The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.
Issues have been reported with the latest versions of the electronic Application Forms v184.108.40.206. The issues are being solved and a second hotfix release is planned for 19th August 2016. While the issues are being fixed, the deadline for the mandatory use of the version 1.20 has been extended until 19th of September 2016. Versions 220.127.116.11 as well as v18.104.22.168 may be used during the extended transitional period. If you are experiencing issues with the forms, please contact the EMA IT service desk via the online portal: https://servicedesk.ema.europa.eu.
Updated versions of all 4 electronic Application Forms (eAF v. 22.214.171.124) have been published following reported issues with the proof of payment section and entering quantities in the initial human MAA form.
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.
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.
Currently accepted version of forms :
- Variations: 126.96.36.199, 1.20 and 188.8.131.52
- Initial MAA Human and Vet, Renewal: 184.108.40.206 and 220.127.116.11, 1.20 and 18.104.22.168
Please Note: eAF forms can only be opened using Adobe Reader versions 10 and 11.
User Guide for the electronic application form for a marketing authorisation (Human)
User Guide for the electronic application form for a marketing authorisation (Veterinary)
Practical user guide for electronic Application Forms (eAF) for human and veterinary products in the EU (14/06/2016) -New
Q & A
Multimedia webinars and training
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
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