1. How to submit an ASMF?
Information about the transmission of documents see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.
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.
Created: 24.11.2014 | Page last modified: 12.06.2015