4. Submission

The Electronic Application Forms offer a convenient, online alternative to the paper forms. In fact, the word-based application forms (AF) have been replaced by the electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation, and support for validation of the form, etc.

These are:

MAA-Human Form;
Variation Form;
Renewal Form
The forms can be accessed at EU Electronic Application Forms eSubmission website and their use for EMA submissions is mandatory since 1 July 2015.