1. 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

2. 2 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

3. 3 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

4. 4 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)

5. 5 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)

6. 6 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

7. 7 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

8. 8 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

9. 9 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.

10. 10 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.

11. 11 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

12. 12 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)

13. 13 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.

14. 14 THANK YOU