WHO TRS 948, 2008 Annex 4

Sathyanarayana M.Sc.
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WHO TRS (Technical Report Series) 948, 2008 Annex 4

Guidelines on (API) Active Pharmaceutical Ingredient Master File Procedure - Annex 4


WHO TRS 948, 2008 Annex 4

Click on the titles below for complete guidelines


TABLE OF CONTENTS


1. Introduction

2. Scope

3. Content of the active pharmaceutical ingredient master file (APIMF)

3.1 Open part of APIMF

3.2 Restricted part of APIMF

4. Use of the APIMF procedure

5. Steps of the APIMF procedure

6. Content of the product dossier when the APIMF procedure is used

7. Changes and updates to the APIMF

Appendix 1  Template letter of access

Appendix 2  Part of covering letter to be submitted by the APIMF holder to WHO


1. Introduction


The main objective of the Active Pharmaceutical Ingredient Master File (APIMF) procedure is to allow valuable confidential intellectual property or “know-how” of the manufacturer of the active pharmaceutical ingredient (API) to be protected, while at the same time allowing the applicant for prequalification or prequalification variation (from now on named in the text as the applicant) to take full responsibility for the finished pharmaceutical product (FPP) and the quality and quality control of the API. The WHO Prequalification Programme thus has access to all the information necessary for an evaluation of the suitability of the use of the API in the FPP


WHO TRS (Technical Report Series) 948, 2008 Annex 4

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