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10 Nov

Posted at 11:37h in

This document provides an overview of the medicines safety regulatory decisions made by the South African Health Products Regulatory Authority (SAHPRA) during October – December 2023. This includes decisions where safety concerns were reviewed and concluded, as well as those safety concerns that remain unresolved...

10 Nov

Posted at 11:34h in

This document provides an overview of the medicines safety regulatory decisions made by the South African Health Products Regulatory Authority (SAHPRA) during October – December 2023. This includes decisions where safety concerns were reviewed and concluded, as well as those safety concerns that remain unresolved...

10 Nov

Posted at 08:57h in

This document provides guidance regarding safe disposal and destruction of medicines and scheduled substances by health facilities in accordance with Regulation 44 of the General Regulations of the Medicines and Related Substances Act, 101 of 1965, and relevant waste legislation. To ensure the correct handling...

31 Oct

Posted at 14:48h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (Categories A and D) containing specified substances. Regarding Category D medicines, the guidance provided herein pertains to general content requirements. Any specific technical guidance indicated in...

27 Oct

Posted at 17:36h in

All guidelines adopted by the South African Health Products Regulatory Authority (SAHPRA) from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) must be read in conjunction with the current, non-draft version of SAHPRA’s Guide to Good Manufacturing Practice for...

01 Oct

Posted at 14:35h in

Dear Applicants, This roadmap outlines the phased implementation of unique product identification requirements for all health products in South Africa, transitioning from batch-level to unit-level serialisation across primary, secondary, and tertiary packaging levels....