR INFORMATION |
|
To:.................................................................................................................................. |
|
Address: ............................................................................................................................. |
|
Application No.: .................................................................................................................... |
|
You are requested to furnish the following information or documents in respect of your application |
|
for ..................................................................................................................................... |
|
(a) ...................................................................................................................................... |
|
(b) ...................................................................................................................................... |
|
(c) ...................................................................................................................................... |
|
(d) ...................................................................................................................................... |
|
within .................................... days of this notice. |
|
If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. |
|
Dated this .............. day of .......................... 20.... |
|
.................................... |
|
|
Form III
[Regulations 5(2) and 8(5)]
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
NOTICE OF REJECTION OF APPLICATION |
|
(1) Here insert the full names and address of the applicant |
To (1) .................................................................................................. |
|
............................................................................................................ |
|
|
(2) Here insert the reference no. of the application |
IN THE MATTER OF (2) ............................................................ you are notified that your application for a health shop permit has been rejected by the Authority on the following grounds: |
|
(a) ....................................................................................................... |
|
|
(b) ....................................................................................................... |
|
|
(c) ....................................................................................................... |
|
|
(d) ....................................................................................................... |
|
|
Dated this .............. day of ......................., 20..... |
|
|
.............................................. |
|
|
|
Form IV
[Regulation 6(1)]
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
HEALTH SHOP PERMIT |
|
Registration No.: ........................................................................ HS/...... |
|
Permit No.: HS/................................................................................ |
|
This is to certify that (Name of Health Shop) .............................................................................. |
|
.............................................................................................................................................. |
|
of (Physical Address) ............................................................................................................. |
|
.............................................................................................................................................. |
|
........................................................................................ is registered to operate a health shop |
|
Name of responsible person: ................................................................................................... |
|
The conditions of the health shop permit are overleaf. |
|
Valid until ..................................................................... 20...... |
|
|
|
.................................... |
|
|
|
Conditions for Health Shop Permit |
|
1. Any change in the ownership, name and location of the health shop shall be approved by the Authority. |
|
2. The health shop shall only sell medicines that are on the prescribed list. |
|
3. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. |
|
4. The health shop permit is not transferable without the written approval of the Authority. |
|
5. The health shop permit shall, upon grant, be displayed conspicuously at the front shop in a place visible to the public. |
Form V
[Regulation 7]
(To be completed in triplicate)
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form VI
[Regulation 8(2)]
(To be completed in triplicate)
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form VII
[Regulation 9]
(To be completed in triplicate)
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form VIII
[Regulation 10]
(To be completed in triplicate)
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form IX
[Regulations 11(3) and 12(3)]
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
NOTICE OF INTENTION TO SUSPEND/REVOKE HEALTH SHOP PERMIT |
|
(1) Here insert the full names and address of holder of permit |
To (1) .................................................................................................. |
|
............................................................................................................ |
|
|
............................................................................................................ |
|
|
(2) Here insert the Permit No. |
IN THE MATTER OF (2) .......................................... you are notified that the Authority intends to *suspend/revoke your permit on the following grounds: |
|
(a) ....................................................................................................... |
|
|
(b) ....................................................................................................... |
|
|
(c) ....................................................................................................... |
|
|
(d) ....................................................................................................... |
|
|
(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your permit should not be *suspended/revoked and to take action to remedy the breaches set out in paragraphs ......................... (above) within (3) .........................days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/revocation of your permit. |
|
Dated this .............. day of ..........................., 20..... |
|
|
(4) Signature of Director- General |
(4) .......................................... |
|
|
Form X
[Regulations 11(5) and 12(5)]
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
NOTICE OF SUSPENSION OR REVOCATION OF HEALTH SHOP PERMIT |
|
(1) Here insert the full names and address of holder of permit |
To (1) .................................................................................................. |
|
|
............................................................................................................ |
||
|
............................................................................................................ |
||
|
(2) Here insert the permit no. |
IN THE MATTER OF (2) .................................... you are notified that the Authority intends to |
(a) ....................................................................................................... |
|
(b) ....................................................................................................... |
||
|
(c) ....................................................................................................... |
||
|
(d) ....................................................................................................... |
||
|
Dated this ............. day of ......................., 20..... |
||
|
|
(4) ......................................... |
|
|
|
Form XI
[Regulation 19]
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
REGISTER OF HEALTH SHOP PERMITS |
|||||
|
No. |
Name and address of business |
Permit number |
Registration number |
Date of issue |
Expiry date |
|
1. |
|||||
|
2. |
|||||
|
3. |
|||||
|
4. |
|||||
|
5. |
|||||
|
6. |
|||||
|
7. |
[Regulation 14]
PRESCRIBED LIST OF MEDICINES FOR HEALTH SHOPS
|
PART A |
|||
|
Item |
Strength |
Pack size |
|
|
Medicines for Asthma |
|||
|
1 |
Salbutamol tablets |
2 mg |
Patient pack |
|
2 |
Salbutamol Inhaler |
100 mcg/dose |
Patient pack |
|
Antibiotics |
|||
|
3 |
Amoxycillin tablets/capsules |
250 mg |
Patient pack |
|
4 |
Amoxycillin oral suspension |
125 mg/5 ml |
Patient pack |
|
5 |
Co-trimoxazole tablets |
400/80 mg |
Patient pack |
|
6 |
Co-trimoxazole suspension |
200/40 mg/5 ml |
Patient pack |
|
7 |
Doxycycline capsules/tablets |
100 mg |
Patient pack |
|
8 |
Metronidazole tablets |
200 mg |
Patient pack |
|
9 |
Tetracycline hyclate ointment |
1% |
Patient pack |
|
10 |
Silver sulfadiazine cream |
10 g |
Patient pack |
|
Antihelmentics |
|||
|
11 |
Albendazole tablets |
400 mg |
Patient pack |
|
Anti-inflammatory/Analgesics |
|||
|
12 |
Ibuprofen tablets |
200 mg |
Patient pack |
|
13 |
Hydrocortisone ointment/cream |
1% |
Patient pack |
|
14 |
Paracetamol tablets |
100 mg, 500 mg |
Patient pack |
|
15 |
Acetylsalicylic acid (Aspirin) tablets |
300 mg |
Patient pack |
|
Anti-fungal Agents |
|||
|
16 |
Nystatin oral suspension |
50 mg/5 ml, 100,000 UI/ml |
Patient pack |
|
17 |
Clotrimazole cream |
1%, 10% |
Patient pack |
|
18 |
Clotrimazole vaginal tablets |
100 mg, 500 mg |
Patient pack |
|
Anti-malarials |
|||
|
19 |
Artemether-lumefantrine tablets |
20/120 mg |
Patient pack |
|
Laxatives |
|||
|
20 |
Bisacodyl tablets |
5 mg |
Patient pack |
|
Anti-histamines |
|||
|
21 |
Cetirizine hydrochloride tablets |
10 mg |
Patient pack |
|
22 |
Cetirizine hydrochloride oral solution |
5 mg/5 ml |
Patient pack |
|
23 |
Chlorpheniramine maleate tablets |
4 mg |
Patient pack |
|
24 |
Chlorpheniramine maleate syrup |
2 mg/5 ml |
Patient pack |
|
Oral Contraceptives |
|||
|
25 |
Ethinylestardiol + Northisterone tablets |
0.03 mg/0.3 mg |
Patient pack |
|
26 |
Ethinylestardiol + Levonogestrel tablets |
0.03 mg/0.15 mg |
Patient pack |
|
Minerals/Vitamins |
|||
|
27 |
Vitamin B complex tablets |
Patient pack |
|
|
28 |
Zinc sulfate tablets |
20 mg |
Patient pack |
|
Fluids and Electrolytes |
|||
|
29 |
Normal saline IV |
0.90% 1 litre |
|
|
30 |
Ringers lactate IV |
1 litre |
PART B
All general sale medicines.
Note: Patient pack means a quantity of medicines sufficient to treat a single patient for a specified condition.
MEDICINES AND ALLIED SUBSTANCES (FEES) REGULATIONS
[Sections 19, 39 and 69]
Arrangement of Regulations
Regulation
SI 38 of 2016.
These Regulations may be cited as the Medicines and Allied Substances (Fees) Regulations, 2016.
The fees set out in the Schedule are prescribed for the matters specified therein.
[Regulation 2]
PRESCRIBED FEES
|
PART I |
|||
|
No. |
Item |
Fee Units |
|
|
City or Municipal Councils |
Other District Councils |
||
|
1. |
Hospital, Pharmacy and Retail |
|
|
|
|
(a) Application for certificate of registration |
15,833 |
7,917 |
|
|
(b) Re-inspection of premises in relation to an application for a certificate of registration |
12,000 |
6,000 |
|
|
(c) Annual returns or no change returns |
8,000 |
5,567 |
|
|
(d) Application for change of premises for retail pharmacy |
15,833 |
7,917 |
|
|
(e) Application for change of location for hospital pharmacy- |
|
|
|
|
(i) within the hospital premises |
2,900 |
1,450 |
|
|
(ii) new premises |
15,833 |
7,917 |
|
2. |
Dispensing Certificate |
|
|
|
(a) Application for dispensing certificate |
4,000 |
2,000 |
|
|
(b) Re-inspection of a facility in relation to an application for a dispensing certificate |
2,500 |
1,167 |
|
|
(c) Renewal of dispensing certificate |
2,500 |
1,167 |
|
|
(d) Application for change of premises for dispensing certificate |
4,000 |
2,000 |
|
|
3. |
Agro-Veterinary Shop |
|
|
|
(a) Application for agro-veterinary shop permit- |
|
|
|
|
(i) Class 1 |
15,833 |
7,917 |
|
|
(ii) Class 2 |
6,833 |
3,500 |
|
|
(iii) Class 3 |
4,000 |
2,000 |
|
|
(b) Re-inspection of premises in relation to an application for an agro-veterinary shop permit- |
|
|
|
|
(i) Class 1 |
12,000 |
6,000 |
|
|
(ii) Class 2 |
4,000 |
2,000 |
|
|
(iii) Class 3 |
2,500 |
1,167 |
|
|
(c) Renewal of agro-veterinary shop permit- |
|
|
|
|
(i) Class 1 |
12,000 |
6,000 |
|
|
(ii) Class 2 |
4,000 |
2,000 |
|
|
(iii) Class 3 |
4,000 |
2,000 |
|
|
(d) Application for change of premises for agro-veterinary shop- |
|
|
|
|
(i) Class 1 |
15,833 |
7,917 |
|
|
(ii) Class 2 |
6,833 |
3,500 |
|
|
(iii) Class 3 |
4,000 |
2,000 |
|
|
4. |
Health Shop |
|
|
|
|
(a) Application for health shop permit |
6,833 |
3,500 |
|
|
(b) Re-inspection of premises in relation to an application for a health shop |
4,000 |
2,000 |
|
|
(c) Renewal of health shop permit |
4,000 |
2,000 |
|
|
(d) Application for change of premises for health shop |
6,833 |
3,500 |
|
5. |
Pharmaceutical Licence (wholesale) |
|
|
|
(a) Application for pharmaceutical licence |
15,367 |
7,700 |
|
|
(b) Re-inspection of premises in relation to an application for a pharmaceutical licence |
11,533 |
5,867 |
|
|
(c) Renewal for pharmaceutical licence |
11,533 |
5,867 |
|
|
(d) Application for change of premises |
15,367 |
7,700 |
|
PART II |
||
|
No. |
Item |
Fee Units |
|
1. |
Pharmaceutical Licence |
|
|
|
(a) Complete manufacture- |
|
|
|
(i) Application for pharmaceutical license |
64,533 |
|
|
(ii) Re-inspection of premises in relation to an application for a pharmaceutical licence |
47,867 |
|
|
(iii) Re-locating to new premises |
64,533 |
|
|
(iv) Inspection of additional production line |
25,400 |
|
|
(v) Inspection of additional production block |
47,867 |
|
|
(vi) Renewal of pharmaceutical licence |
47,867 |
|
|
(b) Primary repackage of medicine- |
|
|
|
(i) Application for pharmaceutical licence |
35,400 |
|
|
(ii) Re-inspection of premises in relation to an application for a pharmaceutical license |
24,400 |
|
|
(iii) Re-locating to new premises |
35,400 |
|
|
(iv) Inspection of additional/modification of production line |
12,200 |
|
|
(v) Inspection of additional/modification of production block |
25,400 |
|
|
(vi) Renewal of pharmaceutical license |
25,400 |
|
|
(c) Secondary repackage of medicine- |
17,700 |
|
|
(i) Application for pharmaceutical licence |
|
|
|
(ii) Re-inspection of premises in relation to an application for a pharmaceutical licence |
12,200 |
|
|
(iii) Inspection of additional/modification of production line |
7,000 |
|
|
(iv) Inspection of additional/modification of production block |
12,200 |
|
|
(v) Renewal of pharmaceutical license |
12,200 |
|
|
(d) Local manufacture of natural remedies- |
|
|
|
(i) Application for pharmaceutical licence |
35,400 |
|
|
(ii) Re-inspection of premises in relation to an application for a |
24,400 |
|
|
(iii) Inspection of additional or modification of production line pharmaceutical license |
25,400 |
|
|
(iv) Inspection of additional or modification of production block |
25,400 |
|
|
(v) Renewal of pharmaceutical license |
25,400 |
|
|
(vi) Re-location to new premises |
25,400 |
|
2. |
Import and Export Permits |
|
|
|
(a) Importation of medicines for personal use |
333 |
|
|
(b) Importation of medicines in small quantities |
2,500 |
|
|
(c) Fees for importation of raw materials (APIs and Excipients) |
333 |
|
|
(d) Fees for import or export permit |
333 |
|
3. |
Marketing authorisation for locally manufactured or packaged medicines or allied substances |
|
|
|
(a) Locally manufactured medicines- |
|
|
|
(i) human |
16,667 |
|
|
(ii) veterinary |
16,667 |
|
|
(b) Locally packaged medicines- |
|
|
|
(i) human |
36,667 |
|
|
(ii) veterinary |
25,867 |
|
|
(c) Allied substances |
5,000 |
|
|
(d) Evaluation of additional information where supplied with application for marketing authorisation - inadequate technical information (quality safety or efficacy) |
5,667 |
|
|
(e) Annual retention fees- |
|
|
|
(i) human medicines |
8,333 |
|
|
(ii) veterinary medicines |
8,333 |
|
|
(iii) allied substances |
3,333 |
|
|
(f) Renewal of marketing authorisation- |
|
|
|
(i) human medicines |
11,667 |
|
|
(ii) veterinary medicines |
10,000 |
|
|
(iii) allied substances |
4,000 |
|
|
(g) Amendment of marketing authorisation- |
|
|
|
(i) minor amendment |
1,333 |
|
|
(ii) major amendment |
6,500 |
|
4. |
Advertising and Promotion of Medicines and Allied Substances |
|
|
|
(a) Advertising medicines to the general public |
16,667 |
|
|
(b) Promotional medicines to the health care professional fees |
3,333 |
|
|
(c) Exhibition of medicines at a public event fees |
6,667 |
|
5. |
Clinical Trials involving a Locally Manufactured Investigational Product |
|
|
|
(a) Clinical trial certificate involving investigational products without marketing authorisation- |
|
|
|
(i) human |
48,333 |
|
|
(ii) veterinary |
34,333 |
|
(b) Clinical trial certificate involving investigational products with marketing authorisation |
||
|
(i) human |
46,667 |
|
|
(ii) veterinary |
32,667 |
|
|
(c) Amendment of clinical trial certificate for a locally manufactured investigational product- |
||
|
(i) minor amendment |
1,333 |
|
|
(ii) major amendment |
6,500 |
|
|
6. |
Good Clinical Practice Inspection for Local Sites |
|
|
GCP inspection fee per site local sites |
50,000 |
|
|
7. |
Other Fees |
|
|
(a) Pre-clearance fees for quality assurance of imports for commercial consignments, Government ministries, departments, programmes, projects and similar institutions |
1.5% of FOB invoice value |
|
|
(b) Pre-clearance fees for quality assurance of imports for unregistered medicines and allied substance for commercial consignments, Government ministries departments, programs projects and similar institutions |
5% of FOB invoice value |
|
|
(c) Pre-clearance fees for quality assurance of imports for donations |
1% of FOB invoice value |
|
|
(d) Pre-clearance fees for quality assurance of imports for active pharmaceutical ingredients (API), bulk finished products and intermediates |
1% of FOB invoice value |
|
|
(e) Amendment to licences, certificates and permits |
167 |
|
|
(f) Duplicate licences, certificates and permits |
167 |
|
|
(g) Transfer of licences, certificates and permits |
167 |
|
|
(h) Issue of certificate of a pharmaceutical product(CPP) |
333 |
|
|
(i) Application for import of Narcotic drugs and psychotropic substances |
333 |
|
|
(j) Inspection of premises for issue of a GMP certificate (local manufacture) |
20,000 |
|
|
(k) Inspection and supervision for disposal of expired products |
3,333 |
|
|
(l) Fast track fees |
Double the applicable application fee |
|
|
(m) Restoration of marketing authorisation medicines |
|
|
|
(i) medicines |
20,000 |
|
|
(ii) allied substances |
4,000 |
|
|
(n) Inspection of register |
167 |
|
|
(o) Late submission of application for renewal of marketing authorisation in respect of locally manufactured medicines or allied substances |
33 for each day application is late |
|
PART III |
||
|
No. |
Item |
Amount |
|
1. |
Application for Marketing Authorisation of Human Medicines Imported as Finished Products |
|
|
|
(a) Generics |
2,000.00 |
|
|
(b) New chemical entities |
2,800.00 |
|
|
(c) Biologicals |
2,800.00 |
|
|
(d) Abridged Applications |
1,700.00 |
|
2. |
Application for Marketing Authorisation of Veterinary Medicines Imported as Finished Products |
|
|
|
(a) Generics |
1,750.00 |
|
|
(b) New chemical entities |
2,100.00 |
|
|
(c) Biologicals |
2,100.00 |
|
|
(d) Abridged applications |
1,550.00 |
|
3. |
Application for Marketing Authorisation Allied Substances Imported as Finished Products |
|
|
|
(a) Allied substances |
500 |
|
4. |
Evaluation of Additional Information for an Application of Medicines and Allied Substances Imported as Finished Products |
|
|
|
(a) Inadequate technical information (quality safety or efficacy) |
400.00 |
|
5. |
Annual Retention Fees for Medicines or Allied Substances Imported as Finished Products |
|
|
|
(a) Human medicines generics |
800.00 |
|
|
(b) Human medicines NCEs |
800.00 |
|
|
(c) Biologicals |
800.00 |
|
|
(d) Veterinary medicines |
700.00 |
|
|
(e) Allied substances |
200.00 |
|
6. |
Renewal of Marketing Authorisation for Medicines or Allied Substances Imported as Finished Products |
|
|
|
(a) Human medicines generics |
1,200.00 |
|
|
(b) Human medicines NCEs |
1,200.00 |
|
|
(c) Biologicals |
1,200.00 |
|
|
(d) Veterinary medicines |
1,000.00 |
|
|
(e) Allied substances |
350.00 |
|
|
(f) Late submission of application for renewal of marketing authorisation in respect of imported medicines or allied substance |
5.00 for each day application is late |
|
7. |
Amendment of Marketing Authorisation for Medicines and Allied Substances imported as finished products |
|
|
|
(a) Minor amendment |
100.00 |
|
|
(b) Major amendment |
500.00 |
|
8. |
Good Manufacturing Practices Inspection for Foreign-Based Manufacturers in Support of Applications for Marketing Authorisation per Manufacturing Site up to Five Production Lines Where all the Manufacturing Process is Carried on One Site |
|
|
|
(a) Full site: Southern Africa |
3,500.00 |
|
|
(b) Full site: Rest of Africa |
5,000.00 |
|
|
(c) Full site: Far East or Asia |
6,500.00 |
|
|
(d) Full site: Europe, America and Australia |
7,500.00 |
|
|
(e) Additional production line |
1,500.00 |
|
|
(f) Fees for GMP documents evaluation (Desk Audits) per manufacturing site |
3,500.00 |
|
9. |
Good Manufacturing Practices Inspection for Foreign-Based Manufacturers in Support of Applications for Marketing Authorisation per Manufacturing Where the Manufacturing Process Carried Out in More Than One Site in the Country Where the Main Site is Located |
|
|
|
(a) Each additional site such as warehousing for raw materials, final packaging, quality control and final release |
1,500.00 |
|
10. |
Clinical Trials involving Imported Investigational Products |
|
|
|
(a) Human clinical trial certificate involving investigational products without marketing authorisation |
3,000.00 |
|
|
(b) Human clinical trial certificate involving investigational products with marketing authorisation |
2,000.00 |
|
|
(c) Veterinary clinical trial certificate involving investigational products without marketing authorisation |
2,100.00 |
|
|
(d) Veterinary clinical trial certificate involving investigational products with marketing authorisation |
2,000.00 |
|
|
(e) Amendment of clinical trial certificate involving an imported investigational product |
|
|
|
(i) minor amendment |
100 |
|
|
(ii) major amendment |
50 |
|
11. |
Good Clinical Practice Inspection Foreign-based Bioequivalence Sites |
|
|
|
(a) Full site - per site per inspection: Southern Africa |
3,500.00 |
|
|
(b) Full site - per site per inspection: Rest of Africa |
5,000.00 |
|
|
(c) Full site - per site per inspection: Far East or Asia |
6,500.00 |
|
|
(d) Full site - per site per inspection: Europe, America and Australia |
7,500.00 |
MEDICINES AND ALLIED SUBSTANCES (IMPORTATION AND EXPORTATION) REGULATIONS
[Sections 35 and 36]
Arrangement of Regulations
Regulation
4. Application for permit to import medicine or allied substance for personal use
5. Request for additional information
6. Rejection of application for permit
13. Exemption of certain travellers from requirement to obtain permit
14. Disposal of medicines or allied substances stocked under insanitary conditions
SI 57 of 2017.
These Regulations may be cited as the Medicines and Allied Substances (Importation and Exportation) Regulations, 2017.
In these Regulations unless the context otherwise requires-
"competent authority" , in relation to a traveller entering Zambia with a medicine or allied substance for that traveller's use, means the medicines and allied substances regulatory authority in the country where the medicine or allied substance was prescribed for use by the traveller;
"dental surgeon" means a health practitioner registered as such under the Health Professions Act, 2009, or duly registered in a foreign country;
"insanitary conditions" means conditions or circumstances that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health;
"medical doctor" means a health practitioner registered as such under the Health Professions Act, 2009, or duly registered in a foreign country;
"permit" means an importation permit issued under section 35 or an exportation permit issued under section 36 of the Act;
"personal use" includes use by a person's relative or animal; and
"veterinary surgeon" has the meaning assigned to the term in the Veterinary and Veterinary Para-Professions Act, 2010, and includes a veterinary surgeon duly registered in a foreign country.
(1) A person that intends to import or export any medicine or allied substance shall apply to the Authority for a permit in Form I set out in the Schedule upon payment of the prescribed fee.
(2) An applicant for a permit to import any medicine or allied substance shall, before being issued with a permit under this regulation, pay the applicable pre-clearance fee prescribed for quality assurance in respect of the medicine or allied substance.
(3) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(4) The Authority may inspect the premises where medicines or allied substances in respect of which an application for a permit is made are kept in order to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority from time to time.
(5) The Authority shall, in considering an application under this regulation, take into account-
(a) the availability on the market in the Republic of the medicines and allied substances and reasons for the intended importation or exportation;
(b) the marketing authorisation status in respect of the medicines or allied substances, where applicable;
(c) the quantities of the medicines or allied substances intended to be imported or exported; and
(d) provisions of any other relevant law.
(6) A person applying for a permit is not required to be a holder of a pharmaceutical licence.
4. Application for permit to import medicine or allied substance for personal use
(1) A person who intends to import any medicine or allied substance for personal use shall apply to the Authority for a permit to import the medicine or allied substance in Form II set out in the Schedule upon payment of the prescribed fee.
(2) The Authority shall within seven days from the date of receipt of an application under this regulation, notify the applicant of the decision of the Authority in respect of the application.
5. Request for additional information
The Authority may request an applicant to submit additional information in relation to an application for a permit in Form III set out in the Schedule.
6. Rejection of application for permit
(1) The Authority shall reject an application for a permit if the applicant-
(a) fails to comply with any condition precedent to the issue of the permit; or
(b) does not meet the requirements of the Act and guidelines issued by the Authority from time to time.
(2) The Authority may reject an application for a permit if the applicant has been convicted of an offence under the Act or any other relevant law and has been sentenced to imprisonment for a period exceeding six months during the last three years.
(3) The Authority shall, where it rejects an application under sub-regulation (1) or (2), inform the applicant of the reasons for the rejection of the application in Form IV set out in the Schedule.
(1) The Authority shall, where the applicant under regulation 3 meets the requirements of the Act, issue a permit in Form V set out in the Schedule.
(2) The Authority shall, where the applicant under regulation 4 meets the requirements of the Act, issue a permit in Form VI set out in the Schedule.
(3) A permit is valid for one year from the date of issue and only in respect of the consignment of medicines or allied substances specified in the permit.
(4) A permit holder that is not able to import or export the medicines or allied substances in respect of which the permit was issued during the period that the permit remains valid may apply for another permit in accordance with regulation 5.
(5) A permit is not renewable.
Except as otherwise provided in these Regulations, a permit holder shall not transfer the permit to another person.
(1) A permit holder that intends to amend that permit holder's permit shall apply to the Authority for amendment of the permit in Form VII set out in the Schedule upon payment of the prescribed fee.
(2) The Authority may amend a permit where-
(a) the name of a business changes;
(b) the port of entry or exit for the medicines or allied substances in respect of which the permit was issued changes; or
(c) there is a change of address of the permit holder.
(3) The Authority shall, within 14 days of the receipt of an application for amendment of a permit, inform the permit holder of its decision.
(4) A permit holder shall, where the Authority grants the application for amendment of the permit, surrender the permit to the Authority and the Authority shall issue an amended permit for the remainder of the permit's validity period in Form V set out in the Schedule.
A permit holder may, where a permit is lost, damaged or defaced, apply to the Authority for a duplicate permit in Form VIII set out in the Schedule upon payment of the prescribed fee.
(1) The Authority shall suspend a permit if the permit holder-
(a) fails to obtain any clearance or permission under any other relevant written law, where required;
(b) contravenes the terms and conditions of the permit or the provisions of the Act or any other relevant written law; or
(c) obtained the permit by fraud or deliberate or negligent submission of false information.
(2) The Authority shall, before suspending a permit, give notice to the permit holder of the intention to suspend the permit and request the permit holder to show cause, within a specified period, why the permit should not be suspended.
(3) A notice of intention to suspend a permit shall be in Form IX set out in the Schedule.
(4) The Authority shall suspend a permit if the permit holder fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of suspension of a permit shall be in Form X set out in the Schedule.
(6) A permit holder shall, where the permit is suspended, immediately surrender the permit to the Authority.
(7) A permit holder shall, during the period that the permit remains suspended, quarantine at the permit holder's cost medicines or allied substances affected by that suspension.
(1) The Authority shall revoke a permit if-
(a) the permit holder contravenes the provisions of the Act or breaches the terms and conditions of the permit;
(b) the permit holder fails to take corrective measures following the suspension of the permit;
(c) it comes to the attention of the Authority that the medicines or allied substances in respect of which the permit was issued are not suitable or have become known to be dangerous or contain substances dangerous to human health, animal health or the environment;
(d) the permit holder fails to comply with any other relevant written law; or
(e) the permit holder obtained the permit by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a permit, give notice to the permit holder of the intention to revoke the permit and request the permit holder to show cause, within a specified period, why the permit should not be revoked.
(3) A notice of intention to revoke a permit shall be in Form IX set out in the Schedule.
(4) The Authority shall revoke a permit if the permit holder fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of revocation of a permit shall be in Form X set out in the Schedule.
(6) A permit holder shall, where a permit is revoked, immediately surrender the permit to the Authority.
(7) Where a permit is revoked, the medicines or allied substances affected by the revocation of the permit shall be quarantined and disposed of as directed by the Authority at the permit holder"™ cost.
13. Exemption of certain travellers from requirement to obtain permit
(1) Subject to sub-regulation (2), these Regulations do not apply to the importation by a traveller entering Zambia of a medicine or allied substance for that traveller's use.
(2) A traveller entering Zambia with a medicine or allied substance for that traveller"™ use shall furnish an inspector at the port of entry with written confirmation from the competent authority that the medicine or allied substance was prescribed for use by the traveller.
14. Disposal of medicines or allied substances stocked under insanitary conditions
The Authority shall, where it establishes that the permit holder stocks medicines or allied substances under insanitary conditions, direct the permit holder to dispose of the medicines or allied substances at the permit holder's cost.
(1) The Authority shall keep and maintain a register of permits in Form XI set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times as the Authority may specify and upon payment of the prescribed fee.
