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The Word based application forms (AF) are being 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.
The implementation is part of the HMA eSubmission roadmap.

The electronic forms and their supporting technical documentation are available below.

News

12 January 2016

  • After 11 January 2016, only version 1.19.0.1 of the eAF will be accepted.
  • There is no need to change the version of the form for ongoing procedures i.e. the previous form versions are accepted for ongoing procedures only.

Forms

  • Currently accepted version of forms : 19.0.1

Please Note: eAF forms can only be opened using Adobe Reader versions 10 and 11.

Form Notice to Applicant Revision

Electronic Forms version 1.19 (effective from the 30th November 2015, Replaces v.1.18 on 11 Jan 2016

Release Notes version 1.19 (effective from the 30th November 2015)

MAA-Human

Revision 12

MAA-Human Form 30/11/2015 New

MAA-H Release Notes 30/11/2015 New

Variation

Revision June 2015

Variation Form 30/11/2015 New

Variation Release Notes 3011/2015 New

Renewal Revision June2012 Renewal Form 30/11/2015 New

Renewal Release Notes 30/11/2015 New

MAA-Vet

Revision 7.4

MAA-Vet Form 30/11/2015 New

MAA-Vet Release Notes 30/11/2015 New

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

Technical guidance Human and Vet (19/10/2015)

Q & A

User Guidance Human & Vet Questions and Answers (19/10/2015)
Benchmark response times eAF performance
eAF training for industry Presentation (12/01/2016) - NEW

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)
eAF training for industry Multimedia webinar (01/12/2015)

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 1.18 (effective from the 3rd August 2015 XML Schema Definition version 1.18 (effective from the 3rd August 2015)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
Human MAA DES DES MAA-Human 01/06/2015 MAA-Human XSD 01/06/2015
Variation DES DES Variation 01/06/2015

Variation XSD 01/06/2015

Renewal DES Renewal 01/06/2015

Renewal XSD 01/06/2015

Vet MAA DES DES MAA-Vet 01/06/2015 MAA-Vet XSD 01/06/2015
Common Dictionary XSD Schema N/A

Common Dictionary 01/06/2015

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

 

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

Future versions

The following section will display forms that are part of a transitional period and should be used for training purpose only until the date they replace the current version.

Document Data Exchange Standard version 1.19 (effective from the 30th November 2015) XML Schema Definition version 1.19 (effective from the 30th November 2015)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
Human MAA DES DES MAA-Human 28/09/2015 MAA-Human XSD 28/09/2015
Variation DES DES Variation 28/09/2015

Variation XSD 28/09/2015

Renewal DES Renewal 28/09/2015

Renewal XSD 28/09/2015

Vet MAA DES DES MAA-Vet 28/09/2015 MAA-Vet XSD 28/09/2015
Common Dictionary XSD Schema N/A

Common Dictionary 28/09/2015

Release milestone plan for eAF:

Milestone Date
Publication of eAF V 01.19.0.1 30/11/15
Replacement eAF V 01.18 by 01.19.0.1 11/01/16
Publication of eAF V 01.20 15/04/16
V 01.19.0.1 withdrawn from website 01/05/16
Replacement eAF V 01.19 by 01.20 01/06/16

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

Links

Eudralex - volume 2 Notice to Applicants for Human applications

Eudralex - volume 6 Notice to Applicants for Veterinary applications

Archives

Announcements End of Pilot announcement
  Mandatory use of the eAF
Regulatory information User testing of electronic application forms underway

 

 


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