Dr R D Sykes DAKAR Senegal 2008
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Transcript of 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
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
SAFETY
•NEW MOLUCULE
•GENERIC
•NEW FORMULA
•TOXICITY
•TARGET ANIMALS
•RESIDUES
ENVIRONMENTAL
Stock Remedies Veterinary Medicines
ENVIRONMENTAL SAFETY
• Diclofenac• Gamma-BHC
EFFICACY
•PRECLINICAL
•CLINICAL
•LOCAL
Stock Remedies Veterinary Medicines
QUALITY
•SOURCE OF ACTIVE
•FORMULA
•MANUFACTURE
WHO – WHERE – HOW
•PACKAGING
•STABILITY
QUALITY
LABORATORIES
• Vaccine Laboratory
• MCC Laboratory
• Industrial Laboratories
GMP – Testing
Inspections
GOOD MANUFACTURING PRACTICE
• INTERNATIONALLY RECOGNISED
• REGULATION COMPLIANT
• SUBJECT TO AUDIT
• CURRENT CERTIFICATE– cGMP
Criteria for establishingstock remedy status
• Drugs for readily diagnosable stock diseases
• Prophylactic substances
• Production enhancing substances
• Commodity animal substances
• Safety of product
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
Requirements for supply of stock remedies
•Any condition of sale
•“For use by or under the control of a veterinarian only”
STOCK REMEDIES
• ECTOPARASITICIDES
• ANTHELMINTICS
• ANTI-MICROBIALS– MASTITIS REMEDIES– ARTHROPOD BORNE DISEASES– PRODUCTION ENHANCERS
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
VEERINARY MEDICINES
• ANTIBIOTICS
• HORMONES
• ANTI-INFLAMMATORIES
• ANAESTHETICS
• TRANQUILISORS
Definition of sale
Means sell by wholesale or retail and includesimport, 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 supplyor dispose of to any person whether for a consideration or otherwise; and sell, sale andsold have corresponding meanings.”
CONTROL
NO STOCK REMEDY OR VETERINARY MEDICINE MAY BE SOLD UNLESS IT
IS REGISTERED
IMSPECTORATE
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
SEAVDRAC
PROBLEMS • Political differences between countries• Political problems within countries• Ignorance • Communication difficulties• Exploitation
– Dumping– Counterfeit products
• Financial constraints• Infrastructure
THANK YOUDUKE