Active substance master file procedure

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This guideline applies to human and veterinary medicines.

Current effective version

Revision 3 - Adopted guideline

Reference number

CHMP/QWP/227/02 Rev. 3/Corr.

EMEA/CVMP/134/02 Rev. 3/Corr.

Published13/07/2012
Effective from01/10/2012
KeywordsActive substance master file (ASMF), letter of access, submission letter, common technical document (CTD)
DescriptionThis document assists in the compilation of the active substance section of the dossiers for a marketing authorisation application or a marketing-authorisation variation of a medicinal product. It is also intended to help active substance master file (ASMF) holders in the compilation of their ASMFs. Read together with additional guidance.


Document history

Revision 3

Current version

Adopted guideline


Additional guidance


Template (annexes)


Overview of comments


Draft guideline

In operation: 01/10/2012–present


Published: 01/10/2012


Published: 13/07/2012


Published: 13/07/2012


Published: 19/01/2012

Revision 2Draft guidelinePublished: 27/04/2005
Revision 1Adopted guidelineIn operation: 31/08/2004–30/09/2012


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