Risk Management Plans for Medicines for Human Use

This document has been prepared to serve as a guideline to the holders of certificate of registration/applicants on the Authority’s requirements regarding risk management plans for medicines, including biological medicines, in South Africa. It represents SAHPRA’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 safety data.