[Regulations 3, 4, 5, 6, 7, 9, 10, 11, 12 and 15]
PRESCRIBED FORMS
Form I
[Regulation 3(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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APPLICATION FOR IMPORTATION/EXPORTATION PERMIT FOR MEDICINE OR ALLIED SUBSTANCE |
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Please complete in block letters |
Shaded fields for official use only |
Application No. |
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Date/Time |
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Information Required |
Information Provided |
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PART I - PARTICULARS OF THE APPLICANT |
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1. Name of business: |
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2. Physical address: |
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3. Postal address: |
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4. Business premises: |
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(a) Telephone number: |
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(b) Fax number: |
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(c) Mobile: |
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(d) E-mail: |
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PART II - PARTICULARS OF IMPORTATION/EXPORTATION |
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5. Port of entry/exit |
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(a) by rail to/from: ................................. station |
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(b) by road via: ................................. (state port of entry/exit) |
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(c) by parcel post to/from: ..................................... (state post office) |
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(d) by parcel post to/from: ....................... (state airport) |
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6. Reason for importation/exportation (please tick what is applicable below) |
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Commercial |
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Donation |
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Other |
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............................................................................................... |
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............................................................................................... |
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7. Attachments (supporting documents) |
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(a) Copy of pharmaceutical licence (where applicant is holder thereof) |
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(b) Copy of practitioners licence (if applicable) |
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(c) Permits under other relevant laws (if applicable) |
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(d) Inventory of medicines or allied substance to be imported/exported (particulars and quantities) |
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8. Conditions for an application for import or export permit |
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Applications must always be made by the actual importer or exporter or their authorised agent: |
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(a) A proforma invoice must accompany each application |
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(b) A separate application is required in respect of each consignment of medicines to be imported or exported |
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(c) The prescribed fees shall be paid for an import permit and must be forwarded with application |
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PART III - DECLARATION AND SIGNATURE |
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I declare that the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I acknowledge that making a false or misleading statement in connection with a medicine or allied substance is an offence punishable by fine or imprisonment. |
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(i) Name: ................................................... |
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(b) Designation: .................................... |
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(c) Signature: ................. Date: .../..../..... (dd/mm/yyyy) |
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FOR OFFICIAL USE ONLY |
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Date of Submission: ..................................... |
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Application No.: ....................................... |
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Payment Receipt No.: ................................. |
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Application in Order (Proceed for inspection): ........................ |
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Application Deficient (Notify applicant on deficiencies): .................... |
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Form II
[Regulation 4(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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APPLICATION FOR PERMIT TO IMPORT MEDICINE OR ALLIED SUBSTANCE FOR PERSONAL USE |
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Please complete in block letters |
Shaded fields for official use only |
Application No. |
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Date and Time |
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Information Required |
Information Provided |
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PART I: PARTICULARS OF THE APPLICANT |
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1. |
Name: |
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2. |
Contact details: |
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(a) Physical address |
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(b) Postal address |
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(c) Telephone No. |
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(d) Mobile phone No. |
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(e) E-mail address |
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PART II: PARTICULARS OF MEDICINE(S) OR ALLIED SUBSTANCE(S) |
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3. |
Name(s) |
Quantity |
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(a) |
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(b) |
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(c) |
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4. |
Attachment(s): |
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Prescription issued by a medical doctor, dental surgeon (where the prescription is for medicine or allied substance connected to dental practice) or veterinary surgeon (where the prescription is for medicine or allied substance connected to veterinary practice) as the case may be |
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PART III: DECLARATION AND SIGNATURE |
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I declare that the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I acknowledge that making a false or misleading statement in connection with a medicine or allied substance is an offence punishable by fine or imprisonment. |
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(a) Name: ................................... |
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(b) Signature: ........... Date: ....../....../...... (dd/mm/yyyy) |
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FOR OFFICIAL USE ONLY |
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Date of Submission: ........................................ |
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Application No.: ........................................... |
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Payment Receipt No.: ....................................... |
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Application Complete (Proceed to issue) ............................... |
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Application Deficient (Notify applicant on deficiencies): ........................ |
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Form III
[Regulation 5]
|
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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REQUEST FOR ADDITIONAL INFORMATION |
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To: .................................................................................................................................................. |
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Physical address: ............................................................................................................................. |
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Application No.: ................................................................................................................................ |
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Street: ............................................................................................................................................. |
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Postal address: ................................................................................................................................ |
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District: ............................................................................................................................................ |
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Province: .......................................................................................................................................... |
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You are requested to furnish, the following information or documents in respect of your application for ................................................................................ within ....................... days of this request. |
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(a) .......................................................................................................................................... |
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(b) .......................................................................................................................................... |
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(c) .......................................................................................................................................... |
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(d) .......................................................................................................................................... |
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(e) .......................................................................................................................................... |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and be rejected. |
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Dated this ............ day of ......................, 20........ |
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........................................................... |
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Form IV
[Regulation 6(3)]
|
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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NOTICE OF REJECTION OF APPLICATION |
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1. Here insert the full names and address of the applicant |
To (1) .............................................................................................................. |
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........................................................................................................................ |
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........................................................................................................................ |
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2. Here insert the reference No. of the application |
IN THE MATTER OF (2) ................................ you are hereby notified that your application for (3) ................... ............ has been rejected by the Authority on the following grounds: |
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3. Here insert type of application |
(a) ................................. |
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(b) ................................. |
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(c) ................................. |
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(d) ................................. |
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Dated this ..... day of ......... 20...... |
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4. Signature of Director-General |
(4) ............. |
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Form V
[Regulation 7(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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Permit No. ................ |
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The Medicines and Allied Substances |
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This is to certify that (Name of permit holder) ..................................................................... of (Physical |
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Address) .......................................................................................................................................... |
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......................................................................................................................................................... |
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......................................................................................................................................................... |
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is authorised to: |
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1. .................................................................... .......................................... |
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2. .................................................................... .......................................... |
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3. .................................................................... .......................................... |
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4. .................................................................... .......................................... |
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[ ] Port of |
This permit is valid until ............................... 20.......... |
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Terms and conditions imposed by the Zambia Medicines Regulatory Authority (refer to notes overleaf) |
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............................................ (Seal) ................................ |
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TERMS AND CONDITIONS OF IMPORTATION/EXPORTATION PERMIT |
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1. This permit is not transferable or renewable. |
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2. The holder of the permit shall produce the permit together with other approved or endorsed documents to an inspector and customs officer at the time of importation or exportation. |
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3. The holder of the permit shall keep records relating to the importation or exportation of medicines or allied substances and avail the records to an inspector for inspection. |
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4. Non-compliance with any of the terms and conditions of the permit shall result in suspension or revocation of permit. |
Form VI
[Regulation 7(2)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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Permit No. ................. |
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The Medicines and Allied Substances |
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IMPORTATION (PERSONAL USE) PERMIT |
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This is to certify that (Name of permit holder) .................................................................................... of |
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(Physical address) ........................................................................................................................... |
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......................................................................................................................................................... |
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......................................................................................................................................................... |
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is authorised to: |
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[ ] import the following |
1. .................................................................... .......................................... |
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2. .................................................................... .......................................... |
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3. .................................................................... .......................................... |
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4. .................................................................... .......................................... |
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[ ] Port of entry .............................................................................................................................. |
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This permit is valid until .................................... 20...... |
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............................................ (Seal) ...................................... |
Form VII
[Regulation 9(1)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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APPLICATION FOR AMENDMENT OF PERMIT |
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Please complete in block letters |
Shaded fields for official use only |
Application No. |
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Date and Time |
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Information Required |
Information Provided |
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PART I: PARTICULARS OF THE APPLICANT |
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1. |
Licence No.: |
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2. |
Name(s) of applicant: |
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3. |
Business address (Head Office): |
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4. |
(a) Telephone No.: |
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(b) Fax No.: |
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(c) Operations: |
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(d) E-mail address: |
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5. |
PART II: PARTICULARS OF AMENDMENT |
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No. Current Information |
Description of Amendment(s) |
Reasons for Amendment |
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1. |
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2. |
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3. |
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4. |
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5. |
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6. |
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6. |
Attachment(s) |
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Attach supporting document(s) where applicable: |
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1. |
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2. |
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3. |
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PART III: DECLARATION AND SIGNATURE |
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I declare that the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I acknowledge that making a false or misleading statement in connection with a medicine or allied substance is an offence punishable by fine or imprisonment. |
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(a) Name: ................................... |
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(b) Designation: ................................. |
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(c) Signature: ......... Date: ....../....../...... (dd/mm/yyyy) |
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FOR OFFICIAL USE ONLY |
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Date of Submission: ........................................ |
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Application No.: ............................................ |
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Payment Receipt No.: ........................................ |
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Application Complete (Proceed to issue) .............................. |
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Application Deficient (Notify applicant on deficiencies): ......................... |
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Form VIII
[Regulation 10]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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APPLICATION FOR DUPLICATE PERMIT |
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Please complete in block letters |
Shaded fields for official use only |
Application No. |
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Date and Time |
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Information Required |
Information Provided |
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PART I: PARTICULARS OF THE APPLICANT |
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1. |
Permit No.: |
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2. |
Name(s) of applicant: |
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3. |
Business address (Head Office): |
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4. |
Permit holder/Responsible person: |
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Operations: |
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PART II: SUPPORTING DOCUMENTATION |
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5. |
Submit an affidavit of loss or damage, of permit and police report |
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PART III: DECLARATION AND SIGNATURE |
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I declare that the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I acknowledge that making a false or misleading statement in connection with a medicine or allied substance is an offence punishable by fine or imprisonment. |
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(a) Name: ................................... |
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(b) Designation: ................................... |
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(c) Signature: ......... Date: ....../....../....... (dd/mm/yyyy) |
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FOR OFFICIAL USE ONLY |
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Date of Submission: ........................................ |
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Application No.: ............................................ |
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Payment Receipt No.: ......................................... |
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Application Complete (Proceed to issue) ............................... |
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Application Deficient (Notify applicant on deficiencies): ....................... |
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Form IX
[Regulation 10]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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(1) Here insert the full names and address of the permit holder |
To (1) ........................................................................................................... |
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(2) Here insert the Permit No. |
IN THE MATTER OF (2) .......................................... you are hereby notified that the Board intends to |
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(b) ................................ |
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(3) Here insert the number of days stipulated |
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Dated this ............. day of ........................., 20........... |
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(4) Signature of Director- General |
(4) ............................................... |
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Form X
[Regulations 11(5) and 12(5)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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(1) Here insert the full names and address of permit holder |
To: (1) .............................................................................................................. |
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......................................................................................................................... |
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(2) Here insert the Permit No. |
IN THE MATTER OF (2) ..................................... you are hereby notified that your permit has been suspended for a period (3) .............. |
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(b) ................................ |
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(c) ................................ |
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(d) ................................ |
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(3) Here insert the number of days stipulated |
You are required to surrender the permit to the Authority immediately. |
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Dated this .......... day of ..........................., 20....... |
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(4) Signature of Director- General |
(4) ............................................... |
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Form XI
[Regulation 15(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
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REGISTER OF IMPORTATION AND EXPORTATION PERMITS |
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No. |
Name of Permit Holder |
Permit Number |
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Expiry Date |
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MEDICINES AND ALLIED SUBSTANCES (CERTIFICATE OF REGISTRATION) REGULATIONS
[Section 69]
Arrangement of Regulations
Regulation
2. Application for certificate of registration
3. Request for additional information
4. Issue of certificate of registration
7. Transfer of certificate of registration
8. Amendment of certificate of registration
9. Suspension or cancellation of certificate of registration
10. Application for re-registration
11. Duplicate certificate of registration
12. Register of certificates of registration
SI 58 of 2017.
These Regulations may be cited as the Medicines and Allied Substances (Certificate of Registration) Regulations, 2017.
2. Application for certificate of registration
A person who intends to operate a pharmacy shall apply to the Authority for a certificate of registration in Form I set out in the Schedule upon payment of the prescribed fee.
3. Request for additional information
The Authority may request an applicant to submit additional information, in relation to an application, in Form II set out in the Schedule.
4. Issue of certificate of registration
The Authority shall, where the applicant meets the requirements of the Act, issue a certificate of registration in Form III set out in the Schedule.
The Authority shall, where it rejects an application, inform the applicant of the rejection in Form IV set out in the Schedule.
(1) The holder of a certificate of registration shall file with the Authority an annual return or where there has been no change in the information provided in an annual return, a no change return in Form V set out in the Schedule upon payment of the prescribed fee.
(2) The annual return shall cover the period 1st January to 31st December of the preceding financial year and the holder of a certificate of registration shall submit the return or no change return by 31st March of the following financial year.
7. Transfer of certificate of registration
An application for the transfer of a certificate of registration shall be made in Form VI set out in the Schedule upon payment of the prescribed fee.
8. Amendment of certificate of registration
A holder of a certificate of registration shall, where a change is made to the registered particulars, notify the Authority within 14 days of the change in Form VII set out in the Schedule.
9. Suspension or cancellation of certificate of registration
(1) The Authority shall, before it suspends or cancels a certificate of registration, notify the holder of the certificate of registration of the intention to suspend or cancel the certificate in Form VIII set out in the Schedule.
(2) Where the holder of a certificate of registration who is notified of the intention to suspend or cancel the certificate of registration under sub-regulation (1) fails to show cause or does not take any remedial measures to the satisfaction of the Authority within the specified time, the Authority shall suspend or cancel the certificate of registration and inform the applicant in Form IX set out in the Schedule.
10. Application for re-registration
A person whose certificate of registration is cancelled may apply for re-registration one year from the date of the cancellation of the certificate in Form I set out in the Schedule upon payment of the prescribed fee.
11. Duplicate certificate of registration
(1) A holder of a certificate of registration may apply for a duplicate certificate in Form X set out in the Schedule upon payment of the prescribed fee.
(2) The Authority may, within 14 days of receipt of an application under sub-regulation (1), issue the applicant with a duplicate certificate in Form XI set out in the Schedule.
12. Register of certificates of registration
(1) The Authority shall keep and maintain a register of certificates of registration in Form XII set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times as the Authority may determine and upon payment of the prescribed fee.
[Regulations 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12]
PRESCRIBED FORMS
Form I
[Regulations 2 and 10]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
Form II
[Regulation 3]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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REQUEST FOR ADDITIONAL INFORMATION |
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Application No.: .................. |
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To: ................................................................................................................................................. |
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Physical address: |
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Plot No.: ......................................................................................................................................... |
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Street: ............................................................................................................................................ |
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Postal address: ............................................................................................................................... |
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District: .......................................................................................................................................... |
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Province: ......................................................................................................................................... |
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You are requested to furnish, within ............................. days of this Notice, the following information or documents in respect of your application for ........................................ |
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(a) ........................................................................................................................................ |
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(b) ........................................................................................................................................ |
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(c) ........................................................................................................................................ |
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(d) ........................................................................................................................................ |
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(e) ........................................................................................................................................ |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and be rejected. |
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Dated this ............. day of ........................, 20........ |
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Form III
[Regulation 4]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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CERTIFICATE OF REGISTRATION |
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Application No.: ................... |
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This is to certify that (Name of Pharmacy): ........................................................................................ |
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of (physical address) ....................................................................................................................... |
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...................................................................................................................................................... |
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is registered as a Pharmacy. |
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The terms and conditions of the certificate of registration are attached herewith. |
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This Certificate is issued on the .............. day of ........................., 20........... |
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............................................... |
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(OVERLEAF) |
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TERMS AND CONDITIONS |
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1. The certificate of registration shall be displayed conspicuously on the premises. |
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2. The holder of the certificate of registration shall, within 14 days of the changes occurring, notify the Authority of any changes in the ownership, physical address, structure of the place of business, name and location of the pharmacy, change of personnel responsible for the management or control of the pharmacy. |
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3. The holder of the certificate of registration shall submit annual returns or no change returns by 31st March of the following financial year. |
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4. The certificate of registration is not transferable without the written approval of the Authority. |
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5. Where the certificate of registration is surrendered, the certificate of registration shall be considered cancelled. |
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6. Where the certificate of registration is cancelled, the holder of the certificate shall surrender it to the Authority. |
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7. Non-compliance with the terms and conditions of the certificate of registration shall result in the suspension or cancellation of the certificate. |
Form IV
[Regulation 5]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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NOTICE OF REJECTION OF APPLICATION |
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1. Here insert the full names and address of the applicant |
To (1) ........................................................................................................... |
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................................................................................................................... |
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2. Here insert the reference No. of the application |
IN THE MATTER OF (2) ..................................... you are hereby notified that your application for (3) ....... has been rejected on the following grounds: |
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3. Here insert type of application |
(a) .............................................................................................................. |
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(b) .............................................................................................................. |
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(c) .............................................................................................................. |
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(d) .............................................................................................................. |
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Dated this ............ day at ......................, 20......... |
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Form V
[Regulation 6(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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ANNUAL RETURN ( ) NO CHANGE RETURN ( ) |
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PART I: PARTICULARS OF CERTIFICATE HOLDER |
Form VI
[Regulation 7]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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PART IV - ENCLOSURES |
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Evidence of transfer between certificate holder and the prospective certificate holder |
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FOR OFFICIAL USE ONLY |
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Date of Submission: ..................................................................................................................... |
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Application No.: ........................................................................................................................... |
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Payment Receipt No.: .................................................................................................................. |
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Application Complete (Proceed for evaluation): ............................................................................... |
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Application Deficient (Refer to applicant for additional information): .................................................... |
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Form VII
[Regulation 8]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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NOTIFICATION OF AMENDMENT OF CERTIFICATE OF REGISTRATION |
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PART I: PARTICULARS OF CERTIFICATE HOLDER |
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Name of business: ......................................... |
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Certificate of Registration No.: ............... Date of issue ................ |
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Name of Pharmacist/Responsible person ................................ |
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PART I: PARTICULARS OF AMENDMENT |
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No. |
Description of amendment(s) |
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SUMMARY OF THE AMENDMENT |
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EXISTING |
PROPOSED AMENDMENT |
DATE OF AMENDMENT |
REASONS FOR AMENDMENT |
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PART III: SUPPORTING DOCUMENTATION |
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Please submit documents, where applicable, to support your application for amendment. |
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PART IV: DECLARATION AND SIGNATURE |
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I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. |
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Particulars of the Person Signing on Behalf of the Applicant |
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(a) Name: ........................................................................................................................... |
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(b) Designation: ................................................................................................................... |
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(c) Signature: ..................................... (d) Date: ............./........../................. (dd/mm/yyyy) |
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FOR OFFICIAL USE ONLY |
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Date of Submission: ..................................................................................................................... |
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Application No.: ........................................................................................................................... |
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Payment Receipt No.: .................................................................................................................. |
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Application Complete (Proceed for evaluation): ............................................................................... |
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Application Deficient (Refer to applicant for additional information): .................................................... |
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Form VIII
[Regulation 9(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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NOTICE OF INTENTION TO SUSPEND OR CANCEL CERTIFICATE OF REGISTRATION |
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Certificate of Registration No.: .................. |
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To: ...................................................................................................................... |
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IN THE MATTER OF .................................................. you are hereby notified that the Authority intends to |
(a) .................................................................................................................................... |
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(b) .................................................................................................................................... |
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(c) .................................................................................................................................... |
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(d) .................................................................................................................................... |
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Accordingly, you are requested to show cause why your certificate of registration should not be function a30(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} |
Dated this .......... day of ........................., 20....... |
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Form IX
[Regulation 9(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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NOTICE OF |
Certificate of Registration No.: ................ |
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To: ...................................................................................................................... |
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........................................................................................................................... |
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IN THE MATTER OF ........................... you are hereby notified that your certificate of registration has been |
(a) .................................................................................................................................... |
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(b) .................................................................................................................................... |
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(c) .................................................................................................................................... |
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(d) .................................................................................................................................... |
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In case of cancellation, you are required to surrender the certificate of registration to the Authority within seven days from the date of cancellation. |
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Dated this ........... day of ........................., 20......... |
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Form X
[Regulation 11(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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APPLICATION FOR DUPLICATE CERTIFICATE OF REGISTRATION |
Form XI
[Regulation 11(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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DUPLICATE CERTIFICATE OF REGISTRATION |
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No.: ................ |
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This is to certify that (Name of Pharmacy) ...................................................................................... |
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................................................................................................................................................... |
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of (physical address) ................................................................................................................... |
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................................................................................................................................................... |
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is registered as a Pharmacy. |
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The conditions of the certificate of registration are attached herewith. |
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This certificate is issued on .......... day of ...................., 20........ |
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Form XII
[Regulation 12(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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REGISTER OF CERTIFICATES OF REGISTRATION |
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No. |
Name and Address of Pharmacy |
Certificate Number |
Date of Issue |
Date of Suspension/Cancellation |
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7. |
MEDICINES AND ALLIED SUBSTANCES (PHARMACEUTICAL LICENCE) REGULATIONS
[Section 34]
Arrangement of Regulations
Regulation
4. Request for additional information
5. Rejection of application for licence
13. Handling of expired, withdrawn, obsolete or unwanted medicines
17. Distribution and wholesale by manufacturer
18. Personnel in wholesale premises
SI 91 of 2018.
These Regulations may be cited as the Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018.
In these Regulations unless the context otherwise requires-
"authorised product" means a product for which marketing authorisation has been granted in accordance with section 39 of the Act;
"good manufacturing practice" means quality assurance that ensures that a pharmaceutical product is produced and controlled to the quality standards appropriate for its intended use and as required by the marketing authorisation;
"insanitary condition" means a condition or circumstance that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health;
"licence" means a pharmaceutical licence issued under section 34 of the Act;
"licensee" means a holder of a licence;
"pharmacist" means a person registered as a pharmacist in accordance with the Health Professions Act, 2009;
"pharmacy technologist" means a person registered as a pharmacy technologist in accordance with the Health Professions Act, 2009;
"phase I clinical trial" means the first trial of a new active ingredient or new formulation in humans or target animal species, often carried out in healthy participants or volunteers to establish a preliminary evaluation of safety, and a first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in humans or target animal species;
"phase II clinical trial" means a pilot clinical trial undertaken in selected populations of patients with the disease or condition intended to be prevented, diagnosed or treated in order to evaluate the safety and efficacy of the medicine or allied substance being tried;
"primary repackaging" means the part of manufacturing that involves packing of the finished dosage form or device into its primary packaging material;
"repacking of medicine" means the act of removing a preparation from its original primary container and placing it into a patient pack, but does not include the act of cutting a blister pack;
"responsible person" means a pharmacist, veterinary surgeon, veterinary para professional or pharmacy technologist;
"secondary repackaging" means the part of manufacturing that involves repacking of medicines into secondary or tertiary packaging material which does not come in direct contact with the finished dosage form or device;
"suitably qualified person" means a pharmacist or veterinary surgeon providing supervisory services to a wholesale outlet;
"veterinary biological" means a virus, vaccine, serum or analogous products used for the purpose of diagnosis or treatment of animal diseases;
"veterinary para professional" means a person registered as a livestock officer or veterinary assistant in accordance with the Veterinary and Veterinary Para Professions Act, 2010;
"veterinary surgeon" means a person registered as a veterinary surgeon in accordance with the Veterinary and Veterinary Para Professions Act, 2010; and
"wholesale" means the buying of medicines or allied substances in bulk for the purpose of reselling to authorised pharmaceutical wholesale dealers, retail pharmacy outlets, hospital pharmacies, agro veterinary shops, health shops or other health facilities for human beings or animals.
(1) A person who intends to manufacture, distribute or deal in any medicine or allied substance shall apply to the Authority for a licence in Form I set out in the Schedule, on payment of the prescribed fee.
(2) A person who intends to manufacture, distribute or deal in any medicine or allied substance at more than one premises shall apply for a licence in respect of each of the premises.
(3) The Authority shall inspect the premises in respect of which an application for a licence is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority from time to time.
4. Request for additional information
The Authority may request an applicant to submit additional information in relation to an application for a licence in Form II set out in the Schedule.
5. Rejection of application for licence
(1) The Authority shall reject an application for a licence if the-
(a) applicant fails to comply with a condition precedent to the issue of the licence;
(b) applicant fails to meet the requirements of the Act;
(c) licence previously issued to the applicant was revoked by the Authority within the period of five years preceding the date of application; or
(d) applicant is convicted of an offence under the Act or any other relevant written law within a period of two years preceding the date of the application.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant of the reason for that rejection in Form III set out in the Schedule.
(1) The Authority shall, where the applicant meets the requirements of the Act, issue a licence in Form IV set out in the Schedule.
(2) A licence is valid for two years from the date of issue.
(3) A responsible person shall manage the premises in respect of which a licence has been issued.
(1) A licensee who intends to renew that licensee's licence shall, at least 90 days before the expiry of the licence, apply to the Authority for renewal of the licence in Form V set out in the Schedule, on payment of the prescribed fee.
(2) The Authority may renew a licence in respect of an application if the applicant meets the requirements of the Act and complies with the terms and conditions of the earlier licence.
(3) The Authority shall, where it renews a licence, issue a new licence.
(4) A licence that is not renewed by the Authority shall lapse on its date of expiry.
(1) A licence shall be used solely by the licensee and is not transferable to any other person without the prior approval of the Authority.
(2) A licensee who intends to transfer the licensee's licence shall apply to the Authority for approval to transfer the licence in Form VI set out in the Schedule, on payment of the prescribed fee.
(3) The Authority shall, where it approves the transfer of a licence, issue the transferee with a licence for the remainder of the validity period of the licence issued to the transferor.
(4) The Authority shall reject an application for the transfer of a licence if the applicant fails to comply with the conditions for the grant of the licence and the provisions of the Act and the guidelines issued by the Authority.
(5) The Authority shall, where it rejects an application to transfer a licence in accordance with sub-regulation (4), inform the applicant of the reasons for the rejection in Form III set out in the Schedule.
(1) A licensee who intends to amend the licensee's licence shall apply to the Authority for amendment of the licence in Form VII set out in the Schedule, upon payment of the prescribed fee.
(2) The Authority may amend a licence where the name of the business or the suitably qualified person changes.
(3) The Authority shall, within 14 days of receipt of the application for amendment of the licence, approve or reject the amendment.
(4) Where the Authority fails to inform the licensee of its decision within 14 days, the amendment shall be considered to be approved.
A licensee may, where a licence is lost, damaged or defaced, apply to the Authority for a duplicate licence in Form VIII set out in the Schedule, upon payment of the prescribed fee.
(1) The Authority shall suspend a licence if the licensee-
(a) operates the business in respect of which it is issued under insanitary conditions;
(b) obtains or sells medicine from an unauthorised supplier or stock or sell an unauthorised product;
(c) fails to maintain the required records on medicines or allied substances; or
(d) contravenes the terms and conditions of the licence or the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a licence, give notice to the licensee of the intention to suspend the licence and request the licensee to show cause, within a specified period, why the licence should not be suspended.
(3) A notice of intention to suspend a licence shall be in Form IX set out in the Schedule.
(4) The Authority shall suspend a licence if the licensee fails to take remedial measures within the period specified in the notice issued in accordance with sub-regulation (2).
(5) A notice of suspension of a licence shall be in Form X set out in the Schedule.
(6) A product affected by the suspension of the licence shall be quarantined at the cost of the licensee during the period of the suspension of the licence.
(7) The Authority shall, where it is established that the licensee manufactures, distributes or deals in a medicine or allied substance under insanitary conditions, direct the licensee to dispose of that medicine or allied substance.
(1) The Authority shall revoke a licence if the licensee-
(a) contravenes the provisions of the Act or breaches the terms and conditions of the licence;
(b) fails to take corrective measures following the suspension of the licence;
(c) changes the business premises without authorisation;
(d) fails to comply with any other relevant written law; or
(e) obtained the licence by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a licence, give notice to the licensee of the intention to revoke the licence and request the licensee to show cause, within a specified period, why the licence should not be revoked.
(3) A notice of intention to revoke a licence shall be in Form IX set out in the Schedule.
(4) The Authority shall revoke a licence if the licensee fails to take remedial measures during the period specified by the Authority.
(5) A notice of revocation of a licence shall be in Form X set out in the Schedule.
(6) Where a licence is revoked, the products on the premises and the recalled products shall be quarantined as directed by the Authority at the former licensee's cost, including the disposal of the products.
(7) The Authority may, where the former licensee fails to comply with a directive issued by the Authority in accordance with sub-regulation (6), deal with the products in a manner the Authority may consider appropriate.
13. Handling of expired, withdrawn, obsolete or unwanted medicines
(1) A licensee shall store a withdrawn, obsolete, unwanted, expired medicines or allied substance in an appropriate container clearly labelled "for destruction within a specified period of time" as stipulated in the guidelines.
(2) A person who contravenes sub-regulation (1) commits an offence and is liable, upon conviction, to a fine not exceeding two thousand five hundred penalty units, and in the case of a continuing offence to a fine not exceeding twenty-five penalty units for each day that the offence continues.
(3) In addition to the penalty provided in sub-regulation (2), the court before which a person is convicted of an offence in accordance with this regulation may order-
(a) that any medicine or allied substance in respect of which the offence is committed be forfeited to the State; and
(b) that the costs for disposal of a medicine or allied substance be borne by the convict.
The Authority may conduct an inspection to ensure compliance with the minimum prescribed requirements for the manufacture, distribution or dealing of a medicine or allied substance.
These Regulations do not apply to a medicine or allied substance manufactured in accordance with guidelines issued by the Authority if the medicine is-
(a) for a pre clinical trial, phase I clinical trial or phase II clinical trial;
(b) compounded by a-
(i) pharmacist for supply within the pharmacy or hospital setting; or
(ii) veterinary surgeon for supply within an agro veterinary shop or health facility for animals;
(c) a human or veterinary biological medicine manufactured by a Government institution for purposes of disease prevention and control; or
(d) a blood product prepared by a veterinary surgeon for administration to animals under that veterinary surgeon's care.
(1) The Authority shall keep and maintain a register of licences in Form XI set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of the prescribed fee.
(3) A person may, upon payment of the prescribed fee, require a copy or extract of any particulars from the register to be certified by the Director General.
(4) Any document purported to be an extract or copy of any entry in the register and duly certified to be a true copy or extract under the hand of the Director General shall be received in evidence as to the matters stated therein in any legal proceedings.
17. Distribution and wholesale by manufacturer
(1) A licensee that is a manufacturer may distribute or undertake the wholesale of medicines or allied substances manufactured under that licence.
