01 Feb Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form
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Archive
01 Feb Additional Strength Biowaiver Application Form
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Archives
Version 3 - 6.38Date updated
...01 Feb Bioequivalence Trial Information Form (BTIF)
Posted at 10:19h
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Archives
Version 3 - 6.32Date updated
...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.