EU Telematics PIM _

EU Electronic Application Forms




Human eSubmission

Veterinary esubmission

eSubmission CMB

CMB Documents





Common Repository






eSubmission Gateway & eSubmission Web Client


Delivery file UI


eSubmission Gateway

PSUR Repository

Industry access

NCA access



eCTD v4.0


EU Module 1





The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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  A feedback form for consolidated comments will be provided to you following your registration.

Please use the Service Desk portal 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. 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. 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, and 1.20.02 and
    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

Form Notice to Applicant Revision Electronic Forms version 1.20 Release Notes version 1.20


Revision 12 MAA-Human Form 18.10.2016 New MAA-H Release Notes 18.10.2016 New
Variation Revision June 2015 Variation Form 18.10.2016 New Variation Release Notes 18.10.2016 New
Renewal Revision June 2012 Renewal Form 18.10.2016 New Renewal Release Notes 18.10.2016 New


Revision 7.4 MAA-Vet Form 18.10.2016 New MAA-Vet Release Notes18.10.2016 New

Release Milestone plan for eAF:

Milestone Date
User Acceptance Testing 16-27/01/17
Deployment date 07/02/2017
Replacement of eAF v1.20.0.3 01/03/2017

Guidance Documents



Q & A

User Guidance Human & Vet Questions and Answers (14.06.2016) New
Benchmark response times eAF performance
eAF for industry Presentation
How to complete an eAF based on version 1.20 Presentation (15.11.2016) New

Multimedia webinars and training

eAF webinar with NCAs – initial MAA Multimedia webinar (10.11.2015)
eAF webinar with NCAs – variation and renewal Multimedia webinar (25.11.2015)
1st eAF training for industry Multimedia webinar (01.12.2015)
2nd eAF training for industry Multimedia webinar (12.01.2016)
How to complete an eAF based on version 1.20 Training video (15.11.2016) New

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: 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:

Document Data Exchange Standard version 1.20 (effective from the 15 April 2016) XML Schema Definition version 1.20 (effective from the 15 April 2016)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 07.06.2016 - New N/A
Human MAA DES DES MAA-Human 09.03.2016 MAA-Human XSD 09.03.2016
Variation DES DES Variation 07.06.2016 - New

Variation XSD 14.06.2016 - New

Renewal DES Renewal 0./03.2016

Renewal XSD 09.03.2016

Vet MAA DES DES MAA-Vet 09.03.2016 MAA-Vet XSD 09.03.2016
Common Dictionary XSD Schema N/A

Common Dictionary 09.03.2016

For technical support, visit the EMA Service Desk portal:



Announcements End of Pilot announcement
  Mandatory use of the eAF
Regulatory information User testing of electronic application forms underway



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