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27 Jan

Posted at 08:16h in

The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all ranitidine-containing medicines with the following Active Pharmaceutical Ingredient; ranitidine. SAHPRA previously issued a media release regarding the recall and quarantine of ranitidine containing medicines (29 October 2019 and...

27 Jan

Posted at 08:14h in

The notice of concern for the above registered products refers. The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all sartan-containing medicines with the following Active Pharmaceutical Ingredients; azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan and...

25 Jan

Posted at 10:36h in

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...

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 South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, efficacy, and quality of medicines. It is...

25 Jan

Posted at 10:30h in

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...

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)...