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