Biological Medicines Amendment guideline

This guideline is intended to provide recommendations to applicants wishing to submit amendments for registered BIOLOGICAL medicines. It represents SAHPRA’s current thinking on ensuring the safety, quality and therapeutic 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 therapeutic efficacy of a medicine in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used, but these should be scientifically and technically justified. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.