Fields marked with an asterisk (*) are required.
Name *
Username *
Password *
Verify password *
Email *
Verify email *
Search Search

PHARMACEUTICAL ACT: SUBSIDIARY LEGISLATION

INDEX TO SUBSIDIARY LEGISLATION

Pharmaceutical Act (Commencement) Order, 2004

Pharmaceutical (Fees) Regulations, 2008

PHARMACEUTICAL ACT (COMMENCEMENT) ORDER, 2004

[Section 1]

Arrangement of Paragraphs

   Paragraph

   1.   Title

   2.   Commencement of Act No. 14 of 2004

SI 94 of 2004.

 

1. Title

This Order may be cited as the Pharmaceutical Act (Commencement) Order, 2004.

 

2. Commencement of Act No. 14 of 2004

The Pharmaceutical Act, 2004, shall come into operation on the date of the publication of this Order.

PHARMACEUTICAL (FEES) REGULATIONS, 2008

[Sections 29, 48 and 64]

[Re-denominate the currency as stipulated under S 4 of Re-denomination Act, 8 of 2012, read with Bank of Zambia Act, 43 of 1996.]

Arrangement of Regulations

   Regulation

   1.   Title

   2.   Prescribed fees

      SCHEDULE

SI 7 of 2008.

 

1. Title

The Regulations may be cited as the Pharmaceutical (Fees) Regulations, 2008.

 

2. Prescribed fees

The fees set out in the Schedule to these Regulations shall be the prescribed fees for the matters mentioned therein.

SCHEDULE

[Regulation 2]

PRESCRIBED FEES

PART I
RETAIL OR HOSPITAL PHARMACY

 

 

Fee units 

1. Application for registration certificate to operate a retail pharmacy 

5,000 

2. Application for registration certificate to operate a hospital pharmacy 

2,834 

3. Inspection fee relating to application to operate a retail or hospital pharmacy 

4,223 

4. Application for change of premises 

2,500 

5. Re-inspection of retail or hospital pharmacy 

2,500 

6. Application for a renewal of a registration certificate 

6,667 

7. Application for renewal of hospital pharmacy registration certificate 

4,445

PART II
IMPORT OR WHOLESALE DEALER’S LICENCE

 

 


{mprestriction ids="2,3,5"}

Fee Units 

1. Application for import licence 

5,556 

2. Application for wholesale dealer’s licence 

5,000 

3. Inspection fees relating to an application for a wholesale dealer’s licence 

4,223 

4. Application for renewal of import licence 

5,000 

5. Application for renewal of wholesale dealer’s licence 

7,778 

6. Application for change of premises for wholesale dealing 

4,445 

7. Re-inspection fee for wholesale dealer 

2,778

PART III
MANUFACTURER’S LICENCE

 

 

Fee Units 

1. Application for licence to manufacture 

10,000 

2. Inspection fee – local manufacturer 

20,000 

3. Application for renewal of manufacture’s licence 

10,000 

4. Application for change of premises 

5,000 

5. Issue of licence to manufacture – 5 years 

50,000 

6. Application for manufacturer’s licence– 

 

   (a) to repackage medicines 

10,000 

   (b) inspection 

11,112 

   (c) annual renewal 

7,778 

   (d) re-inspection 

5,000 

   (e) change of premises 

4,445

PART IV
OTHER SERVICES

 

 

Fee Units 

1. Screening fees for import authorisation 

2% of invoice value in kwacha 

2. Screening fees for export authorisation 

278 

3. Application for clinical trail certificate 

2,778 

4. Application for product licence of an investigational product 

16,889 

5. Application for issue of GMP certificate 

2,223 

6. Application for import of narcotics and psychotropic substances 

223 

7. Minor amendments to dossier or labelling 

1,389 

8. Major amendments to dossier 

2,778 

9. Issue of certificate of a pharmaceutical product (CPP) 

278 

10. Amendment to product licence imported 

1,389 

11. Amendments to licences and certificates locally manufactured and locally packaged 

1,389 

12. Amendments to import or export authorisation 

1% of invoice value in kwacha 

13. Application for approval of advertisement, promotion, launch, etc 

5,556 

14. Application for fast track registration 

18,334 

15. Inspection for good clinical practice 

29,445 

16. Inspection and supervision of disposal of expired 

500 per day products 

17. Application by an individual for importation or exportation of a medicine for personal use 

278 

18. Application for change of category of distribution 

5,556 

19. Inspection of premises for issue of a GMP certificate 

2,000 

20. Application by an authorised institution for the importation of small quantities of drugs for specific patient(s

2,500 

21. Application for registration for import of a medicine for supply through government public tenders (Where the medicine is required to be maintained on the market, a fresh application fee shall be paid.) 

4,223 

22. Replacement of lost document, licence or certificate 

1,389 

23. Application for restoration of a product licence 

16,667

PART V
PRODUCT REGISTRATION

 

 

Registration Fee Units 

Retention Fee Units 

1. Human medicines 

 

 

Application for registration– 

 

 

   (a)   Imported as finished Product; 

21,112 

14,056 

   (b)   Packaged in Zambia 

18,334 

14,056 

   (c)   Locally manufactured 

4,223 

2,778 

   (d)   New chemical entities 

23,334 

11,278 

   (e)   Biological including vaccines 

23,334 

11,278 

2. Veterinary medicines 

 

 

   (a)    Imported as a finished product 

12,778 

10,556 

   (b)    Packaged in Zambia 

8,445 

10,556 

   (c)    Locally manufactured 

2,834 

2,223 

3.Herbal Medicinal product 

 

 

   (a)    Imported as a finished product 

21,112 

14,056 

   (b)    Herbal medicinal product packaged in Zambia 

12,778 

10,566 

   (c)    Herbal medicinal locally manufactured 

4,223 

2,778 

4. Allied substances 

 

 

   (a) Application for restoration of a product licence 

16,667 

14,056 

   (b) Registration of an allied substance 

4,223 

2,778 

Note: 

1 fee unit = K180.00 

 

{/mprestriction}