The  Electronic  Application Forms offer an alternative, convenient, online version of the currently used paper forms, which are published and maintained on the European Commission’s EudraLex website. These electronic forms are designed to reflect and capture the same content as the paper-based application forms.

• The paper-based application forms for medicinal products for human use are published and maintained in EudraLex Volume 2
• The paper-based application forms for medicinal products for veterinary use are published and maintained in EudraLex Volume 6.
• The electronic forms and their supporting technical documentation are  available below.

eAF Term Request Form

If you need to request a missing substance or other term in order to complete an eAF, please use the eAF Term Request Form. Once completed, you will need to submit your form via email to eAF@ema.europa.eu

 

Forms

Form	Notice to Applicant Revision	Electronic Forms	Release Notes
MAA-Human	Revision 10.1	MAA-Human Form 10/06/2014 New	MAA-H Release Notes  10/06/2014 New
Variation	Revision July 2013	Variation Form 10/06/2014 New	Variation Release Notes -10/06/2014 New
Renewal	Revision October 2012	Renewal Form 10/06/2014 New	Renewal Release Notes 10/06/2014New
MAA-Vet	Revision 7.3	MAA-Vet Form 10/06/2014 New	MAA-Vet Release Notes 10/06/2014 New

User Documents

User Guidance	Questions and Answers 05/06/2014 New
Annex 1	How to request additional terms in eAF 02/07/2013
Announcements	End of Pilot announcement
Statement of Intent	Statement of Intent - Human Statement of Intent - Vet
Multi Media Webinar	How to request additional terms in eAF
eAF defects and workaround solutions document	eAF defects and workaround solutions document 22/04/2014 New

Technical Documents

The Data Exchange Standards and XML Schema Definitions published here are intended to allow software developers within other organisations to develop systems to process the electronic application form data and build equivalent systems, if required. The EMA will ensure that the latest versions of these documents are published here.

Document	Data Exchange Standard version 1.15 (effective June 10 2014)	XML Schema Definition
DES 3.0 Technical Guide	N/A	N/A
Human MAA DES	DES MAA-Human 06/05/2014 New	MAA-Human XSD 10/06/2014 - New
Variation DES	DES Variation 06/05/2014 New	Variation XSD 10/06/2014 - New
Renewal	DES Renewal 06/05/2014 New	Renewal XSD 10/06/2014 New
Vet MAA DES	DES MAA-Vet 06/05/2014 New	MAA-Vet XSD 10/06/2014 - New
Common Dictionary XSD Schema	N/A	Common Dictionary 10/06/2014New

This website will be updated with the most recent versions of electronic application forms, and related supporting documentation. To help users, we have now included an RSS feed, which will quickly flag exactly what’s changed on the website. Simply click on the RSS feed link here or at the top of the page (eAF RSS Feed) and subscribe to the electronic application forms feed. For more information about RSS feeds, please visit our RSS Guide page.

If you have any questions regarding these electronic application forms, please contact the eAF service desk with your query: eaf@ema.europa.eu.