01 Feb Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form
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2022 Aug...
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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
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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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