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This guideline is intended to provide guidance to applicants wishing to submit an appeal against all regulatory decisions which are administrative in nature. Any person aggrieved by the decision of the Authority may appeal against such decision by notifying the Chief Executive Officer within thirty (30)...

This guideline is intended to provide guidance to applicants wishing to submit new application for registration of biological medicines. It represents the Authority’s current thinking on the safety, efficacy and quality of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right...

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...

This guideline has been prepared to serve as a guideline to enable the direct payment of fees into the bank account of SAHPRA and must be read together with the relevant...