Clinical guideline

Clinical guideline

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines containing specified substances. 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


Download version 2 (2.09)

Date updated

2022 Aug

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