GUIDELINE FOR ADVERSE DRUG REACTIONS (ADRS) REPORTING FOR HEALTHCARE PROFESSIONALS

The document in the link below has been prepared to serve as a guideline to healthcare professionals, reporting adverse drug reactions and product quality problems. It represents South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, quality and efficacy of medicines (including vaccines, complementary medicines and old medicines), medical devices and in-vitro diagnostics (IVDs). It is not intended as an exclusive approach. SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of medicines including vaccines complementary medicines and old medicines and may make amendments in keeping with the knowledge which is current at the time of consideration of safety data.

Guidelines and ADR Reporting form are available from the SAHPRA website. The ADR reporting form is also available as Appendix B of the below document.

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