eSubmission: Projects

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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

Veterinary eSubmission

eSubmission expert group

eSubmission expert group documents

Systems:

eSubmission Gateway & eSubmission Web Client

Projects:

Paediatric submissions

SPOR

eSignatures

Introduction

To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.

For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.

The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.

Preparation of the next major version (version 4.0) is now ongoing within the ICH.

For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.

For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.

The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.

For technical support, 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.

For details on how to find us please click here.

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Previous news is available here

What's New in eSubmission Today?

21-04-2021

Planned maintenance of the eSubmission Gateway and the eSubmission Gateway Web client (Production Axway Gateway) this weekend

The Production Axway Gateway (eSubmission Gateway and the Web Client) will be unavailable from Friday 23/04 at 18:00 until Monday 26/04 at 06:00 due to essential maintenance. For any further information, please contact Service Desk

and

Essential maintenance to SPOR data services - 24 April 2021

Essential maintenance is scheduled to be carried out to SPOR data services - between 8:00-12:00 on Saturday 24 April. Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp) and eAF Web Application) will be affected, as well as internal or external access to SPOR portal. For any further information, please contact Service Desk

15-04-2021

All EMA IT systems unavailable from 16 to 18 April 2021

All European Medicines Agency (EMA) information technology (IT) systems apart from the corporate website (www.ema.europa.eu) will be intermittently unavailable from 18:00 on Friday 16 April to 11:00 on Sunday 18 April 2021 (Central European Summer Time, CEST), due to essential maintenance.

The EMA corporate website will remain available during this period but it may not be possible to access any other EMA-hosted website or online application.
The EMA product emergency hotline and phone number for notifying EMA of suspected quality defects or product recalls will operate as usual during this period.

09-04-2021

Updated eCTD EU M1 specification now available

The eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.4 and the related release notes are available
here. There are no changes to the DTD and hence this version enters into force as of date of publication and can be used immediately. It is recommended to use the new version as soon as possible.

Please note that the release notes provide practical information on the changes and it is strongly recommended to review the release notes to fully understand the changes made in the specification.

25-03-2021

Digital Application Dataset Integration (DADI) project

The European Medicines Regulatory Network has launched a new telematics project called the Digital Application Dataset Integration project (DADI) to modernise and improve use of the EU electronic Application Forms (eAFs). DADI has been established as the successor to the Common European Single Submission Portal (CESSP) phase 1 project.
More details are available here.

11-03-2021

A new version of the eSubmission Gateway XML delivery file is now available

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of ‘nitrosamine related’ radio button for initial variation submissions (human domain only) and renaming the ‘Customer Reference’ field to ‘purchase order number’ for all relevant submission types and submission units (H&V).
The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.

Users should note that the delivery files created prior to the new release will not work after the go live

08-03-2021

A new version of the eSubmission Gateway XML delivery file for veterinary changes is now available

An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is now available. This update has introduced changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number). The details on the changes are provided in the related release notes which are available here and the updated user guide is available here

Users should note that the delivery files created prior to the new release will not work after the go live

04-03-2021

A new version of the eSubmission Gateway XML delivery file for veterinary changes is planned for release in the evening of 8th March 2021

An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is planned for release in the evening of 8th March 2021. This update will introduce changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number).

Users should note that the delivery files created prior to the new release will not work after the go live.

04-03-2021

A new version of the eSubmission Gateway XML delivery file planned for release in the evening of 11th March 2021

An updated version of the eSubmission Gateway XML delivery file user interface is planned for release in the evening of 11th March 2021. This update will introduce changes to the delivery file (addition of nitrosamine related radio button for initial variation submissions and renaming the Customer Reference field to PO number for all relevant submission types and submission units.

Users should note that the delivery files created prior to the new release will not work after the go live.

08-02-2020

Updated version of the VNeeS specification now available

The Guideline on eSubmissions for Veterinary products has been updated to version 2.7.1, applicable immediately. This minor change is Brexit related change in the list of country codes in table 4.

This change has no impact on the validation rules and the current VNeeS Checker tool (v2.6) remains unchanged.

16-01-2021

Mandatory use of eAF v1.24.0.1

It is now mandatory to use the version 1.24.0.1 of all four eAFs.

The term United Kingdom has been removed from the EU/EEA country grouping on 1st of January 2021 for selection in any version of the forms (in the fields where EU/EEA countries are listed).

Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

EMA
©1995-2021 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