DEPARTMENT OF AGRICULTURE PRESENTATION TO PARLIAMENTARY PORTFOLIO COMMITTEE ON AGRICULTURE AND LAND AFFAIRS ON VETERINARY PHARMACEUTICALS

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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

• 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. 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 Medicines
• Veterinary Medicinal Products
• Veterinary Medicines
• Stock Remedies

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B. 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 Plants
• Fertilizer
• Pest Control Operators and
• Stock Remedies (Animal Medicines)

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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

• 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 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

• 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 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

• 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
AGRICULTURE

• APEA Bill aimed to update replace Act No. 36 of
  1947
• Completed 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

• 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 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