The Veterinary Medicines Unit of SAHPRA protects animal health by assuring the quality, safety and efficacy of veterinary medicines. Our work also helps to protect the safety of food derived from animals by establishing withdrawal periods. We continue to play a role in antimicrobial resistance for companion and food producing animals.
Our responsibilities
- Assessing veterinary medicine applications in terms of quality, safety and efficacy
- Monitoring and taking action on reports of adverse drug reactions reported
- Developing/updating policy and guidance on regulation and control of veterinary medicines
- Authorisation of use of unregistered veterinary medicines under Section 21 (Act 101, 1965)
- Authorisation of clinical trial protocols
The unit’s employees come from backgrounds of veterinary medicine, pharmacology, pharmacy and animal science while our advisory committees have expertise in veterinary medicine fields such as: wildlife, microbiology, toxicology, pharmacology, epidemiology, poultry, porcine and companion animal medicine, theriogeniology and animal production/herd health.
Veterinary Guidelines
VICH Guidelines adopted
SAHPRA develops/updates and implements science-based technical requirements for veterinary medicines. South Africa recognises the importance of global collaboration with other players in veterinary medicines registration and therefore obtained observer status in VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) in February 2013. In our endeavour to harmonise with the rest of the VICH member/observer countries SAHPRA has adopted VICH guidelines, and endorses the principles and practices described therein.
Registration and use of veterinary products
New registration applications
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- General Information Guideline: Veterinary medicines
- Veterinary Medicines Clinical Guideline – templates below accompany this guideline:
- Quality and Bioequivalence: Technical requirements for veterinary medicines
- Veterinary medicines exemptions from certain medicine registration
requirements - Veterinary Medicines Registration form (VMRF1)
New variations
Use of unregistered products under Section 21 (Act 101 of 1965)
New veterinary clinical trial applications
Regulatory decisions and notices
Reporting adverse drug reactions
- VARF1 ADR reporting form for veterinary medicines
Frequently asked questions (FAQs)
| Questions | Answers |
| Who can apply for registration of a veterinary medicine in South Africa? | A citizen, resident in South Africa. |
| Which veterinary products are registerable with Act 101, 1965? | Scheduled medicines including antibiotics |
| How do I apply for permission to carry out a veterinary medicine clinical trial? What is the relevance of Act 35/1984 in that process? | Complete the VCT1 application as per the guideline document: “Guideline on completion of the veterinary medicines clinical trial application form”. Attach the completed “Owner Consent form” and proof of payment as per “SAHPRA Fees Gazette no 42474”. Where biological medicines are used in the study, approval should also be sought from Section 20 of Act 35/1984 (Animal Disease Control Act). Approval by both departments should be granted before commencement of the study. |
| How do I apply for use of an unregistered veterinary medicine from SAHPRA? What is the cost involved? What is the expected turnaround time for authorisation? For how long is the authorisation letter valid? | The “Authority may authorize sale of unregistered products, medical devices or IVDs for certain purposes”. The forms are available on the website under “Veterinary medicines”. Complete the application form, attach proof of payment (SAHPRA Fees Gazette no 42474) and email to pervetS21@sahpra.org.za If this is a repeat request please include a completed progress report as well (see guideline 3.11: “Section 21 application for unregistered veterinary medicines”. Each patient must have their own application form completed. If all the information submitted is correct and there are no queries, the turnaround time is 24 working hours. |
| Which SAHPRA guideline takes into account Minor Use Minor Species (MUMS)? | Guideline 2.48: “Veterinary medicines exemptions from certain medicine registration requirements”. |