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24 Jan

Posted at 12:44h in

This guideline is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...

24 Jan

Posted at 12:40h in

This guideline document is intended to provide recommendations to applicants wishing to submit applications for the registration of Biosimilar Medicines. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, quality, and efficacy of medicines. It is not intended as...

24 Jan

Posted at 12:39h in

This document provides guidance to applicants regarding the acceptability of proposed proprietary names of products submitted for registration as medicines. It represents the current thinking of the South African Health Products Regulatory Authority on the naming policy, how the naming policy is intended to inform...

30 Aug

Posted at 15:30h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines. It represents the SAHPRA’s current thinking on the quality, safety, and efficacy of these medicines. It is not intended as an exclusive approach. SAHPRA reserves the...