BfArM and PEI declare expressly, that related to the implementation of the HMA eSubmission Roadmap new marketing authorisation applications for national purpose only are required to be in eCTD format as of 1 July 2018 in accordance with corresponding European harmonised decisions. Both federal competent authorities will ensure that not only technical and organisational requirements are in place to implement the eSubmission Roadmap of the Heads of Medicines Agencies (HMA) version 2.0 agreed on 24 February 2017, but also that any legislative prerequisites are fulfilled as soon as possible in order to allow requesting electronic submissions.