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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

12-07-2016

Issues have been reported with the latest versions of the electronic Application Forms v1.20.0.1 and, while the issues are being investigated and fixed, new versions of all the 4 forms are planned to be published within the next coming weeks, exact date of this new release is yet to be confirmed. If you are experiencing issues with the forms, please contact the EMA IT service desk via the online portal: https://servicedesk.ema.europa.eu.

30-06-2016

Updated versions of all 4 electronic Application Forms (eAF v. 1.20.0.1) have been published following reported issues with the proof of payment section and entering quantities in the initial human MAA form.

21-06-2016

Variation eAF: Two issues have been detected with the new version of the variation application form (eAF v. 1.20) affecting the use of the form in its current state for MRP/DCP applications. EMA is currently fixing these defects affecting selection of Reference Member State (MRP/DCP procedures) and the Proof of Payment section. The form may continue to be used for Centralised Procedure applications and National Procedure applications. A new version of the form will be published later this week. If you have already started to fill in the application form v. 1.20 and you are submitting an application prior to the publication of the hotfix version, please provide the information from Proof of Payment section as a separate annex to the application form. Alternatively, you may use version 1.19. Please note that once the hotfix version becomes available the information already filled in v. 1.20 can be imported to the new version.  We would like to thank those users who have reported the issues with the forms.

14-06-2016

Version 1.20 of the electronic Application Forms (eAF) and the related release notes are now available This version of the forms provides usability improvements and defect fixes and aims to improve the user experience for all users. Version 1.20 of the forms may be used from 14th June 2016 and will fully replace the current version of eAF v. 01.19 after a transitional period on1 August 2016. Version 1.19 of the forms will be withdrawn from the eAF website on 1 July 2016 however it may be used until 1 August 2016. The use of the eAFs is mandatory for all human and veterinary submissions.

eaf

Forms

Currently accepted version of forms :

  • Variations: 1.19.0.2, 1.20 and 1.20.0.1
  • Initial MAA Human and Vet, Renewal: 1.19.0.1 and 1.19.0.2, 1.20 and 1.20.0.1

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

Form Notice to Applicant Revision Electronic Forms version 1.20 Replaces v.1.19 on 1st August 2016 Release Notes version 1.20

MAA-Human

Revision 12 MAA-Human Form 30/06/2016 New MAA-H Release Notes 30/06/2016 New
Variation Revision June 2015 Variation Form 30/06/2016 New Variation Release Notes 30/06/2016 New
Renewal Revision June 2012 Renewal Form 30/06/2016 New Renewal Release Notes 30/06/2016 New

MAA-Vet

Revision 7.4 MAA-Vet Form 30/06/2016 New MAA-Vet Release Notes 30/06/2016 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

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 1.19 (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

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 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

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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