1. LEGISLATION, REGISTRATION AND CONTROL PROCEDURES FOR VETERINARY MEDICINAL PRODUCTS IN SOUTH AFRICA Dr R D Sykes DAKAR Senegal 2008

2. Medicines and Related Substances Control Act (Act 101/1965) Medicines Foodstuffs, Cosmetics and Disinfectants Act (Act 54/1972) Fertilizer, Farm Feeds, Agriculture and Stock Remedies Act (Act 36/1947) CONTROL ACTS Veterinary and Paraveterinary Professions Act (Act 19/82) Pharmacy Act (Act 53/1974) CONTROLS REGISTRATION

3. SAFETY NEW MOLUCULE GENERIC NEW FORMULA TOXICITY TARGET ANIMALS RESIDUES ENVIRONMENTAL Stock Remedies Veterinary Medicines

4. ENVIRONMENTAL SAFETY Diclofenac Gamma-BHC

5. EFFICACY PRECLINICAL CLINICAL LOCAL Stock Remedies Veterinary Medicines

6. QUALITY SOURCE OF ACTIVE FORMULA MANUFACTURE WHO – WHERE – HOW PACKAGING STABILITY

7. QUALITY LABORATORIES Vaccine Laboratory MCC Laboratory Industrial Laboratories GMP – Testing Inspections

8. GOOD MANUFACTURING PRACTICE INTERNATIONALLY RECOGNISED REGULATION COMPLIANT SUBJECT TO AUDIT CURRENT CERTIFICATE –cGMP

9. Criteria for establishing stock remedy status Drugs for readily diagnosable stock diseases Prophylactic substances Production enhancing substances Commodity animal substances Safety of product

10. Requirements for supply of stock remedies No deviations from requirements and instructions as indicated on label Veterinarian may make own recommendation May only be sold in original pack

11. Requirements for supply of stock remedies Any condition of sale For use by or under the control of a veterinarian only

12. STOCK REMEDIES ECTOPARASITICIDES ANTHELMINTICS ANTI-MICROBIALS –MASTITIS REMEDIES –ARTHROPOD BORNE DISEASES –PRODUCTION ENHANCERS

13. Criteria for establishing POM status Substances controlled by conventions Requirements for special precautions regarding safety Handling requirements Necessity for precise diagnosis or therapeutic measures POM for human use

14. VEERINARY MEDICINES ANTIBIOTICS HORMONES ANTI-INFLAMMATORIES ANAESTHETICS TRANQUILISORS

15. Definition of sale Means sell by wholesale or retail and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorise, direct or allow sale or prepare or possess for purpose of sale, and barter or exchange or supply or dispose of to any person whether for a consideration or otherwise; and sell, sale and sold have corresponding meanings.

16. CONTROL NO STOCK REMEDY OR VETERINARY MEDICINE MAY BE SOLD UNLESS IT IS REGISTERED IMSPECTORATE

17. SEAVDRAC NEEDS Food security Unique diseases and parasites Information on drug source, supply and quality Access to international evaluations applicable to local conditions Ecotoxicological information to protect local biodiversity Post-registration control and use monitoring. –Inadequate administrative structures –Vague or inadequate lines of authority –Duplication of functions

18. SEAVDRAC PROBLEMS Political differences between countries Political problems within countries Ignorance Communication difficulties Exploitation –Dumping –Counterfeit products Financial constraints Infrastructure

19. THANK YOU DUKE