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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

12-04-2016

  • A second webinar for NCAs on eAF: Overview and best practices how to automatically import data from eAFs into NCA IT-systems will be held on 15 June 2016, from 10:00 to 11:30 CET. This webinar is dedicated to National Competent Authorities and is organised in collaboration with the Network Training Centre. Registrations are accepted until 13 June 2016. For more information and to register, please visit the NTC website.

Note: A major change is being introduced to section 2 of the Variations eAF version 1.20 (“Products concerned by this application”), in response to industry and NCAs feedback.

- We are introducing a new simplified layout to this section
- Annexes A and B will no longer need to be submitted, as this information will be incorporated in this section of the eAF.
- The 1.19 xml data for section 2 of the variation form will not import into the 1.20 version of the form, since the underlying schema has been changed and this will result in the need to rekey data into that section only.

This change will affect national, MRP/DCP and centralised procedure. This is a major change which needs extensive testing therefore we are asking for your participation.

Forms

Currently accepted version of forms :

    • Variations: 1.19.0.2
    • Initial MAA Human and Vet, Renewal: 1.19.0.1 and 1.19.0.2

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 23/02/2016 New

MAA-H Release Notes 23/02/2016 New

Variation

Revision June 2015

Variation Form 23/02/2016 New

Variation Release Notes 23/02/2016 New

Renewal Revision June2012 Renewal Form 23/02/2016 New

Renewal Release Notes 23/02/2016 New

MAA-Vet

Revision 7.4

MAA-Vet Form 23/02/2016 New

MAA-Vet Release Notes 23/02/2016 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 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 1.19 (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

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

Future versions - New

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 1.20 (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 09/03/2016 N/A
Human MAA DES DES MAA-Human 09/03/2016 MAA-Human XSD 09/03/2016
Variation DES DES Variation 09/03/2016

Variation XSD 09/03/2016

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

Release milestone plan for eAF:

Milestone Date
Publication of eAF V 01.20 14/06/16 - New
V 01.19.0.1 withdrawn from website 01/07/16 - New
Replacement eAF V 01.19 by 01.20 01/08/16 - New

If you have any questions regarding these electronic application forms, please contact the eAF service desk with your query: 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

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

 

 


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