Archive
22 Mar Requests to use unregistered veterinary medicines under Section 21 of Act 101 of 1965
Posted at 13:47h
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This document provides guidance on access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Applicants are required to comply with the provisions of the Act and Regulations....
08 Mar Collection of Outstanding Retention Fees
Posted at 17:02h
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This document is intended to provide communication to the Medical Device Establishment Licence Industry in relation to the Appointment of Yellow Clip Financial Services....
06 Mar Communication to Industry – Implementation of Regulatory Information Management System
Posted at 19:38h
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As you are aware, SAHPRA has been focused on progressing the digital transformation of the organisation over the past few years. We have different initiatives underway to digitalise our business processes....
06 Mar Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation
Posted at 11:16h
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Kindly note that this communication serves to communicate two (2) processes that the SAHPRA Pharmacovigilance (PV) unit has revised. You are urged to take note of these revisions....
29 Feb Minimum Requirements For Establishment of Internal Rules
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This document is intended to provide communication to applicants and holders of authorities of activities regulated by the Hazardous Substances Act, Act 15 of 1993 and amended regarding the requirements for internal rules that must be drawn up terms of Regulation 7 of the Regulations...
15 Feb African Medicines Regulatory Harmonization 2023 Highlights
Posted at 13:12h
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AUDA-NEPAD has published its 2023 Highlights Edition on African Medicines Regulatory Harmonization (AMRH) featuring articles on: Harmony in healthcare 2023 highlights of the Good Manufacturing Practice Technical Committee Evaluation of Medicinal Products Technical Committee virtual meeting Plans for the College for African Regulatory Science Professionals ...
31 Jan Regulations Relating to Medical Devices and In-Vitro Diagnostic Medical Devices (IVDs)
Posted at 11:26h
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19 Jan Pharmacare and Multiple Collaborators DHCPL: Valaciclovir/Aciclovir – Containing Medicines – Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Posted at 12:09h
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Dear Healthcare Professional, Aspen Pharmacare, Adcock Ingram Limited, Pharma Dynamics and Sandoz SA (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to draw your attention to the following important safety information associated with the use of valaciclovir/aciclovir-containing medicines registered...
16 Jan Guidelines For Users of Electronic Therapeutic Devices Emitting Ionizing Radiation
Posted at 13:55h
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This Guideline sets out requirements for radiation safety associated with the use of therapeutic devices emitting ionizing radiation. The Hazardous substances Act, 1973 (Act 15 of 1973) and Regulations (No R1332 of 3 August 1973)....