1. How to submit an ASMF?

Information about the transmission of documents see Guideline: electronic Release Regulation EEVO (L_Z45).

2. What are the requirements for an Active Substance Master File (ASMF), which is part of an application for marketing authorisation, variation or renewal?

If an ASMF has to be included in an application file the up-to-date version of the ASMF has to be enclosed. This version has to reflect the current state of the art according to respective updated European requirements.

3. How should an ASMF be submitted for more than one MAA by the ASMF holder?

ASMF holders who are submitting an ASMF for more than one MAA (=Marketing Authorization Application) should submit their ASMF and its changes in the latest version only once. For the correct technical use and preservation of the eCTD-lifecycle of this standalone dossier it is mandatory that every new Letter of Access in relation to a specific MAA should be submitted in an updated eCTD sequence as well as changes to the ASMF.
For example 1: An ASMF has been submitted to the NCA (=National competent authority) with eCTD-sequence 0000 for medicinal product A. In any later MAA referencing to this ASMF, the ASMF holder is only required to submit the new Letter of Access for medicinal product B in an subsequent eCTD-sequence (e.g. eCTD-sequence 0001, 0002, …).


Further inquiry note