This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines. It represents the South African Health...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Health Supplements. It represents the South African Health Product Regulatory Authority’s current thinking on the quality, safety, and efficacy of these medicines. It is not intended as an...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines intends to invite comment from ...
This document has been prepared to serve as guidance to stakeholders regarding the regulation pathway of Category D medicines ( complementary medicines registration. It represe...
This document has been archived....
This document has been archived....
This document has been archived.
This document is intended to provide communication to applicants wishing to submit variations to existing registrations. This will be a “living document” and will be updated. Kindly note that this is an interim document and that the information will be incorporated into a General Information...
This guideline is intended to provide recommendations to applicants wishing to submit new registration applications, as well as variations, for reliance review-based evaluation. It represents the Authority’s current thinking on the safety, efficacy and quality of medicines. It is not intended as an exclusive approach....
This document guides the requirements for Good Manufacturing Practice (GMP) in South Africa. This guideline is not intended as an exclusive approach. The South African Health Products Regulatory Authority (SAHPRA) reserves the right to request any additional information to establish the safety, quality, and efficacy...