Guideline for Selection of Reference Products for Applications of Generic Medicines

This document guides applicants who seek to apply for new registration of generics supported by Bioequivalence studies. The South African Health Products Regulatory Authority (SAHPRA) can request additional information to establish whether the health products meet the safety, quality and performance standards. While other approaches can be used, the processes should be proven scientifically and technically. SAHPRA is committed to ensuring that all registered health products meet the safety, quality and performance standards. Applicants must adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.