ASMF: CMDh updates Information on "Worksharing Procedure"

Although the document "The worksharing procedure for the assessment of Active Substance Master File (ASMF)" by the two coordination groups CMDh and CMDv had only just been updated in May 2024, another amendment was made at the end of 2025. The current revision 5 now complies with the requirements of the new "Variations Regulation" (Commission Delegated Regulation (EU) 2024/1701 of March 11, 2024, amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorizations for medicinal products for human use) and can be viewed on the CMDh's website (Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human).

In addition to the updates and additions resulting from the new "Variations Regulation", which are particularly evident in Annex 4, for example, the so-called "ASMF Summary" and all related activities and requirements have been removed. As the ASMF Summary was included in many paragraphs of the document, this resulted in a number of changes, all of which are clearly indicated by track changes in the text.

The new Revision 5 of "The worksharing procedure for the assessment of Active Substance Master File (ASMF)" can be found on the CMDh website in the "WORKING GROUP ON ACTIVE SUBSTANCE MASTER FILE PROCEDURES" section.