Active Substance Master File (ASMF)

EMA Guideline on Active Substance Master File Procedure

EMA Additional guidance on documents relating to an Active Substance Master File

Templates for Active Substance Master File (ASMF) procedures

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

CMDh website for latest advice on ASMF procedures (Joint WG website including procedural guidance)

 Training presentations on Active Substance Master File (ASMF) work sharing procedure:

• ASMF worksharing - Introduction to the procedure (October 2018)
• Requesting an EU_ASMF repository number (October 2018)
• Submitting an initial worksharing ASMF (October 2018)
• Determining the parent procedure (October 2018)
• Assessment report template (October 2018)
• Sharing assessment reports (October 2018)
• Submitting a variation to an ASMF (October 2018)
• Use of an approved ASMF in a new procedure (October 2018)