Guideline for Patient Information Leaflet for Human Medicines (Categories A D)

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. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical guidance indicated in Category D medicine guidelines should be applied. In addition to this guideline, 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 will be of the required quality, safety, and efficacy.

Guidelines and application forms are available from the office of the Chief Executive Officer and the website.