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Active Substance Master File (ASMF)

Guideline on Active Substance Master File Procedure, 19 May 2011

Additional guidance on documents relating to an active substance master file, 20 September 2012

Mandate of the Working Group on Active Substance Master File Procedures, 19 May 2011

CMDh-CMDv Questions & Answers Active Substance Master File (ASMF)

Active Substance Master File (ASMF) in the Mutual Recognition and Decentralised Procedures

Template for Active Substance Master File (ASMF) Type IB Variation Assessment Report 

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