The European Commission's application forms (human and veterinary) for application for marketing authorisation

The EU application forms must be used for all human and veterinary applications for marketing authorisations for medicinal products in Denmark, regardless of the type of procedure. The application forms are now available in eAF format.

If the application form is submitted electronically, it must be locked by uploading an image file in the signature field. The application form must not be changed after it has been locked, for example by way of PDF rendering or addition or removal of pages.

If the application form is submitted on paper, the eAF must also be used. After completion of the form, the inbuilt validation function should be run, and the application form is printed while it is still unlocked – i.e. without an uploaded image file in the signature field. The printed application form must be signed before you send it.

The Danish Medicines Agency has written a special guideline on how to complete sections 2.4.1, 2.4.2 and 2.4.3 of the application form for applications under the national procedure, the mutual recognition procedure and the decentralised procedure.

Application forms and guidelines

The European Commission’s electronic application forms are available at the EMA’s website: esubmission.ema.europa.eu/eaf/