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

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 ensure that all registered medicines will be of the required quality, safety and efficacy.

Archives

Download Version 2 (2.14)

Date updated

2022 oct

Download latest version
File Type: pdf
Category: Guideline
Unit: Clinical Evaluations Management, General ECTD & human medicines, Health Products Authorisation