(2) Despite sub-regulation (1), a licensee that is a manufacturer dealing in medicines or allied substances manufactured by another manufacturer shall not undertake the wholesale of the medicines or allied substances manufactured by the other manufacturer.
(3) A manufacturer that intends to undertake the wholesale of a medicine or allied substance manufactured by another manufacturer shall apply to the Authority for a separate licence.
18. Personnel in wholesale premises
(1) A licensee that is a wholesale dealer in medicines or allied substances for the use in or on humans or animals shall employ a pharmacist on a full time basis for purposes of the wholesale of the medicines or allied substances and may, in addition to the pharmacist, employ a pharmacy technologist.
(2) A licensee that is a wholesale dealer in medicines or allied substances for use in or on animals shall employ a veterinary surgeon on a full time basis for the purposes of the wholesale of the medicines or allied substances and may, in addition to the veterinary surgeon, employ a veterinary para professional.
(3) A licensee that is a wholesale dealer and employs a pharmacist or veterinary surgeon on a part time basis for purposes of the wholesale of medicines or allied substances shall, in addition to the veterinary surgeon or pharmacist, employ a pharmacy technologist or veterinary para professional on a full time basis, as the case may be.
A person who contravenes a provision of these Regulations for which a penalty is not provided commits an offence and is liable, upon conviction, to a fine not exceeding two thousand five hundred penalty units, and in the case of a continuing offence to a fine not exceeding twenty-five penalty units for each day that the offence continues.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 16]
PRESCRIBED FORMS
FORM I
[Regulation 3(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM II
[Regulation 4]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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REQUEST FOR ADDITIONAL INFORMATION |
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To: ......................................................... |
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Address: ....................................................... |
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Application No.: .................................................... |
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You are requested to furnish the following information or documents in respect of your application for ........... within ............... days of this notice. |
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(a) ..................................................... |
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(b) ..................................................... |
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(c) ..................................................... |
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(d) ..................................................... |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and be rejected. |
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Dated this ..... day of ........... 20.. |
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............. |
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FORM III
[Regulations 5(2) and 8(5)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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NOTICE OF REJECTION OF APPLICATION |
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(1) Here insert name and address of the applicant |
To (1) ................................................................................................ |
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......................................................................................................... |
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(2) Here insert the reference No. of the application |
IN THE MATTER OF (2) .................................................. you are notified that your application for (3) ........... has been rejected by the Authority on the following grounds: |
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(3) Here insert type of application |
(a) .................................................................................................... |
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(b) .................................................................................................... |
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(c) .................................................................................................... |
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(d) .................................................................................................... |
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Dated this ..... day of .......... 20.. |
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(4) Signature of Director- General |
(4) .............................................. |
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FORM IV
[Regulation 6(1)]
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PHARMACEUTICAL LICENCE TERMS AND CONDITIONS |
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Non-compliance with any of the conditions stated below will result in suspension or revocation of licence. |
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The licensee shall- |
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(a) comply with the minimum current good manufacturing practice (cGMP) or Good Distribution Practices (GDP) as may be applicable and cause to be obtained marketing authorisation in Zambia (where applicable) of all such products as are manufactured and conform to such other standards as may be specified by the Authority from time to time; |
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(b) comply with relevant regulations and guidelines specific to the licence; |
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(c) conspicuously display the licence at the premises where the activities conducted; |
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(d) maintain such staff, premises, equipment and facilities for manufacture, or distribution of the medicinal products as applicable at the time of grant of the licence; |
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(e) where the licensee is licensed to manufacture medicines or allied substances and wishes to manufacture additional dosage forms not included in the attached list, submit an application to the Authority for the inclusion of the additional dosage forms and this licence shall be deemed to extend to the dosage form so included; |
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(f) keep readily available for inspection by an inspector of the Authority, durable records of documentation as specified in the guidelines; |
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(g) notify the Authority of any changes that require an amendment to the licence; and |
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(h) where the licence is revoked surrender it to the Authority immediately. |
FORM V
[Regulation 7(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM VI
[Regulation 8(2)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM VII
[Regulation 9(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM VIII
[Regulation 10]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM IX
[Regulations 11(3) and 12(3)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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NOTICE OF INTENTION TO *SUSPEND/REVOKE PHARMACEUTICAL LICENCE |
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(1) Here insert the full names and address of the licensee |
To (1) ........................................................................................................ |
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................................................................................................................. |
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(2) Here insert the licence No. |
IN THE MATTER OF (2) ............................................. you are notified that the Authority intends to *suspend/revoke your licence on the following grounds: |
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(a) ........................................................................................................... |
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(b) .......................................... |
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(c) ............................................... |
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(d) ............................................ |
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Accordingly, you are requested to show cause why your licence should not be *suspended/revoked and to take action to remedy the breaches set out in paragraphs ........... (above) within (3) ..... days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/revocation of your licence. |
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(3) Here insert type of application |
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Dated this ............. day of ........................ 20........ |
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(4) Signature of Director- General |
(4) ............................................ |
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FORM X
[Regulations 11(5) and 12(5)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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NOTICE OF *SUSPENSION/REVOCATION OF PHARMACEUTICAL LICENCE |
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(1) Here insert the full names and address of the licensee |
To (1) ........................................................................................................ |
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................................................................................................................. |
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(2) Here insert the licence No. |
IN THE MATTER OF (2) .............................................................. you are notified that your licence has been *suspended for a period of (3) ........ /revoked on the following grounds: |
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(3) Here insert number of days stipulated |
(a) .......................................................................................................... |
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(b) ......................................... |
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(c) ......................................... |
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(d) .......................................... |
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Dated this .............. day of ...................... 20........ |
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(4) Signature of Director- General |
(4) ....................................... |
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FORM XI
[Regulation 16(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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REGISTER OF PHARMACEUTICAL LICENCES |
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No. |
Name of Licensee |
Licence Number |
Date of Issue |
Expiry Date |
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1. |
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2. |
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3. |
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4. |
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5. |
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6. |
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7. |
MEDICINES AND ALLIED SUBSTANCES (MARKETING AUTHORISATION OF MEDICINES) REGULATIONS
[Sections 39 and 69]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY PROVISIONS
PART II
MARKETING AUTHORISATION OF MEDICINES
3. Application for marketing authorisation
4. Request for additional information
5. Grant of marketing authorisation
7. Validity of marketing authorisation
9. Amendment of marketing authorisation
10. Surrender of marketing authorisation
11. Transfer of marketing authorisation
12. Suspension of marketing authorisation
13. Restoration of marketing authorisation
14. Revocation of marketing authorisation
15. Application for duplicate marketing authorisation
16. Renewal of marketing authorisation
PART III
CATEGORY OF DISTRIBUTION OF MEDICINE
18. Categories of distribution of medicines
19. Re-categorisation of Medicine
PART IV
LABELLING AND PACKAGING
20. Labelling and packaging requirements for medicine
21. Package insert for medicine
22. Patient information leaflet
23. Revocation of S.I. No. 47 of 1993
SI 79 of 2019.
PART I
PRELIMINARY PROVISIONS
These Regulations may be cited as the Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019.
In these Regulations, unless the context otherwise requires-
"active pharmaceutical ingredient" means a substance intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body, and may be used as is or in the manufacture of a pharmaceutical dosage form;
"batch" means a defined quantity of a starting material, packaging or medicinal product processed in a single process or series of processes and expected to be homogeneous;
"bio-availability" means the rate and extent of availability of an active pharmaceutical ingredient from a dosage form as determined by its concentration time curve in the systemic circulation or by its excretion in urine;
"bio-equivalence data" means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical alternatives becomes available at the site of drug action administered;
"commercial pack" means the presentation of a finished medicinal product as it will be placed on market;
"composition" means a tabulation of ingredients represented in form of proportion, degree of strength, quality and purity in which the ingredients are contained in a medicinal product;
"container" means a bottle, jar, box, packet, sachet or other receptacle, not being a capsule or other article, in which the product is or is to be administered or consumed, and where the receptacle is or is to be contained in another receptacle, includes the former receptacle but not the latter receptacle;
"description of the product" means a full visual description of the medicinal product, including colour, size, shape and other relevant features;
"dosage form" means the form in which a medicinal product is presented, such as solution, suspension, elixir, eye drop, emulsion, ointment, suppository, tablet or capsule;
"excipient" means a substance intended to be used as is or in the manufacture of a medicinal product for a specific function, but does not exert pharmacological activity;
"expiry date" means the date given by the manufacturer and placed on the container of a medicinal product up to which the product is expected to remain within the given specifications if stored according to manufacturer's instructions;
"finished pharmaceutical product" means a product that has undergone all the stages of production, including packaging in its final container and labelling;
"formulation" means the composition of a dosage form, including the characteristics of its raw materials and the operations required to process it;
"general sale medicine (GS)" means a medicine which is intended to be supplied or sold without a prescription with or without the supervision of a registered pharmacist in a pharmacy or in any other licensed premises;
"general sale medicines veterinary (GSV)" means veterinary medicine which is intended to be supplied by any retailer approved by the Authority;
"herbal medicine" includes a herb, herbal material, herbal preparation and finished herbal product that contains as an active ingredient, a part of a plant or other plant material or combination;
"holder of marketing authorisation" means a person to whom a medicinal product has been issued a market authorisation and is responsible for all aspects of the medicinal product including quality, safety, efficacy and compliance with conditions of marketing authorisation;
"international non proprietary name" means a unique name of a medicine that is globally recognised and is public property;
"labelling" means affixing to or displaying on a container or package, the product information, ingredients and content of the product;
"local responsible person" means a person residing in Zambia and appointed in accordance with regulation 17;
"marketing authorisation number" means an identification number issued to a medicinal product granted marketing authorisation;
"pharmacy medicine (P)" means a medicine which is intended to be supplied or sold without a prescription but under the supervision of a registered pharmacist;
"pharmacy medicines veterinary (PV)" means veterinary medicine which is intended to be supplied by a registered veterinary surgeon, pharmacist or veterinary para professional with or without a prescription;
"prescription only medicine (POM)" means a medicine which is intended to be supplied, sold or dispensed only under a prescription issued by an authorised prescriber;
"prescription only medicine veterinary (POM V)" means veterinary medicines which is intended to be supplied on prescription by a veterinary surgeon;
"proprietary name" means the trade or brand name that is unique to a particular medicine and by which it is generally identified;
"quality standard" means the specifications used to control the nature, strength, purity, composition, quantity or other characteristics of an ingredient or finished pharmaceutical product to ensure that it is fit for its purpose;
"shelf life" means the period of time during which an active pharmaceutical ingredient or medicinal product, if stored correctly, is expected to comply with the approved specification as determined by stability studies on a number of batches of the active pharmaceutical ingredient or medicinal product;
"stability" means the ability of a medicine to retain its properties within approved specifications throughout its shelf life;
"WHO type certificate of a pharmaceutical product" means a certificate of the type defined in the World Health Organisation certification scheme on the quality of pharmaceutical products in international commerce; and
"veterinary medicine" means a substance or mixture of substances manufactured, sold or presented for use in-
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in an animal;
(b) restoring, correcting or beneficial modification of organic or mental functions in an animal; and
(c) an article intended for use as a component of any article specified in paragraphs (a) or (b), but does not include a medical device or its component, part or accessory.
PART II
MARKETING AUTHORISATION OF MEDICINES
3. Application for marketing authorisation
(1) A person who intends to place a medicine on the market shall apply to the Authority for a marketing authorisation in Form I set out in the Schedule on payment of the fee set out in the Medicines and Allied Substances (Fees) Regulations, 2016.
(2) The application referred to in sub-regulation (1) shall be accompanied by-
(a) at least two samples of the product in the smallest proposed commercial pack size;
(b) a dossier which shall contain-
(i) a summary and overview of quality, non-clinical and clinical data;
(ii) chemical, pharmaceutical and biological data relevant to the application;
(iii) non-clinical data, where applicable; and
(iv) clinical or bio-equivalence data;
(c) in the case of a herbal medicine, documentation relating to the quality assessment, safety assessment and efficacy assessment of the herbal medicine; and
(d) any other information relating to the safety, quality and efficacy of the medicine in respect of which the application is made.
(3) The Authority shall, on receipt of an application for a marketing authorisation, conduct an assessment to evaluate the safety, quality and efficacy of the medicine in respect of which the application is made.
4. Request for additional information
The Authority may request an applicant to submit additional information or samples in relation to an application in Form II set out in the Schedule on payment of a prescribed fee.
5. Grant of marketing authorisation
The Authority shall grant a marketing authorisation in Form III set out in the Schedule, if the Authority is satisfied-
(a) with the information submitted on the safety, quality and efficacy of the medicine;
(b) with the labeling and packaging of the medicine;
(c) with the indications, dosage form, dosage and route of administration of the medicine; and
(d) that the medicine is manufactured in compliance with the requirements of current good manufacturing practices as recommended by the World Health Organisation or any other recognised entity.
(1) The Authority shall reject an application for marketing authorisation if-
(a) the applicant fails to meet the requirements for the issue of the marketing authorisation;
(b) there is insufficient data to support the safety, quality and efficacy of the product;
(c) in the case of a local manufacturer, the pharmaceutical licence to manufacture is suspended or revoked;
(d) an ingredient contained in the medicine is banned or not recommended for any other reason as determined by the Authority;
(e) the medicine in respect of which the application is made is considered unregistrable based on treatment guidelines or disease patterns in the Republic; and
(f) the applicant provides false information in the application.
(2) The Authority shall, where it refuses a marketing authorisation under sub-regulation (1), inform the applicant in Form IV set out in the Schedule.
7. Validity of marketing authorisation
A marketing authorisation is valid for five years, subject to the terms and conditions of the market authorisation.
(1) The holder of a marketing authorisation shall pay an annual retention fee to the Authority in respect of the following year at the end of every year during which the authorisation is valid, except the year when the authorisation is granted.
(2) The annual retention fee for the following year shall be-
(a) effective from 1st January of the year following the grant of the marketing authorisation; and
(b) paid to the Authority by 31st December of each year.
(3) Where a marketing authorisation is granted during the last quarter of a calendar year, the holder of the marketing authorisation shall be exempted from paying the annual retention fee for the following year.
(4) Where the holder of a marketing authorisation fails to pay the annual retention fee by 31st December for a particular product-
(a) the marketing authorisation issued in respect of that product shall be suspended;
(b) the Authority shall not authorise the importation of the product;
(c) in case of locally manufactured products, the Authority shall not authorise the continued manufacture of the product; and
(d) the marketing authorisation in respect of the product may be revoked by the Authority.
9. Amendment of marketing authorisation
(1) A person who wishes to amend a marketing authorisation shall apply to the Authority in Form V set out in the Schedule on payment of a prescribed fee.
(2) The Authority shall, within 90 days from the date of receipt of an application for the amendment of a marketing authorisation, consider the application and notify the holder of the marketing authorisation of its decision.
10. Surrender of marketing authorisation
Where the holder of a marketing authorisation decides not to continue with the business to which the marketing authorisation relates, the holder shall notify the Authority and surrender the marketing authorisation.
11. Transfer of marketing authorisation
(1) A marketing authorisation is solely for use by the holder of the marketing authorisation and is not transferable to any other person without the prior approval of the Authority.
(2) A person who wishes to transfer a marketing authorisation shall apply to the Authority in Form VI set out in the Schedule on payment of a prescribed fee.
(3) The Authority shall, within 60 days from the date of receipt of the application for the transfer of the marketing authorisation, notify the applicant of the decision of the Authority in respect of the application.
(4) Where the Authority approves the transfer of a marketing authorisation, it shall issue a new marketing authorisation to the transferee.
12. Suspension of marketing authorisation
(1) The Authority may suspend a marketing authorisation if-
(a) there are concerns regarding the safety, quality or efficacy of the medicine to which it relates;
(b) the holder of the marketing authorisation fails to pay the annual retention fee;
(c) the holder of the marketing authorisation fails to comply with any term or condition of the marketing authorisation; or
(d) the medicine in respect of which the marketing authorisation was issued poses a risk or threat to public health.
(2) The Authority shall, before suspending a marketing authorisation, give notice to the holder of a marketing authorisation of the intention to suspend the marketing authorisation in Form VII set out in the Schedule.
(3) The Authority shall, if the holder of a marketing authorisation fails to remedy the defects within the period specified by the Authority in the notice issued in sub-regulation (2), suspend the marketing authorisation and notify the holder of the marketing authorisation in Form VIII set out in the Schedule.
(4) The holder of a marketing authorisation shall, during the period of suspension of a marketing authorisation, quarantine the affected medicine as directed by the Authority at the holder of the marketing authorisation's cost.
13. Restoration of marketing authorisation
(1) The Authority may restore a suspended marketing authorisation if the Authority is satisfied that corrective measures have been taken by the holder of the marketing authorisation as directed by the Authority.
(2) The Authority shall issue the notice of restoration of a suspended marketing authorisation in Form IX set out in the Schedule.
14. Revocation of marketing authorisation
(1) The Authority may revoke a marketing authorisation if the holder-
(a) contravenes the terms and conditions of the marketing authorisation;
(b) manufactures medicine that does not comply with the quality standard for that medicine;
(c) fails to comply with current good manufacturing practices;
(d) fails to comply with the terms and conditions for the suspension under regulation 12; or
(e) obtained the authorisation on the basis of fraud, negligence or misrepresentation.
(2) The Authority shall, before revoking a marketing authorisation, give notice to the holder of the marketing authorisation of the intention to revoke the marketing authorisation in Form X set out in the Schedule.
(3) The Authority shall, where the holder of a marketing authorisation fails to remedy the breaches specified in the notice within the period specified by the Authority, revoke the marketing authorisation and notify the holder in Form XI set out in the Schedule.
(4) The holder of a marketing authorisation shall, on the revocation of the marketing authorisation, recall and quarantine or dispose of the medicine to which the revocation relates as directed by the Authority at the holder of the marketing authorisation's cost.
15. Application for duplicate marketing authorisation
(1) A holder of a marketing authorisation whose marketing authorisation is lost, defaced or damaged may apply for a duplicate marketing authorisation in Form XII set out in the Schedule on payment of a prescribed fee.
(2) The Authority shall, within 14 days of receipt of an application under sub-regulation (1), issue a duplicate marketing authorisation to the applicant.
16. Renewal of marketing authorisation
(1) A person who wishes to renew a marketing authorisation shall apply to the Authority at least 180 days before the expiry date of the marketing authorisation in Form XIII set out in the Schedule on payment of a prescribed fee.
(2) An application for the renewal of a marketing authorisation shall be accompanied by-
(a) a consolidated report of any amendments made to the marketing authorisation, including adverse drug reaction reports and safety updates; and
(b) the product quality review report.
(3) The Authority shall renew a marketing authorisation if the holder has complied with the terms and conditions of the marketing authorisation.
(4) The Authority shall, where the Authority refuses to renew a marketing authorisation, notify the applicant in Form IV set out in the Schedule.
(5) A holder of a marketing authorisation whose application for renewal has been rejected may submit an application for a marketing authorisation in accordance with regulation 3.
(1) Subject to the Companies Act, 2017 and any other relevant written law, a foreign based applicant shall appoint a local responsible person to-
(a) submit an application, document and sample of products to the Authority on behalf of the applicant or holder of the marketing authorisation; and
(b) receive the decision of the Authority relating to the application on behalf of the applicant or holder of the marketing authorisation.
(2) Subject to sub-regulation (1), where the application is granted, the holder of the marketing authorisation shall ensure that a local responsible person implements the pharmacovigilance plan on behalf of the foreign holder of the marketing authorisation.
PART III
CATEGORY OF DISTRIBUTION OF MEDICINE
18. Categories of distribution of medicines
(1) The Authority shall, where it grants a marketing authorisation, specify the appropriate category of distribution of the medicine which relates to the marketing authorisation.
(2) A person may sell or supply medicine for human use under the following categories-
(a) prescription only medicine;
(b) pharmacy medicine; and
(c) general sale medicine.
(3) A person may sell or supply veterinary medicine under the following categories-
(a) prescription only medicine-veterinary;
(b) pharmacy medicine veterinary; and
(c) general sale medicine veterinary.
19. Recategorisation of medicine
The Authority shall take into consideration the safety profile of the medicine when determining the category of distribution and may move certain medicines from one category to another.
PART IV
LABELLING AND PACKAGING
20. Labelling and packaging requirements for medicine
(1) A holder of a marketing authorisation shall label the primary package or container of a medicine to show-
(a) the name and dosage form of the medicine;
(b) the name and quantity of active pharmaceutical ingredient or in case of a herbal medicine, a botanical, english or other name, and the quantity of each ingredient;
(c) the quantity or volume of the medicine per unit pack;
(d) the indications and directions for use, including the target species in case of veterinary medicine;
(e) the storage instructions;
(f) the expiry date;
(g) the batch number;
(h) the marketing authorisation number;
(i) the name and address of the holder of the marketing authorisation;
(j) suitable coding;
(k) the name of the manufacturer, if different from the holder of the marketing authorisation;
(l) the category of distribution;
(m) a precautionary statement "Keep away from the reach of children";
(n) in case of a veterinary medicine, a statement "For Veterinary Use Only"; and
(o) any other information required by the Authority for purposes of the Act.
(2) Where the space on a primary container of medicine is not adequate to accommodate the information specified in sub-regulation (1), the holder of a marketing authorisation shall label the primary container to indicate the-
(a) name and dosage form of the medicine;
(b) quantity or volume of the medicine per unit pack;
(c) expiry date;
(d) name and quantity of active ingredient, or in case of a herbal medicine, a botanical, English or other name, and the quantity of each ingredient;
(e) marketing authorisation number;
(f) storage instructions; and
(g) batch number, except that all the particulars specified under sub-regulation (1) shall be set out on the secondary package.
(3) A holder of a marketing authorisation shall, where the container of medicine is unable to accommodate the information under sub-regulation (2), indicate the details of labelling requirements for each type of container as may be determined by the Authority.
(4) This regulation does not apply to medicine that is repackaged for dispensing.
(5) Despite the other provisions of this regulation, the Authority may waive the labeling requirements, as appropriate, to ensure the safety, quality and efficacy of the medicine.
21. Package insert for medicine
An original container of a medicine shall be accompanied by a package insert printed in legible letters in English stating the-
(a) name and dosage form of the medicine;
(b) name and quantity of active pharmaceutical ingredient, or in case of a herbal medicine, a botanical, English or other name, and the quantity of each ingredient;
(c) indications, in case of a veterinary medicine, specifying target species;
(d) dosage and directions for use, in case of a veterinary medicine, specific to each target species;
(e) contra-indications;
(f) side effects;
(g) drug interactions;
(h) precautions and warnings, including withdrawal periods, in case of a veterinary medicine used in food producing animals;
(i) symptoms, signs, treatment and management of overdose;
(j) presentation of the medicine;
(k) description of packaging and container closure system;
(l) storage instructions;
(m) shelf life;
(n) name and address of the holder of the marketing authorisation; and
(o) name of the manufacturer, if different from the holder of the marketing authorisation.
22. Patient information leaflet
A holder of a marketing authorisation shall provide a patient information leaflet for general sale medicine and medicine used in chronic conditions.
23. Revocation of S.I. No. 47 of 1993
The Pharmacy and Poisons (Medicines) (Importation, Manufacture and Sale) Order, 1993, is revoked.
[Regulations 3, 4, 5, 6, 9, 11, 12, 13, 14, 15, 16 and 18]
PRESCRIBED FORMS
FORM I
[Regulations 3(1) and 16(5)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
FORM II
[Regulation 4]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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REQUEST FOR ADDITIONAL INFORMATION |
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Application No: ..................... |
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To: ....................................................................................................................................... |
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Address: ............................................................................................................................... |
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You are requested to furnish, within ........................................... days of this Notice, the following information or documents in respect of your application for ......................................................... |
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(a) .............................................................................................................................. |
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(b) .............................................................................................................................. |
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(c) .............................................................................................................................. |
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(d) .............................................................................................................................. |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. |
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Dated this .... day of ........., 20.. |
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............... |
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FORM III
[Regulation 5]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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MARKETING AUTHORISATION |
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Marketing Authorisation No. MA ../.. |
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Name of Medicine: ............................................ |
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Dosage form: ............................................... |
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Pack size |
Shelf life (Months) |
Category of distribution |
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Name of active ingredient |
Quality standards |
Strength |
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................ |
................ |
................ |
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................ |
................ |
................ |
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................ |
................ |
................ |
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Name and address of holder of marketing authorisation: |
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............................................................................... |
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............................................................................... |
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............................................................................... |
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............................................................................... |
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Valid until ........................................ |
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The terms and conditions of the marketing authorisation are attached herewith. |
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.............. |
............. |
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TERMS AND CONDITIONS OF THE MARKETING AUTHORISATION |
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The holder of a marketing authorisation shall- |
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(a) ensure that the medicine- |
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(i) is manufactured in compliance with the current Good Manufacturing Practices (cGMP) as recommended by the World Health Organisation (WHO) or any other recognised entity; |
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(ii) conforms with the quality standards, safety and efficacy and is suitable for the purpose for which it is intended; |
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(iii) conforms to the summary of product characteristics; |
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(b) ensure compliance with good distribution practices and that the medicine is supplied in accordance with the requirements applicable to the categories of distribution specified on this marketing authorisation and with regulations on labeling of medicine; |
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(c) maintain an appropriate pharmacovigilance system for monitoring, detecting and reporting adverse drug reactions and the performance of products granted marketing authorisation; |
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(d) pay to the Authority the annual retention fees, sample analysis fees and other fees as prescribed; |
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(e) ensure that the marketing authorisation is not transferred without the written approval of the Authority; |
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(f) for a foreign-based holder of marketing authorisation, appoint a local responsible person; |
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(g) notify the Authority of any change that requires an amendment to a marketing authorisation; |
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(h) when necessary or as directed by the Authority, withdraw any product from the market that is injurious to, or is likely to be injurious to public health; and |
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(i) provide additional information or product sample when required to do so by the Authority for purposes of the Act. |
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NOTE: |
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Non-compliance with any of the terms or conditions of a marketing authorisation will result in suspension or revocation of the marketing authorisation. |
FORM IV
[Regulations 6(2) and 16(4)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF REJECTION OF APPLICATION FOR A MARKETING |
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Application No.: ..... |
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(1) Here insert the full names and address of the applicant |
To (1) .......................................................... |
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............................................................................................................ |
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(2) Here insert the reference No. of the application and the product name |
IN THE MATTER OF (2) ................................ you are notified that your application for (3) a marketing authorisation/renewal of a marketing authorisation has been rejected by the Authority on the following grounds: |
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(3) Here insert the applicable application |
(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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Dated this .... day of ............. 20.. |
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......................................... |
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FORM V
[Regulation 9(1)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
FORM VI
[Regulation 11(2)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
FORM VII
[Regulation 12(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF INTENTION TO SUSPEND A MARKETING AUTHORISATION |
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Application No.: ...... |
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(1) Here insert name of holder of marketing authorisation |
To (1) ............................................................ |
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............................................................................................................ |
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(2) Here insert name of medicine and marketing authorisation number |
IN THE MATTER OF (2) .................................................. you are hereby notified that the Authority intends to suspend your marketing authorisation on the following grounds- |
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(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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(3) Here insert number of days |
Accordingly, you are requested to show cause why your marketing authorisation should not be suspended and to take action to remedy the breaches set out in paragraphs .......... (above) within (3) ........... days of receiving this notice. Failure to remedy the said breaches shall result in the suspension of your marketing authorisation. |
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Dated this ..... day of ............ 20... |
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........................................... |
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FORM VIII
[Regulation 12(3)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF SUSPENSION OF MARKETING AUTHORISATION |
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(1) Here insert name of holder of marketing authorisation |
To (1) ...................................................... |
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............................................................................................................ |
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(2) Here insert name of medicine and marketing authorisation number |
IN THE MATTER OF (2) .................................................... you are hereby notified that your marketing authorisation has been suspended for (3) .............. on the following grounds: |
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(3) Here insert period of suspension |
(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(4) Here insert period of days |
Accordingly, you are requested to take action to remedy the breaches set out in paragraphs ........................ (above) within (4) .................. days of receiving this Notice. Failure to remedy the said breaches shall result in the revocation of your marketing authorisation. |
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Dated this .............. day of ..................... 20......... |
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......................................... |
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FORM IX
[Regulation 13(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF RESTORATION OF MARKETING AUTHORISATION |
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(1) Here insert name of holder of marketing authorisation |
To (1) ....................................................... |
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............................................................................................................ |
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(2) Here insert name of medicine and marketing authorisation number |
IN THE MATTER OF (2) ................................................... you are hereby notified that your marketing authorisation has been restored. |
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Note that you are required to comply with the terms and conditions attached to the marketing authorisation. |
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Dated this ... day of ........... 20.... |
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........................................ |
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FORM X
[Regulation 14(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF INTENTION TO REVOKE MARKETING AUTHORISATION |
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(1) Here insert name of holder of marketing authorisation |
To (1) .......................................................... |
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............................................................................................................ |
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(2) Here insert name of medicine and marketing authorisation number |
IIN THE MATTER OF (2) ................................................ you are hereby notified that the Authority intends to revoke your marketing authorisation on the following grounds: |
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(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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(3) Here insert number of days |
Accordingly, you are requested to show cause why your marketing authorisation should not be revoked for the breaches set out in paragraphs .......................... (above) within (3) ....................... days of receiving this notice. Failure to remedy the said breaches shall result in the revocation of your marketing authorisation. |
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Dated this .... day of ........ 20... |
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.......................................... |
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FORM XI
[Regulation 14(3)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF REVOCATION OF MARKETING AUTHORISATION |
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(1) Here insert name of holder of marketing authorisation |
To (1) .......................................................... |
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............................................................................................................ |
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(2) Here insert name of medicine and marketing authorisation number |
IN THE MATTER OF (2) ................................... you are hereby notified that your marketing authorisation has been revoked on the following grounds: |
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(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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You are therefore required to surrender the marketing authorisation to the Authority within 21 days from the date of revocation. |
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You are also required to comply with the terms and conditions attached. |
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Dated this .... day of ............... 20.. |
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...................................... |
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FORM XII
[Regulation 15(1)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
FORM XIII
[Regulation 16(1)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
MEDICINES AND ALLIED SUBSTANCES (EXPERT ADVISORY COMMITTEE) REGULATIONS
[Section 9]
Arrangement of Regulations
Regulation
4. Qualifications to be appointed as member
5. Tenure of office and vacancy
SI 80 of 2019.
