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

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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.