EU Telematics PIM _

EU Electronic Application Forms




Human eSubmission
eCTD v3.2
eCTD EU M1 specification

Veterinary eSubmission
eSubmission expert group

eSubmission expert group 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


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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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


Previous news can be found here.


Please note that from 1 January 2020, the Formatted Table Template will no longer be maintained by EMA.

The use of the XML delivery files is mandatory and the users are required to fill in all the submission attributes correctly through the eSubmission Delivery File UI since all attributes in the delivery file are used to support important searches in the Common Repository.

The delivery file must be attached to the submission when it is sent via the eSubmission Gateway or the Web Client.

The use of XML delivery files also supports the EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications and it ensures continuous and immediate access to up-to-date dossiers for internal and network users.

Please note that below mentioned fields are crucial and must be filled in correctly:

  • Customer reference (Purchase order information) for all relevant fee related submissions
  • Related procedure number for all submissions that already have a procedure number assigned
  • RMP version number where applicable
  • Withdrawal information for consolidating sequence unit type.


Version of the Human Marketing authorisation Application (maa) electronic Application Form (eAF) is now available. The release v1.23.1.4 is a bug fix release to correct business rules implementation in sections 1.4 and 1.5. Further details are available on the release notes. This bug fix release does not affect the Data Exchange Standard (DES). Applicants are reminded that the version of the form should not be changed during an ongoing procedure.


Version of the 4 electronic Application Forms (eAF) is now available. This release (v1.23.1.3) is a bug fix release to correct a number of issues which affect the forms. Further details are available in the release notes. This bug fix release does not affect the Data Exchange Standard (DES).
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.


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 13 MAA-Human Form (09-12-2019) New MAA-H Release Notes (09-12-2019) New
Variation Revision February 2018 Variation Form (10-10-2019) Variation Release Notes1.23.1.3 (10-10-2019)
Renewal Revision February 2018 Renewal Form (10-10-2019) Renewal Release Notes (10-10-2019)


Revision 8 MAA-Vet Form (10-10-2019) MAA-Vet Release Notes (10-10-2019)
Summary of eAF changes in current release     Summary of changes (09-12-2019) New

Release Milestone plan for eAF



Publication of eAF v1.23.1.4 maa 09/12/2019

Withdrawal of eAF v1.23.1.3 maa from the website


Transitional period - maa is accepted by the EMA and NCAs

09/12/2019 – 11/01/2020

Mandatory use eAF v1.23.1.4 maa






eAF and CESSP release schedule


Guidance Documents



Q & A

User Guidance Human & Vet Questions and Answers 01.03.2019
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

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
Using Referential and Organisation data in eAF Webinar PDF 29.06.2018

eAF Term Request Form

If you need to request a missing 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 a request for an update of an already existing term in order to complete the eAF, please submit a request through the SPOR Portal - providing as much supporting documentation as possible (e.g. name of the product concerned, SmPC, etc.). Please note you need to be registered with SPOR prior to submission of change requests: 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:

Document Data Exchange Standard version (effective from 13 July 2018) XML Schema Definition version (effective from 28.09 2018)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 13.07.2018 N/A
Human MAA DES DES MAA-Human 13.07.2018 MAA-Human XSD 28.09.2018
Variation DES DES Variation 13.07.2018

Variation XSD 28.09.2018

Renewal DES Renewal 13.07.2018 Renewal XSD 28.09.2018
Vet MAA DES DES MAA-Vet 13.07.2018 MAA-Vet XSD 28.09.2018
Common Dictionary XSD Schema N/A Common Dictionary 28.09.2018

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



1995-2020 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