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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

MAA-H Release Notes  10/06/2014

Variation

Revision July 2013

Variation Form 10/06/2014

Variation Release Notes -10/06/2014

Renewal Revision October 2012 Renewal Form 10/06/2014

Renewal Release Notes 10/06/2014

MAA-Vet

Revision 7.3

MAA-Vet Form 10/06/2014

MAA-Vet Release Notes 10/06/2014

User Documents

User Guidance

Questions and Answers 05/06/2014

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

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) Data Exchange Standard version 1.16 (effective from 26th September 2014)

XML Schema Definitioncurrent version 1.15

XML Schema Definition version 1.16 (effective from 26th September 2014)
DES 3.0 Technical Guide N/A N/A N/A N/A
Human MAA DES DES MAA-Human 06/05/2014 DES MAA-Human 22/08/2014 New MAA-Human XSD 10/06/2014 MAA-Human XSD 22/08/2014 - New
Variation DES DES Variation
6/05/20140
DES Variation 22/08/2014 New Variation XSD
10/06/2014

Variation XSD 22/08/2014 - New

Renewal DES Renewal
06/05/2014
DES Renewal 22/08/2014 New Renewal XSD
10/06/2014

Renewal XSD 22/08/2014 New

Vet MAA DES DES MAA-Vet
06/05/2014
DES MAA-Vet 22/08/2014 New MAA-Vet XSD
10/06/2014
MAA-Vet XSD 22/08/2014 - New
Common Dictionary XSD Schema N/A N/A Common Dictionary 10/06/2014

Common Dictionary 22/08/2014New


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.

 

 

 
 


© 1995-2014 European Medicines Agency | Last update: 25-08-2014 | Contact: esubmission@ema.europa.eu