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 application forms for medicinal products for human use are published and maintained in EudraLex Volume 2
• The application forms for medicinal products for veterinary use are published and maintained in EudraLex Volume 6.
• The forms and their supporting technical documentation are  available below:

Forms

Form	Revision	Electronic Forms	Release Notes
MAA-Human	Revision 9	MAA-Human Form	MAA-H Release Notes
Variation	Revision Dec 2009	Variation Form	Variation Release Notes
Renewal	Revision Feb 2007	Renewal Form	Renewal Release Notes
MAA-Vet	Revision 7.2	MAA-Vet Form	MAA-Vet Release Notes

User Documents

User Guidance	Questions and Answers
Pilot Guidance	Pilot Guidance
Training Presentation	Training Presentation
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	MAA-Human XSD
Variation DES	DES Variation	Variation XSD
Renewal	DES Renewal	Renewal XSD
Vet MAA DES	DES MAA-Vet	MAA-Vet XSD
Common Dictionary XSD Schema	N/A	Common Dictionary

The Electronic Application Forms (eAF) pilot commenced on March 12th 2012 and is expected to run for four months The pilot initially only allowed pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and for variation and renewal applications for human and veterinary medicines. From 2 May, initial veterinary applications will also be accepted.

This website will be updated in parallel to any updates of the above mentioned EudraLex Volume 2 and EudraLex Volume 6 websites with the most recent versions of electronic application forms, and related supporting documentation.

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