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Dr R D Sykes DAKAR Senegal 2008

LEGISLATION, REGISTRATION AND CONTROL PROCEDURES FOR VETERINARY MEDICINAL PRODUCTS IN SOUTH AFRICA. Dr R D Sykes DAKAR Senegal 2008. Medicines and Related Substances Control Act (Act 101/1965) Medicines. CONTROLS. Veterinary and Paraveterinary Professions Act

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Dr R D Sykes DAKAR Senegal 2008

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  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 CONTROLS Veterinary and Paraveterinary Professions Act (Act 19/82) CONTROL ACTS Pharmacy Act (Act 53/1974) Foodstuffs, Cosmetics and Disinfectants Act (Act 54/1972) Fertilizer, Farm Feeds, Agriculture and Stock Remedies Act (Act 36/1947) REGISTRATION

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

  4. ENVIRONMENTAL SAFETY • Diclofenac • Gamma-BHC

  5. EFFICACY Stock Remedies Veterinary Medicines • PRECLINICAL • CLINICAL • LOCAL

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

  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 establishingstock 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 YOUDUKE

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