For the documentation provided through the Common European Submission Portal (CESP) – applications for all types of Marketing authorisation; applications for all types of Renewal; applications for all types of Variations and Notifications under Article 61(3) with the only exception - application for Transfer of Marketing authorisation:
- when the documentation is submitted through CESP, it is not necessary to submit it on CD/DVD;
- when the documents for which an original signature is required (cover letter, application form, QP declaration) are signed with a qualified electronic signature - their submission in paper is not necessary.
The submission of Product Information (Summary of Product Characteristics, Patient Leaflet, Labelling and mock-ups), in two copies printed on one side for all procedures that require it, remains mandatory.
