Archive
29 Jun General Information Guideline for Registration of Veterinary Medicines
Posted at 15:25h
in
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of veterinary medicines. ...
20 Dec Pre-registration veterinary medicines tracker guide
Posted at 11:55h
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Kindly be advised that applicants may track the progress of their new veterinary medicine registration applications on the SAHPRA website....
21 Sep Bioequivalence Trial Information for Veterinary Medicines
Posted at 09:14h
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This document should be completed by the applicant to ensure the inclusion of all necessary Bioequivalence Trial information....
20 Sep Residue Overall Summary (ROS)
Posted at 17:57h
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Residues Overall Summary (ROS) should be completed for pharmaceutical products intended for food producing species....
20 Sep Veterinary Medicines Biowaiver Application Form for Parenterals
Posted at 17:50h
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The formulation and API characteristics, including the route of administration and species, are factors which may affect requirements to waive bioequivalence studies (i.e., to compare the rate and extent of absorption between two formulations containing same active substances). Applicants must submit the following relevant information...
01 Sep Veterinary Clinical Trial Application Template
Posted at 11:01h
in
This document has been archived....
01 Sep Application form for unregistered veterinary medicines (Section 21)
Posted at 10:58h
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