Guideline for Professional Information for Human Medicines (Categories A and D)

Guideline for Professional Information for Human Medicines (Categories A and 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 specific 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.

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Download Version 2 (2.16)

Date updated

2022 Sept

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