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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:

RSS eAF RSS Feed

Forms

Form Notice to Applicant Revision Electronic Forms Release Notes

MAA-Human

Revision 9

MAA-Human Form 31/10/2012

MAA-H Release Notes  31/10/2012

Variation

Revision Dec 2009

Variation Form 31/10/2012

Variation Release Notes 31/10/2012

Renewal Revision October 2012 Renewal Form 01/03/2013

Renewal Release Notes 31/10/2012

MAA-Vet

Revision 7.2

MAA-Vet Form 31/10/2012

MAA-Vet Release Notes 31/10/2012

User Documents

User Guidance

Questions and Answers 31/10/2012

Training Presentation Training Presentation
Announcements End of Pilot announcement
Statement of Intent Statement of Intent - Human
Statement of Intent - Vet

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 XML Schema Definition
DES 3.0 Technical Guide DES Technical Guide N/A
Human MAA DES DES MAA-Human 31/10/2012 MAA-Human XSD 31/10/2012
Variation DES DES Variation 31/10/2012

Variation XSD 31/10/2012

Renewal DES Renewal 31/10/2012

Renewal XSD 31/10/2012

Vet MAA DES DES MAA-Vet 31/10/2012 MAA-Vet XSD 31/10/2012
Common Dictionary XSD Schema N/A

Common Dictionary 31/10/2012


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.

 

 

 
 


© 1995-2013 European Medicines Agency | Last update: 01-03-2013 | Contact: esubmission@ema.europa.eu