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27 Jan

Posted at 22:39h in

Customs and Port Health Service (PHS) in SA, is the first line of defence to protect the citizens of the Republic of South Africa against the health risks associated with cross-border movement of people, conveyances, baggage, cargo and imported consignments. Among the imported consignments are...

27 Jan

Posted at 08:18h in

A clone is defined as an application submitted by the Innovator as a copy of its own product under a different proprietary name at any stage during the product life cycle. A replica is defined as a copy of an already registered generic product,...

27 Jan

Posted at 08:17h in

The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity,...

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...

26 Jan

Posted at 13:43h in

To all Applicants: Kindly note that COVID-19 Clinical Trial Applications do not follow the above predetermined submission due dates. They can be submitted to SAHPRA at any time. The last COVID-19 CTC meeting for 2022 is on the 09 December 2022 and the submission due...