These Regulations may be cited as the Medicines and Allied Substances (Expert Advisory Committee) Regulations, 2019.
In these Regulations, unless the context otherwise requires-
"Chairperson" means the person elected as Chairperson by the members;
"Committee" means the Expert Advisory Committee constituted by the Board in accordance with section 9 of the Act; and
"member" means a member of the Expert Advisory Committee.
(1) The Committee consists of the following part-time members-
(a) three persons with expertise in human medicine;
(b) two persons with expertise in veterinary medicine; and
(c) two persons with expertise in allied substances.
(2) The members shall elect the Chairperson and Vice-Chairperson from amongst themselves.
4. Qualifications to be appointed as member
A person qualifies to be appointed as a member if that person-
(a) is a citizen;
(b) is not an undischarged bankrupt;
(c) is not legally disqualified;
(d) has not been convicted of an offence under the Act or any other written law and sentenced to imprisonment for a period exceeding six months without the option of a fine within a period of five years preceding the appointment; and
(e) is not facing disciplinary action relating to professional misconduct.
5. Tenure of office and vacancy
(1) A member shall hold office for a period of three years and may be re-appointed for a further term of three years.
(2) The office of a member becomes vacant if that member-
(a) is absent, without reasonable excuse, from three consecutive meetings of the Committee of which the member has had notice;
(b) is adjudged bankrupt;
(c) is convicted of an offence under the Act or any other law and sentenced to imprisonment for a period exceeding six months;
(d) is found guilty of professional misconduct;
(e) is legally disqualified from performing the duties of a member;
(f) dies; or
(g) resigns.
(3) On the expiration of the period for which member is appointed, the member shall continue to hold office until a successor is appointed, but in no case shall the further period exceed four months.
The Board may, where the office of a member becomes vacant before the expiry of the term of office, appoint another member in place of the member who vacates office but that member shall hold office only for the unexpired part of the term.
(1) Subject to the other provisions of this Act, the Committee may regulate its own procedure.
(2) The Committee shall meet for the transaction of business at least once in every three months at such places and times as the Committee may determine.
(3) A meeting of the Committee may be called by the Chairperson, on giving notice of not less than 14 days, and shall be called by the Chairperson if not less than one-third of the members so request in writing, except that if the urgency of any particular matter does not permit the giving of the notice, a special meeting may be called on giving a shorter notice.
(4) Five members shall constitute a quorum at any meeting of the Committee.
(5) There shall preside at any meeting of the Committee-
(a) the Chairperson;
(b) in the absence of the Chairperson, the Vice-Chairperson; and
(c) in the absence of the Chairperson and the Vice-Chairperson, such other member as the members present may elect for the purpose of that meeting.
(6) A decision of the Committee on any question shall be by a majority of the members present and voting at the meeting and in the event of an equality of votes, the person presiding at the meeting shall have a casting vote in addition to that person's deliberative vote.
(7) The Committee may invite any person, whose presence is in its opinion desirable, to attend and participate in the deliberations of the meeting of the Committee, but that person shall not have any vote.
(8) Where a member is for any reason unable to attend a meeting of the Committee, that member may, in writing, nominate another person from the same organisation to attend the meeting in that member's stead and that person shall be deemed to be a member for the purposes of that meeting.
(9) The validity of any proceedings, acts or decisions of the Committee shall not be affected by any vacancy in the membership of the Committee or by any defect in the appointment of any member or by reason that any person not entitled to do so, took part in the proceedings.
(10) The Committee shall cause minutes to be kept of proceedings in every meeting of the Committee.
There shall be paid to a member of the Committee such allowances as the Minister may determine, subject to the approval of the Emoluments Commission.
(1) If a person is present at a meeting of the Committee at which any matter is the subject of consideration, and in which matter that person or that person's relative is directly or indirectly interested in a private capacity, that person shall, as soon as is practicable after the commencement of the meeting, declare that interest and shall not, unless the Committee otherwise directs, take part in any consideration or discussion of, or vote on, any question relating to that matter.
(2) A declaration of interest made under sub-paragraph (1) shall be recorded in the minutes of the meeting at which it is made.
(3) In this regulation, "relative" has the meaning assigned to the word in the Anti-Corruption Commission Act, 2012.
{/mprestriction}
MEDICINES AND ALLIED SUBSTANCES ACT: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
Medicines and Allied Substances (Agro-Veterinary Shops) Regulations
Medicines and Allied Substances (Dispensing Certificates) Regulations
Medicines and Allied Substances (Health Shops) Regulations
Medicines and Allied Substances (Fees) Regulations
Medicines and Allied Substances (Importation and Exportation) Regulations
Medicines and Allied Substances (Certificate of Registration) Regulations
Medicines and Allied Substances (Pharmaceutical Licence) Regulations
Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations
Medicines and Allied Substances (Expert Advisory Committee) Regulations
MEDICINES AND ALLIED SUBSTANCES (AGRO-VETERINARY SHOPS) REGULATIONS
[Section 29]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
AGRO-VETERINARY SHOP PERMIT
5. Rejection of application for permit
7. Application for renewal of permit
10. Application for duplicate permit
13. Location of agro-veterinary shop
14. Identity of agro-veterinary shop
15. Sale of veterinary medicines
16. Sale, supply and dispensing of veterinary medicines
17. Storage of veterinary medicines
PART III
GENERAL PROVISIONS
18. Register of agro-veterinary shop permits
SI 10 of 2016.
PART I
PRELIMINARY
These Regulations may be cited as the Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016.
In these Regulations, unless the context otherwise requires-
"authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act;
"insanitary conditions" means the conditions or circumstances that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health;
"permit" means an agro-veterinary shop permit issued under section 29 of the Act; and
"responsible person" means a person who has the control and management of an agro-veterinary shop.
PART II
AGRO-VETERINARY SHOP PERMIT
(1) A person shall apply to the Authority for a permit in Form I set out in the First Schedule.
(2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(3) A separate application shall be made and a separate permit issued in respect of each premises.
(4) The Authority may inspect the premises in respect of which an application for a permit is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority.
The Authority may request an applicant to submit information in relation to an application for a permit in Form II set out in the First Schedule.
5. Rejection of application for permit
(1) The Authority shall reject an application for a permit if-
(a) the applicant fails to meet the requirements of the Act and the guidelines issued by the Authority;
(b) the permit issued to the applicant was revoked by the Authority within a period of two years preceding the application; or
(c) the applicant is convicted of an offence under the Act or any other relevant written law.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the First Schedule.
(1) The Authority shall, where the applicant meets the requirements of the Act and the guidelines issued by the Authority, issue a permit in Form IV set out in the First Schedule.
(2) A permit shall be valid for two years from the date of issue.
(3) A permit may be issued in respect of the following classes of agro-veterinary shops-
(a) Class I, to stock for sell the veterinary medicines and allied substances specified in Part A of the Second Schedule;
(b) Class II, to stock for sale the veterinary medicines and allied substances as specified in Part B of the Second Schedule; and
(c) Class III, to stock for sale the veterinary medicines and allied substances specified in Part C of the Second Schedule.
(4) The classes of agro-veterinary shops shall be managed as follows-
(a) Class I, by a registered veterinary surgeon or pharmacist;
(b) Class II, by a registered veterinary para-professional under the supervision of a registered veterinary surgeon or pharmacist; and
(c) Class III, by a suitably qualified person as determined by the Authority.
7. Application for renewal of permit
(1) An application for the renewal of a permit shall be made to the Authority in Form V set out in the First Schedule.
(2) The Authority shall, within 14 days of receipt of an application for the renewal of a permit, grant the application if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the permit.
(3) A permit that is not renewed by the Authority lapses on its date of expiry.
(1) A permit shall be used solely by the holder and is not transferable to any other person without the prior approval of the Authority.
(2) An application for approval to transfer a permit shall be made to the Authority in Form VI set out in the First Schedule.
(3) The Authority shall, within 30 days of receipt of an application for the transfer of a permit, approve the transfer if the applicant meets the requirements of the Act and the guidelines issued by the Authority and issue the transferee with a new permit.
(4) The Authority shall reject an application for the transfer of a permit if the applicant fails to comply with the conditions for the grant of the permit, the provisions of the Act and the guidelines issued by the Authority.
(5) The Authority shall, where it rejects an application to transfer a permit under sub-regulation (4), inform the applicant in Form III set out in the First Schedule.
(1) The Authority may amend a permit where-
(a) some other person succeeds to the interest of the business of the holder;
(b) the name of the business changes; or
(c) there is a change in the employment of the responsible person.
(2) An application for the amendment of a permit shall be made in Form VII set out in the First Schedule.
(3) The Authority shall communicate its decision to the permit holder within 14 days of receipt of the application for amendment of the permit.
(4) The Authority shall, where it approves the amendment of a permit, issue the applicant with a new permit.
10. Application for duplicate permit
A person may, where a permit is lost, damaged or defaced, apply to the Authority for a duplicate permit in Form VIII set out in the First Schedule.
(1) The Authority shall suspend a permit if-
(a)the holder operates the agro-veterinary shop in respect of which it is issued under insanitary conditions;
(b) the holder or manager of the agro-veterinary shop in respect of which it is issued obtains or sells veterinary medicines from unauthorised suppliers or stocks and sells unauthorised products;
(c) the agro-veterinary shop in respect of which it was issued contravenes the prescribed standards or the provisions of the Act;
(d) the agro-veterinary shop is not managed or controlled by a responsible person determined by the Authority;
(e) the responsible person fails to maintain the required records on veterinary medicines and allied substances;
(f) the agro-veterinary shop stocks and sells medicines that are not on the prescribed list; or
(g) the holder contravenes the terms and conditions of the permit, the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a permit, give notice to the holder of the intention to suspend the permit and request the holder to show cause, within a specified period, why the permit should not be suspended.
(3) A notice of intention to suspend a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall suspend a permit if the holder of the permit fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of the suspension of a permit shall be in Form X set out in the First Schedule.
(6) The Authority shall, during the period of the suspension of the permit, quarantine any product affected by the suspension of the permit at the cost of the permit holder.
(1) The Authority shall revoke a permit if the holder-
(a) contravenes the provisions of the Act or any other relevant written law or breaches the terms or conditions of the permit;
(b) fails to take corrective measures following the suspension of the permit within the specified period;
(c) changes the agro-veterinary shop premises without authorisation; or
(d) obtained the permit by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a permit, give notice to the holder of the permit of the intention to revoke the permit and request the holder to show cause, within a specified period, why the permit should not be revoked.
(3) A notice of the intention to revoke a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall revoke a permit if the holder fails to take remedial measures during the period specified by the Authority.
(5) A notice of the revocation of a permit shall be in Form X set out in the First Schedule.
(6) Upon the revocation of a permit, the medicines and allied substances on the premises shall be quarantined and disposed of as directed by the Authority at the holder's cost.
13. Location of agro-veterinary shop
The Authority shall, in considering an application for a permit, give priority to submissions filed by the applicants in the following areas-
(a) rural areas and districts where access to medicines is limited; and
(b) peripheral areas of municipalities or cities, where access to medicines is limited.
14. Identity of agro-veterinary shop
An agro-veterinary shop shall fix a standard logo for purposes of identifying the agro-veterinary shop as specified in the guidelines issued by the Authority.
15. Sale of veterinary medicines
A holder of a permit shall sell the veterinary medicines prescribed in the Second Schedule.
16. Sale, supply and dispensing of veterinary medicines
Veterinary medicines shall be sold, supplied and dispensed in accordance with the guidelines issued by the Authority.
17. Storage of veterinary medicines
(1) The storage of veterinary medicines in an agro-veterinary shop shall be in the manufacturer's original container and under conditions stipulated by the manufacturer.
(2) Where veterinary medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines.
(3) The Authority shall, where it is established that the holder of a permit stocks veterinary medicines or products under insanitary conditions, direct the holder to dispose of the veterinary medicines or products at the holder's cost.
PART III
GENERAL PROVISIONS
18. Register of agro-veterinary shop permits
(1) The Authority shall keep and maintain a register of agro-veterinary permits in Form XI set out in the First Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of an inspection fee prescribed in the Third Schedule.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12]
PRESCRIBED FORMS
Form I
[Regulation 3(1)]
(To be completed in triplicate)
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Form II
[Regulation 4]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) |
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The Medicines and Allied Substances (Agro-Veterinary Shops) Regulations, 2016 |
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REQUEST FOR INFORMATION |
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To: ................................................................................................................................ |
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Address: ....................................................................................................................... |
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Application No.: ............................................................................................................. |
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You are requested to furnish the following information or documents in respect of your application for ................................................................................................................ |
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(a) ............................................................................................................................ |
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(b) ............................................................................................................................ |
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(c) ............................................................................................................................ |
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(d) ............................................................................................................................ |
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within ..................... days of this notice. |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. |
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Dated this ............ day of ......................... 20...... |
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.................................................. |
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Form III
[Regulations 5(2) and 8(5)]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF REJECTION OF APPLICATION |
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(1) Here insert the full names and address of the applicant |
To (1) ................................................................................................. |
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................................................................................................. |
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(2) Here insert the reference No. of the application |
IN THE MATTER OF (2) ........................................ you are notified that your application for (3) .................................................... has been rejected by the Authority on the following grounds: |
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(3) Here insert type of application |
(a) ....................................................................................... |
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(b) .......................................................................................... |
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(c) ............................................................................................ |
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(d) ........................................................................................... |
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Dated this .......... day of ........................, 20...... |
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................................................. |
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Form IV
[Regulation 6]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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AGRO-VETERINARY SHOP PERMIT |
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Registration No.: .................................................. AVS |
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Permit No.: AVS/........................................................ |
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This is to certify that (Name of agro-veterinary shop) ..................................................... |
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..................................................................................................................................... |
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of (Physical address) .................................................................................................... |
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.................................................................................................................................... |
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................................................................... is registered to operate an agro-veterinary shop. |
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Name of responsible person: ........................................................................................... |
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The conditions of the agro-veterinary shop permit are overleaf. |
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This permit is valid until ......................... 20..... |
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.................................................. |
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Conditions for agro-veterinary shop permit |
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1. Any change in the responsible person, name, location or condition of permit of the agro-veterinary shop shall be approved by the Authority. |
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2. The agro-veterinary shop shall only stock and sell medicinal products that are on the prescribed list. |
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3. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. |
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4. The agro-veterinary shop permit is not transferable without the written approval of the Authority. |
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5. The agro-veterinary shop permit shall, upon grant, be displayed conspicuously at the front shop in a place visible to the public. |
Form V
[Regulation 7(1)]
(To be completed in triplicate)
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Form VI
[Regulation 8(2)]
(To be completed in triplicate)
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Form VII
[Regulation 9]
(To be completed in triplicate)
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Form VIII
[Regulation 10]
(To be completed in triplicate)
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Form IX
[Regulations 11(3) and 12(3)]
(To be completed in triplicate)
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF INTENTION TO SUSPEND/REVOKE AGRO-VETERINARY SHOP PERMIT |
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(1) Here insert the full names and address of holder of permit |
To (1) ............................................................................................ |
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...................................................................................................... |
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..................................................................................................... |
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(2) Here insert the Permit No. |
IN THE MATTER OF (2) ....................... .... you are notified that the Authority intends to *suspend/revoke your permit on the following grounds: |
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(a) ............................................................................................... |
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(b) ............................................................................................... |
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(c) ............................................................................................... |
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(d) ............................................................................................... |
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(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your permit should not be *suspended/revoked and to take action to remedy the breaches set out in paragraphs ......................... (above) within (3) ............ days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/revocation of your permit. |
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Dated this ............. day of ......................... 20..... |
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(4) Signature of Director-General |
(4) ................................................ |
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Form X
[Regulations 11(5) and 12(5)]
(To be completed in triplicate)
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF SUSPENSION OR REVOCATION OF AGRO-VETERINARY SHOP PERMIT |
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(1) Here insert the full names and address of holder of permit |
To (1) ................................................................................ |
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.......................................................................................... |
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(2) Here insert the permit no. |
IN THE MATTER OF (2) ................................................. you are notified that your permit has been *suspended for a period of (3) .................... /*revoked on the following grounds: |
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(3) Here insert the period |
(a) ................................................................................ |
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(4) Signature of Director-General |
(b) ............................................................................... |
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(c) .............................................................................. |
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(d) .............................................................................. |
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Dated this ............. day of ......................... 20..... |
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(4) ................................................ |
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Form XI
[Regulation 18]
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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REGISTER OF AGRO-VETERINARY SHOP PERMITS |
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No. |
Name and address of business |
Permit No. |
Class of permit |
Registration number |
Date of issue |
Expiry date |
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1. |
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2. |
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3. |
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4. |
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5. |
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6. |
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7. |
[Regulations 16(3) and 15(1)]
VETERINARY PRODUCTS FOR AGRO-VETERINARY SHOPS
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A. Agro-Veterinary Shop Class I |
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1. All prescription-only veterinary medicine (POM-V) with marketing authorisation |
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2. All pharmacy (P-V) veterinary medicines with market authorisation |
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3. All general sales (GS-V) veterinary medicines and allied substances |
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4. All medicines that have been imported with special authorisation |
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5. Medicines and allied substances added by guidelines issued by the Authority on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
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B. Agro-Veterinary Shops Class II |
|
Part A |
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No. |
Item |
Dosage Form |
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Analgesics- non-steroidal anti-inflammatories |
||
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1 |
Acetaminophen |
Tablets or powder |
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2 |
Carprofen |
Tablets |
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3 |
Diclofenac |
Tablets or gel |
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4 |
Dimethyl sulfoxide (DMSO) |
Tablets, or cream or ointment |
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5 |
Dipyrone |
Injection |
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6 |
Flunixin meglumine |
Injection |
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7 |
Ketoprofen |
Tablets or powder |
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8 |
Meloxicam |
Tablets or powder |
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Antiprotozoa |
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1 |
Amprolium |
Injectable solutions |
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2 |
Amprolium |
Soluble powders |
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3 |
Parvaquone |
Injectable solutions |
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4 |
Burparvaquone |
Injectable solutions |
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5 |
Diminazene aceturate |
Injectable solutions |
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6 |
Diminazene aceturate |
Injectable solutions granules |
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7 |
Imidocarb dipropionate |
Injectable solutions |
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8 |
Isometamidium chloride |
Injectable solutions |
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9 |
Parvarquone |
Injectable solutions powder |
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10 |
Quinapyramine sulphate/chloride |
Injectable solutions |
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Antifungals |
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1 |
Fluconazole |
Tablets or powder |
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2 |
Griseofulvin |
Tablets or capsules |
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3 |
Ketoconazole |
Tablets, capsules, lotions, shampoo |
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Antihistamines |
||
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1 |
Chlorpheniramine |
Tablets |
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2 |
Cimetidine |
Tablets |
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3 |
Diphenhydramine |
Tablets |
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4 |
Cetirizine |
Tablets |
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Antimicrobials |
||
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1 |
Amikacin |
Tablets |
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2 |
Amoxicillin |
Tablets, capsules or injection |
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3 |
Ampicillin |
Tablets, capsules or injection |
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4 |
Doxycycline |
Tablets, capsules or injection |
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5 |
Neomycin |
Pessaries, ointment or creams |
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6 |
Oxytetracycline injectable solutions |
All concentrations and dosage forms |
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7 |
Oxytetracycline soluble powder |
All concentrations and dosage forms |
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8 |
Oxytetracycline soluble powder with vitamins |
All concentrations and dosage forms |
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9 |
Penicillin |
Injection |
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10 |
Penicillin-streptomycin |
Injection |
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11 |
Sulfadimidine |
Injectable solutions 33% w/v, 33.3% |
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12 |
Sulfadimidine |
Powder |
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13 |
Tetracycline |
Ointment or spray |
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14 |
Tetracycline |
Powder |
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15 |
Tiamulin |
Powder |
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Autonomic drugs |
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1 |
Atropine |
Injection |
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2 |
Bethanechol |
Injection |
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3 |
Glycopyrrolate |
Injection |
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Electrolytes/Nutritional |
||
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1 |
Calcium |
Injection and powder |
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2 |
Iron |
Injection or oral liquid |
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3 |
Methionine, D-L |
Powder |
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4 |
Multivitamin |
Injectable solution |
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5 |
Multivitamin |
Soluble powder |
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6 |
Potassium |
Injection |
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7 |
Selenium/Vitamin E |
Injection |
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8 |
Taurine |
Injection |
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9 |
Vitamin A & D |
Injection |
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10 |
Vitamin B complex |
Injection |
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11 |
Vitamin C |
Tablets or powder |
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12 |
Vitamin D |
Injection |
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13 |
Vitamin K |
Injection |
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14 |
Sodium chloride 0.9% (N-Saline) |
Solution |
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15 |
Dextrose 5%, 10%, 50% |
Solution |
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16 |
Ringers lactate |
Solution |
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Gastrointestinal agents |
||
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1 |
Metoclopramide |
Tablets |
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2 |
Sucralfate |
Tablets |
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Hormones |
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1 |
Dexamethasone |
Injection |
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2 |
Dinoprost |
Injection |
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3 |
Estradiol cypionate |
Injection |
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4 |
Gonadorelin |
Injection |
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5 |
Oxytocin |
Injection |
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6 |
Progesterone |
Injection |
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7 |
Stilboestral dipropionate |
Injection |
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8 |
Triamcinolone |
Injection |
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Respiratory |
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1 |
Aminophyline |
Tablet or injection |
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2 |
Dextromethorphan |
Injection |
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3 |
Doxapram |
Injection |
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Sedatives |
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1 |
Acepromazine |
Tablet |
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Miscellaneous |
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1 |
Methimazole |
Tablet |
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2 |
Propylene glycol |
Liquid |
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3 |
Protamine sulfate |
Powder |
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Allied substances (Acaricides) |
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1 |
Chlorfenvinphos |
Concentrate |
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2 |
Dichlorvos |
Concentrate |
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Anthelmintics |
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1 |
Albendazole |
Bolus up to 2.5 g |
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2 |
Albendazole |
Suspensions 2.5% w/v,10% w/v |
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3 |
Clorsulon |
Injection |
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4 |
Closantel |
Injection or drench |
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5 |
Febantel |
Drench, bolus or injection |
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6 |
Fenbendazole |
Drench, bolus or injection |
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7 |
Haloxon |
Drench |
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8 |
Hexachloroethane |
Drench |
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9 |
Hexachloroparaxylene |
Drench |
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10 |
Hexachlorophene |
Drench |
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11 |
Ivermectin |
Bolus or powder |
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12 |
Ivermectin |
Injectable solutions |
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13 |
Levamisole |
Bolus or powder |
|
14 |
Levamisole hydrochloride |
Drench, powder or injection |
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15 |
Levamisole phosphate injection |
Injection |
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16 |
Mebendazole |
Drench, tablets, bolus |
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17 |
Niclosamide |
Drench or bolus |
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18 |
Nitoxynil |
Drench or bolus |
|
19 |
Oxfendazole |
Drench or bolus |
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20 |
Oxibendazole |
Drench or bolus |
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21 |
Oxyclozanide |
Drench or bolus |
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22 |
Oxyclozanide |
Drench or bolus |
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23 |
Parbendazole |
Drench or bolus |
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24 |
Piperazine citrate |
Soluble powders |
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25 |
Piperazine citrate |
Tablets |
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26 |
Praziquantel |
Tablets |
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27 |
Pyrantel |
Tablets or oral liquid |
|
28 |
Rafoxanide |
Drench or bolus |
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29 |
Tetramisole |
Drench or bolus |
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30 |
Thiabendazole |
Drench or bolus |
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31 |
Thiophanate |
Drench or bolus |
|
32 |
Trichlorfon |
Drench or bolus |
|
33 |
Triclabendazole |
Drench or bolus |
|
34 |
Ivermectin/clorsulon |
Injection |
|
35 |
Levamisole/oxyclozanide |
Drench or bolus |
|
36 |
Piperazine citrate/pyrantel parmoate |
Tablets or oral liquid |
|
37 |
Levamisole/piperazine dihydrochloride |
Powder |
|
Biologicals: |
|
Poultry vaccines |
||
|
1 |
Anticoccidial vaccines |
All dosage forms |
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2 |
Chicken anaemia virus vaccines |
All dosage forms |
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3 |
Fowl cholera vaccines |
All dosage forms |
|
4 |
Fowl pox vaccines |
All dosage forms |
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5 |
Fowl typhoid vaccines |
All dosage forms |
|
6 |
Infectious bronchitis vaccines |
All dosage forms |
|
7 |
Infectious bronchitis/newcastle disease/egg drop syndrome baccines |
All dosage forms |
|
8 |
Infectious bronchitis/newcastle inactivated vaccines |
All dosage forms |
|
9 |
Infectious bursal disease vaccines |
All dosage forms |
|
10 |
Infectious coryza vaccines |
All dosage forms |
|
11 |
Infectious laryngotracheitis vaccines |
All dosage forms |
|
12 |
Newcastle cloned vaccines |
All dosage forms |
|
13 |
Newcastle disease live vaccine |
All dosage forms |
|
14 |
Newcastle disease inactivated vaccines |
All dosage forms |
|
15 |
Newcastle disease thermostable vaccines |
All dosage forms |
|
16 |
Salmonella vaccines for avians |
All dosage forms |
|
17 |
Egg drop syndrome vaccines |
All dosage forms |
|
Ruminant vaccines |
||
|
1 |
Anaplasmosis vaccines |
All dosage forms |
|
2 |
Anthrax vaccines |
All dosage forms |
|
3 |
Avian & bovine tuberculin kit |
Injectible |
|
4 |
Black leg-clostridium chauvoei vaccines |
All dosage forms |
|
5 |
Blackleg/anthrax vaccines |
All dosage forms |
|
6 |
Blue tongue vaccines |
All dosage forms |
|
7 |
Botulism vaccines |
All dosage forms |
|
8 |
Botulism/anthrax vaccines |
All dosage forms |
|
9 |
Anthrax/black quarter/botulism vaccines |
All dosage forms |
|
10 |
Bovine ephemeral fever vaccines |
All dosage forms |
|
11 |
Brucella vaccines |
All dosage forms |
|
12 |
Calf paratyphoid live and killed vaccines |
All dosage forms |
|
13 |
Enzootic abortion vaccines |
All dosage forms |
|
14 |
Clostridial/pasteurella vaccines |
All dosage forms |
|
15 |
Infectious bovine rhinotracheitis/parainfluenza/bovine respiratory syncitial virus/bovine viral diarrhoea (combination) vaccines, both live and killed |
All dosage forms |
|
16 |
Leptospirosis vaccines |
All dosage forms |
|
17 |
Lumpy skin disease vaccines |
All dosage forms |
|
18 |
Milk ring test antigen |
All dosage forms |
|
19 |
Multiclostridials vaccines |
All dosage forms |
|
20 |
Pasturella vaccines |
All dosage forms |
|
21 |
Pulpy kidney vaccines |
All dosage forms |
|
22 |
Rift valley fever vaccines, live and inactivated |
All dosage forms |
|
23 |
Rota/corona/E.coli vaccine for cattle |
All dosage forms |
|
24 |
Rift valley fever inactivated vaccine for cattle |
All dosage forms |
|
25 |
Rift valley fever live vaccine for sheep |
All dosage forms |
|
26 |
Bovine rota/coronavirus vaccine/clostridium perfringens type C/escherichia coli bacterin/toxoid Injectable vaccine/toxoid |
All dosage forms |
|
27 |
Sheep multiclostridial vaccines |
All dosage forms |
|
28 |
Tetanus vaccines |
All dosage forms |
|
29 |
Tetanus toxoid |
All dosage forms |
|
30 |
Bovine ephemeral fever vaccines |
All dosage forms |
|
31 |
Vibriosis vaccines |
All dosage forms |
|
Pig vaccines |
||
|
1 |
Parvovirus killed vaccine/erysipelothrix/leptospira bacterin vaccine/toxoid |
All dosage forms |
|
2 |
Boar-taint vaccines |
All dosage forms |
|
3 |
E. coli/clostridium perfringens type C beta toxoid |
All dosage forms |
|
Vaccines for companion animals |
||
|
1 |
Equine influenza virus vaccines |
All dosage forms |
|
2 |
Feline viral rhinotracheitis/feline calicivirus/feline panleukopenia vaccines |
All dosage forms |
|
3 |
Canine parvovirus vaccines |
All dosage forms |
|
4 |
Horse sickness polyvalent vaccine |
All dosage forms |
|
5 |
Canine distemper/adenovirus type 2/ parainfluenza/parvovirus modified live virus vaccine/ leptospira bacterin vaccine/toxoid |
All dosage forms |
|
6 |
Rabies vaccines |
All dosage forms |
|
Intra-Uterine infusion drugs |
||
|
1 |
Intrauterine pessaries |
Pessaries |
|
Intramammary infusion drugs |
||
|
1 |
Mastitis intramammary infusion |
Ointments |
|
Ophthalmologic drug |
||
|
1 |
Cloxacillin eye ointment 16.7% w/w |
Ointments |
|
2 |
Dexamethasone ointment or drops |
Ointments or drops |
|
3 |
Doxycycline |
Eye powder |
|
4 |
Neomycin |
Ointment or drops |
|
5 |
Oxytetracycline |
Powder or ointment |
|
Antiseptics |
||
|
1 |
Povidone iodine |
Concentrate |
|
Part B |
||
|
1. All general sales (GSV) veterinary medicines and allied substances |
||
|
2. Medicines and allied substances added by guidelines issued by the Authority on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
||
|
Agro-Veterinary Shop Class III |
||
|
Part A |
|
No. |
Item |
Dosage Form |
|
Analgesics-non-steroidal anti-inflammatories |
||
|
1 |
Diclofenac |
Tablets or gel |
|
2 |
Dipyrone |
Injection |
|
Antiprotozoa |
||
|
1 |
Amprolium |
Soluble powders |
|
Diminazene aceturate |
Injectable solutions |
|
|
Antihistamines |
||
|
1 |
Chlorpheniramine |
Tablets |
|
Antimicrobials |
||
|
1 |
Oxytetracycline injectable solutions |
All concentrations and dosage forms |
|
2 |
Oxytetracycline soluble powder |
All concentrations and dosage forms |
|
3 |
Oxytetracycline soluble powder with vitamins |
All concentrations and dosage forms |
|
4 |
Tetracycline |
Ointment or spray |
|
5 |
Tetracycline |
Powder |
|
Electrolytes/Nutritional |
||
|
1 |
Multivitamin |
Soluble powder |
|
2 |
Potassium |
Injection |
|
3 |
Vitamin C |
Tablets or powder |
|
Allied substances (Acaricides) |
||
|
1 |
Chlorfenvinphos |
Concentrate |
|
Anthelmintics |
||
|
1 |
Albendazole |
Bolus up to 2.5 g |
|
2 |
Albendazole |
Suspensions 2.5% w/v,10% w/v |
|
3 |
Closantel |
Injection or drench |
|
4 |
Ivermectin |
Bolus or powder |
|
5 |
Levamisole |
Bolus or powder |
|
6 |
Oxfendazole |
Drench or bolus |
|
7 |
Oxyclozanide |
Drench or bolus |
|
8 |
Parbendazole |
Drench or bolus |
|
9 |
Piperazine citrate |
Soluble powders |
|
10 |
Piperazine citrate |
Tablets |
|
11 |
Praziquantel |
Tablets |
|
12 |
Pyrantel |
Tablets or oral liquid |
|
Biologicals: |
|
|
|
Poultry vaccines |
||
|
1 |
Newcastle disease |
Thermostable vaccines |
|
Ophthalmologic drug |
||
|
1 |
Cloxacillin eye ointment 16.7% w/w |
Ointments |
|
2 |
Doxycycline |
Eye powder |
|
3 |
Neomycin |
Ointment or drops |
|
4 |
Oxytetracycline |
Power or ointment |
|
|
||
|
Part B |
||
|
1. All general sales (GSV) veterinary medicines and allied substances |
||
|
2. Medicines and allied substances added by guidelines issued by the Authority, and are categorised for distribution in Class 3 agro-veterinary shops, on the recommendation of the Ministry responsible for veterinary services in response to changing disease epidemiological status or disease outbreaks |
||
|
Note: All medicines with marketing authorisation for use in humans, if prescribed for use in animals, shall only be accessed from registered pharmacies on prescription from a registered veterinary surgeon. |
MEDICINES AND ALLIED SUBSTANCES (DISPENSING CERTIFICATES) REGULATIONS
[Section 28]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
DISPENSING CERTIFICATE
3. Application for certificate
5. Rejection of application for certificate
7. Application for renewal of certificate
10. Application for duplicate certificate
PART III
GENERAL PROVISIONS
15. Register of dispensing certificates
SI 11 of 2016.
