Active substance master file procedure

This guideline applies to human and veterinary medicines.

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

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