ISSN 0796 - 0271 Supplement “A” to The Gambia Gazette No. 14 of 10th March, 2023 Legal Notice No. 10 of 2023 REPUBLIC OF THE GAMBIA MEDICINES AND RELATED PRODUCTS (FEES AND FINES) REGULATIONS, 2023
Medicines and Related Products (Fees and Fines) Regulations, 2022 MEDICINES AND RELATED PRODUCTS ACT, 2014 MEDICINES AND RELATED PRODUCTS (FEES AND FINES) REGULATIONS, 2022 IN EXERCISE of the power conferred on the Minister under section 65 of the Medicines and Related Products Act, 2014 these Regulations are made. 1. Citation These Regulations may be cited as the Medicines and Related Products (Fees and Fines) Regulations, 2022. 2. Fees and fines for medicines and related products The fees and fines for medicines and related products are as follows— Fees and Fines I. REGISTER AMOUNT | AMOUNT (GMD) | (USD$) i. | Controlled medicines register 1000 NO. | DESCRIPTION I. SERVICE APPLICATION FEES AMOUNT | AMOUNT (GMD) | (USD$) _ 5000 - NO. | DESCRIPTION Good Manufacturing Practices (GMP) inspection-in-country Good Manufacturing Practices (GMP) 2. | inspection-in-country (herbal, 2000 - cosmetics, household chemicals) _| Good Manufacturing Practices (GMP) s. inspection-international (West Africa) : seni Good Manufacturing Practices 4. | (GMP) inspection-international (other . 7000 countries) Disposal application fee medicines & B, related products ia 6. Change of name and location on 5000 permits for importation license 7 Change of name and location on 4000 ‘_| permits for storage facility 8. Advertisement fee per medicine or 5000 related product per script or medium 1
Medicines and Related Products (Fees and Fines) Regulations, 2022 lil. ANNUAL LICENCES AMOUNT | AMOUNT NO. | DESCRIPTION (GMD) (USD$) 4 Manufacturing licence (conventional * | medicines) 100,000 ie Manufacturing licence (herbal 2. | medicines, nutritional supplements, 20,000 cosmetics and household chemicals) Importation licence for 3. pharmaceutical business importers 50,000 Importation licence for distributors of 4, | herbal medicines and nutritional 10,000 supplements Importation licence for distributors of 5. | veterinary medicines 20,000 Importation licence for distributors of 6. | medical devices 20,000 Importation licence for distributors of diagnostic agents, laboratory 7. | consumables and other related 20,000 products Importation licence for distributors of 8. | cosmetics 5,000 9. | Repackaging licence 50,000 IV. PERMITS AND FEES PER CONSIGNMENT AMOUNT | AMOUNT NO. | DESCRIPTION (GMD) (USD$) Import clearance permit for 1. | pharmaceutical importers 1000 —— | Import permit for private hospitals 2. | and clinics 3000 Import permit for non-governmental 3. organizations hospitals and clinics 2000 4 Import clearance permit for 4000 “_| distributors of veterinary medicines, 2
Medicines and Related Products (Fees and Fines) Regulations, 2022 nutritional supplements, herbal medicines, medical devices, diagnostic agents, laboratory consumables, cosmetics, household chemicals and other related products Inspection of medicines and related products consignments 1000 Inspection of medicines and related products consignments outside Official working hours 2000 Export, re-export and transit transportation permit 3000 PRODUCTS FEES STORAGE FACILITIES FOR MEDICINES AND RELATED DESCRIPTION AMOUNT | AMOUNT (GMD) | (USD$) Pharmaceutical warehouse for importers 2000 Pharmaceutical warehouse for manufacturing companies 5000 Storage facilities for private or non- governmental organizations hospitals and clinics 2000 Storage facilities for distributors of nutritional supplements, herbal medicines, cosmetics, household chemicals, medical devices, diagnostic agents (laboratory consumables) and other related | products 2000 5. Permit or licence for bonded _| warehouses 5000 L Vi. MEDICINES AND RELATED PRODUCTS REGISTRA TION FEES NO. DESCRIPTION | AMOUNT | AMOUNT (GMD) _| (USDS) | 1. Application fees for the registration of new chemical entity 500 2. Application fees for the renewal of the registration of new chemical entity 500
Medicines and Related Products (Fees and Fines) Regulations, 2022 Application fees for registration of 3. | imported medicines (excluding herbal 300 and nutritional supplements) Application fees for the renewal of the registration of medicines 300 ts (excluding herbal and nutritional supplements) Application fees for registration of 5 herbal medicines products, nutritional 100 supplements, cosmetics and household chemicals Application fees for major variation 6. | (international) of medicines and 100 related products Application fees for minor variation 7. | (international) of medicines and 50 related products Application fees for minor 8 | variation (national) of medicines 25 and related products 9 | Listing fee (before registration) 25 Application fees for registration of 10. ‘ 5 medical devices a.| Machines or equipment 300 b. |} Others 100 VII. CLINICAL TRIALS APPLICATION FEES AMOUNT | AMOUNT NO. | DESCRIPTION (GMD) (USD$) 1. | International Sponsor a. Clinical trial authorisation fee for 4000 medicines Clinical trial authorisation fee for d. related & other products aun c. | Amendment to clinical trial protocol 300 ry Import authorisation application for 2000 investigational product " Repackaging or Relabelling for 2000 investigation products
Medicines and Related Products (Fees and Fines) Requlations, 2022 2. | National Sponsor Clinical trial authorisation fee: 2000 sponsor Public research institution funded 1500 Academic research 1000 Amendment to clinical trial protocol 100 Import authorisation application for 2000 investigational product f Repackaging or relabelling for "| investigation products a/9;o) » @ 2000 Vill. OMNIBUS FEES Any other application for Licencing or Permit sup b. | Change in Recordals 2000 Any other request for Post Market 3500 Surveillance IX. ADMINISTRATIVE FINES NO. | DESCRIPTION AMOUNT (GMD) 1. | Distribution, storage and sale of unapproved or substandard and fake medicines and related products by — (a) a wholesaler 100,000 (b) a retailer 50,000 2. | Importation of unapproved or substandard and fake medicines and related products by — (a) a corporate body 200,000 (b) an individual 100,000 3. | Importation of medicines and related products by an unlicensed or unauthorised — (a) corporate body 200,000
Medicines and Related Products (Fees and Fines) Regulations, 2022 (b) individual 100,000 4. | Distribution, storage, and sale of medicines and related products by an unlicensed or unauthorised — (a) corporate body 100,000 (b) individual 50,000 5. | Distribution, storage, and sale of medicines and 50,000 related products at unlicensed or unauthorised premises 6. | Conducting unapproved export, re-export or in- transit business of medicines and related products by — (a) a corporate body 100,000 (b) an individual 50,000 7. | Hawking or peddling of medicines and related products by an unlicensed or unauthorised 25,000 person 8. | Unapproved advertisements of medicines and related products 50,000 9. | Conduct of unapproved clinical trial [ 200,000 10. | Unauthorised importation of investigational product for clinical trial 200,000 11. | Conduct of unapproved amendment of clinical trial protocol 50,000 12. | Unreported clinical trial protocol violations [ (critical or major) 100,000 13. | Any other violation of the Medicines and 10,000 Related Products Act, 2014 or the Medicines to and Related Products Regulations, 2020 200,000
Medicines and Related Products (Fees and Fines) Regulations, 2022 3. Registration and renewal periods An individual who, or a corporate body which, deals in any medicine or related product shall register it for five years and renew it after every three years. 4. Repeal The Registration Fees and Charges for Medical Products, 2017 is repealed.