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)

 

 

 

Regulatory decisions and notices

  • Database of Professional Information and registered veterinary medicines

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.

VICH GUIDELINES ADOPTED BY SAHPRA

Quality guidelines

GL 1 – Validation of Analytical Procedures: Definition and Terminology

GL 2 – Validation of Analytical Procedures: Methodology

GL 3 – Stability Testing of New Veterinary Drug Substances and Medicinal Products

GL 4 – Stability Testing for New Veterinary Dosage Forms

GL 5 – Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products

GL 8 – Stability Testing for Medicated Premixes

GL 10 – Impurities in New Veterinary Drug Substances

GL 11 – Impurities in New Veterinary Medicinal Products

GL 17 – Stability Testing of New Biotechnological / Biological Veterinary Medicinal Products

GL 18 – Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients

GL 25 – Testing of Residual Formaldehyde

GL 26 – Testing of Residual Moisture 

GL 45 – Quality – Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products

GL 51 – Statistical evaluation of stability data

Veterinary Clinical Guideline new template 25-02-2020

ADR Reporting Post Marketing January 2020 v6 31 January 2020

Veterinary Medicines Exemptions guidelines final for website

Toxicology guidelines

GL 22 – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing

GL 23 – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing

GL 28 – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing

GL 31 – Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: Repeat-Dose (90 Days) Toxicity Testing

GL 32 – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing

GL 33 – Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Testing

GL 37 – Guidance for Industry: Studies to Evaluate the Safety of residues of veterinary drugs in human food: Repeat-Dose Chronic toxicity testing

GL 54 – Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General approach to establish an acute reference dose (ARfD)

Efficacy guidelines

GL 52 – Blood Level Bioequivalence Study

Safety

GL 43 – Target Animal Safety – Pharmaceuticals: Target Animal Safety for Veterinary Pharmaceutical Products

MRLs, Residues and Withdrawal Periods guidelines

GL 36 – Studies to Evaluate the Safety of residues of veterinary drugs in human food: General Approach to Establish a Microbiological acceptable daily intake (ADI)

GL 46 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Metabolism study to determine the quantity and identify the nature of residues

GL 47 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals

GL 48 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods

GL 49 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Validation of analytical methods used in residue depletion studies

GL 56 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods (draft: under consideration)

GL 57 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species

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”.

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Contact details

You can reach the Veterinary Medicines Unit the offices by:

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Telephone: +27128427587