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20 Sep

Posted at 17:50h in

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

Posted at 11:01h in

This template is intended to provide recommendations to applicants wishing to submit veterinary clinical trial applications. The template should be completed in conjunction with the attached guideline document. ...

25 Jul

Posted at 13:23h in

This document guides access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and clarifies the mandate, intent and scope of this section and Regulation 29 of the General Regulations...

02 Feb

Posted at 23:55h in

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...