DEPARTMENT OF AGRICULTURE PRESENTATION TO PARLIAMENTARY PORTFOLIO COMMITTEE ON AGRICULTURE AND LAND...
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Transcript of DEPARTMENT OF AGRICULTURE PRESENTATION TO PARLIAMENTARY PORTFOLIO COMMITTEE ON AGRICULTURE AND LAND...
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DEPARTMENT OF AGRICULTURE PRESENTATION TO PARLIAMENTARY PORTFOLIO COMMITTEE ON AGRICULTURE
AND LAND AFFAIRS ON VETERINARY PHARMACEUTICALS
DEPARTMENT OF AGRICULTURE PRESENTATION TO PARLIAMENTARY PORTFOLIO COMMITTEE ON AGRICULTURE
AND LAND AFFAIRS ON VETERINARY PHARMACEUTICALS
19 SEPTEMBER 2006
BY: REGISTRAR ACT NO. 36 OF 1947 Dr E Mokantla
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OUTLINE OF PRESENTATION OUTLINE OF PRESENTATION
A. INTRODUCTION
B. ACT NO. 36 OF 1947
C. ACT NO. 101 of 1965
D. RELATIONSHIP BETWEEN ACT 36 AND ACT 101
E. CURRENT DEVELOPMENTS AT DEPARTMENT OF
AGRICULTURE
F. WAY FORWARD
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A. INTRODUCTIONA. INTRODUCTION
Regulation of Veterinary Pharmaceuticals is administered under:
1.The Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act ( Act No. 36 of 1947) in DoA, and
2. The Medicines and Related Substance Control Act, 1965 (Act No. 101 of 1965) in DoH
Veterinary Pharmaceuticals are also referred to as:
Animal MedicinesVeterinary Medicinal Products Veterinary MedicinesStock Remedies
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B. ACT NO. 36 OF 1947B. ACT NO. 36 OF 1947
The Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act ( Act No. 36 of 1947) administered by the DoA and regulates:
Agricultural Remedies (Pesticides)Farm Feeds (Livestock Feeds and Pet Food)Sterilizing PlantsFertilizerPest Control Operators andStock Remedies (Animal Medicines)
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B. ACT NO. 36 OF 1947 CONT…B. ACT NO. 36 OF 1947 CONT…
DEFINITION OF A STOCK REMEDY
Means a substance intended or offered to be used in connection with domestic animals, livestock, poultry or wild animals (including wild birds), for the prevention, treatment or cure of any disease, infection or other unhealthy condition, or for the maintenance or other improvement of health, growth, production or working capacity , but excluding any substance so far as it is controlled under the Medicines and Related Substance Control Act, 1965 (Act No.101 of 1965)
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B. ACT NO. 36 OF 1947 CONT…B. ACT NO. 36 OF 1947 CONT…
Examples are• Antiparasitics
– Endoparasiticides– Ectoparasiticides
• Antiprotozoals (Anti-coccidials, anti-babesials)• Antifungals (for ringworms)• Mastitis remedies• Antibiotics (Tetracyclines, sulphonamides)• Disinfectants• Vaccines• Production Enhancers (Growth Promoters)• Dermatology Preparations
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C. ACT 101 OF 1965C. ACT 101 OF 1965
DEFINITION OF VETERINARY MEDICINES
Any substance or mixture of substances, other than a stock remedy registered in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, (Act No. 36 of 1947), used or purporting to be suitable for use or manufactured or sold for use in connection with vertebrates, for treatment, diagnosis, prevention or cure of any disease, infection or other unhealthy condition, or for the maintenance or improvement of health, growth, production or working capacity, or for curing, correcting or modifying any somatic or organic function, or for correcting or modifying behavior
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C. ACT NO. 101 of 1965 CONT…C. ACT NO. 101 of 1965 CONT…
Examples of Veterinary Medicines • Ethical medicines / Scheduled Medicines (safety
issues) e.g.– Anaesthetics, – Narcotics, – Behavior Modifying Drugs– Some antibiotics etc
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D. RELATIONSHIP BETWEEN ACT 36 AND ACT 101D. RELATIONSHIP BETWEEN ACT 36 AND ACT 101
Cooperation on regulation of Veterinary Pharmaceuticals
Department of Agriculture is represented in the committees of Department of Health
Medicines Control Council (MCC)
Veterinary Products Policy Committee – To contribute to the development and coordination
of policy that will ensure harmonisation of the registration processes of Veterinary products in the Country
– To promote broadly the awareness of the registration process, its controls and benefits, safety aspects of approved products for the public, animals and environment.
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D. RELATIONSHIP BETWEEN ACT 36 AND ACT 101 CONT…D. RELATIONSHIP BETWEEN ACT 36 AND ACT 101 CONT…
Veterinary Clinical Committee– Provide expertise for the registration of
Veterinary Medicines
Scheduling Committee– Make recommendation as to where medicine has
to be registered DoA or DoH– Not represented in the committee, but
recommendations by committee serve at the MCC, where DoA is represented.
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E. CURRENT DEVELOPMENTS AT DEPARTMENT OF AGRICULTUREE. CURRENT DEVELOPMENTS AT DEPARTMENT OF AGRICULTURE
APEA Bill aimed to update replace Act No. 36 of 1947Completed 2003 Submitted to Minister
• Returned due to: Policy vacuum
Development of policies was as a result of the returned Agricultural Production Enhancement Agents (APEA) Bill
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E. CURRENT DEVELOPMENTS AT DEPARTMENT OF AGRICULTURE CONT…E. CURRENT DEVELOPMENTS AT DEPARTMENT OF AGRICULTURE CONT…
Department of Agriculture is currently developing the Stock Remedies (Animal Medicines) Policy
Policy aims to address:
The control and regulation of only Stock Remedies
Facilitate discussions between the two Veterinary Pharmaceutical Regulatory bodies (DoA and DoH)
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I. WAY FORWARDI. WAY FORWARD
1. Possible Regulation of Veterinary Pharmaceuticals under the same Act needs a thorough consultation, consideration and investigation by both Departments
2. Departments of Agriculture and Health have agreed to work on the programme to discuss regulatory issues that require the attention of both departments
3. To develop a memorandum of understanding between the two Departments.
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THANK YOU