The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.
News
Previous news can be found here.
29-06-2020
There is a short delay in the start of the UAT for the eAF v1.24.0.0 – new dates will be communicated very soon. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu
11-06-2020
eAF v1.24.0.0 release milestone plan and updated release schedule for eAF now available
An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available below.
Version 1.24.0.0 of the variation and renewal electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 months transitional period and mandatory use from November 2020. The release v1.24.0.0 will provide a major change into the section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:
The testing by Industry and NCAs is planned to take place as follows:
- Industry: from Mon 29/06/20 to Fri 03/07/20
- NCAs*: from Mon 06/07/20 to Fri 10/07/20 (*Based on the eAFs received from Industry)
Please note that these dates are subject to change depending on the outcome of internal UAT. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu
Further details on the release scope and the confirmed dates for the UAT will be provided soon.
31-03-2020
In the view that many applicants and MAHs are now working from home due to the Covid-19 situation, we would like to remind the users of the eAF functionality which may facilitate working during exceptional circumstances with variable internet bandwidths.
The electronic Application Forms can be saved directly from the eSubmission website to the users local machine and most fields can be filled in off-line, without access to internet. Only those fields that require substance/term related searches, and the use of OMS for address details requires connection to the internet. Validation feature and most dropdown lists are loaded to the form at the time when the form is opened and can be used even when the user is not connected to the internet enabling most of the form to be filled in without internet connection.
The performance of the forms with regards to the speed is unfortunately not optimal, mainly due to the technology used and the multiple business rules built in to the form, and hence, the network is working hard on the replacement of the PDF format forms with a web-based forms. The new web based forms for human and veterinary MAAs are planned for release later this year (timelines subject to change due to Covid-19 situation).
The eAFs are submitted as a part of the dossier which, for centralised procedure applications, must be submitted via the eSubmissions Gateway. In case the users are experiencing issues with the eAFs or preparing and sending submissions via the eSubmission Gateway or Web Client, we strongly recommend raising a ticket with detailed description of the issue via the EMA service desk portal.
It is important to include as many details as possible of the issue and, for example attaching screenshots or the form in question to aid investigation for the reasons of the issue.
Forms
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 :
As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.
Q & A
Multimedia webinars and training
eAF Term Request process (Updated)
If you need to request a new 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 an update of an already existing term in order to complete the eAF, please submit a request through the Referential Management Services (RMS) of the SPOR portal providing as much supporting documentation as possible (e.g. name of the product concerned, SmPC, justification for the request, etc.). The ‘RMS Web User Manual’, which provides a step-by-step guide on how to submit change requests, can be found under the 'Documents' section of the RMS portal.
Please note that you need to be registered with SPOR prior to the submission of change requests. The ‘SPOR User Registration Manual’, which provides detailed information on how to register in SPOR, can be found under the 'Document' section of the RMS portal. The user guide for managing referential and organisation data in eAF is available here.
Technical Documents
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
Links
