Veterinary Medicines

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 protcols

 

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.

Registration and use of veterinary products

  • New registration applications
    • General Information Guideline: Veterinary medicines
    • Veterinary Medicines Clinical Guideline
    • Quality and Bioequivalence: Technical requirements for veterinary medicines
    • Veterinary medicines exemptions from certain medicine registration
      requirements
    • Veterinary Medicines Registration form (VMRF1)

 

  • New variations
    • Variations addendum for human and veterinary medicines
    • Application form (Link to HPA)

 

 

Regulatory decisions and notices

Reporting adverse drug reactions

  • VARF1 ADR reporting form for veterinary medicines

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.

Frequently asked questions (FAQs)

QuestionWho can apply for registration of a veterinary medicine in South Africa?
AnswerA citizen, resident in South Africa.
QuestionWhich veterinary products are registerable with Act 101, 1965?
AnswerScheduled medicines including antibiotics
QuestionHow do I apply for permission to carry out a veterinary medicine clinical trial? What is the relevance of Act 35/1984 in that process?
AnswerComplete 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.
QuestionHow 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?
AnswerThe “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 Nonhlanhla.skosana@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.
QuestionWhich SAHPRA guideline takes into account Minor Use Minor Species (MUMS)?
AnswerGuideline 2.48: “Veterinary medicines exemptions from certain medicine registration
requirements”.

Contact details

You can reach the Veterinary Medicines Unit the offices by:

E-mail: Add new email address
Telephone: +27128427587