PART I
PRELIMINARY
These Regulations may be cited as the Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016.
In these Regulations, unless the context otherwise requires-
"authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act; and
"certificate" means the dispensing certificate issued under section 28 of the Act.
PART II
DISPENSING CERTIFICATE
3. Application for certificate
(1) A person shall apply to the Authority for a certificate in Form I set out in the Schedule.
(2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(3) A separate application shall be made and a separate certificate issued in respect of each health facility.
(4) The Authority may inspect the health facility in respect of which an application for a certificate is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority.
(5) The Authority shall consider the following matters in determining an application for a certificate-
(a) the number of health facilities in the area;
(b) the classification of the health facility; and
(c) the competence of the health practitioners responsible for dispensing the medicines.
The Authority may request an applicant to submit information in relation to an application for a certificate in Form II set out in the Schedule.
5. Rejection of application for certificate
(1) The Authority shall reject an application for a certificate if-
(a) the applicant fails to meet the requirements of the Act and the guidelines issued by the Authority;
(b) the certificate issued to the applicant was revoked by the Authority within the preceding two years before the date of the application;
(c) the applicant's practising certificate is withdrawn by the relevant professional body; or
(d) the applicant is convicted of an offence under the Act or any other relevant written law.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the Schedule.
(1) The Authority shall, where the applicant meets the requirements of the Act and the guidelines issued by the Authority, issue a certificate in Form IV set out in the Schedule.
(2) A certificate shall be valid for two years from the date of issue.
7. Application for renewal of certificate
(1) An application for the renewal of a certificate shall be made to the Authority in Form V set out in the Schedule.
(2) The Authority shall, within 14 days of the application for a certificate, renew the certificate if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the certificate.
(3) A certificate that is not renewed by the Authority lapses on its date of expiry.
A certificate shall be used solely by the holder and is not transferable to any other person.
(1) The Authority may amend a certificate where the name of the business changes.
(2) An application for the amendment of a certificate shall be made in Form VI set out in the Schedule.
(3) The Authority shall, where it approves an application for the amendment of a certificate, issue the applicant with a new certificate.
10. Application for duplicate certificate
A person may, where a certificate is lost, damaged or defaced, apply to the Authority for a duplicate certificate in Form VII set out in the Schedule.
(1) The Authority shall suspend a certificate if-
(a)the holder dispenses medicine under insanitary conditions;
(b) the holder or manager of the health facility in respect of which it is issued obtains or sells medicines from unauthorised suppliers or stocks and sells unauthorised products;
(c) the health facility does not comply with good dispensing practices determined by the Authority;
(d) the holder fails to maintain the required records on medicines and allied substances; or
(e) the holder contravenes the terms and conditions of the certificate or the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a certificate, give notice to the holder of the intention to suspend the certificate and request the holder to show cause, within a specified period, why the certificate should not be suspended.
(3) A notice of intention to suspend a certificate shall be in Form VIII set out in the Schedule.
(4) The Authority shall suspend a certificate if the holder of the certificate fails to take remedial measures within the period specified in the notice issued under sub-regulation (3).
(5) A notice of the suspension of a certificate shall be in Form IX set out in the Schedule.
(6) During the period of the suspension of the certificate-
(a) the product affected by the suspension of the certificate shall be quarantined and disposed of at the cost of the certificate holder; and
(b) the health facility to which it relates shall not dispense medicines, except for emergency cases.
(7) The Authority shall lift the suspension of a certificate where the holder complies with the terms and conditions of the suspension.
(1) The Authority shall revoke a certificate if the holder-
(a) contravenes the provisions of the Act or breaches the terms or conditions of the certificate;
(b) fails to take corrective measures following the suspension of the certificate within the specified period;
(c) obtained the certificate by fraud or deliberate or negligent submission of false information or statements; or
(d) fails to comply with any other relevant written law.
(2) The Authority shall, before revoking a certificate, give notice to the holder of the certificate of the intention to revoke the certificate and request the holder to show cause, within a specified period, why the certificate should not be revoked.
(3) A notice of the intention to revoke a certificate shall be in Form VIII set out in the First Schedule.
(4) The Authority shall revoke a certificate if the holder fails to take remedial measures during the period specified by the Authority.
(5) A notice of the revocation of a certificate shall be in Form IX set out in the Schedule.
(6) Upon the revocation of a certificate, the products in the health facility shall be quarantined or disposed of as directed by the Authority at the holder's cost.
(1) Medicines in a health facility shall be dispensed in accordance with the guidelines issued by the Authority.
(2) A holder of a dispensing certificate who undertakes dispensing activities shall stock medicines of the required quality, safety and efficacy.
(3) A patient may request a medical practitioner for a written prescription to enable the patient obtain medicines from any other health facility of their choice.
(1) The storage of medicines in a health facility shall be in the manufacturer's original container and under conditions stipulated by the manufacturer.
(2) The Authority shall, where it determines that the holder of a certificate stocks medicines or products under insanitary conditions, direct the holder to dispose of the medicines or products at the holder's cost.
(3) Where medicines are transferred to another container, care shall be taken to protect the integrity of the product and prevent contamination of the medicines.
PART III
GENERAL PROVISIONS
15. Register of dispensing certificates
(1) The Authority shall keep and maintain a register of dispensing certificates in Form X set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of a prescribed inspection fee.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 15]
PRESCRIBED FORMS
Form I
[Regulation 3(1)]
(To be completed in triplicate)
|
|
Form II
[Regulation 4]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
REQUEST FOR INFORMATION |
|
To: ...................................................................................................................... |
|
Address: .............................................................................................................. |
|
Application No.: .................................................................................................... |
|
You are requested to furnish the following information in respect of your application for ................................................ within ..................................... days of this Notice: |
|
(a) .................................................................................................................. |
|
(b) .................................................................................................................. |
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(c) .................................................................................................................. |
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(d) .................................................................................................................. |
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If you fail to furnish the requested information within the stipulated period, your application |
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Dated this ............. day of ............................. 20.... |
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................................... |
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Form III
[Regulation 5(2)]
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|
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The Medicines and Allied Substances Act, 2013 |
|
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The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|
|
NOTICE OF REJECTION OF APPLICATION |
|
|
(1) Here insert the full names and address of the applicant |
To (1) ............................................................................................................ |
|
..................................................................................................................... |
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(2) Here insert the reference No. of the application |
IN THE MATTER OF (2) ................................................. you are notified that your application for (3) .............................................................. has been rejected by the Authority on the following grounds: |
|
(3) Here insert type of application |
(a) ............................................................................................................ |
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(b) ............................................................................................................ |
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(c) ............................................................................................................ |
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(d) ............................................................................................................ |
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Dated this ............. day of .............................., 20..... |
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................................... |
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Form IV
[Regulation 6]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
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DISPENSING CERTIFICATE |
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Registration No.: ..................................... DC |
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Certificate No.: DC/................................... |
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This is to certify that ......................................................................................................... |
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....................................................................................................................................... |
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of (Physical address) ....................................................................................................... |
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....................................................................................................................................... |
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.............................................................................................. may dispense medicines at |
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....................................................................................................................................... |
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Name of Health Facility: ................................................................................................... |
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This Certificate is valid until ................................... 20.... |
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The conditions of the Dispensing Certificate are overleaf. |
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..................................... |
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Conditions for Dispensing Certificate |
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1. The holder shall inform the Authority of any change in the details of the Dispensing Certificate. |
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2. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. |
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3. The Dispensing Certificate is not transferable to any other person. |
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4. The Dispensing Certificate shall, upon grant, be displayed conspicuously at the health facility in a place visible to the public. |
Form V
[Regulation 7(1)]
(To be completed in triplicate)
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Form VI
[Regulation 9(2)]
(To be completed in triplicate)
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Form VII
[Regulation 10]
(To be completed in triplicate)
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Form VIII
[Regulations 11(3) and 12(3)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
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NOTICE OF INTENTION TO SUSPEND/REVOKE DISPENSING CERTIFICATE |
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(1) Here insert the full names and address of holder of certificate |
To (1) ................................................................................................... |
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............................................................................................................ |
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............................................................................................................ |
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(2) Here insert the Certificate No. |
IN THE MATTER OF (2) ...................................................... you are notified that the Authority intends to *suspend/revoke your certificate on the following grounds: |
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(a) ................................................................................................ |
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(b) ................................................................................................ |
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(c) ................................................................................................ |
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(d) ................................................................................................ |
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(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your certificate should not be suspended/revoked and to take action to remedy the breaches set out in paragraphs ................................... (above) within (3) .................... days of receiving this notice. Failure to remedy the specified breaches shall result in the *suspension/revocation of your certificate. |
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Dated this ............... day of ................................... 20...... |
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................................... |
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Form IX
[Regulations 11(5) and 12(5)]
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|||
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
|||
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NOTICE OF SUSPENSION/REVOCATION OF DISPENSING CERTIFICATE |
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(1) Here insert the full names and address of holder of certificate |
To (1) ................................................................................................................. |
||
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.......................................................................................................................... |
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(2) Here insert the Registration No. |
(2) ..................................................................................................................... |
||
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(3) Here insert the Certificate No. |
IN THE MATTER OF (3) ..................................................... you are notified that your certificate has been |
(4) Here insert the period |
........................................................................................................................... |
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........................................................................................................................... |
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........................................................................................................................... |
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........................................................................................................................... |
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Dated this ........... day of ...................... 20...... |
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..................................... |
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{mprestriction ids="2,3,5"} |
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Form X
[Regulation 15(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Dispensing Certificates) Regulations, 2016 |
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REGISTER OF DISPENSING CERTIFICATES |
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No. |
Name of Certificate Holder |
Name and Address of Business |
Registration Number |
Date of Issue |
Expiry Date |
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1. |
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2. |
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3. |
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4. |
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5. |
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6. |
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7. |
MEDICINES AND ALLIED SUBSTANCES (HEALTH SHOPS) REGULATIONS
[Section 30]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
HEALTH SHOP PERMIT
5. Rejection of application for permit
7. Application for renewal of permit
10. Application for duplicate permit
16. Dispensing of medicines in health shop
PART III
GENERAL PROVISIONS
18. Register of health shop permits
SI 12 of 2016.
PART I
PRELIMINARY
These Regulations may be cited as the Medicines and Allied Substances (Health Shops) Regulations, 2016.
In these Regulations, unless the context otherwise requires-
"authorised supplier" means a holder of a pharmaceutical licence issued under section 34 of the Act;
"health shop dispenser" means a person responsible for managing the health shop and has undergone training approved by the Authority;
"patient pack" means a quantity of medicines sufficient to treat a single patient for a specified condition;
"permit" means a health shop permit issued under section 30 of the Act;
"re-packing of medicines" means the act of removing a preparation from its original primary container and placing it into a patient pack, but does not include the act of cutting of a blister pack;
"responsible person" means a pharmacist or pharmacy technologist; and
"supervising pharmacist" means a pharmacist providing supervisory services to a health shop.
PART II
HEALTH SHOP PERMIT
(1) A person shall apply to the Authority for a permit in Form I set out in the First Schedule.
(2) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(3) A separate application shall be made and a separate permit issued in respect of each premises.
(4) The Authority may inspect the premises in respect of which an application for a permit is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority.
The Authority may request an applicant to submit information in relation to an application in Form II set out in the First Schedule.
5. Rejection of application for permit
(1) The Authority shall reject an application for a permit if-
(a) the applicant fails to comply with any condition precedent to the issue of the permit;
(b) the permit issued to the applicant was revoked by the Authority within a period of two years preceding the date of the application; or
(c) the applicant is convicted of an offence under the Act or any other relevant written law.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant within seven days of the decision in Form III set out in the First Schedule.
(1) The Authority shall, where the applicant meets the requirements of the guidelines issued by the Authority and the Act, issue a permit in Form IV set out in the First Schedule.
(2) A permit shall be valid for two years from the date of issue.
(3) A health shop shall be managed by a health shop dispenser under the supervision of a responsible person.
7. Application for renewal of permit
(1) An application for the renewal of a permit shall be made to the Authority in Form V set out in the First Schedule.
(2) The Authority shall, within 14 days of the receipt of an application for the renewal of a permit, grant the application for the renewal of the permit if the applicant meets the requirements of the Act and the guidelines issued by the Authority and has complied with the terms and conditions of the permit.
(3) The Authority shall, where it renews a permit, issue a new permit to the applicant.
(4) A permit that is not renewed by the Authority lapses on its date of expiry.
(1) A permit shall be used solely by the holder and is not transferable to any other person without the prior approval of the Authority.
(2) An application for approval to transfer a permit shall be made to the Authority in Form VI set out in the First Schedule.
(3) The Authority shall, within 30 days of receipt of an application for the transfer of a permit, approve the transfer if the applicant meets the requirements of the Act, and issue the transferee with a permit.
(4) The Authority shall reject an application for the transfer of a permit if the applicant fails to comply with the conditions for the grant of the permit, the provisions of the Act and the guidelines issued by the Authority.
(5) The Authority shall, where it rejects an application to transfer a permit under sub-regulation (4)-
(a) inform the applicant in Form III set out in the First Schedule; and
(b) suspend or revoke the permit.
(1) The Authority may amend a permit where-
(a) some other person succeeds to the interest in the business belonging to the holder of the permit; or
(b) the name of the business changes.
(2) An application for the amendment of a permit shall be made in Form VII set out in the First Schedule.
(3) The Authority shall communicate its decision to the permit holder within 14 days of receipt of the application for the permit.
(4) The Authority shall, where it approves the amendment of a permit, issue the applicant with a new permit.
10. Application for duplicate permit
A person shall, where that person's permit is lost, damaged or defaced, apply to the Authority for a duplicate permit in Form VIII set out in the First Schedule.
(1) The Authority shall suspend a permit if-
(a) the holder operates the health shop under insanitary conditions;
(b) the holder obtains or sells medicine from unauthorised suppliers or stocks and sells unauthorised products;
(c) the health shop in respect of which it was issued contravenes the prescribed standards;
(d) the health shop is not managed or controlled by a responsible person determined by the Authority;
(e) the responsible person fails to maintain the required records on medicines;
(f) the health shop stocks and sells medicines that are not on the prescribed list; or
(g) the holder contravenes the terms and conditions of the permit, the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a permit, give notice to the holder of the intention to suspend the permit and request the holder to show cause, within a specified period, why the permit should not be suspended.
(3) A notice of intention to suspend a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall suspend a permit if the holder of the permit fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of the suspension of a permit shall be in Form X set out in the First Schedule.
(6) The product affected by the suspension of the permit shall be quarantined at the cost of the permit holder during the period of the suspension of the permit.
(1) The Authority shall revoke a permit if the holder-
(a) contravenes the provisions of the Act or any other relevant written law or breaches the terms or conditions of the permit;
(b) fails to take corrective measures following the suspension of the permit within the specified period;
(c) changes the health shop premises without authorisation; or
(d) obtained the permit by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a permit, give notice to the holder of the permit of the intention to revoke the permit and request the holder to show cause, within a specified period, why the permit should not be revoked.
(3) A notice of the intention to revoke a permit shall be in Form IX set out in the First Schedule.
(4) The Authority shall revoke a permit if the holder fails to take remedial measures during the period specified by the Authority.
(5) A notice of the revocation of a permit shall be in Form X set out in the First Schedule.
(6) The Authority shall, where it determines that the holder stocks medicines in the health shop under insanitary conditions, direct the holder to dispose of the medicine.
(7) A holder of a permit shall, where the permit is revoked, quarantine the products on the premises and dispose of the products as directed by the Authority at the holder's cost.
(1) The Authority shall, in considering an application for a permit, prioritise the submissions filed by applicants in the following areas-
(a) rural areas and districts where access by the members of the public to medicines is limited; and
(b) peripheral areas of big towns or cities, where access to medicines is limited.
(2) The Authority shall, when considering the grant of a permit, take into account the availability of dispensing facilities in the area with respect to which the permit relates.
(1) A holder of a permit shall only sell the medicines prescribed in the Second Schedule.
(2) A health shop shall not stock for sale prescription only medicines and pharmacy sale medicines which are not specified in the prescribed list for health shops.
A health shop shall affix a standard logo for purposes of identifying the health shop as specified in the guidelines issued by the Authority.
16. Dispensing of medicines in health shop
Dispensing of medicines in a health shop shall be in accordance with the guidelines for dispensing of medicines in a health shop issued by the Authority.
The storage of medicines in a health shop shall be in the patient pack size and under conditions stipulated by the manufacturer.
PART III
GENERAL PROVISIONS
18. Register of health shop permits
(1) The Authority shall keep and maintain a register of health shop permits in Form XI set out in the First Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of an inspection fee as prescribed in the Medicines and Allied Substances (Fees) Regulations, 2015.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12]
Form I
[Regulation 3(1)]
(To be completed in triplicate)
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form II
[Regulation 4]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
REQUEST FOR INFORMATION |
|
To:.................................................................................................................................. |
|
Address: ............................................................................................................................. |
|
Application No.: .................................................................................................................... |
|
You are requested to furnish the following information or documents in respect of your application |
|
for ..................................................................................................................................... |
|
(a) ...................................................................................................................................... |
|
(b) ...................................................................................................................................... |
|
(c) ...................................................................................................................................... |
|
(d) ...................................................................................................................................... |
|
within .................................... days of this notice. |
|
If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. |
|
Dated this .............. day of .......................... 20.... |
|
.................................... |
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Form III
[Regulations 5(2) and 8(5)]
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
NOTICE OF REJECTION OF APPLICATION |
|
(1) Here insert the full names and address of the applicant |
To (1) .................................................................................................. |
|
............................................................................................................ |
|
|
(2) Here insert the reference no. of the application |
IN THE MATTER OF (2) ............................................................ you are notified that your application for a health shop permit has been rejected by the Authority on the following grounds: |
|
(a) ....................................................................................................... |
|
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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Dated this .............. day of ......................., 20..... |
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|
.............................................. |
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Form IV
[Regulation 6(1)]
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
HEALTH SHOP PERMIT |
|
Registration No.: ........................................................................ HS/...... |
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Permit No.: HS/................................................................................ |
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This is to certify that (Name of Health Shop) .............................................................................. |
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.............................................................................................................................................. |
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of (Physical Address) ............................................................................................................. |
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.............................................................................................................................................. |
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........................................................................................ is registered to operate a health shop |
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Name of responsible person: ................................................................................................... |
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The conditions of the health shop permit are overleaf. |
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Valid until ..................................................................... 20...... |
|
|
|
.................................... |
|
|
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Conditions for Health Shop Permit |
|
1. Any change in the ownership, name and location of the health shop shall be approved by the Authority. |
|
2. The health shop shall only sell medicines that are on the prescribed list. |
|
3. The premises and the manner in which the business is to be conducted must comply with the requirements of the Medicines and Allied Substances Act, No. 3 of 2013, and any other relevant written law. |
|
4. The health shop permit is not transferable without the written approval of the Authority. |
|
5. The health shop permit shall, upon grant, be displayed conspicuously at the front shop in a place visible to the public. |
Form V
[Regulation 7]
(To be completed in triplicate)
|
|
|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form VI
[Regulation 8(2)]
(To be completed in triplicate)
|
|
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
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The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form VII
[Regulation 9]
(To be completed in triplicate)
|
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form VIII
[Regulation 10]
(To be completed in triplicate)
|
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|
THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
Form IX
[Regulations 11(3) and 12(3)]
|
|
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
NOTICE OF INTENTION TO SUSPEND/REVOKE HEALTH SHOP PERMIT |
|
(1) Here insert the full names and address of holder of permit |
To (1) .................................................................................................. |
|
............................................................................................................ |
|
|
............................................................................................................ |
|
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(2) Here insert the Permit No. |
IN THE MATTER OF (2) .......................................... you are notified that the Authority intends to *suspend/revoke your permit on the following grounds: |
|
(a) ....................................................................................................... |
|
|
(b) ....................................................................................................... |
|
|
(c) ....................................................................................................... |
|
|
(d) ....................................................................................................... |
|
|
(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your permit should not be *suspended/revoked and to take action to remedy the breaches set out in paragraphs ......................... (above) within (3) .........................days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/revocation of your permit. |
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Dated this .............. day of ..........................., 20..... |
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(4) Signature of Director- General |
(4) .......................................... |
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Form X
[Regulations 11(5) and 12(5)]
|
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
NOTICE OF SUSPENSION OR REVOCATION OF HEALTH SHOP PERMIT |
|
(1) Here insert the full names and address of holder of permit |
To (1) .................................................................................................. |
|
|
............................................................................................................ |
||
|
............................................................................................................ |
||
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(2) Here insert the permit no. |
IN THE MATTER OF (2) .................................... you are notified that the Authority intends to |
(a) ....................................................................................................... |
|
(b) ....................................................................................................... |
||
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(c) ....................................................................................................... |
||
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(d) ....................................................................................................... |
||
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Dated this ............. day of ......................., 20..... |
||
|
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(4) ......................................... |
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Form XI
[Regulation 19]
|
|
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THE ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
The Medicines and Allied Substances Act, 2013 |
|
(Act No. 3 of 2013) |
|
The Medicines and Allied Substances (Health Shops) Regulations, 2016 |
|
REGISTER OF HEALTH SHOP PERMITS |
|||||
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No. |
Name and address of business |
Permit number |
Registration number |
Date of issue |
Expiry date |
|
1. |
|||||
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2. |
|||||
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3. |
|||||
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4. |
|||||
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5. |
|||||
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6. |
|||||
|
7. |
[Regulation 14]
PRESCRIBED LIST OF MEDICINES FOR HEALTH SHOPS
|
PART A |
|||
|
Item |
Strength |
Pack size |
|
|
Medicines for Asthma |
|||
|
1 |
Salbutamol tablets |
2 mg |
Patient pack |
|
2 |
Salbutamol Inhaler |
100 mcg/dose |
Patient pack |
|
Antibiotics |
|||
|
3 |
Amoxycillin tablets/capsules |
250 mg |
Patient pack |
|
4 |
Amoxycillin oral suspension |
125 mg/5 ml |
Patient pack |
|
5 |
Co-trimoxazole tablets |
400/80 mg |
Patient pack |
|
6 |
Co-trimoxazole suspension |
200/40 mg/5 ml |
Patient pack |
|
7 |
Doxycycline capsules/tablets |
100 mg |
Patient pack |
|
8 |
Metronidazole tablets |
200 mg |
Patient pack |
|
9 |
Tetracycline hyclate ointment |
1% |
Patient pack |
|
10 |
Silver sulfadiazine cream |
10 g |
Patient pack |
|
Antihelmentics |
|||
|
11 |
Albendazole tablets |
400 mg |
Patient pack |
|
Anti-inflammatory/Analgesics |
|||
|
12 |
Ibuprofen tablets |
200 mg |
Patient pack |
|
13 |
Hydrocortisone ointment/cream |
1% |
Patient pack |
|
14 |
Paracetamol tablets |
100 mg, 500 mg |
Patient pack |
|
15 |
Acetylsalicylic acid (Aspirin) tablets |
300 mg |
Patient pack |
|
Anti-fungal Agents |
|||
|
16 |
Nystatin oral suspension |
50 mg/5 ml, 100,000 UI/ml |
Patient pack |
|
17 |
Clotrimazole cream |
1%, 10% |
Patient pack |
|
18 |
Clotrimazole vaginal tablets |
100 mg, 500 mg |
Patient pack |
|
Anti-malarials |
|||
|
19 |
Artemether-lumefantrine tablets |
20/120 mg |
Patient pack |
|
Laxatives |
|||
|
20 |
Bisacodyl tablets |
5 mg |
Patient pack |
|
Anti-histamines |
|||
|
21 |
Cetirizine hydrochloride tablets |
10 mg |
Patient pack |
|
22 |
Cetirizine hydrochloride oral solution |
5 mg/5 ml |
Patient pack |
|
23 |
Chlorpheniramine maleate tablets |
4 mg |
Patient pack |
|
24 |
Chlorpheniramine maleate syrup |
2 mg/5 ml |
Patient pack |
|
Oral Contraceptives |
|||
|
25 |
Ethinylestardiol + Northisterone tablets |
0.03 mg/0.3 mg |
Patient pack |
|
26 |
Ethinylestardiol + Levonogestrel tablets |
0.03 mg/0.15 mg |
Patient pack |
|
Minerals/Vitamins |
|||
|
27 |
Vitamin B complex tablets |
Patient pack |
|
|
28 |
Zinc sulfate tablets |
20 mg |
Patient pack |
|
Fluids and Electrolytes |
|||
|
29 |
Normal saline IV |
0.90% 1 litre |
|
|
30 |
Ringers lactate IV |
1 litre |
PART B
All general sale medicines.
Note: Patient pack means a quantity of medicines sufficient to treat a single patient for a specified condition.
MEDICINES AND ALLIED SUBSTANCES (FEES) REGULATIONS
[Sections 19, 39 and 69]
Arrangement of Regulations
Regulation
SI 38 of 2016.
These Regulations may be cited as the Medicines and Allied Substances (Fees) Regulations, 2016.
The fees set out in the Schedule are prescribed for the matters specified therein.
