Guideline for the API Master File (APIMF) Procedure

Guideline for the API Master File (APIMF) Procedure

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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Download version 3 (Previously documented has SAHPGL-PEM-02)

Date updated

2022 Nov

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File Type: pdf
Category: Guideline
Unit: General ECTD & human medicines, Pharmaceutical Evaluation Management, Pre-Reg