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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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
Presentation	How to request additional terms in eAF 27/10/2014 New
Announcements	End of Pilot announcement
Statement of Intent	Statement of Intent - Human Statement of Intent - Vet
Form	eAF Term Request Form 27/10/2014 New

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	DES 3.0 technical guide	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 02/10/2014 New

If you have any questions regarding these electronic application forms, please contact the eAF service desk with your query: eaf@ema.europa.eu.