[Regulation 2]
PRESCRIBED FEES
|
PART I |
|||
|
No. |
Item |
Fee Units |
|
|
City or Municipal Councils |
Other District Councils |
||
|
1. |
Hospital, Pharmacy and Retail |
|
|
|
|
(a) Application for certificate of registration |
15,833 |
7,917 |
|
|
(b) Re-inspection of premises in relation to an application for a certificate of registration |
12,000 |
6,000 |
|
|
(c) Annual returns or no change returns |
8,000 |
5,567 |
|
|
(d) Application for change of premises for retail pharmacy |
15,833 |
7,917 |
|
|
(e) Application for change of location for hospital pharmacy- |
|
|
|
|
(i) within the hospital premises |
2,900 |
1,450 |
|
|
(ii) new premises |
15,833 |
7,917 |
|
2. |
Dispensing Certificate |
|
|
|
(a) Application for dispensing certificate |
4,000 |
2,000 |
|
|
(b) Re-inspection of a facility in relation to an application for a dispensing certificate |
2,500 |
1,167 |
|
|
(c) Renewal of dispensing certificate |
2,500 |
1,167 |
|
|
(d) Application for change of premises for dispensing certificate |
4,000 |
2,000 |
|
|
3. |
Agro-Veterinary Shop |
|
|
|
(a) Application for agro-veterinary shop permit- |
|
|
|
|
(i) Class 1 |
15,833 |
7,917 |
|
|
(ii) Class 2 |
6,833 |
3,500 |
|
|
(iii) Class 3 |
4,000 |
2,000 |
|
|
(b) Re-inspection of premises in relation to an application for an agro-veterinary shop permit- |
|
|
|
|
(i) Class 1 |
12,000 |
6,000 |
|
|
(ii) Class 2 |
4,000 |
2,000 |
|
|
(iii) Class 3 |
2,500 |
1,167 |
|
|
(c) Renewal of agro-veterinary shop permit- |
|
|
|
|
(i) Class 1 |
12,000 |
6,000 |
|
|
(ii) Class 2 |
4,000 |
2,000 |
|
|
(iii) Class 3 |
4,000 |
2,000 |
|
|
(d) Application for change of premises for agro-veterinary shop- |
|
|
|
|
(i) Class 1 |
15,833 |
7,917 |
|
|
(ii) Class 2 |
6,833 |
3,500 |
|
|
(iii) Class 3 |
4,000 |
2,000 |
|
|
4. |
Health Shop |
|
|
|
|
(a) Application for health shop permit |
6,833 |
3,500 |
|
|
(b) Re-inspection of premises in relation to an application for a health shop |
4,000 |
2,000 |
|
|
(c) Renewal of health shop permit |
4,000 |
2,000 |
|
|
(d) Application for change of premises for health shop |
6,833 |
3,500 |
|
5. |
Pharmaceutical Licence (wholesale) |
|
|
|
(a) Application for pharmaceutical licence |
15,367 |
7,700 |
|
|
(b) Re-inspection of premises in relation to an application for a pharmaceutical licence |
11,533 |
5,867 |
|
|
(c) Renewal for pharmaceutical licence |
11,533 |
5,867 |
|
|
(d) Application for change of premises |
15,367 |
7,700 |
|
PART II |
||
|
No. |
Item |
Fee Units |
|
1. |
Pharmaceutical Licence |
|
|
|
(a) Complete manufacture- |
|
|
|
(i) Application for pharmaceutical license |
64,533 |
|
|
(ii) Re-inspection of premises in relation to an application for a pharmaceutical licence |
47,867 |
|
|
(iii) Re-locating to new premises |
64,533 |
|
|
(iv) Inspection of additional production line |
25,400 |
|
|
(v) Inspection of additional production block |
47,867 |
|
|
(vi) Renewal of pharmaceutical licence |
47,867 |
|
|
(b) Primary repackage of medicine- |
|
|
|
(i) Application for pharmaceutical licence |
35,400 |
|
|
(ii) Re-inspection of premises in relation to an application for a pharmaceutical license |
24,400 |
|
|
(iii) Re-locating to new premises |
35,400 |
|
|
(iv) Inspection of additional/modification of production line |
12,200 |
|
|
(v) Inspection of additional/modification of production block |
25,400 |
|
|
(vi) Renewal of pharmaceutical license |
25,400 |
|
|
(c) Secondary repackage of medicine- |
17,700 |
|
|
(i) Application for pharmaceutical licence |
|
|
|
(ii) Re-inspection of premises in relation to an application for a pharmaceutical licence |
12,200 |
|
|
(iii) Inspection of additional/modification of production line |
7,000 |
|
|
(iv) Inspection of additional/modification of production block |
12,200 |
|
|
(v) Renewal of pharmaceutical license |
12,200 |
|
|
(d) Local manufacture of natural remedies- |
|
|
|
(i) Application for pharmaceutical licence |
35,400 |
|
|
(ii) Re-inspection of premises in relation to an application for a |
24,400 |
|
|
(iii) Inspection of additional or modification of production line pharmaceutical license |
25,400 |
|
|
(iv) Inspection of additional or modification of production block |
25,400 |
|
|
(v) Renewal of pharmaceutical license |
25,400 |
|
|
(vi) Re-location to new premises |
25,400 |
|
2. |
Import and Export Permits |
|
|
|
(a) Importation of medicines for personal use |
333 |
|
|
(b) Importation of medicines in small quantities |
2,500 |
|
|
(c) Fees for importation of raw materials (APIs and Excipients) |
333 |
|
|
(d) Fees for import or export permit |
333 |
|
3. |
Marketing authorisation for locally manufactured or packaged medicines or allied substances |
|
|
|
(a) Locally manufactured medicines- |
|
|
|
(i) human |
16,667 |
|
|
(ii) veterinary |
16,667 |
|
|
(b) Locally packaged medicines- |
|
|
|
(i) human |
36,667 |
|
|
(ii) veterinary |
25,867 |
|
|
(c) Allied substances |
5,000 |
|
|
(d) Evaluation of additional information where supplied with application for marketing authorisation - inadequate technical information (quality safety or efficacy) |
5,667 |
|
|
(e) Annual retention fees- |
|
|
|
(i) human medicines |
8,333 |
|
|
(ii) veterinary medicines |
8,333 |
|
|
(iii) allied substances |
3,333 |
|
|
(f) Renewal of marketing authorisation- |
|
|
|
(i) human medicines |
11,667 |
|
|
(ii) veterinary medicines |
10,000 |
|
|
(iii) allied substances |
4,000 |
|
|
(g) Amendment of marketing authorisation- |
|
|
|
(i) minor amendment |
1,333 |
|
|
(ii) major amendment |
6,500 |
|
4. |
Advertising and Promotion of Medicines and Allied Substances |
|
|
|
(a) Advertising medicines to the general public |
16,667 |
|
|
(b) Promotional medicines to the health care professional fees |
3,333 |
|
|
(c) Exhibition of medicines at a public event fees |
6,667 |
|
5. |
Clinical Trials involving a Locally Manufactured Investigational Product |
|
|
|
(a) Clinical trial certificate involving investigational products without marketing authorisation- |
|
|
|
(i) human |
48,333 |
|
|
(ii) veterinary |
34,333 |
|
(b) Clinical trial certificate involving investigational products with marketing authorisation |
||
|
(i) human |
46,667 |
|
|
(ii) veterinary |
32,667 |
|
|
(c) Amendment of clinical trial certificate for a locally manufactured investigational product- |
||
|
(i) minor amendment |
1,333 |
|
|
(ii) major amendment |
6,500 |
|
|
6. |
Good Clinical Practice Inspection for Local Sites |
|
|
GCP inspection fee per site local sites |
50,000 |
|
|
7. |
Other Fees |
|
|
(a) Pre-clearance fees for quality assurance of imports for commercial consignments, Government ministries, departments, programmes, projects and similar institutions |
1.5% of FOB invoice value |
|
|
(b) Pre-clearance fees for quality assurance of imports for unregistered medicines and allied substance for commercial consignments, Government ministries departments, programs projects and similar institutions |
5% of FOB invoice value |
|
|
(c) Pre-clearance fees for quality assurance of imports for donations |
1% of FOB invoice value |
|
|
(d) Pre-clearance fees for quality assurance of imports for active pharmaceutical ingredients (API), bulk finished products and intermediates |
1% of FOB invoice value |
|
|
(e) Amendment to licences, certificates and permits |
167 |
|
|
(f) Duplicate licences, certificates and permits |
167 |
|
|
(g) Transfer of licences, certificates and permits |
167 |
|
|
(h) Issue of certificate of a pharmaceutical product(CPP) |
333 |
|
|
(i) Application for import of Narcotic drugs and psychotropic substances |
333 |
|
|
(j) Inspection of premises for issue of a GMP certificate (local manufacture) |
20,000 |
|
|
(k) Inspection and supervision for disposal of expired products |
3,333 |
|
|
(l) Fast track fees |
Double the applicable application fee |
|
|
(m) Restoration of marketing authorisation medicines |
|
|
|
(i) medicines |
20,000 |
|
|
(ii) allied substances |
4,000 |
|
|
(n) Inspection of register |
167 |
|
|
(o) Late submission of application for renewal of marketing authorisation in respect of locally manufactured medicines or allied substances |
33 for each day application is late |
|
PART III |
||
|
No. |
Item |
Amount |
|
1. |
Application for Marketing Authorisation of Human Medicines Imported as Finished Products |
|
|
|
(a) Generics |
2,000.00 |
|
|
(b) New chemical entities |
2,800.00 |
|
|
(c) Biologicals |
2,800.00 |
|
|
(d) Abridged Applications |
1,700.00 |
|
2. |
Application for Marketing Authorisation of Veterinary Medicines Imported as Finished Products |
|
|
|
(a) Generics |
1,750.00 |
|
|
(b) New chemical entities |
2,100.00 |
|
|
(c) Biologicals |
2,100.00 |
|
|
(d) Abridged applications |
1,550.00 |
|
3. |
Application for Marketing Authorisation Allied Substances Imported as Finished Products |
|
|
|
(a) Allied substances |
500 |
|
4. |
Evaluation of Additional Information for an Application of Medicines and Allied Substances Imported as Finished Products |
|
|
|
(a) Inadequate technical information (quality safety or efficacy) |
400.00 |
|
5. |
Annual Retention Fees for Medicines or Allied Substances Imported as Finished Products |
|
|
|
(a) Human medicines generics |
800.00 |
|
|
(b) Human medicines NCEs |
800.00 |
|
|
(c) Biologicals |
800.00 |
|
|
(d) Veterinary medicines |
700.00 |
|
|
(e) Allied substances |
200.00 |
|
6. |
Renewal of Marketing Authorisation for Medicines or Allied Substances Imported as Finished Products |
|
|
|
(a) Human medicines generics |
1,200.00 |
|
|
(b) Human medicines NCEs |
1,200.00 |
|
|
(c) Biologicals |
1,200.00 |
|
|
(d) Veterinary medicines |
1,000.00 |
|
|
(e) Allied substances |
350.00 |
|
|
(f) Late submission of application for renewal of marketing authorisation in respect of imported medicines or allied substance |
5.00 for each day application is late |
|
7. |
Amendment of Marketing Authorisation for Medicines and Allied Substances imported as finished products |
|
|
|
(a) Minor amendment |
100.00 |
|
|
(b) Major amendment |
500.00 |
|
8. |
Good Manufacturing Practices Inspection for Foreign-Based Manufacturers in Support of Applications for Marketing Authorisation per Manufacturing Site up to Five Production Lines Where all the Manufacturing Process is Carried on One Site |
|
|
|
(a) Full site: Southern Africa |
3,500.00 |
|
|
(b) Full site: Rest of Africa |
5,000.00 |
|
|
(c) Full site: Far East or Asia |
6,500.00 |
|
|
(d) Full site: Europe, America and Australia |
7,500.00 |
|
|
(e) Additional production line |
1,500.00 |
|
|
(f) Fees for GMP documents evaluation (Desk Audits) per manufacturing site |
3,500.00 |
|
9. |
Good Manufacturing Practices Inspection for Foreign-Based Manufacturers in Support of Applications for Marketing Authorisation per Manufacturing Where the Manufacturing Process Carried Out in More Than One Site in the Country Where the Main Site is Located |
|
|
|
(a) Each additional site such as warehousing for raw materials, final packaging, quality control and final release |
1,500.00 |
|
10. |
Clinical Trials involving Imported Investigational Products |
|
|
|
(a) Human clinical trial certificate involving investigational products without marketing authorisation |
3,000.00 |
|
|
(b) Human clinical trial certificate involving investigational products with marketing authorisation |
2,000.00 |
|
|
(c) Veterinary clinical trial certificate involving investigational products without marketing authorisation |
2,100.00 |
|
|
(d) Veterinary clinical trial certificate involving investigational products with marketing authorisation |
2,000.00 |
|
|
(e) Amendment of clinical trial certificate involving an imported investigational product |
|
|
|
(i) minor amendment |
100 |
|
|
(ii) major amendment |
50 |
|
11. |
Good Clinical Practice Inspection Foreign-based Bioequivalence Sites |
|
|
|
(a) Full site - per site per inspection: Southern Africa |
3,500.00 |
|
|
(b) Full site - per site per inspection: Rest of Africa |
5,000.00 |
|
|
(c) Full site - per site per inspection: Far East or Asia |
6,500.00 |
|
|
(d) Full site - per site per inspection: Europe, America and Australia |
7,500.00 |
MEDICINES AND ALLIED SUBSTANCES (IMPORTATION AND EXPORTATION) REGULATIONS
[Sections 35 and 36]
Arrangement of Regulations
Regulation
4. Application for permit to import medicine or allied substance for personal use
5. Request for additional information
6. Rejection of application for permit
13. Exemption of certain travellers from requirement to obtain permit
14. Disposal of medicines or allied substances stocked under insanitary conditions
SI 57 of 2017.
These Regulations may be cited as the Medicines and Allied Substances (Importation and Exportation) Regulations, 2017.
In these Regulations unless the context otherwise requires-
"competent authority" , in relation to a traveller entering Zambia with a medicine or allied substance for that traveller's use, means the medicines and allied substances regulatory authority in the country where the medicine or allied substance was prescribed for use by the traveller;
"dental surgeon" means a health practitioner registered as such under the Health Professions Act, 2009, or duly registered in a foreign country;
"insanitary conditions" means conditions or circumstances that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health;
"medical doctor" means a health practitioner registered as such under the Health Professions Act, 2009, or duly registered in a foreign country;
"permit" means an importation permit issued under section 35 or an exportation permit issued under section 36 of the Act;
"personal use" includes use by a person's relative or animal; and
"veterinary surgeon" has the meaning assigned to the term in the Veterinary and Veterinary Para-Professions Act, 2010, and includes a veterinary surgeon duly registered in a foreign country.
(1) A person that intends to import or export any medicine or allied substance shall apply to the Authority for a permit in Form I set out in the Schedule upon payment of the prescribed fee.
(2) An applicant for a permit to import any medicine or allied substance shall, before being issued with a permit under this regulation, pay the applicable pre-clearance fee prescribed for quality assurance in respect of the medicine or allied substance.
(3) The Authority shall, within 14 days of the receipt of an application, notify the applicant of the decision of the Authority in respect of the application.
(4) The Authority may inspect the premises where medicines or allied substances in respect of which an application for a permit is made are kept in order to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority from time to time.
(5) The Authority shall, in considering an application under this regulation, take into account-
(a) the availability on the market in the Republic of the medicines and allied substances and reasons for the intended importation or exportation;
(b) the marketing authorisation status in respect of the medicines or allied substances, where applicable;
(c) the quantities of the medicines or allied substances intended to be imported or exported; and
(d) provisions of any other relevant law.
(6) A person applying for a permit is not required to be a holder of a pharmaceutical licence.
4. Application for permit to import medicine or allied substance for personal use
(1) A person who intends to import any medicine or allied substance for personal use shall apply to the Authority for a permit to import the medicine or allied substance in Form II set out in the Schedule upon payment of the prescribed fee.
(2) The Authority shall within seven days from the date of receipt of an application under this regulation, notify the applicant of the decision of the Authority in respect of the application.
5. Request for additional information
The Authority may request an applicant to submit additional information in relation to an application for a permit in Form III set out in the Schedule.
6. Rejection of application for permit
(1) The Authority shall reject an application for a permit if the applicant-
(a) fails to comply with any condition precedent to the issue of the permit; or
(b) does not meet the requirements of the Act and guidelines issued by the Authority from time to time.
(2) The Authority may reject an application for a permit if the applicant has been convicted of an offence under the Act or any other relevant law and has been sentenced to imprisonment for a period exceeding six months during the last three years.
(3) The Authority shall, where it rejects an application under sub-regulation (1) or (2), inform the applicant of the reasons for the rejection of the application in Form IV set out in the Schedule.
(1) The Authority shall, where the applicant under regulation 3 meets the requirements of the Act, issue a permit in Form V set out in the Schedule.
(2) The Authority shall, where the applicant under regulation 4 meets the requirements of the Act, issue a permit in Form VI set out in the Schedule.
(3) A permit is valid for one year from the date of issue and only in respect of the consignment of medicines or allied substances specified in the permit.
(4) A permit holder that is not able to import or export the medicines or allied substances in respect of which the permit was issued during the period that the permit remains valid may apply for another permit in accordance with regulation 5.
(5) A permit is not renewable.
Except as otherwise provided in these Regulations, a permit holder shall not transfer the permit to another person.
(1) A permit holder that intends to amend that permit holder's permit shall apply to the Authority for amendment of the permit in Form VII set out in the Schedule upon payment of the prescribed fee.
(2) The Authority may amend a permit where-
(a) the name of a business changes;
(b) the port of entry or exit for the medicines or allied substances in respect of which the permit was issued changes; or
(c) there is a change of address of the permit holder.
(3) The Authority shall, within 14 days of the receipt of an application for amendment of a permit, inform the permit holder of its decision.
(4) A permit holder shall, where the Authority grants the application for amendment of the permit, surrender the permit to the Authority and the Authority shall issue an amended permit for the remainder of the permit's validity period in Form V set out in the Schedule.
A permit holder may, where a permit is lost, damaged or defaced, apply to the Authority for a duplicate permit in Form VIII set out in the Schedule upon payment of the prescribed fee.
(1) The Authority shall suspend a permit if the permit holder-
(a) fails to obtain any clearance or permission under any other relevant written law, where required;
(b) contravenes the terms and conditions of the permit or the provisions of the Act or any other relevant written law; or
(c) obtained the permit by fraud or deliberate or negligent submission of false information.
(2) The Authority shall, before suspending a permit, give notice to the permit holder of the intention to suspend the permit and request the permit holder to show cause, within a specified period, why the permit should not be suspended.
(3) A notice of intention to suspend a permit shall be in Form IX set out in the Schedule.
(4) The Authority shall suspend a permit if the permit holder fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of suspension of a permit shall be in Form X set out in the Schedule.
(6) A permit holder shall, where the permit is suspended, immediately surrender the permit to the Authority.
(7) A permit holder shall, during the period that the permit remains suspended, quarantine at the permit holder's cost medicines or allied substances affected by that suspension.
(1) The Authority shall revoke a permit if-
(a) the permit holder contravenes the provisions of the Act or breaches the terms and conditions of the permit;
(b) the permit holder fails to take corrective measures following the suspension of the permit;
(c) it comes to the attention of the Authority that the medicines or allied substances in respect of which the permit was issued are not suitable or have become known to be dangerous or contain substances dangerous to human health, animal health or the environment;
(d) the permit holder fails to comply with any other relevant written law; or
(e) the permit holder obtained the permit by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a permit, give notice to the permit holder of the intention to revoke the permit and request the permit holder to show cause, within a specified period, why the permit should not be revoked.
(3) A notice of intention to revoke a permit shall be in Form IX set out in the Schedule.
(4) The Authority shall revoke a permit if the permit holder fails to take remedial measures within the period specified in the notice issued under sub-regulation (2).
(5) A notice of revocation of a permit shall be in Form X set out in the Schedule.
(6) A permit holder shall, where a permit is revoked, immediately surrender the permit to the Authority.
(7) Where a permit is revoked, the medicines or allied substances affected by the revocation of the permit shall be quarantined and disposed of as directed by the Authority at the permit holder' cost.
13. Exemption of certain travellers from requirement to obtain permit
(1) Subject to sub-regulation (2), these Regulations do not apply to the importation by a traveller entering Zambia of a medicine or allied substance for that traveller's use.
(2) A traveller entering Zambia with a medicine or allied substance for that traveller' use shall furnish an inspector at the port of entry with written confirmation from the competent authority that the medicine or allied substance was prescribed for use by the traveller.
14. Disposal of medicines or allied substances stocked under insanitary conditions
The Authority shall, where it establishes that the permit holder stocks medicines or allied substances under insanitary conditions, direct the permit holder to dispose of the medicines or allied substances at the permit holder's cost.
(1) The Authority shall keep and maintain a register of permits in Form XI set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times as the Authority may specify and upon payment of the prescribed fee.
[Regulations 3, 4, 5, 6, 7, 9, 10, 11, 12 and 15]
PRESCRIBED FORMS
Form I
[Regulation 3(1)]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|
APPLICATION FOR IMPORTATION/EXPORTATION PERMIT FOR MEDICINE OR ALLIED SUBSTANCE |
||
|
Please complete in block letters |
Shaded fields for official use only |
Application No. |
|
Date/Time |
||
|
Information Required |
Information Provided |
|
|
PART I - PARTICULARS OF THE APPLICANT |
||
|
1. Name of business: |
||
|
2. Physical address: |
||
|
3. Postal address: |
||
|
4. Business premises: |
||
|
(a) Telephone number: |
||
|
(b) Fax number: |
||
|
(c) Mobile: |
||
|
(d) E-mail: |
||
|
PART II - PARTICULARS OF IMPORTATION/EXPORTATION |
||
|
5. Port of entry/exit |
|
|
|
(a) by rail to/from: ................................. station |
||
|
(b) by road via: ................................. (state port of entry/exit) |
||
|
(c) by parcel post to/from: ..................................... (state post office) |
||
|
(d) by parcel post to/from: ....................... (state airport) |
||
|
6. Reason for importation/exportation (please tick what is applicable below) |
||
|
Commercial |
||
|
Donation |
||
|
Other |
||
|
............................................................................................... |
||
|
............................................................................................... |
||
|
7. Attachments (supporting documents) |
||
|
(a) Copy of pharmaceutical licence (where applicant is holder thereof) |
||
|
(b) Copy of practitioners licence (if applicable) |
||
|
(c) Permits under other relevant laws (if applicable) |
||
|
(d) Inventory of medicines or allied substance to be imported/exported (particulars and quantities) |
||
|
8. Conditions for an application for import or export permit |
||
|
Applications must always be made by the actual importer or exporter or their authorised agent: |
||
|
(a) A proforma invoice must accompany each application |
||
|
(b) A separate application is required in respect of each consignment of medicines to be imported or exported |
||
|
(c) The prescribed fees shall be paid for an import permit and must be forwarded with application |
||
|
PART III - DECLARATION AND SIGNATURE |
||
|
I declare that the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I acknowledge that making a false or misleading statement in connection with a medicine or allied substance is an offence punishable by fine or imprisonment. |
||
|
(i) Name: ................................................... |
||
|
(b) Designation: .................................... |
||
|
(c) Signature: ................. Date: .../..../..... (dd/mm/yyyy) |
||
|
FOR OFFICIAL USE ONLY |
||
|
Date of Submission: ..................................... |
||
|
Application No.: ....................................... |
||
|
Payment Receipt No.: ................................. |
||
|
Application in Order (Proceed for inspection): ........................ |
||
|
Application Deficient (Notify applicant on deficiencies): .................... |
||
|
|
Form II
[Regulation 4(1)]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|
APPLICATION FOR PERMIT TO IMPORT MEDICINE OR ALLIED SUBSTANCE FOR PERSONAL USE |
|||
|
Please complete in block letters |
Shaded fields for official use only |
Application No. |
|
|
Date and Time |
|||
|
Information Required |
Information Provided |
|
|
|
PART I: PARTICULARS OF THE APPLICANT |
|||
|
1. |
Name: |
||
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2. |
Contact details: |
||
|
(a) Physical address |
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|
(b) Postal address |
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|
(c) Telephone No. |
|||
|
(d) Mobile phone No. |
|||
|
(e) E-mail address |
|||
|
PART II: PARTICULARS OF MEDICINE(S) OR ALLIED SUBSTANCE(S) |
|||
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3. |
Name(s) |
Quantity |
|
|
(a) |
|||
|
(b) |
|||
|
(c) |
|||
|
4. |
Attachment(s): |
||
|
Prescription issued by a medical doctor, dental surgeon (where the prescription is for medicine or allied substance connected to dental practice) or veterinary surgeon (where the prescription is for medicine or allied substance connected to veterinary practice) as the case may be |
|||
|
PART III: DECLARATION AND SIGNATURE |
|||
|
I declare that the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I acknowledge that making a false or misleading statement in connection with a medicine or allied substance is an offence punishable by fine or imprisonment. |
|||
|
(a) Name: ................................... |
|||
|
(b) Signature: ........... Date: ....../....../...... (dd/mm/yyyy) |
|
||
|
FOR OFFICIAL USE ONLY |
|||
|
Date of Submission: ........................................ |
|||
|
Application No.: ........................................... |
|||
|
Payment Receipt No.: ....................................... |
|||
|
Application Complete (Proceed to issue) ............................... |
|||
|
Application Deficient (Notify applicant on deficiencies): ........................ |
|||
|
|
Form III
[Regulation 5]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|
REQUEST FOR ADDITIONAL INFORMATION |
|
To: .................................................................................................................................................. |
|
Physical address: ............................................................................................................................. |
|
Application No.: ................................................................................................................................ |
|
Street: ............................................................................................................................................. |
|
Postal address: ................................................................................................................................ |
|
District: ............................................................................................................................................ |
|
Province: .......................................................................................................................................... |
|
You are requested to furnish, the following information or documents in respect of your application for ................................................................................ within ....................... days of this request. |
|
(a) .......................................................................................................................................... |
|
(b) .......................................................................................................................................... |
|
(c) .......................................................................................................................................... |
|
(d) .......................................................................................................................................... |
|
(e) .......................................................................................................................................... |
|
If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and be rejected. |
|
Dated this ............ day of ......................, 20........ |
|
........................................................... |
|
|
Form IV
[Regulation 6(3)]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|
NOTICE OF REJECTION OF APPLICATION |
|
1. Here insert the full names and address of the applicant |
To (1) .............................................................................................................. |
|
........................................................................................................................ |
|
|
........................................................................................................................ |
|
|
2. Here insert the reference No. of the application |
IN THE MATTER OF (2) ................................ you are hereby notified that your application for (3) ................... ............ has been rejected by the Authority on the following grounds: |
|
3. Here insert type of application |
(a) ................................. |
|
(b) ................................. |
|
|
(c) ................................. |
|
|
(d) ................................. |
|
|
Dated this ..... day of ......... 20...... |
|
|
4. Signature of Director-General |
(4) ............. |
|
|
Form V
[Regulation 7(1)]
|
|
|
|
ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
|
Permit No. ................ |
|
|
The Medicines and Allied Substances |
|
|
|
This is to certify that (Name of permit holder) ..................................................................... of (Physical |
|
Address) .......................................................................................................................................... |
|
|
......................................................................................................................................................... |
|
|
......................................................................................................................................................... |
|
|
is authorised to: |
|
|
[ ] function a15(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} function a16(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} |
1. .................................................................... .......................................... |
|
2. .................................................................... .......................................... |
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|
3. .................................................................... .......................................... |
|
|
4. .................................................................... .......................................... |
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|
[ ] Port of |
This permit is valid until ............................... 20.......... |
|
Terms and conditions imposed by the Zambia Medicines Regulatory Authority (refer to notes overleaf) |
|
|
|
|
|
............................................ (Seal) ................................ |
|
TERMS AND CONDITIONS OF IMPORTATION/EXPORTATION PERMIT |
|
1. This permit is not transferable or renewable. |
|
2. The holder of the permit shall produce the permit together with other approved or endorsed documents to an inspector and customs officer at the time of importation or exportation. |
|
3. The holder of the permit shall keep records relating to the importation or exportation of medicines or allied substances and avail the records to an inspector for inspection. |
|
4. Non-compliance with any of the terms and conditions of the permit shall result in suspension or revocation of permit. |
Form VI
[Regulation 7(2)]
|
|
|
|
ZAMBIA MEDICINES REGULATORY AUTHORITY |
|
|
Permit No. ................. |
|
|
The Medicines and Allied Substances |
|
|
IMPORTATION (PERSONAL USE) PERMIT |
|
|
This is to certify that (Name of permit holder) .................................................................................... of |
|
|
(Physical address) ........................................................................................................................... |
|
|
......................................................................................................................................................... |
|
|
......................................................................................................................................................... |
|
|
is authorised to: |
|
|
[ ] import the following |
1. .................................................................... .......................................... |
|
2. .................................................................... .......................................... |
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|
3. .................................................................... .......................................... |
|
|
4. .................................................................... .......................................... |
|
|
[ ] Port of entry .............................................................................................................................. |
|
|
This permit is valid until .................................... 20...... |
|
|
............................................ (Seal) ...................................... |
Form VII
[Regulation 9(1)]
(To be completed in triplicate)
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|
APPLICATION FOR AMENDMENT OF PERMIT |
|||
|
Please complete in block letters |
Shaded fields for official use only |
Application No. |
|
|
Date and Time |
|||
|
Information Required |
Information Provided |
|
|
|
PART I: PARTICULARS OF THE APPLICANT |
|||
|
1. |
Licence No.: |
||
|
2. |
Name(s) of applicant: |
||
|
3. |
Business address (Head Office): |
||
|
4. |
(a) Telephone No.: |
||
|
(b) Fax No.: |
|||
|
(c) Operations: |
|||
|
(d) E-mail address: |
|||
|
5. |
PART II: PARTICULARS OF AMENDMENT |
||
|
|
No. Current Information |
Description of Amendment(s) |
Reasons for Amendment |
|
1. |
|||
|
2. |
|||
|
3. |
|||
|
4. |
|||
|
5. |
|||
|
6. |
|||
|
6. |
Attachment(s) |
||
|
Attach supporting document(s) where applicable: |
|||
|
1. |
|||
|
2. |
|||
|
3. |
|||
|
PART III: DECLARATION AND SIGNATURE |
|||
|
I declare that the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I acknowledge that making a false or misleading statement in connection with a medicine or allied substance is an offence punishable by fine or imprisonment. |
|||
|
(a) Name: ................................... |
|||
|
(b) Designation: ................................. |
|||
|
(c) Signature: ......... Date: ....../....../...... (dd/mm/yyyy) |
|||
|
FOR OFFICIAL USE ONLY |
|||
|
Date of Submission: ........................................ |
|||
|
Application No.: ............................................ |
|||
|
Payment Receipt No.: ........................................ |
|||
|
Application Complete (Proceed to issue) .............................. |
|||
|
Application Deficient (Notify applicant on deficiencies): ......................... |
|||
|
|
Form VIII
[Regulation 10]
(To be completed in triplicate)
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|
APPLICATION FOR DUPLICATE PERMIT |
|||
|
Please complete in block letters |
Shaded fields for official use only |
Application No. |
|
|
Date and Time |
|||
|
Information Required |
Information Provided |
|
|
|
PART I: PARTICULARS OF THE APPLICANT |
|||
|
1. |
Permit No.: |
||
|
2. |
Name(s) of applicant: |
||
|
3. |
Business address (Head Office): |
||
|
4. |
Permit holder/Responsible person: |
||
|
Operations: |
|||
|
PART II: SUPPORTING DOCUMENTATION |
|||
|
5. |
Submit an affidavit of loss or damage, of permit and police report |
||
|
PART III: DECLARATION AND SIGNATURE |
|||
|
I declare that the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I acknowledge that making a false or misleading statement in connection with a medicine or allied substance is an offence punishable by fine or imprisonment. |
|||
|
(a) Name: ................................... |
|||
|
(b) Designation: ................................... |
|||
|
(c) Signature: ......... Date: ....../....../....... (dd/mm/yyyy) |
|||
|
FOR OFFICIAL USE ONLY |
|||
|
Date of Submission: ........................................ |
|||
|
Application No.: ............................................ |
|||
|
Payment Receipt No.: ......................................... |
|||
|
Application Complete (Proceed to issue) ............................... |
|||
|
Application Deficient (Notify applicant on deficiencies): ....................... |
|||
|
|
Form IX
[Regulation 10]
(To be completed in triplicate)
|
|
|||
|
The Medicines and Allied Substances Act, 2013 |
|||
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|||
|
NOTICE OF INTENTION TO function a20(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} |
|||
|
(1) Here insert the full names and address of the permit holder |
To (1) ........................................................................................................... |
||
|
......................................................................................................................... |
|||
|
(2) Here insert the Permit No. |
IN THE MATTER OF (2) .......................................... you are hereby notified that the Board intends to |
(a) ................................ |
|
|
(b) ................................ |
|||
|
(c) ................................ |
|||
|
(d) ................................ |
|||
|
(3) Here insert the number of days stipulated |
Accordingly, you are requested to show cause why your permit should not be function a23(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} |
||
|
Dated this ............. day of ........................., 20........... |
|||
|
(4) Signature of Director- General |
(4) ............................................... |
||
|
|
Form X
[Regulations 11(5) and 12(5)]
(To be completed in triplicate)
|
|
|||
|
The Medicines and Allied Substances Act, 2013 |
|||
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|||
|
NOTICE OF function a25(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} |
|||
|
(1) Here insert the full names and address of permit holder |
To: (1) .............................................................................................................. |
||
|
......................................................................................................................... |
|||
|
(2) Here insert the Permit No. |
IN THE MATTER OF (2) ..................................... you are hereby notified that your permit has been suspended for a period (3) .............. |
(a) ................................ |
|
|
(b) ................................ |
|||
|
(c) ................................ |
|||
|
(d) ................................ |
|||
|
(3) Here insert the number of days stipulated |
You are required to surrender the permit to the Authority immediately. |
||
|
Dated this .......... day of ..........................., 20....... |
|||
|
(4) Signature of Director- General |
(4) ............................................... |
||
|
|
Form XI
[Regulation 15(1)]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 |
|
REGISTER OF IMPORTATION AND EXPORTATION PERMITS |
|
No. |
Name of Permit Holder |
Permit Number |
|
Expiry Date |
|
|
1. |
|||||
|
2. |
|||||
|
3. |
|||||
|
4. |
|||||
|
5. |
|||||
|
6. |
|||||
|
7. |
MEDICINES AND ALLIED SUBSTANCES (CERTIFICATE OF REGISTRATION) REGULATIONS
[Section 69]
Arrangement of Regulations
Regulation
2. Application for certificate of registration
3. Request for additional information
4. Issue of certificate of registration
7. Transfer of certificate of registration
8. Amendment of certificate of registration
9. Suspension or cancellation of certificate of registration
10. Application for re-registration
11. Duplicate certificate of registration
12. Register of certificates of registration
SI 58 of 2017.
