Waivers From Certain Medicine Registration Requirements For Medicines For Human Use

Waivers From Certain Medicine Registration Requirements For Medicines For Human Use

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the SAHPRA’s current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive approach. 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. Alternative approaches may be used, but these should be scientifically and technically justified. SAHPRA is committed to ensure that all registered medicines will be of the required quality, safety and efficacy. It is important that applicants adhere to all administrative requirements to avoid delays in the processing and evaluation of applications.

Date updated

2022 Aug

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File Type: pdf
Category: Guideline
Unit: Corporate, Finance, General ECTD & human medicines