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25 Jan

Posted at 11:58h in

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...

25 Jan

Posted at 11:56h in

This document has been prepared to serve as guidance to stakeholders regarding the regulation pathway of Category D medicines ( complementary medicines registration. It represe...

25 Jan

Posted at 10:33h in

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....

25 Jan

Posted at 10:30h in

This document is intended to serve as guidance on the requirements for Good Manufacturing Practice (GMP) in South Africa. This guideline is not intended as an exclusive approach....

25 Jan

Posted at 10:24h in

This guideline provides recommendations to applicants who intend to submit applications for the registration or authorisation of medicines intended to be available to those affected by a public health emergency. It represents the current thinking of the South African Health Products Regulatory Authority (the Authority)...

25 Jan

Posted at 10:20h in

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

25 Jan

Posted at 10:17h in

This document is intended to provide requirements to applicants wishing to submit applications for the registration of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained....