Reminder to applicants regarding requirements for future eCTD submissions

07/12/2012

Reminder to applicants regarding requirements for future eCTD submissions

Applicants are advised that the new technical validation criteria v.4.1 for Electronic Common Technical Document (eCTD) came into force on 1 December 2012. The European Medicines Agency will continue to accept eCTD submission in the previous format v.3.1 until 31 January 2013. However, from 1 February 2013, any submission that does not comply with the new eCTD validation criteria v.4.1 will lead to non-acceptance of applications.