Complementary Medicines Registration Application ZA-CTD-Quality

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Complementary Medicines. It represents the South African Health Product Regulatory Authority’s current thinking on the quality, safe ty, and efficacy of these medicines. It is not intended as an exclusive approach. any additional information to establish the safety, qua The SAHPRA reserves the right to request lity 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 medici nes will be of the required quality, safety and efficacy. It is important t 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 website Version 1: P ublication for implementation : www.sahpra.org.za.

2020 Jun