The EU M1 will be updated to support the new Variation Regulation coming into force 1st January 2010. The new EU M1 v1.4 has been drafted togheter with stakeholders from EMEA, MS and industry, and will be published on this website and by NTA in early August. EU M1 v1.4 is highly recommended from 1st January 2010, and will be mandatory for all eCTDs for all procedures by February 2010. (source)