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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Document Number: SAHPGL-PEM-03
Version: 3
Date Updated: 23/11/2022
File Type: pdf
Category: Guideline
Unit: General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management