eAF: electronic application form

The eAF replaced the paper and Word application forms in Volume 2B of the Notice to Applicants. Its use has been mandatory since 1 January 2016 for all human initial marketing authorisation applications, variations and renewals in the centralised, mutual recognition, decentralised and national procedures. There are three forms: the marketing authorisation application form, the variation form and the renewal form. They are maintained by EMA with the Member States and published with release notes, a technical guide and a question and answer document, and each submission must use a version that is still valid on the day it is filed.

The current forms are interactive PDFs whose drop-down lists are drawn from SPOR: organisations and locations come from OMS, and terms such as pharmaceutical forms, routes and units come from RMS. The completed form is included in the eCTD sequence in Module 1.2 and the same file goes to every authority in the procedure. EMA is replacing the PDF forms with web-based forms in the PLM Portal, starting with the variation form for centrally authorised products, and the web form exports the data to the same structure so that authorities can read it automatically.

In practice the form drives validation. National authorities and EMA check that the procedure type, the holder, the products and the scope of changes on the form agree with the cover letter, the dossier and the fee paid. For variations the form lists the classification code of each change from the Commission's classification guideline, the present and proposed text, and, for grouped or worksharing submissions, every authorisation covered.

What goes wrong: the form is produced on an outdated version and rejected at technical validation; a holder or site is typed in by hand because its OMS record is missing, so the form fails the SPOR check; the proposed text on the form differs from the product information in the dossier; a grouped variation lists a scope that does not match the classification codes; and a form locked with the wrong procedure number has to be regenerated across all concerned member states. Treating the form as the first document to finish rather than the last one to fill in avoids most of these.