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.
- 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.
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: firstname.lastname@example.org
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
||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
Eudralex - volume 2 Notice to Applicants for Human applications
Eudralex - volume 6 Notice to Applicants for Veterinary applications