Archive
01 Feb Quality And Bioequivalence Abridged Review Template
Posted at 10:20h
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This template has been updated to conform to the new SAHPRA document format....
25 Jan Guideline for the API Master File (APIMF) Procedure
Posted at 10:20h
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines and variations. It represents the Authority’s current thinking on medicines' safety, efficacy and quality. It is not intended as an exclusive approach....
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