Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts

This document has been prepared to serve as a recommendation to applicants regarding the recalls and withdrawal of medicines, and the South African Health Products Regulatory Authority’s current thinking on the safety, quality, and efficacy of medicines. SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine and may make amendments in keeping with the knowledge which is current at the time of consideration of data which has been submitted regarding any recalls. SAHPRA is committed to ensuring that all medicines that are registered are of the required quality, safety, and efficacy. Applicants need to adhere to these requirements.