Guideline for Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals

This document has been prepared to serve as a guideline to healthcare professionals reporting adverse drug reactions, adverse event following immunisations 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.

This document has been prepared to serve as a guideline for healthcare professionals reporting adverse drug reactions and product quality problems. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. 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 and may make amendments in keeping with the current knowledge at the time of consideration of safety data.

Guidelines and ADR Reporting & Quality Problem Forms are available from the SAHPRA website. The ADR Reporting Form is also available as Appendix A of this document.