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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

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Forms

Form Notice to Applicant Revision Electronic Forms Release Notes

MAA-Human

Revision 10.1

MAA-Human Form - 02/10/2014 New

MAA-H Release Notes -  02/10/2014 New

Variation

Revision July 2013

Variation Form -02/10/2014 New

Variation Release Notes -02/10/2014 New

Renewal Revision October 2012 Renewal Form - 02/10/2014 New

Renewal Release Notes - 02/10/2014 New

MAA-Vet

Revision 7.3

MAA-Vet Form - 02/10/2014 New

MAA-Vet Release Notes - 02/10/2014 New

User Documents

User Guidance

Questions and Answers

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 1.16 XML Schema Definition version 1.16
DES 3.0 Technical Guide N/A N/A
Human MAA DES DES MAA-Human 26/09/2014 New MAA-Human XSD 02/10/2014 - New
Variation DES DES Variation 26/09/2014 New

Variation XSD 02/10/2014 - New

Renewal DES Renewal 26/09/2014 New

Renewal XSD 02/10/2014 New

Vet MAA DES DES MAA-Vet 26/09/2014 New MAA-Vet XSD 02/10/2014 - New
Common Dictionary XSD Schema N/A

Common Dictionary 02/10/2014New

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: 02-10-2014 | Contact: esubmission@ema.europa.eu