Active substance master file procedure - Scientific guideline

This guideline applies to human and veterinary medicines.

The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or 'know-how' of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance. National Competent Authorities/EMA thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product.

Keywords: Active substance master file (ASMF), letter of access, submission letter

Current version - Final

Final Guideline on Active Substance Master File Procedure - Revision 4

AdoptedLegal effective date: 17/06/2019Reference Number: CHMP/QWP/227/02 Rev 4, EMEA/CVMP/134/02 Rev 4 Corr.Summary:

The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the

European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or

'know-how' of the manufacturer of the active substance (ASM) to be protected, while at the same time

allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the

medicinal product and the quality and quality control of the active substance. National Competent

Authorities/EMA thus have access to the complete information that is necessary for an evaluation of

the suitability of the use of the active substance in the medicinal product.

Document history

Guideline on active substance master file procedure - Revision 3

AdoptedReference Number: CHMP/QWP/227/02 Rev.3 Corr.

Additional guidance on documents relating to an active substance master file

Reference Number: EMA/CHMP/CVMP/QWP/549010/2012Summary:

Additional guidance on completing the Annex 2-letter of access, Annex 3-submission letter and administrative details for documents relating to an active substance master file and Annex 4-withdrawal of access letter of the active substance master file procedure guidance (CHMP/QWP/227/02 Rev 3, EMEA/CVMP/134/02 Rev 03)

Overview of comments received on draft guideline on active substance master file procedure - Revision 3

Reference Number: EMA/314313/2012

Template - Active substance-master-file procedure

Draft guideline on active substance master file procedure - Revision 3

Consultation dates: 12/01/2012 to 12/03/2012Draft: consultation closedReference Number: CHMP/QWP/227/02 Rev 3Summary:

This guideline replaces guideline CPMP/QWP/227/02 Rev 2 (EMEA/CVMP/134/02 Rev.2).

Draft guideline on active substance master file procedure - Revision 2

Draft: consultation closedReference Number: CPMP/QWP/ 227/02 Rev. 2

Guideline on active substance master file procedure - Revision 1

AdoptedLegal effective date: 31/08/2004Reference Number: CPMP/QWP/227/02 Rev. 1