EU Telematics PIM _

EU Electronic Application Forms




Human eSubmission

Veterinary esubmission

eSubmission CMB

CMB Documents

External Links




Common Repository






eSubmission Gateway & eSubmission Web Client


Delivery file UI


eSubmission Gateway


PAM submission form

PSUR Repository

Industry access

NCA access



eCTD v4.0


EU Module 1


Paediatric submissions







The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.



Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on Saturday, 10 March and Sunday, 11 March 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.


New versions of the 4 electronic Application Forms (eAF v. and the related release notes are now available. This new version is a hotfix release v1.22.0.1 of the forms and can be used as of today, 16th February 2018. The version of the form should not be changed during an ongoing procedure.


As of 15 February 2018 version 1.22 of the four electronic Application Forms (eAFs) are mandatory. Older versions of the forms will no longer be supported.

Previous news can be found here.


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 :

Form Notice to Applicant Revision Electronic Forms version Release Notes version


Revision 12 MAA-Human Form v1.22.0.1
16.02..2018 New
MAA-H Release Notes 16.02..2018 New
Variation Revision June 2015 Variation Form v1.22.0.1
16.02..2018 New
Variation Release Notes 16.02..2018 New
Renewal Revision June 2015 Renewal Form v1.22.0.1
16.02..2018 New
Renewal Release Notes16.02..2018 New


Revision 7.5 MAA-Vet Form v1.22.0.1
16.02..2018 New
MAA-Vet Release Notes 16.02..2018 New
Summary of eAF changes in current release     Summary of changes 15.12.2018 New

Release Milestone plan for eAF:

Guidance Documents



Q & A

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

EudraVigilance system downtime – impact on PSUR Repository and the eAF

Document 05.10.2017 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
Using Referential and Organisation data in eAF Webinar presentation 28.11.2017

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.

From January 2018, you may continue submit email requests (as above) or submit the new RMS change requests via the RMS portal to request updates to referential terms (recommended).

From July 2018, you will only be able to submit RMS change requests via the portal to request updates to referential terms.
As of January 2018 new substance requests and updates should be submitted via requests made to the EMA Service Desk portal. When submitting a substance request to the EMA Service Desk please provide supporting documentation for the substance (e.g. product SmPC or substance specifications). email address will be discontinued in Q1 2018.

The user guide for managing referential and organisation data in SPOR 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:

Document Data Exchange Standard version
(effective from the 16 Feb 2018)
XML Schema Definition version
(effective from the 16 Feb 2018)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 16.02.2018 New N/A
Human MAA DES DES MAA-Human 15.11.2017 MAA-Human XSD 16.02.2018 New
Variation DES DES Variation 15.11.2017 Variation XSD 16.02.2018 New
Renewal DES Renewal 15.11.2017 Renewal XSD 16.02.2018 New
Vet MAA DES DES MAA-Vet 15.11.2017 MAA-Vet XSD 16.02.2018 New
Common Dictionary XSD Schema N/A Common Dictionary 16.02.2018 New

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



© 1995-2018 European Medicines Agency | Disclaimer| For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here