The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation, and support for validation of form, etc. Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap.

The electronic forms and supporting technical documentation are available below.

News

19-09-2016

Use of the eAF v1.20 is now mandatory. Use of previous versions is accepted only for ongoing applications – the version of the form should not be changed in the middle of the procedure.

19-08-2016

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.2) have been published following reported issues. Use of the version 01.20 will become mandatory after an extended transitional period on19 September 2016.

Forms

Currently accepted version of forms :

• Initial MAA Human and Vet, Variations and Renewal: 1.20,1.20.0.1 and 1.20.02
  We strongly recommend using the latest version of the forms where possible.
  

Please Note: eAFs should be signed and locked using Adobe Reader versions 10 and 11
For reviewing locked and signed forms we recommend using  Adobe Reader or Adobe Acrobat versions 10 and 11

Guidance Documents

Regulatory

• User Guide for the electronic application form for a marketing authorisation (Human) 
• User Guide for the electronic application form for a marketing authorisation (Veterinary)

Technical

• Practical user guide for electronic Application Forms (eAF) for human and veterinary products in the EU (14/06/2016) -New

Q & A

User Guidance Human & Vet	Questions and Answers (14/06/2016) New
Benchmark response times	eAF performance
eAF for industry	Presentation

Multimedia webinars and training

eAF webinar with NCAs – initial MAA	Multimedia webinar (10/11/2015)
eAF webinar with NCAs – variation and renewal	Multimedia webinar (25/11/2015)
1st eAF training for industry	Multimedia webinar (01/12/2015)
2nd eAF training for industry	Multimedia webinar (12/01/2016) - NEW

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. For further information, please see the presentation: How to request additional terms in eAF

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.

Current version of technical documents:

Document	Data Exchange Standard version 1.20 (effective from the 15 April 2016)	XML Schema Definition version 1.20 (effective from the 15 April 2016)
DES 3.0 Technical Guide	DES 3.0 technical guide	N/A
eAF DES change summary	DES change summary 07/06/2016 - New	N/A
Human MAA DES	DES MAA-Human 09/03/2016	MAA-Human XSD 09/03/2016
Variation DES	DES Variation 07/06/2016 - New	Variation XSD 14/06/2016 - New
Renewal	DES Renewal 09/03/2016	Renewal XSD 09/03/2016
Vet MAA DES	DES MAA-Vet 09/03/2016	MAA-Vet XSD 09/03/2016
Common Dictionary XSD Schema	N/A	Common Dictionary 09/03/2016

For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu

Links

• Eudralex - volume 2 Notice to Applicants for Human applications
• Eudralex - volume 6 Notice to Applicants for Veterinary applications

Archives