The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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
09-05-2017
Version 1.21 of the eAFs will become available on 20 June 2017. The release v1.21 will provide usability improvements and technical defect fixes.
We are organising a User Acceptance Testing (UAT) to support the release of this next version of the forms:
- The testing by Industry and NCAs will take place
- Industry: from Mon 22/05/17 to Fri 26/05/17
- NCAs*: from Mon 29/05/17 to Fri 02/06/17 (*Based on the eAFs received from Industry)
If you wish to participate, please email eSubprogofficer@ema.europa.eu. A feedback form for consolidated comments will be provided to you following your registration.
25-04-2017
A new version of the eAF v1.21.0.0 is planned to be published on 20 June 2017. Please see the updated Release Milestone Plan below. This release will affect the the Data Exchange Standard (DES) of the MAA-Human and MAA-Vet forms. The updated DES and XSD documents are added below under Technical Documents.
08-03-2017
Users of the variation form who are wishing to import data from v1.20.0.3 or earlier are reminded to remove all the scopes in section 3 before exporting the xml in to v1.20.0.5. as the format of the numbering has changed and will cause issue if not deleted before importing to the new version of the form. There is no need to untick the scopes if importing from v1.20.0.4 to v1.20.0.5.
23-02-2017
A defect in section 2 of variation eAF causing fields to overlap and an issue affecting the co-rapporteur field in the human MAA form have been detected and subsequently fixed. New version v.1.20.0.5 of the variation and MAA human forms and the updated release notes are now available below. Please note that the Data Exchange Standard (DES) has not changed in this release. The new versions of the forms can be used as of today and the version 1.20.0.5 will fully replace previous versions on1 March 2017. Please note that there is no change to Renewal and MAA vet forms – the version number 1.20.0.4 will remain for renewal and vet MAA forms.
07-02-2017
Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.4 – initially called v1.21) are now available. This new release implements a large number of defect fixes and usability improvements. Please note that the Data Exchange Standard (DES) has not changed in this release.
15-11-2016
A video tutorial on How to complete an eAF based on version 1.20 is now available. Please see the“Guidance documents” section below for links to the presentation slides and the video. This material focuses on changes introduced in the version 1.20 of the form as well as some remaining known issues and workarounds.
01-10-2016
Applicants are reminded that the section 2 of the electronic Application Form (eAF) should be filled in with product details. The use of the footnote is only allowed for those applications that contain complex form and strength data where it may be impossible to enter details in the provided fields, for example complex vaccines. Footnote should not be used for applications where the product details can be entered in section 2. Convenient ‘clone’ function is now available reducing need to type similar information multiple times.
Forms
Currently accepted version of forms :
- Variations and Human MAA: 1.20.0.5
- Vet MAA and Renewal: 1.20.0.4
Please Note: eAFs should be filled out, signed and locked using Adobe Reader versions 10 and 11
For reviewing locked and signed forms we recommend using Adobe Reader or Adobe Acrobat versions 10 and 11
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: mdms@ema.europa.eu. For further information, please see the presentation: How to request additional terms in eAF
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
