The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.
Essential maintenance to computer applications
The eAF will be impacted by essential maintenance to SPOR data services on Saturday, 10 March and Sunday, 11 March 2018. The eAF will be impacted for the ATC code field (MAA human and vet and the renewal form) and for the areas where Organisations and Locations are used (however manual input of data is allowed for these areas). There is no impact to the Variation application form. All other dropdown menus for controlled terminology will continue to work during this maintenance activity.
New versions of the 4 electronic Application Forms (eAF v. 18.104.22.168) and the related release notes are now available. This new version is a hotfix release v22.214.171.124 of the forms and can be used as of today, 16th February 2018. The version of the form should not be changed during an ongoing procedure.
As of 15 February 2018 version 1.22 of the four electronic Application Forms (eAFs) are mandatory. Older versions of the forms will no longer be supported.
Previous news can be found here.
Please note that applicants should use Adobe Reader or Adobe Reader DC for locking the forms. Adobe Acrobat or Acrobat Pro DC should not be used for filling and locking the forms as this may cause issues when the locked forms are opened/viewed by the recipient who may be using Adobe Reader/Adobe Reader DC.
Currently accepted version of forms :
Q & A
Multimedia webinars and training
eAF Term Request Form
From January 2018, you may continue submit email requests (as above) or submit the new RMS change requests via the RMS portal to request updates to referential terms (recommended).
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.
From July 2018, you will only be able to submit RMS change requests via the portal to request updates to referential terms.
As of January 2018 new substance requests and updates should be submitted via requests made to the EMA Service Desk portal. When submitting a substance request to the EMA Service Desk please provide supporting documentation for the substance (e.g. product SmPC or substance specifications).
firstname.lastname@example.org email address will be discontinued in Q1 2018.
The user guide for managing referential and organisation data in SPOR is available here.
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