This guideline provides an outline of the principles and process to be followed in the donation of medicines, medical devices, and in vitro diagnostics (IVDs). The guideline applies to both people and entities wishing to make donations and the recipients of such donations. The South African...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of...
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 guideline is intended to provide recommendations to applicants wishing to submit new registration applications, as well as variations, for reliance review-based evaluation....
This document provides guidelines for the requirements of Good Manufacturing Practice (GMP) in South Africa. This guideline is not an exclusive approach. SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine. SAHPRA may amend this...
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)...
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....