For electronic submission, please follow the links below:
http://esubmission.ema.europa.eu/eaf/
https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f
National Requirements
During the initial two months of the mandatory use, the paper, CD/DVD forms will continue to be accepted.
Note that, the documents that need to be signed will continue to be issued in hard copy and in their original form.
Additionally, NCA may request CD/DVD in the event of an issue with the CESP submission.
Below you can find supporting material and guidelines concerning the electronic submission:
1st Multimedia Webinar eAF training for industry:
https://www.youtube.com/watch?v=Zv8CITWtlDY&feature=youtu.be
2nd Multimedia Webinar eAF training for industry:
https://www.youtube.com/watch?v=fIZ6_45bayc
|