These Regulations may be cited as the Medicines and Allied Substances (Certificate of Registration) Regulations, 2017.
2. Application for certificate of registration
A person who intends to operate a pharmacy shall apply to the Authority for a certificate of registration in Form I set out in the Schedule upon payment of the prescribed fee.
3. Request for additional information
The Authority may request an applicant to submit additional information, in relation to an application, in Form II set out in the Schedule.
4. Issue of certificate of registration
The Authority shall, where the applicant meets the requirements of the Act, issue a certificate of registration in Form III set out in the Schedule.
The Authority shall, where it rejects an application, inform the applicant of the rejection in Form IV set out in the Schedule.
(1) The holder of a certificate of registration shall file with the Authority an annual return or where there has been no change in the information provided in an annual return, a no change return in Form V set out in the Schedule upon payment of the prescribed fee.
(2) The annual return shall cover the period 1st January to 31st December of the preceding financial year and the holder of a certificate of registration shall submit the return or no change return by 31st March of the following financial year.
7. Transfer of certificate of registration
An application for the transfer of a certificate of registration shall be made in Form VI set out in the Schedule upon payment of the prescribed fee.
8. Amendment of certificate of registration
A holder of a certificate of registration shall, where a change is made to the registered particulars, notify the Authority within 14 days of the change in Form VII set out in the Schedule.
9. Suspension or cancellation of certificate of registration
(1) The Authority shall, before it suspends or cancels a certificate of registration, notify the holder of the certificate of registration of the intention to suspend or cancel the certificate in Form VIII set out in the Schedule.
(2) Where the holder of a certificate of registration who is notified of the intention to suspend or cancel the certificate of registration under sub-regulation (1) fails to show cause or does not take any remedial measures to the satisfaction of the Authority within the specified time, the Authority shall suspend or cancel the certificate of registration and inform the applicant in Form IX set out in the Schedule.
10. Application for re-registration
A person whose certificate of registration is cancelled may apply for re-registration one year from the date of the cancellation of the certificate in Form I set out in the Schedule upon payment of the prescribed fee.
11. Duplicate certificate of registration
(1) A holder of a certificate of registration may apply for a duplicate certificate in Form X set out in the Schedule upon payment of the prescribed fee.
(2) The Authority may, within 14 days of receipt of an application under sub-regulation (1), issue the applicant with a duplicate certificate in Form XI set out in the Schedule.
12. Register of certificates of registration
(1) The Authority shall keep and maintain a register of certificates of registration in Form XII set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times as the Authority may determine and upon payment of the prescribed fee.
[Regulations 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12]
PRESCRIBED FORMS
Form I
[Regulations 2 and 10]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
Form II
[Regulation 3]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
|
REQUEST FOR ADDITIONAL INFORMATION |
|
Application No.: .................. |
|
To: ................................................................................................................................................. |
|
Physical address: |
|
Plot No.: ......................................................................................................................................... |
|
Street: ............................................................................................................................................ |
|
Postal address: ............................................................................................................................... |
|
District: .......................................................................................................................................... |
|
Province: ......................................................................................................................................... |
|
You are requested to furnish, within ............................. days of this Notice, the following information or documents in respect of your application for ........................................ |
|
(a) ........................................................................................................................................ |
|
(b) ........................................................................................................................................ |
|
(c) ........................................................................................................................................ |
|
(d) ........................................................................................................................................ |
|
(e) ........................................................................................................................................ |
|
If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and be rejected. |
|
Dated this ............. day of ........................, 20........ |
|
.............................................. |
|
|
Form III
[Regulation 4]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
|
CERTIFICATE OF REGISTRATION |
|
Application No.: ................... |
|
This is to certify that (Name of Pharmacy): ........................................................................................ |
|
of (physical address) ....................................................................................................................... |
|
...................................................................................................................................................... |
|
is registered as a Pharmacy. |
|
The terms and conditions of the certificate of registration are attached herewith. |
|
This Certificate is issued on the .............. day of ........................., 20........... |
|
............................................... |
|
|
|
(OVERLEAF) |
|
TERMS AND CONDITIONS |
|
1. The certificate of registration shall be displayed conspicuously on the premises. |
|
2. The holder of the certificate of registration shall, within 14 days of the changes occurring, notify the Authority of any changes in the ownership, physical address, structure of the place of business, name and location of the pharmacy, change of personnel responsible for the management or control of the pharmacy. |
|
3. The holder of the certificate of registration shall submit annual returns or no change returns by 31st March of the following financial year. |
|
4. The certificate of registration is not transferable without the written approval of the Authority. |
|
5. Where the certificate of registration is surrendered, the certificate of registration shall be considered cancelled. |
|
6. Where the certificate of registration is cancelled, the holder of the certificate shall surrender it to the Authority. |
|
7. Non-compliance with the terms and conditions of the certificate of registration shall result in the suspension or cancellation of the certificate. |
Form IV
[Regulation 5]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
|
NOTICE OF REJECTION OF APPLICATION |
|
1. Here insert the full names and address of the applicant |
To (1) ........................................................................................................... |
|
................................................................................................................... |
|
|
2. Here insert the reference No. of the application |
IN THE MATTER OF (2) ..................................... you are hereby notified that your application for (3) ....... has been rejected on the following grounds: |
|
3. Here insert type of application |
(a) .............................................................................................................. |
|
(b) .............................................................................................................. |
|
|
(c) .............................................................................................................. |
|
|
(d) .............................................................................................................. |
|
|
Dated this ............ day at ......................, 20......... |
|
|
.............................................. |
|
|
|
Form V
[Regulation 6(1)]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
|
ANNUAL RETURN ( ) NO CHANGE RETURN ( ) |
|
PART I: PARTICULARS OF CERTIFICATE HOLDER |
Form VI
[Regulation 7]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
|
PART IV - ENCLOSURES |
|
Evidence of transfer between certificate holder and the prospective certificate holder |
|
FOR OFFICIAL USE ONLY |
|
Date of Submission: ..................................................................................................................... |
|
Application No.: ........................................................................................................................... |
|
Payment Receipt No.: .................................................................................................................. |
|
Application Complete (Proceed for evaluation): ............................................................................... |
|
Application Deficient (Refer to applicant for additional information): .................................................... |
|
|
Form VII
[Regulation 8]
|
|
|
The Medicines and Allied Substances Act, 2013 |
|
The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
|
NOTIFICATION OF AMENDMENT OF CERTIFICATE OF REGISTRATION |
|
PART I: PARTICULARS OF CERTIFICATE HOLDER |
|
Name of business: ......................................... |
|
Certificate of Registration No.: ............... Date of issue ................ |
|
Name of Pharmacist/Responsible person ................................ |
|
PART I: PARTICULARS OF AMENDMENT |
|
|
No. |
Description of amendment(s) |
|
1. |
|
|
2. |
|
|
3. |
|
SUMMARY OF THE AMENDMENT |
|||
|
EXISTING |
PROPOSED AMENDMENT |
DATE OF AMENDMENT |
REASONS FOR AMENDMENT |
|
PART III: SUPPORTING DOCUMENTATION |
|||
|
Please submit documents, where applicable, to support your application for amendment. |
|||
|
PART IV: DECLARATION AND SIGNATURE |
|
I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. |
|
Particulars of the Person Signing on Behalf of the Applicant |
|
(a) Name: ........................................................................................................................... |
|
(b) Designation: ................................................................................................................... |
|
(c) Signature: ..................................... (d) Date: ............./........../................. (dd/mm/yyyy) |
|
FOR OFFICIAL USE ONLY |
|
Date of Submission: ..................................................................................................................... |
|
Application No.: ........................................................................................................................... |
|
Payment Receipt No.: .................................................................................................................. |
|
Application Complete (Proceed for evaluation): ............................................................................... |
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Application Deficient (Refer to applicant for additional information): .................................................... |
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Form VIII
[Regulation 9(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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NOTICE OF INTENTION TO SUSPEND OR CANCEL CERTIFICATE OF REGISTRATION |
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Certificate of Registration No.: .................. |
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To: ...................................................................................................................... |
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........................................................................................................................... |
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IN THE MATTER OF .................................................. you are hereby notified that the Authority intends to |
(a) .................................................................................................................................... |
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(b) .................................................................................................................................... |
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(c) .................................................................................................................................... |
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(d) .................................................................................................................................... |
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Accordingly, you are requested to show cause why your certificate of registration should not be function a30(msg) { myWindow=window.open('','','width=234,height=156,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100');myWindow.document.write(msg);} |
Dated this .......... day of ........................., 20....... |
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.......................................... |
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Form IX
[Regulation 9(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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NOTICE OF |
Certificate of Registration No.: ................ |
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To: ...................................................................................................................... |
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........................................................................................................................... |
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IN THE MATTER OF ........................... you are hereby notified that your certificate of registration has been |
(a) .................................................................................................................................... |
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(b) .................................................................................................................................... |
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(c) .................................................................................................................................... |
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(d) .................................................................................................................................... |
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In case of cancellation, you are required to surrender the certificate of registration to the Authority within seven days from the date of cancellation. |
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Dated this ........... day of ........................., 20......... |
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........................................... |
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Form X
[Regulation 11(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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APPLICATION FOR DUPLICATE CERTIFICATE OF REGISTRATION |
Form XI
[Regulation 11(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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DUPLICATE CERTIFICATE OF REGISTRATION |
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No.: ................ |
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This is to certify that (Name of Pharmacy) ...................................................................................... |
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................................................................................................................................................... |
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of (physical address) ................................................................................................................... |
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................................................................................................................................................... |
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is registered as a Pharmacy. |
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The conditions of the certificate of registration are attached herewith. |
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This certificate is issued on .......... day of ...................., 20........ |
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........................................ |
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Form XII
[Regulation 12(1)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 |
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REGISTER OF CERTIFICATES OF REGISTRATION |
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No. |
Name and Address of Pharmacy |
Certificate Number |
Date of Issue |
Date of Suspension/Cancellation |
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1. |
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2. |
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3. |
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4. |
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5. |
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7. |
MEDICINES AND ALLIED SUBSTANCES (PHARMACEUTICAL LICENCE) REGULATIONS
[Section 34]
Arrangement of Regulations
Regulation
4. Request for additional information
5. Rejection of application for licence
13. Handling of expired, withdrawn, obsolete or unwanted medicines
17. Distribution and wholesale by manufacturer
18. Personnel in wholesale premises
SI 91 of 2018.
These Regulations may be cited as the Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018.
In these Regulations unless the context otherwise requires-
"authorised product" means a product for which marketing authorisation has been granted in accordance with section 39 of the Act;
"good manufacturing practice" means quality assurance that ensures that a pharmaceutical product is produced and controlled to the quality standards appropriate for its intended use and as required by the marketing authorisation;
"insanitary condition" means a condition or circumstance that could cause contamination of a medicine or allied substance with dirt or filth or could render the medicine or allied substance injurious or dangerous to health;
"licence" means a pharmaceutical licence issued under section 34 of the Act;
"licensee" means a holder of a licence;
"pharmacist" means a person registered as a pharmacist in accordance with the Health Professions Act, 2009;
"pharmacy technologist" means a person registered as a pharmacy technologist in accordance with the Health Professions Act, 2009;
"phase I clinical trial" means the first trial of a new active ingredient or new formulation in humans or target animal species, often carried out in healthy participants or volunteers to establish a preliminary evaluation of safety, and a first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in humans or target animal species;
"phase II clinical trial" means a pilot clinical trial undertaken in selected populations of patients with the disease or condition intended to be prevented, diagnosed or treated in order to evaluate the safety and efficacy of the medicine or allied substance being tried;
"primary repackaging" means the part of manufacturing that involves packing of the finished dosage form or device into its primary packaging material;
"repacking of medicine" means the act of removing a preparation from its original primary container and placing it into a patient pack, but does not include the act of cutting a blister pack;
"responsible person" means a pharmacist, veterinary surgeon, veterinary para professional or pharmacy technologist;
"secondary repackaging" means the part of manufacturing that involves repacking of medicines into secondary or tertiary packaging material which does not come in direct contact with the finished dosage form or device;
"suitably qualified person" means a pharmacist or veterinary surgeon providing supervisory services to a wholesale outlet;
"veterinary biological" means a virus, vaccine, serum or analogous products used for the purpose of diagnosis or treatment of animal diseases;
"veterinary para professional" means a person registered as a livestock officer or veterinary assistant in accordance with the Veterinary and Veterinary Para Professions Act, 2010;
"veterinary surgeon" means a person registered as a veterinary surgeon in accordance with the Veterinary and Veterinary Para Professions Act, 2010; and
"wholesale" means the buying of medicines or allied substances in bulk for the purpose of reselling to authorised pharmaceutical wholesale dealers, retail pharmacy outlets, hospital pharmacies, agro veterinary shops, health shops or other health facilities for human beings or animals.
(1) A person who intends to manufacture, distribute or deal in any medicine or allied substance shall apply to the Authority for a licence in Form I set out in the Schedule, on payment of the prescribed fee.
(2) A person who intends to manufacture, distribute or deal in any medicine or allied substance at more than one premises shall apply for a licence in respect of each of the premises.
(3) The Authority shall inspect the premises in respect of which an application for a licence is made to determine if the applicant meets the requirements of the Act and the guidelines issued by the Authority from time to time.
4. Request for additional information
The Authority may request an applicant to submit additional information in relation to an application for a licence in Form II set out in the Schedule.
5. Rejection of application for licence
(1) The Authority shall reject an application for a licence if the-
(a) applicant fails to comply with a condition precedent to the issue of the licence;
(b) applicant fails to meet the requirements of the Act;
(c) licence previously issued to the applicant was revoked by the Authority within the period of five years preceding the date of application; or
(d) applicant is convicted of an offence under the Act or any other relevant written law within a period of two years preceding the date of the application.
(2) The Authority shall, where it rejects an application under sub-regulation (1), inform the applicant of the reason for that rejection in Form III set out in the Schedule.
(1) The Authority shall, where the applicant meets the requirements of the Act, issue a licence in Form IV set out in the Schedule.
(2) A licence is valid for two years from the date of issue.
(3) A responsible person shall manage the premises in respect of which a licence has been issued.
(1) A licensee who intends to renew that licensee's licence shall, at least 90 days before the expiry of the licence, apply to the Authority for renewal of the licence in Form V set out in the Schedule, on payment of the prescribed fee.
(2) The Authority may renew a licence in respect of an application if the applicant meets the requirements of the Act and complies with the terms and conditions of the earlier licence.
(3) The Authority shall, where it renews a licence, issue a new licence.
(4) A licence that is not renewed by the Authority shall lapse on its date of expiry.
(1) A licence shall be used solely by the licensee and is not transferable to any other person without the prior approval of the Authority.
(2) A licensee who intends to transfer the licensee's licence shall apply to the Authority for approval to transfer the licence in Form VI set out in the Schedule, on payment of the prescribed fee.
(3) The Authority shall, where it approves the transfer of a licence, issue the transferee with a licence for the remainder of the validity period of the licence issued to the transferor.
(4) The Authority shall reject an application for the transfer of a licence if the applicant fails to comply with the conditions for the grant of the licence and the provisions of the Act and the guidelines issued by the Authority.
(5) The Authority shall, where it rejects an application to transfer a licence in accordance with sub-regulation (4), inform the applicant of the reasons for the rejection in Form III set out in the Schedule.
(1) A licensee who intends to amend the licensee's licence shall apply to the Authority for amendment of the licence in Form VII set out in the Schedule, upon payment of the prescribed fee.
(2) The Authority may amend a licence where the name of the business or the suitably qualified person changes.
(3) The Authority shall, within 14 days of receipt of the application for amendment of the licence, approve or reject the amendment.
(4) Where the Authority fails to inform the licensee of its decision within 14 days, the amendment shall be considered to be approved.
A licensee may, where a licence is lost, damaged or defaced, apply to the Authority for a duplicate licence in Form VIII set out in the Schedule, upon payment of the prescribed fee.
(1) The Authority shall suspend a licence if the licensee-
(a) operates the business in respect of which it is issued under insanitary conditions;
(b) obtains or sells medicine from an unauthorised supplier or stock or sell an unauthorised product;
(c) fails to maintain the required records on medicines or allied substances; or
(d) contravenes the terms and conditions of the licence or the provisions of the Act or any other relevant written law.
(2) The Authority shall, before suspending a licence, give notice to the licensee of the intention to suspend the licence and request the licensee to show cause, within a specified period, why the licence should not be suspended.
(3) A notice of intention to suspend a licence shall be in Form IX set out in the Schedule.
(4) The Authority shall suspend a licence if the licensee fails to take remedial measures within the period specified in the notice issued in accordance with sub-regulation (2).
(5) A notice of suspension of a licence shall be in Form X set out in the Schedule.
(6) A product affected by the suspension of the licence shall be quarantined at the cost of the licensee during the period of the suspension of the licence.
(7) The Authority shall, where it is established that the licensee manufactures, distributes or deals in a medicine or allied substance under insanitary conditions, direct the licensee to dispose of that medicine or allied substance.
(1) The Authority shall revoke a licence if the licensee-
(a) contravenes the provisions of the Act or breaches the terms and conditions of the licence;
(b) fails to take corrective measures following the suspension of the licence;
(c) changes the business premises without authorisation;
(d) fails to comply with any other relevant written law; or
(e) obtained the licence by fraud or deliberate or negligent submission of false information or statements.
(2) The Authority shall, before revoking a licence, give notice to the licensee of the intention to revoke the licence and request the licensee to show cause, within a specified period, why the licence should not be revoked.
(3) A notice of intention to revoke a licence shall be in Form IX set out in the Schedule.
(4) The Authority shall revoke a licence if the licensee fails to take remedial measures during the period specified by the Authority.
(5) A notice of revocation of a licence shall be in Form X set out in the Schedule.
(6) Where a licence is revoked, the products on the premises and the recalled products shall be quarantined as directed by the Authority at the former licensee's cost, including the disposal of the products.
(7) The Authority may, where the former licensee fails to comply with a directive issued by the Authority in accordance with sub-regulation (6), deal with the products in a manner the Authority may consider appropriate.
13. Handling of expired, withdrawn, obsolete or unwanted medicines
(1) A licensee shall store a withdrawn, obsolete, unwanted, expired medicines or allied substance in an appropriate container clearly labelled "for destruction within a specified period of time" as stipulated in the guidelines.
(2) A person who contravenes sub-regulation (1) commits an offence and is liable, upon conviction, to a fine not exceeding two thousand five hundred penalty units, and in the case of a continuing offence to a fine not exceeding twenty-five penalty units for each day that the offence continues.
(3) In addition to the penalty provided in sub-regulation (2), the court before which a person is convicted of an offence in accordance with this regulation may order-
(a) that any medicine or allied substance in respect of which the offence is committed be forfeited to the State; and
(b) that the costs for disposal of a medicine or allied substance be borne by the convict.
The Authority may conduct an inspection to ensure compliance with the minimum prescribed requirements for the manufacture, distribution or dealing of a medicine or allied substance.
These Regulations do not apply to a medicine or allied substance manufactured in accordance with guidelines issued by the Authority if the medicine is-
(a) for a pre clinical trial, phase I clinical trial or phase II clinical trial;
(b) compounded by a-
(i) pharmacist for supply within the pharmacy or hospital setting; or
(ii) veterinary surgeon for supply within an agro veterinary shop or health facility for animals;
(c) a human or veterinary biological medicine manufactured by a Government institution for purposes of disease prevention and control; or
(d) a blood product prepared by a veterinary surgeon for administration to animals under that veterinary surgeon's care.
(1) The Authority shall keep and maintain a register of licences in Form XI set out in the Schedule.
(2) The register referred to in sub-regulation (1) shall be kept at the offices of the Authority and shall be open to inspection by the public at such times and upon payment of the prescribed fee.
(3) A person may, upon payment of the prescribed fee, require a copy or extract of any particulars from the register to be certified by the Director General.
(4) Any document purported to be an extract or copy of any entry in the register and duly certified to be a true copy or extract under the hand of the Director General shall be received in evidence as to the matters stated therein in any legal proceedings.
17. Distribution and wholesale by manufacturer
(1) A licensee that is a manufacturer may distribute or undertake the wholesale of medicines or allied substances manufactured under that licence.
(2) Despite sub-regulation (1), a licensee that is a manufacturer dealing in medicines or allied substances manufactured by another manufacturer shall not undertake the wholesale of the medicines or allied substances manufactured by the other manufacturer.
(3) A manufacturer that intends to undertake the wholesale of a medicine or allied substance manufactured by another manufacturer shall apply to the Authority for a separate licence.
18. Personnel in wholesale premises
(1) A licensee that is a wholesale dealer in medicines or allied substances for the use in or on humans or animals shall employ a pharmacist on a full time basis for purposes of the wholesale of the medicines or allied substances and may, in addition to the pharmacist, employ a pharmacy technologist.
(2) A licensee that is a wholesale dealer in medicines or allied substances for use in or on animals shall employ a veterinary surgeon on a full time basis for the purposes of the wholesale of the medicines or allied substances and may, in addition to the veterinary surgeon, employ a veterinary para professional.
(3) A licensee that is a wholesale dealer and employs a pharmacist or veterinary surgeon on a part time basis for purposes of the wholesale of medicines or allied substances shall, in addition to the veterinary surgeon or pharmacist, employ a pharmacy technologist or veterinary para professional on a full time basis, as the case may be.
A person who contravenes a provision of these Regulations for which a penalty is not provided commits an offence and is liable, upon conviction, to a fine not exceeding two thousand five hundred penalty units, and in the case of a continuing offence to a fine not exceeding twenty-five penalty units for each day that the offence continues.
[Regulations 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 16]
PRESCRIBED FORMS
FORM I
[Regulation 3(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM II
[Regulation 4]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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REQUEST FOR ADDITIONAL INFORMATION |
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To: ......................................................... |
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Address: ....................................................... |
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Application No.: .................................................... |
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You are requested to furnish the following information or documents in respect of your application for ........... within ............... days of this notice. |
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(a) ..................................................... |
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(b) ..................................................... |
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(c) ..................................................... |
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(d) ..................................................... |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and be rejected. |
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Dated this ..... day of ........... 20.. |
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............. |
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FORM III
[Regulations 5(2) and 8(5)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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NOTICE OF REJECTION OF APPLICATION |
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(1) Here insert name and address of the applicant |
To (1) ................................................................................................ |
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......................................................................................................... |
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(2) Here insert the reference No. of the application |
IN THE MATTER OF (2) .................................................. you are notified that your application for (3) ........... has been rejected by the Authority on the following grounds: |
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(3) Here insert type of application |
(a) .................................................................................................... |
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(b) .................................................................................................... |
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(c) .................................................................................................... |
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(d) .................................................................................................... |
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Dated this ..... day of .......... 20.. |
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(4) Signature of Director- General |
(4) .............................................. |
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FORM IV
[Regulation 6(1)]
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PHARMACEUTICAL LICENCE TERMS AND CONDITIONS |
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Non-compliance with any of the conditions stated below will result in suspension or revocation of licence. |
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The licensee shall- |
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(a) comply with the minimum current good manufacturing practice (cGMP) or Good Distribution Practices (GDP) as may be applicable and cause to be obtained marketing authorisation in Zambia (where applicable) of all such products as are manufactured and conform to such other standards as may be specified by the Authority from time to time; |
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(b) comply with relevant regulations and guidelines specific to the licence; |
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(c) conspicuously display the licence at the premises where the activities conducted; |
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(d) maintain such staff, premises, equipment and facilities for manufacture, or distribution of the medicinal products as applicable at the time of grant of the licence; |
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(e) where the licensee is licensed to manufacture medicines or allied substances and wishes to manufacture additional dosage forms not included in the attached list, submit an application to the Authority for the inclusion of the additional dosage forms and this licence shall be deemed to extend to the dosage form so included; |
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(f) keep readily available for inspection by an inspector of the Authority, durable records of documentation as specified in the guidelines; |
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(g) notify the Authority of any changes that require an amendment to the licence; and |
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(h) where the licence is revoked surrender it to the Authority immediately. |
FORM V
[Regulation 7(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM VI
[Regulation 8(2)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM VII
[Regulation 9(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM VIII
[Regulation 10]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
FORM IX
[Regulations 11(3) and 12(3)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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NOTICE OF INTENTION TO *SUSPEND/REVOKE PHARMACEUTICAL LICENCE |
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(1) Here insert the full names and address of the licensee |
To (1) ........................................................................................................ |
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................................................................................................................. |
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(2) Here insert the licence No. |
IN THE MATTER OF (2) ............................................. you are notified that the Authority intends to *suspend/revoke your licence on the following grounds: |
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(a) ........................................................................................................... |
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(b) .......................................... |
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(c) ............................................... |
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(d) ............................................ |
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Accordingly, you are requested to show cause why your licence should not be *suspended/revoked and to take action to remedy the breaches set out in paragraphs ........... (above) within (3) ..... days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/revocation of your licence. |
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(3) Here insert type of application |
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Dated this ............. day of ........................ 20........ |
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(4) Signature of Director- General |
(4) ............................................ |
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FORM X
[Regulations 11(5) and 12(5)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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NOTICE OF *SUSPENSION/REVOCATION OF PHARMACEUTICAL LICENCE |
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(1) Here insert the full names and address of the licensee |
To (1) ........................................................................................................ |
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................................................................................................................. |
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(2) Here insert the licence No. |
IN THE MATTER OF (2) .............................................................. you are notified that your licence has been *suspended for a period of (3) ........ /revoked on the following grounds: |
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(3) Here insert number of days stipulated |
(a) .......................................................................................................... |
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(b) ......................................... |
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(c) ......................................... |
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(d) .......................................... |
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Dated this .............. day of ...................... 20........ |
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(4) Signature of Director- General |
(4) ....................................... |
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FORM XI
[Regulation 16(1)]
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ZAMBIA MEDICINES REGULATORY AUTHORITY |
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018 |
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REGISTER OF PHARMACEUTICAL LICENCES |
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No. |
Name of Licensee |
Licence Number |
Date of Issue |
Expiry Date |
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1. |
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2. |
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3. |
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4. |
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5. |
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6. |
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7. |
MEDICINES AND ALLIED SUBSTANCES (MARKETING AUTHORISATION OF MEDICINES) REGULATIONS
[Sections 39 and 69]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY PROVISIONS
PART II
MARKETING AUTHORISATION OF MEDICINES
3. Application for marketing authorisation
4. Request for additional information
5. Grant of marketing authorisation
7. Validity of marketing authorisation
9. Amendment of marketing authorisation
10. Surrender of marketing authorisation
11. Transfer of marketing authorisation
12. Suspension of marketing authorisation
13. Restoration of marketing authorisation
14. Revocation of marketing authorisation
15. Application for duplicate marketing authorisation
16. Renewal of marketing authorisation
PART III
CATEGORY OF DISTRIBUTION OF MEDICINE
18. Categories of distribution of medicines
19. Re-categorisation of Medicine
PART IV
LABELLING AND PACKAGING
20. Labelling and packaging requirements for medicine
21. Package insert for medicine
22. Patient information leaflet
23. Revocation of S.I. No. 47 of 1993
SI 79 of 2019.
