On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101...
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This document has been archived....
Thiomersal (also referred to as thimerosal or ethyl mercury) has been included as a preservative in some vaccines, notably those intended for multi-dose use....
With reference to the communication issued on 30 June 2025 (HPA05-2025/26, Version 5), SAHPRA wishes to inform all holders of certificates of registration that the current predefined submission window for Type II variation applications (including related changes bundled variation submissions) within the period 02 January...
SAHPRA wishes to inform you of a fee discrepancy identified on the SAHPRA Engagement Portal affecting the following submission types:...
This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
Applicants are advised to submit clinical trial applications before the due date. Applicants submitted after the due date will not be accepted....
SAHPRA requests electronic submission of the latest PSMF by 12 November 2025, including PV staffing details and a list of registered and marketed products. Submit via email to GVP@sahpra.org.za with the specified subject line....
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....
