State Institute for Drug Control announces that the use of the electronic Application Form (eAF) will be mandatory for all types of applications (new Marketing Authorisation Applications, Renewals and Variations) from 1st of January 2016. For further information click on the link below:
http://esubmission.ema.europa.eu/eaf/index.html
Please note, that the eAF is necessary to submit only in one copy in a paper form.
The submission of the applications remains the same. It is still required to submit the application in a paper form correctly filled in original document “Cover letter, similar to a standard one, in the Slovak language“ with identical data listed in the eAF and in the confirmation of payment as well.
