General ECTD & human medicines Archives - Page 8 of 11 - SAHPRA

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22 Feb

Posted at 09:57h in

This guideline is intended to provide recommendations to applicants wishing to submit multiple applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an...

01 Feb

Posted at 10:09h in

The Validation Template is used on receipt of an application to verify that all required information has been supplied to SAHPRA in order to evaluate a variation application for a medicinal product for human use submitted in eCTD format. It is also used for follow-up...