Complementary Medicines – Health Supplements Safety and Efficacy

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Health Supplements. It represents the South African Health Product Regulatory Authority’s current thinking on the quality, safety, and efficacy of these medicines. It is not intended as an exclusive approach. The 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. The SAHPRA is committed to ensure that all registered medicines will be of the required quality, safety and efficacy. It is important that applicants also adhere to the administrative requirements to avoid delays in the processing and evaluation of applications. Guidelines and application forms are available from the office of the SAHPRA website www.sahpra.org.za Further Annexures associated, but not yet included, with this guideline will be published for public comment prior to implementation.

2022 Mar