Post-marketing Reporting of Adverse Drug Reactions for Human Medicines in South Africa

This document serves as a guideline to Applicants/ holders of certificates of registration (HCRs) on the reporting of adverse drug reactions/ events. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality, and efficacy of medicines. The Authority reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine and may make amendments to the approved conditions of registration in keeping with the knowledge which is current at the time of consideration of safety data.