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...
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 ...
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...
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)....
This guideline sets out the requirements and recommendations when applying for a license to import any electronic device emitting ionizing radiation. The Hazardous Substances Act 15, 1973....
Dear Healthcare Professional, In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the below listed companies would like to inform you about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with the use of valaciclovir/aciclovir- containing medicines....
COVID-19 Clinical Trials - Two-Weekly Progress Reports Pilot – Clinical Trial Applications...