12 Jan Clinical Trial Insurance for New Clinical Trial Applications
Posted at 13:26h
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This document has been archived....
Archive
05 Jan Electronic Submission of Serious Adverse Events (SAE) Reports – E2b Reporting
Posted at 15:09h
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This document has been archived....
18 Dec Communication on Vaccines Containing Thiomersal as Preservative
Posted at 10:29h
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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....
18 Dec Variations Communication
Posted at 08:27h
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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...
10 Dec SAHPRA Engagement Portal – Launch Update
Posted at 12:52h
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SAHPRA wishes to inform you of a fee discrepancy identified on the SAHPRA Engagement Portal affecting the following submission types:...
18 Nov Core Business Escalation Procedure
Posted at 10:18h
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This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
17 Nov Clinical Trials Committee Meeting and Submission Dates for 2026
Posted at 13:45h
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Applicants are advised to submit clinical trial applications before the due date. Applicants submitted after the due date will not be accepted....
04 Nov Request for Submission of Latest PSMF and Product/PV Resourcing Information
Posted at 10:23h
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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....
01 Oct Traceability Guideline – Implementation Roadmap
Posted at 14:35h
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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....
29 Sep Communication to Industry – SAHPRA Online Directory Update
Posted at 16:13h
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The SAHPRA OTC Online Directory has been operational for some time. As outlined in the OTC Toolkit, it is mandatory to include the required lock-ins on all Schedule 0–2 promotional and advertising materials....