EMA - E-submission – New requirements as of 1 July 2015:

Mandatory use of EMA gateway

Starting on 1 July 2015, companies should send all applications for the centralized procedure in eCTD format only via the EMA’s eSubmission Gateway. Upon receipt by the EMA, eCTD applications are then stored in the common repository where they can be immediately accessed by all national competent authorities. Submissions to Member States via the Common European Submission Platform (CESP) remain in use for other procedure types.


Electronic Application Form mandatory

Furthermore, as of 1 July 2015 companies are obliged to use the EMA’s electronic application forms (eAF) for marketing authorization applications, variations and renewals. Non-eAF forms will no longer be accepted. The forms are available on the eSubmission website under http://esubmission.ema.europa.eu/eaf/index.html

The use of eAFs will become mandatory for all other EU marketing authorization procedures (DCP, MRP, national) in January 2016.