To accommodate several change requests submitted since version 2.0 was in force September 2013, a revision of the EU eCTD Module 1 Specification has taken place and is now published as a draft version 3.0 for public consultation. The updated specification (highlighted and clean) versions with relevant release notes and comments template are now available on the EU M1 page of the eSubmission website. Comments should be provided by 14 September 2015 to EUM1Spec@ema.europa.eu

http://esubmission.ema.europa.eu/eumodule1/index.htm
http://esubmission.ema.europa.eu/eumodule1/docs/EU%20Module%201%20v3%20Release%20Notes.pdf