Guideline for Labelling of Medicines Intended for Human Use

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (Categories A and D) containing specified substances. Regarding Category D medicines, the guidance provided herein pertains to general content requirements. Any specific technical guidance indicated in Category D medicine guidelines should be applied. In addition to this guideline, the South African Health Products Regulatory Authority (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. SAHPRA is committed to ensuring that all registered medicines meet the required standards of quality, safety, and efficacy. Guidelines and application forms are available via the SAHPRA website.