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.
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
SI 7 of 2008.
The Regulations may be cited as the Pharmaceutical (Fees) Regulations, 2008.
The fees set out in the Schedule to these Regulations shall be the prescribed fees for the matters mentioned therein.
[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
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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
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