Veterinary Medicines Clinical Guideline

This guideline is intended to provide recommendations to applicants wishing to submit clinical applications for the registration of veterinary medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the quality, safety, and efficacy of a medicine in keeping with the knowledge current at the time of evaluation. SAHPRA is committed to ensure that all registered medicines will be of the required quality, safety, and efficacy. Guidelines and application forms are available from the office of the Chief Executive Officer and the website.

This guideline is accompanied by these templates:

1. Veterinary Medicines Biowaiver Application Form for Parenterals - Click here
2. Residues Overall Summary (ROS) - Click here
3. Bioequivalence Trial Information for Veterinary Medicines - Click here