Regulatory Compliance Archives

25 Mar Once-off Renewal of Expired Resolution Letters for Low-risk GDP Sahpra Pharma Licensed Sites One-time Renewal of Expired Gdp Resolution Letters

Posted at 11:24h in

This communication is intended to inform the relevant GDP license holders of the one-time renewal of expired GDP resolution letters. SAHPRA is introducing this initiative as a targeted measure to strengthen compliance management while addressing operational challenges. Frequently Asked Questions (FAQ): One-Time Renewal of Expired GDP...

18 Dec Variations Communication

Posted at 08:27h in

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 in

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 in

This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....

10 Nov Guideline for Destruction of Medicines and Scheduled Substances

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...

06 Nov Post-Marketing Surveillance (PMS) Report for Selected Human Medicines Circulating in South Africa 2022/2023

Posted at 10:12h in

This report displays results of the quality of medicines, including medicines for the treatment of HIV, TB, hyperglycaemia, high blood pressure and hypothyroidism. There are several factors that may lead to medicines not fully complying with quality requirements and specifications. Those factors may include manufacturing...

01 Oct Traceability Guideline – Implementation Roadmap

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....

01 Oct Guideline on Traceability of Health Products

Posted at 14:31h in

The purpose of the document is to guide the implementation of global standards for product identification, data capture, and data sharing. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The implementation of unique...

24 Jun Report for Monitoring and Advertising of Promotional Material

Posted at 14:10h in

The role of the South African Health Products Regulatory Authority (SAHPRA) regarding advertising and marketing of medicines....

10 Mar Communication to Industry – Intention to Declare Medicines Compounded in terms of Section 14(4) Containing GLP-1or GLP-1/GIP Agonists Undesirable

Posted at 08:32h in

SAHPRA intends to declare medicines compounded in terms of Section 14(4) of the Medicines Act containing Glucagon-Like Peptide-1 (GLP-1) Active Components or a combination of Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide agonist (GIP) Active Components undesirable in terms of Section 23 of the Medicines...

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