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.
- Important Notice to MAHs: All EMA IT systems will be temporarily unavailable from 06:00 on Saturday 16 April to 06:00 on Sunday 17 April 2016 (UK time) due to essential maintenance. This will prevent users from being able to connect to the eAF webservices at that time slot. More information is available here.
- Publication of eAF version 1.20: Please be informed that following a very high number of testing feedback for the new version of the eAF, we are revising the publication date and the subsequent dates applicable to this version of the form. The new date will be communicated on this webpage as soon as possible. We apologise for any inconvenience.
- 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.
23 February 2016
- Version 01.19.0.2 of the eAFs has been made available to fix technical issue related to the locking of the variation form and issues with the availability of the controlled terminologies in all forms. If you have already started to fill in version 220.127.116.11 of the variation form please import the user filled data to the new version to ensure that the form is fully locked. This can be done using the functionality to export the user filled data from 18.104.22.168 and import it into 22.214.171.124.
Version 126.96.36.199 will continue to be accepted for Renewal and Initial MAA Human and Vet applications, however you may wish to use the data import functionality to ensure optimum performance.
22 February 2016
We would like to inform you of the forthcoming User Acceptance Testing (UAT) of version 1.20 of the eAFs.
Timing for Industry and NCAs:
- UAT done by Industry: from Mon 21/03/16 to Thu 24/03/16
- UAT done by NCAs*: from Tue 29/03/16 to Fri 01/04/16
*Based on the eAF received from Industry
Should you wish to volunteer to participate, please email firstname.lastname@example.org
A feedback form for consolidated comments will be sent to you following receipt of your interest.
Note: A particular 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.
We encourage the NCAs to advertise this UAT to their national, local industry bodies/companies.
Currently accepted version of forms :
- Variations: 188.8.131.52
- Initial MAA Human and Vet, Renewal: 184.108.40.206 and 220.127.116.11
Please Note: eAF forms can only be opened using Adobe Reader versions 10 and 11.
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: email@example.com
For further information, please see the presentation: How to request additional terms in eAF
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:
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.
Release milestone plan for eAF:
|Publication of eAF V 01.20
||15/04/16 - Pending revision
|V 01.19.0.1 withdrawn from website
||01/05/16 - Pending revision
|Replacement eAF V 01.19 by 01.20
||01/06/16 - Pending Revision
If you have any questions regarding these electronic application forms, please contact the eAF service desk with your query: https://servicedesk.ema.europa.eu
Eudralex - volume 2 Notice to Applicants for Human applications
Eudralex - volume 6 Notice to Applicants for Veterinary applications