2020 Feb...
Category D Medicines (Complementary Medicines) has been established in the General Regulations made in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Medicines compliant with the prescribed definition for this category are included in Guidance on progression to regulatory compliance...
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...
Medicines Act” means the Medicines and Related Substances Act, 1965 (Act 101 of 1965), as amended. ...
The amended Guideline 7.02 (Roadmap and Transitional Process for the regulation of Complementary medicines) with transitional arrangements was developed and published on the SAHPRA website by early August 2019. The guideline established the roadmap and general overview for the regulatory pathway of complementary medicines including...
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,...
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,...
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...
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...
The Marketing Authorisation for Global Health Products (hereinafter referred to as MAGHP) procedure is a Swissmedic project in the area of regulatory systems strengthening. The aim of...