The Q&A document "Q&A on Active Substance master file (ASMF)" of the CMDh, CMDv and the EMA, which was last revised in March 2022, has now been updated again in November 2022 and published on the HMA (Heads of Medicines Agencies) website in the CMDh section.
The following questions and the corresponding answer texts have been revised:
22. Where an ASMF Holder prepares a new version of ASMF following finalisation of a marketing authorisation or variation application, can the MAH inform Authorities about this new version by submitting an official letter?
23. Since all changes in new ASMF version have already been communicated to the authorities during a marketing authorisation application or variation application, can the MAH submit the updated sections of a new version in eCTD format outside of scope of variation?
25. How should I version my ASMF submission?
The following questions have been added:
26. How should different version numbers be tracked?
27. How is the version numbering of ASMF's related to the eCTD sequence?