PART I
PRELIMINARY PROVISIONS
These Regulations may be cited as the Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019.
In these Regulations, unless the context otherwise requires-
"active pharmaceutical ingredient" means a substance intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body, and may be used as is or in the manufacture of a pharmaceutical dosage form;
"batch" means a defined quantity of a starting material, packaging or medicinal product processed in a single process or series of processes and expected to be homogeneous;
"bio-availability" means the rate and extent of availability of an active pharmaceutical ingredient from a dosage form as determined by its concentration time curve in the systemic circulation or by its excretion in urine;
"bio-equivalence data" means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical alternatives becomes available at the site of drug action administered;
"commercial pack" means the presentation of a finished medicinal product as it will be placed on market;
"composition" means a tabulation of ingredients represented in form of proportion, degree of strength, quality and purity in which the ingredients are contained in a medicinal product;
"container" means a bottle, jar, box, packet, sachet or other receptacle, not being a capsule or other article, in which the product is or is to be administered or consumed, and where the receptacle is or is to be contained in another receptacle, includes the former receptacle but not the latter receptacle;
"description of the product" means a full visual description of the medicinal product, including colour, size, shape and other relevant features;
"dosage form" means the form in which a medicinal product is presented, such as solution, suspension, elixir, eye drop, emulsion, ointment, suppository, tablet or capsule;
"excipient" means a substance intended to be used as is or in the manufacture of a medicinal product for a specific function, but does not exert pharmacological activity;
"expiry date" means the date given by the manufacturer and placed on the container of a medicinal product up to which the product is expected to remain within the given specifications if stored according to manufacturer's instructions;
"finished pharmaceutical product" means a product that has undergone all the stages of production, including packaging in its final container and labelling;
"formulation" means the composition of a dosage form, including the characteristics of its raw materials and the operations required to process it;
"general sale medicine (GS)" means a medicine which is intended to be supplied or sold without a prescription with or without the supervision of a registered pharmacist in a pharmacy or in any other licensed premises;
"general sale medicines veterinary (GSV)" means veterinary medicine which is intended to be supplied by any retailer approved by the Authority;
"herbal medicine" includes a herb, herbal material, herbal preparation and finished herbal product that contains as an active ingredient, a part of a plant or other plant material or combination;
"holder of marketing authorisation" means a person to whom a medicinal product has been issued a market authorisation and is responsible for all aspects of the medicinal product including quality, safety, efficacy and compliance with conditions of marketing authorisation;
"international non proprietary name" means a unique name of a medicine that is globally recognised and is public property;
"labelling" means affixing to or displaying on a container or package, the product information, ingredients and content of the product;
"local responsible person" means a person residing in Zambia and appointed in accordance with regulation 17;
"marketing authorisation number" means an identification number issued to a medicinal product granted marketing authorisation;
"pharmacy medicine (P)" means a medicine which is intended to be supplied or sold without a prescription but under the supervision of a registered pharmacist;
"pharmacy medicines veterinary (PV)" means veterinary medicine which is intended to be supplied by a registered veterinary surgeon, pharmacist or veterinary para professional with or without a prescription;
"prescription only medicine (POM)" means a medicine which is intended to be supplied, sold or dispensed only under a prescription issued by an authorised prescriber;
"prescription only medicine veterinary (POM V)" means veterinary medicines which is intended to be supplied on prescription by a veterinary surgeon;
"proprietary name" means the trade or brand name that is unique to a particular medicine and by which it is generally identified;
"quality standard" means the specifications used to control the nature, strength, purity, composition, quantity or other characteristics of an ingredient or finished pharmaceutical product to ensure that it is fit for its purpose;
"shelf life" means the period of time during which an active pharmaceutical ingredient or medicinal product, if stored correctly, is expected to comply with the approved specification as determined by stability studies on a number of batches of the active pharmaceutical ingredient or medicinal product;
"stability" means the ability of a medicine to retain its properties within approved specifications throughout its shelf life;
"WHO type certificate of a pharmaceutical product" means a certificate of the type defined in the World Health Organisation certification scheme on the quality of pharmaceutical products in international commerce; and
"veterinary medicine" means a substance or mixture of substances manufactured, sold or presented for use in-
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in an animal;
(b) restoring, correcting or beneficial modification of organic or mental functions in an animal; and
(c) an article intended for use as a component of any article specified in paragraphs (a) or (b), but does not include a medical device or its component, part or accessory.
PART II
MARKETING AUTHORISATION OF MEDICINES
3. Application for marketing authorisation
(1) A person who intends to place a medicine on the market shall apply to the Authority for a marketing authorisation in Form I set out in the Schedule on payment of the fee set out in the Medicines and Allied Substances (Fees) Regulations, 2016.
(2) The application referred to in sub-regulation (1) shall be accompanied by-
(a) at least two samples of the product in the smallest proposed commercial pack size;
(b) a dossier which shall contain-
(i) a summary and overview of quality, non-clinical and clinical data;
(ii) chemical, pharmaceutical and biological data relevant to the application;
(iii) non-clinical data, where applicable; and
(iv) clinical or bio-equivalence data;
(c) in the case of a herbal medicine, documentation relating to the quality assessment, safety assessment and efficacy assessment of the herbal medicine; and
(d) any other information relating to the safety, quality and efficacy of the medicine in respect of which the application is made.
(3) The Authority shall, on receipt of an application for a marketing authorisation, conduct an assessment to evaluate the safety, quality and efficacy of the medicine in respect of which the application is made.
4. Request for additional information
The Authority may request an applicant to submit additional information or samples in relation to an application in Form II set out in the Schedule on payment of a prescribed fee.
5. Grant of marketing authorisation
The Authority shall grant a marketing authorisation in Form III set out in the Schedule, if the Authority is satisfied-
(a) with the information submitted on the safety, quality and efficacy of the medicine;
(b) with the labeling and packaging of the medicine;
(c) with the indications, dosage form, dosage and route of administration of the medicine; and
(d) that the medicine is manufactured in compliance with the requirements of current good manufacturing practices as recommended by the World Health Organisation or any other recognised entity.
(1) The Authority shall reject an application for marketing authorisation if-
(a) the applicant fails to meet the requirements for the issue of the marketing authorisation;
(b) there is insufficient data to support the safety, quality and efficacy of the product;
(c) in the case of a local manufacturer, the pharmaceutical licence to manufacture is suspended or revoked;
(d) an ingredient contained in the medicine is banned or not recommended for any other reason as determined by the Authority;
(e) the medicine in respect of which the application is made is considered unregistrable based on treatment guidelines or disease patterns in the Republic; and
(f) the applicant provides false information in the application.
(2) The Authority shall, where it refuses a marketing authorisation under sub-regulation (1), inform the applicant in Form IV set out in the Schedule.
7. Validity of marketing authorisation
A marketing authorisation is valid for five years, subject to the terms and conditions of the market authorisation.
(1) The holder of a marketing authorisation shall pay an annual retention fee to the Authority in respect of the following year at the end of every year during which the authorisation is valid, except the year when the authorisation is granted.
(2) The annual retention fee for the following year shall be-
(a) effective from 1st January of the year following the grant of the marketing authorisation; and
(b) paid to the Authority by 31st December of each year.
(3) Where a marketing authorisation is granted during the last quarter of a calendar year, the holder of the marketing authorisation shall be exempted from paying the annual retention fee for the following year.
(4) Where the holder of a marketing authorisation fails to pay the annual retention fee by 31st December for a particular product-
(a) the marketing authorisation issued in respect of that product shall be suspended;
(b) the Authority shall not authorise the importation of the product;
(c) in case of locally manufactured products, the Authority shall not authorise the continued manufacture of the product; and
(d) the marketing authorisation in respect of the product may be revoked by the Authority.
9. Amendment of marketing authorisation
(1) A person who wishes to amend a marketing authorisation shall apply to the Authority in Form V set out in the Schedule on payment of a prescribed fee.
(2) The Authority shall, within 90 days from the date of receipt of an application for the amendment of a marketing authorisation, consider the application and notify the holder of the marketing authorisation of its decision.
10. Surrender of marketing authorisation
Where the holder of a marketing authorisation decides not to continue with the business to which the marketing authorisation relates, the holder shall notify the Authority and surrender the marketing authorisation.
11. Transfer of marketing authorisation
(1) A marketing authorisation is solely for use by the holder of the marketing authorisation and is not transferable to any other person without the prior approval of the Authority.
(2) A person who wishes to transfer a marketing authorisation shall apply to the Authority in Form VI set out in the Schedule on payment of a prescribed fee.
(3) The Authority shall, within 60 days from the date of receipt of the application for the transfer of the marketing authorisation, notify the applicant of the decision of the Authority in respect of the application.
(4) Where the Authority approves the transfer of a marketing authorisation, it shall issue a new marketing authorisation to the transferee.
12. Suspension of marketing authorisation
(1) The Authority may suspend a marketing authorisation if-
(a) there are concerns regarding the safety, quality or efficacy of the medicine to which it relates;
(b) the holder of the marketing authorisation fails to pay the annual retention fee;
(c) the holder of the marketing authorisation fails to comply with any term or condition of the marketing authorisation; or
(d) the medicine in respect of which the marketing authorisation was issued poses a risk or threat to public health.
(2) The Authority shall, before suspending a marketing authorisation, give notice to the holder of a marketing authorisation of the intention to suspend the marketing authorisation in Form VII set out in the Schedule.
(3) The Authority shall, if the holder of a marketing authorisation fails to remedy the defects within the period specified by the Authority in the notice issued in sub-regulation (2), suspend the marketing authorisation and notify the holder of the marketing authorisation in Form VIII set out in the Schedule.
(4) The holder of a marketing authorisation shall, during the period of suspension of a marketing authorisation, quarantine the affected medicine as directed by the Authority at the holder of the marketing authorisation's cost.
13. Restoration of marketing authorisation
(1) The Authority may restore a suspended marketing authorisation if the Authority is satisfied that corrective measures have been taken by the holder of the marketing authorisation as directed by the Authority.
(2) The Authority shall issue the notice of restoration of a suspended marketing authorisation in Form IX set out in the Schedule.
14. Revocation of marketing authorisation
(1) The Authority may revoke a marketing authorisation if the holder-
(a) contravenes the terms and conditions of the marketing authorisation;
(b) manufactures medicine that does not comply with the quality standard for that medicine;
(c) fails to comply with current good manufacturing practices;
(d) fails to comply with the terms and conditions for the suspension under regulation 12; or
(e) obtained the authorisation on the basis of fraud, negligence or misrepresentation.
(2) The Authority shall, before revoking a marketing authorisation, give notice to the holder of the marketing authorisation of the intention to revoke the marketing authorisation in Form X set out in the Schedule.
(3) The Authority shall, where the holder of a marketing authorisation fails to remedy the breaches specified in the notice within the period specified by the Authority, revoke the marketing authorisation and notify the holder in Form XI set out in the Schedule.
(4) The holder of a marketing authorisation shall, on the revocation of the marketing authorisation, recall and quarantine or dispose of the medicine to which the revocation relates as directed by the Authority at the holder of the marketing authorisation's cost.
15. Application for duplicate marketing authorisation
(1) A holder of a marketing authorisation whose marketing authorisation is lost, defaced or damaged may apply for a duplicate marketing authorisation in Form XII set out in the Schedule on payment of a prescribed fee.
(2) The Authority shall, within 14 days of receipt of an application under sub-regulation (1), issue a duplicate marketing authorisation to the applicant.
16. Renewal of marketing authorisation
(1) A person who wishes to renew a marketing authorisation shall apply to the Authority at least 180 days before the expiry date of the marketing authorisation in Form XIII set out in the Schedule on payment of a prescribed fee.
(2) An application for the renewal of a marketing authorisation shall be accompanied by-
(a) a consolidated report of any amendments made to the marketing authorisation, including adverse drug reaction reports and safety updates; and
(b) the product quality review report.
(3) The Authority shall renew a marketing authorisation if the holder has complied with the terms and conditions of the marketing authorisation.
(4) The Authority shall, where the Authority refuses to renew a marketing authorisation, notify the applicant in Form IV set out in the Schedule.
(5) A holder of a marketing authorisation whose application for renewal has been rejected may submit an application for a marketing authorisation in accordance with regulation 3.
(1) Subject to the Companies Act, 2017 and any other relevant written law, a foreign based applicant shall appoint a local responsible person to-
(a) submit an application, document and sample of products to the Authority on behalf of the applicant or holder of the marketing authorisation; and
(b) receive the decision of the Authority relating to the application on behalf of the applicant or holder of the marketing authorisation.
(2) Subject to sub-regulation (1), where the application is granted, the holder of the marketing authorisation shall ensure that a local responsible person implements the pharmacovigilance plan on behalf of the foreign holder of the marketing authorisation.
PART III
CATEGORY OF DISTRIBUTION OF MEDICINE
18. Categories of distribution of medicines
(1) The Authority shall, where it grants a marketing authorisation, specify the appropriate category of distribution of the medicine which relates to the marketing authorisation.
(2) A person may sell or supply medicine for human use under the following categories-
(a) prescription only medicine;
(b) pharmacy medicine; and
(c) general sale medicine.
(3) A person may sell or supply veterinary medicine under the following categories-
(a) prescription only medicine-veterinary;
(b) pharmacy medicine veterinary; and
(c) general sale medicine veterinary.
19. Recategorisation of medicine
The Authority shall take into consideration the safety profile of the medicine when determining the category of distribution and may move certain medicines from one category to another.
PART IV
LABELLING AND PACKAGING
20. Labelling and packaging requirements for medicine
(1) A holder of a marketing authorisation shall label the primary package or container of a medicine to show-
(a) the name and dosage form of the medicine;
(b) the name and quantity of active pharmaceutical ingredient or in case of a herbal medicine, a botanical, english or other name, and the quantity of each ingredient;
(c) the quantity or volume of the medicine per unit pack;
(d) the indications and directions for use, including the target species in case of veterinary medicine;
(e) the storage instructions;
(f) the expiry date;
(g) the batch number;
(h) the marketing authorisation number;
(i) the name and address of the holder of the marketing authorisation;
(j) suitable coding;
(k) the name of the manufacturer, if different from the holder of the marketing authorisation;
(l) the category of distribution;
(m) a precautionary statement "Keep away from the reach of children";
(n) in case of a veterinary medicine, a statement "For Veterinary Use Only"; and
(o) any other information required by the Authority for purposes of the Act.
(2) Where the space on a primary container of medicine is not adequate to accommodate the information specified in sub-regulation (1), the holder of a marketing authorisation shall label the primary container to indicate the-
(a) name and dosage form of the medicine;
(b) quantity or volume of the medicine per unit pack;
(c) expiry date;
(d) name and quantity of active ingredient, or in case of a herbal medicine, a botanical, English or other name, and the quantity of each ingredient;
(e) marketing authorisation number;
(f) storage instructions; and
(g) batch number, except that all the particulars specified under sub-regulation (1) shall be set out on the secondary package.
(3) A holder of a marketing authorisation shall, where the container of medicine is unable to accommodate the information under sub-regulation (2), indicate the details of labelling requirements for each type of container as may be determined by the Authority.
(4) This regulation does not apply to medicine that is repackaged for dispensing.
(5) Despite the other provisions of this regulation, the Authority may waive the labeling requirements, as appropriate, to ensure the safety, quality and efficacy of the medicine.
21. Package insert for medicine
An original container of a medicine shall be accompanied by a package insert printed in legible letters in English stating the-
(a) name and dosage form of the medicine;
(b) name and quantity of active pharmaceutical ingredient, or in case of a herbal medicine, a botanical, English or other name, and the quantity of each ingredient;
(c) indications, in case of a veterinary medicine, specifying target species;
(d) dosage and directions for use, in case of a veterinary medicine, specific to each target species;
(e) contra-indications;
(f) side effects;
(g) drug interactions;
(h) precautions and warnings, including withdrawal periods, in case of a veterinary medicine used in food producing animals;
(i) symptoms, signs, treatment and management of overdose;
(j) presentation of the medicine;
(k) description of packaging and container closure system;
(l) storage instructions;
(m) shelf life;
(n) name and address of the holder of the marketing authorisation; and
(o) name of the manufacturer, if different from the holder of the marketing authorisation.
22. Patient information leaflet
A holder of a marketing authorisation shall provide a patient information leaflet for general sale medicine and medicine used in chronic conditions.
23. Revocation of S.I. No. 47 of 1993
The Pharmacy and Poisons (Medicines) (Importation, Manufacture and Sale) Order, 1993, is revoked.
[Regulations 3, 4, 5, 6, 9, 11, 12, 13, 14, 15, 16 and 18]
PRESCRIBED FORMS
FORM I
[Regulations 3(1) and 16(5)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
FORM II
[Regulation 4]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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REQUEST FOR ADDITIONAL INFORMATION |
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Application No: ..................... |
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To: ....................................................................................................................................... |
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Address: ............................................................................................................................... |
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You are requested to furnish, within ........................................... days of this Notice, the following information or documents in respect of your application for ......................................................... |
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(a) .............................................................................................................................. |
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(b) .............................................................................................................................. |
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(c) .............................................................................................................................. |
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(d) .............................................................................................................................. |
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If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. |
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Dated this .... day of ........., 20.. |
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............... |
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FORM III
[Regulation 5]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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MARKETING AUTHORISATION |
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Marketing Authorisation No. MA ../.. |
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Name of Medicine: ............................................ |
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Dosage form: ............................................... |
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Pack size |
Shelf life (Months) |
Category of distribution |
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Name of active ingredient |
Quality standards |
Strength |
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Name and address of holder of marketing authorisation: |
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Valid until ........................................ |
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The terms and conditions of the marketing authorisation are attached herewith. |
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TERMS AND CONDITIONS OF THE MARKETING AUTHORISATION |
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The holder of a marketing authorisation shall- |
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(a) ensure that the medicine- |
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(i) is manufactured in compliance with the current Good Manufacturing Practices (cGMP) as recommended by the World Health Organisation (WHO) or any other recognised entity; |
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(ii) conforms with the quality standards, safety and efficacy and is suitable for the purpose for which it is intended; |
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(iii) conforms to the summary of product characteristics; |
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(b) ensure compliance with good distribution practices and that the medicine is supplied in accordance with the requirements applicable to the categories of distribution specified on this marketing authorisation and with regulations on labeling of medicine; |
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(c) maintain an appropriate pharmacovigilance system for monitoring, detecting and reporting adverse drug reactions and the performance of products granted marketing authorisation; |
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(d) pay to the Authority the annual retention fees, sample analysis fees and other fees as prescribed; |
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(e) ensure that the marketing authorisation is not transferred without the written approval of the Authority; |
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(f) for a foreign-based holder of marketing authorisation, appoint a local responsible person; |
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(g) notify the Authority of any change that requires an amendment to a marketing authorisation; |
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(h) when necessary or as directed by the Authority, withdraw any product from the market that is injurious to, or is likely to be injurious to public health; and |
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(i) provide additional information or product sample when required to do so by the Authority for purposes of the Act. |
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NOTE: |
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Non-compliance with any of the terms or conditions of a marketing authorisation will result in suspension or revocation of the marketing authorisation. |
FORM IV
[Regulations 6(2) and 16(4)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF REJECTION OF APPLICATION FOR A MARKETING |
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Application No.: ..... |
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(1) Here insert the full names and address of the applicant |
To (1) .......................................................... |
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(2) Here insert the reference No. of the application and the product name |
IN THE MATTER OF (2) ................................ you are notified that your application for (3) a marketing authorisation/renewal of a marketing authorisation has been rejected by the Authority on the following grounds: |
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(3) Here insert the applicable application |
(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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Dated this .... day of ............. 20.. |
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FORM V
[Regulation 9(1)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
FORM VI
[Regulation 11(2)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
FORM VII
[Regulation 12(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF INTENTION TO SUSPEND A MARKETING AUTHORISATION |
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Application No.: ...... |
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(1) Here insert name of holder of marketing authorisation |
To (1) ............................................................ |
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............................................................................................................ |
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(2) Here insert name of medicine and marketing authorisation number |
IN THE MATTER OF (2) .................................................. you are hereby notified that the Authority intends to suspend your marketing authorisation on the following grounds- |
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(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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(3) Here insert number of days |
Accordingly, you are requested to show cause why your marketing authorisation should not be suspended and to take action to remedy the breaches set out in paragraphs .......... (above) within (3) ........... days of receiving this notice. Failure to remedy the said breaches shall result in the suspension of your marketing authorisation. |
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Dated this ..... day of ............ 20... |
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FORM VIII
[Regulation 12(3)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF SUSPENSION OF MARKETING AUTHORISATION |
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(1) Here insert name of holder of marketing authorisation |
To (1) ...................................................... |
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(2) Here insert name of medicine and marketing authorisation number |
IN THE MATTER OF (2) .................................................... you are hereby notified that your marketing authorisation has been suspended for (3) .............. on the following grounds: |
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(3) Here insert period of suspension |
(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(4) Here insert period of days |
Accordingly, you are requested to take action to remedy the breaches set out in paragraphs ........................ (above) within (4) .................. days of receiving this Notice. Failure to remedy the said breaches shall result in the revocation of your marketing authorisation. |
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Dated this .............. day of ..................... 20......... |
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FORM IX
[Regulation 13(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF RESTORATION OF MARKETING AUTHORISATION |
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(1) Here insert name of holder of marketing authorisation |
To (1) ....................................................... |
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............................................................................................................ |
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(2) Here insert name of medicine and marketing authorisation number |
IN THE MATTER OF (2) ................................................... you are hereby notified that your marketing authorisation has been restored. |
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Note that you are required to comply with the terms and conditions attached to the marketing authorisation. |
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Dated this ... day of ........... 20.... |
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FORM X
[Regulation 14(2)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF INTENTION TO REVOKE MARKETING AUTHORISATION |
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(1) Here insert name of holder of marketing authorisation |
To (1) .......................................................... |
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(2) Here insert name of medicine and marketing authorisation number |
IIN THE MATTER OF (2) ................................................ you are hereby notified that the Authority intends to revoke your marketing authorisation on the following grounds: |
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(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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(3) Here insert number of days |
Accordingly, you are requested to show cause why your marketing authorisation should not be revoked for the breaches set out in paragraphs .......................... (above) within (3) ....................... days of receiving this notice. Failure to remedy the said breaches shall result in the revocation of your marketing authorisation. |
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Dated this .... day of ........ 20... |
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FORM XI
[Regulation 14(3)]
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
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NOTICE OF REVOCATION OF MARKETING AUTHORISATION |
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(1) Here insert name of holder of marketing authorisation |
To (1) .......................................................... |
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(2) Here insert name of medicine and marketing authorisation number |
IN THE MATTER OF (2) ................................... you are hereby notified that your marketing authorisation has been revoked on the following grounds: |
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(a) ....................................................................................................... |
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(b) ....................................................................................................... |
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(c) ....................................................................................................... |
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(d) ....................................................................................................... |
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You are therefore required to surrender the marketing authorisation to the Authority within 21 days from the date of revocation. |
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You are also required to comply with the terms and conditions attached. |
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Dated this .... day of ............... 20.. |
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FORM XII
[Regulation 15(1)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
FORM XIII
[Regulation 16(1)]
(To be completed in triplicate)
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The Medicines and Allied Substances Act, 2013 |
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The Medicines and Allied Substances |
MEDICINES AND ALLIED SUBSTANCES (EXPERT ADVISORY COMMITTEE) REGULATIONS
[Section 9]
Arrangement of Regulations
Regulation
4. Qualifications to be appointed as member
5. Tenure of office and vacancy
SI 80 of 2019.
These Regulations may be cited as the Medicines and Allied Substances (Expert Advisory Committee) Regulations, 2019.
In these Regulations, unless the context otherwise requires-
"Chairperson" means the person elected as Chairperson by the members;
"Committee" means the Expert Advisory Committee constituted by the Board in accordance with section 9 of the Act; and
"member" means a member of the Expert Advisory Committee.
(1) The Committee consists of the following part-time members-
(a) three persons with expertise in human medicine;
(b) two persons with expertise in veterinary medicine; and
(c) two persons with expertise in allied substances.
(2) The members shall elect the Chairperson and Vice-Chairperson from amongst themselves.
4. Qualifications to be appointed as member
A person qualifies to be appointed as a member if that person-
(a) is a citizen;
(b) is not an undischarged bankrupt;
(c) is not legally disqualified;
(d) has not been convicted of an offence under the Act or any other written law and sentenced to imprisonment for a period exceeding six months without the option of a fine within a period of five years preceding the appointment; and
(e) is not facing disciplinary action relating to professional misconduct.
5. Tenure of office and vacancy
(1) A member shall hold office for a period of three years and may be re-appointed for a further term of three years.
(2) The office of a member becomes vacant if that member-
(a) is absent, without reasonable excuse, from three consecutive meetings of the Committee of which the member has had notice;
(b) is adjudged bankrupt;
(c) is convicted of an offence under the Act or any other law and sentenced to imprisonment for a period exceeding six months;
(d) is found guilty of professional misconduct;
(e) is legally disqualified from performing the duties of a member;
(f) dies; or
(g) resigns.
(3) On the expiration of the period for which member is appointed, the member shall continue to hold office until a successor is appointed, but in no case shall the further period exceed four months.
The Board may, where the office of a member becomes vacant before the expiry of the term of office, appoint another member in place of the member who vacates office but that member shall hold office only for the unexpired part of the term.
(1) Subject to the other provisions of this Act, the Committee may regulate its own procedure.
(2) The Committee shall meet for the transaction of business at least once in every three months at such places and times as the Committee may determine.
(3) A meeting of the Committee may be called by the Chairperson, on giving notice of not less than 14 days, and shall be called by the Chairperson if not less than one-third of the members so request in writing, except that if the urgency of any particular matter does not permit the giving of the notice, a special meeting may be called on giving a shorter notice.
(4) Five members shall constitute a quorum at any meeting of the Committee.
(5) There shall preside at any meeting of the Committee-
(a) the Chairperson;
(b) in the absence of the Chairperson, the Vice-Chairperson; and
(c) in the absence of the Chairperson and the Vice-Chairperson, such other member as the members present may elect for the purpose of that meeting.
(6) A decision of the Committee on any question shall be by a majority of the members present and voting at the meeting and in the event of an equality of votes, the person presiding at the meeting shall have a casting vote in addition to that person's deliberative vote.
(7) The Committee may invite any person, whose presence is in its opinion desirable, to attend and participate in the deliberations of the meeting of the Committee, but that person shall not have any vote.
(8) Where a member is for any reason unable to attend a meeting of the Committee, that member may, in writing, nominate another person from the same organisation to attend the meeting in that member's stead and that person shall be deemed to be a member for the purposes of that meeting.
(9) The validity of any proceedings, acts or decisions of the Committee shall not be affected by any vacancy in the membership of the Committee or by any defect in the appointment of any member or by reason that any person not entitled to do so, took part in the proceedings.
(10) The Committee shall cause minutes to be kept of proceedings in every meeting of the Committee.
There shall be paid to a member of the Committee such allowances as the Minister may determine, subject to the approval of the Emoluments Commission.
(1) If a person is present at a meeting of the Committee at which any matter is the subject of consideration, and in which matter that person or that person's relative is directly or indirectly interested in a private capacity, that person shall, as soon as is practicable after the commencement of the meeting, declare that interest and shall not, unless the Committee otherwise directs, take part in any consideration or discussion of, or vote on, any question relating to that matter.
(2) A declaration of interest made under sub-paragraph (1) shall be recorded in the minutes of the meeting at which it is made.
(3) In this regulation, "relative" has the meaning assigned to the word in the Anti-Corruption Commission Act, 2012.
{/mprestriction}