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Levels of advancement

II­9

Veterinary

medicines

and veterinary biologicals

1.

The VS cannot regulate the usage of veterinary

The authority and capability of the VS to regulate veterinary medicines

medicines and veterinary biologicals.

2.

The

VS

has

only

limited

capability

to

exercise

and veterinary biologicals.

administrative control (including registration) over the usage,

including import and production, of veterinary medicines and veterinary biologicals. 3. The VS exercise quality control (technical standards) over the import, production and distribution of veterinary medicines and veterinary biologicals. 4. The VS exercise complete control over registration, sale and usage of veterinary medicines and veterinary biologicals. 5. The VS implement systems to monitor the use of veterinary medicines, veterinary biologicals and their side

effects (pharmacovigilance).

Results Strengths : The Act 101 from 1965 has been replaced by Act 13 of 2003 on prescription medicines and controlled substances together with the Ministry of Health. A Veterinary Oversight Committee has been established to develop the regulations in collaboration with the Ministry of Health Weaknesses : Act 13 of 2003 can still not be enforced as operational regulations are still not in place. There are still antibiotics (oxytetracyclines) which remain over the counter medicines. Due to the long distances and a lack of veterinarians even prescription drugs have to be administered by farmers Supporting documentation (documents or photos): Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, No 36 of 1947 Detailed findings during visit: Control of veterinary medicines and biologicals: The control of medicines and biologicals is administered under The Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act from 1947; Medicines and Related Substances Act, 1965; The Medicines And Related Substances Control Act from 2003; and The Prevention Of Undesirable Residues in Meat Act, 1991. The Medicines and Related Substances Control Act, 2003 is technically not yet in force, as subsidiary regulations required for its operations are still under development. The registration of stock remedies is administered by the Registrar of Act 36 who is appointed by the Minister responsible for Agriculture. The official is the head of the Law Enforcement Division of the Directorate of Extension and Engineering Services in the Ministry of Agriculture Water and Forestry. The Act also provides for the designation of technical advisors and analysts to the Registrar. The Technical Advisor is currently a state veterinarian in the Epidemiology Section. The state

71

Namibia PVS report version II 23012009

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