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.
12 January 2016
- After 11 January 2016, only version 188.8.131.52 of the eAF will be accepted.
- There is no need to change the version of the form for ongoing procedures i.e. the previous form versions are accepted for ongoing procedures only.
- Currently accepted version of forms : 19.0.1
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)
Technical guidance Human and Vet (19/10/2015)
Q & A
Multimedia webinars and training
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
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 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 01.19.0.1
|Replacement eAF V 01.18 by 01.19.0.1
|Publication of eAF V 01.20
|V 01.19.0.1 withdrawn from website
|Replacement eAF V 01.19 by 01.20
If you have any questions regarding these electronic application forms, please contact the eAF service desk with your query: email@example.com.
Eudralex - volume 2 Notice to Applicants for Human applications
Eudralex - volume 6 Notice to Applicants for Veterinary applications