To the attention of interested parties
Use of electronic forms for applications for authorisation, renewal, variations (electronic Application Form, eAF).
Please be advised that, as of 1 January 2016, use of electronic Application Forms (eAF) has become mandatory for applications related to authorisation, renewal and variations, respectively, (Centralised Procedure, MRP, DCP and National Procedure) for medicinal products for human use.
Therefore, please take into account the following aspects, in particular:
– eAFs and technical documentation are available at: http://esubmission.ema.europa.eu/eaf/index.html;
– as regards the National Procedure, on-paper Application Forms are only accepted in January and February;
– full details can be found on the eAF webpage, under “Guidance documents”