EU Telematics PIM _
 

EU Electronic Application Forms

_

Home

_
Upcoming meetings
_

Human eSubmission

_
Veterinary esubmission
_

eSubmission CMB

_
CMB Documents
_

Documentation

_

Projects:

_

Common Repository

_
CESP
_

eCTD

_

eAF

_
eASMF
_

EU Module 1

_

eSubmission Gateway and eSubmission Web Client

_
PSUR Repository NEW
_

eCTD NMV/RPS

_

eSignatures

_
_

 

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: mdms@ema.europa.eu

RSS news feed

User Acceptance Testing (UAT)

The HMA eSubmission Roadmap foresees mandatory usage of the electronic Application Forms for Centralised Procedure (Human and Vet) from 1 July 2015 onwards and for all other procedure types from the beginning of 2016. The next version of the eAFs is now available for User Acceptance Testing until 5th of March 2015 for limited number of testers.

If you are interested to participate in this exercise, please send an email to Gareth.Wilson@ext.ema.europa.eu to receive the test package. Feedback on test results should be sent to Gareth.Wilson@ext.ema.europa.eu by 05 March at the latest.

Forms

Form Notice to Applicant Revision Electronic Forms Release Notes

MAA-Human

Revision 10.1

MAA-Human Form

MAA-H Release Notes

Variation

Revision July 2013

Variation Form

Variation Release Notes

Renewal Revision October 2012 Renewal Form

Renewal Release Notes

MAA-Vet

Revision 7.3

MAA-Vet Form

MAA-Vet Release Notes

User Documents

User Guidance

Questions and Answers

Presentation How to request additional terms in eAF
Announcements End of Pilot announcement
  Mandatory use of the eAF
Statement of Intent Statement of Intent - Human
Statement of Intent - Vet
Form eAF Term Request Form

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 Data Exchange Standard version 1.17 (effective from 23rd Feb 2015) XML Schema Definition version 1.16 XML Schema Definition version 1.17(effective from 23rd Feb 2015)
DES 3.0 Technical Guide DES 3.0 technical guide DES 3.0 technical guide N/A N/A
Human MAA DES DES MAA-Human 26/09/2014 DES MAA-Human 16/02/2015New MAA-Human XSD 02/10/2014 MAA-Human XSD 16/02/2015New
Variation DES DES Variation 26/09/2014 DES Variation 16/02/2015New

Variation XSD 02/10/2014

Variation XSD 16/02/2015New

Renewal DES Renewal 26/09/2014 DES Renewal 16/02/2015New

Renewal XSD 02/10/2014

Renewal XSD 16/02/2015New

Vet MAA DES DES MAA-Vet 26/09/2014 DES MAA-Vet 16/02/2015New MAA-Vet XSD 02/10/2014 MAA-Vet XSD 16/02/2015New
Common Dictionary XSD Schema N/A N/A

Common Dictionary 02/10/2014

Common Dictionary 16/02/2015New

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: 17-02-2015 | Contact: esubmission@ema.europa.eu