General information guideline

Archived previous version: 2.01 (Version 10)

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and 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 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. SAHPRA is committed to ensure that all registered medicines will be of the required quality, safety and efficacy. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications. This guideline is relevant only to human medicines, including biological and complementary medicines. Separate guidelines apply to the registration of veterinary medicines, medical devices and other health products.