The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.
Version 1.21 of the eAFs will become available on 7 February 2017. The release v1.21 will provide mainly technical defect fixes and usability improvements.
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 16/01/17 to Thu 19/01/17
- NCAs*: from Tue 23/01/17 to Fri 27/01/17 (*Based on the eAFs received from Industry)
If you wish to participate, please email Beatriz.Calvo@ema.europa.eu. A feedback form for consolidated comments will be provided to you following your registration.
Please use the Service Desk portal https://servicedesk.ema.europa.eu to raise any queries related to the eAFs. Procedural queries related to MRP, DCP and National procedures should be directed to the relevant National Competent Authority.
eAF release schedule for v1.21 is now available. This release will deliver defect fixes and usability improvements.
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.
Updated versions of 4 electronic Application Forms (eAF v. 220.127.116.11) have been published following reported issues.
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.
Use of the eAF v1.20 is now mandatory. Use of previous versions is accepted only for ongoing applications – the version of the form should not be changed in the middle of the procedure.
Updated versions of 4 electronic Application Forms (eAF v. 18.104.22.168) have been published following reported issues. Use of the version 01.20 will become mandatory after an extended transitional period on19 September 2016.
Currently accepted version of forms :
- Initial MAA Human and Vet, Variations and Renewal: 1.20,22.214.171.124 and 1.20.02 and 126.96.36.199
We strongly recommend using the latest version of the forms where possible.
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: email@example.com. For further information, please see the presentation: How to request additional terms in eAF
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