Active Substance Master File (ASMF)

For guidance on Active substance master file procedure please be referred to the EMA website on ASMF.

 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)