The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.
Previous news can be found here.
Essential maintenance to computer applications
The eAF will be impacted by essential maintenance to SPOR data services on Saturday, 15 December and Sunday, 16 December 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.
The eAF User Guidance Human & Vet Q&A has been updated and can also be found under the section “Guidance documents / Q&A”.
New versions of the 4 electronic Application Forms (eAF v. 184.108.40.206) and the related release notes are now available. This new version is a hotfix release of the forms and can be used as of 28th September 2018.
The current versions (v220.127.116.11) of the forms can be used and will fully replace the version 18.104.22.168 after a transitional period, on 15 October 2018 as detailed in the eAF Release Milestone plan. The version of the form should not be changed during an ongoing procedure.
Essential maintenance to computer applications
The eAF will be impacted by essential maintenance to SPOR data services on between 08:00-18:00 hrs (UK time) Saturday, 25 August 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.
The regulatory user guides for the electronic application form for a marketing authorisation (Human and Veterinary) have been updated, see section Guidance documents / Regulatory.
New versions of the 4 electronic Application Forms (eAF v. 1.23) and the related release notes are now available.
This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. This new version, 1.23 of the forms can be used as of today (13th July 2018) and will fully replace the version 22.214.171.124 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure.
Version 1.23 of the electronic Application Forms (eAFs) will become available on 13 July 2018. The release v1.23 will provide further integration with OMS from SPOR (Organisational/address data) and NTA changes, User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:
- The testing by Industry and NCAs will take place
- Industry: from Mon 11/06/18 to Fri 18/06/18
- NCAs*: from Mon 19/06/18 to Fri 22/06/18 (*Based on the eAFs received from Industry)
If you wish to participate, please register by email with eSubprogofficer@ema.europa.eu. A feedback form for consolidated comments will be provided to you following your registration. Please follow Summary of changes, document which shows clearly before and after areas and changes to eAF that focus on test scenarios for current UAT. UAT version of Summary of changes will be sent via email with UAT package. Final version will be published on website later (13 July 2018).
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
If you need to request a missing substance in order to complete an eAF, please submit a request for substance insertion with the corresponding SmPC to the EMA Service Desk portal.
If you need to request a new term (e.g. pharmaceutical form or unit of measurement) or a request for an update of an already existing term in order to complete the eAF, please submit a request through the SPOR Portal - http://spor.ema.europa.eu/rmswi/#/ providing as much supporting documentation as possible (e.g. name of the product concerned, SmPC, etc.). Please note you need to be registered with SPOR prior to submission of change requests: https://register.ema.europa.eu/identityiq/login.jsf. The user guide for managing referential and organisation data in eAF 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