Electronic Application Form - eAF - Guidance for using and completing eAFs
From 1 January 2016 the use of electronic application forms (eAF) for MRP/DCP and national procedures (human and veterinary) will be mandatory within electronic submissions. Electronic Application Forms together with Guidance Documents and Questions and Answers can be found at eaf-eSubmission website.
The currently used application forms in Word format published by the European Commission will no longer be available and only the latest version of the electronic application form will be used for all EU procedures, including CP, MRP/DCP and national procedures.
Electronic Application Forms have to be used for:
- New Applications according to §§ 7a, 9a, 9b, 9c, 9d, 10 Abs. 1(1), 10 Abs. 1 (2), 10 Abs. 9, 10a, 10b, 11, 11a and 12 AMG
- Renewal Applications according to § 20 AMG
- Variations according to Variation Regulation (EC) Nr. 1234/2008
For all other applications respective Application Forms (http://www.basg.gv.at/arzneimittel/formulare/nationale-zulassung-und-lifecycle/) will still be available.
Guidance Documents for completing eAFs in national procedures is available in German:
In case of technical questions please contact eafema.europaeu or georg.neuwirtheragesat respectively natagesat for national applications, rmsagesat for applications where AT acts as RMS and basg-cmsagesat for applications where AT acts as CMS.
Created: 02.12.2015 | Page last modified: 30.06.2016