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Human eSubmission
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eSubmission expert group documents

Systems:

eSubmission Gateway & eSubmission Web Client

Projects:

CESSP Dataset Module (AF)

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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What's New in eSubmission Today?

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.

17-12-2020

Following the deployment of the v1.17.3.0 of the PSUR Repository, the version release notes are now available here.

Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.

15-12-2020

eAF v1.24.0.1 now available

New version 1.24.0.1 of all four eAFs is now available to allow the users a short transitional period before the start of the mandatory use of the form. The changes in this version of the forms (v1.24.0.1) relate to the Member State, OMS and Country fields in all 4 forms and the changes are implemented due to the end of the transitional period following Brexit and in the view of the Northern Ireland protocol.

The changes, in summary, are either addition of a new ‘country’ United Kingdom (Northern Ireland) in the EU and EEA country lists and removal of United Kingdom from the EU and EEA country lists in RMS. Additionally, 3 new country ‘groupings’ have been created in RMS to either remove or add United Kingdom or United Kingdom (Northern Ireland) where these terms should or shouldn’t be displayed. Some minor amendments to which country grouping certain fields are pointing to have also been made.

The short transitional period will coincide with the transitional period with the previous version of the eAFs (v1.23.1.3 variation, renewal, MAA Vet)/1.23.1.4 MAA Human) which was initially planned to end on 15th of December 2020.
The users are now allowed to submit applications using version 1.23.1.3/1.23.1.4 until the end of 2020. The version 1.23.1.3/1.23.1.4 has been removed from the eAF website however, it does remain acceptable for submissions until the end of 2020.

The new Brexit related version can be used for procedures starting after 1.1.2021.

There will be a short transitional period for the use of previous version 1.24.0.0 until the 15th of January for those applications that do not require use of terms United Kingdom or United Kingdom (Northern Ireland).
From 1st of January 2021 term United Kingdom will be removed from EU/EEA country grouping and it will no longer be available for selection in any version of the forms (in the fields where EU/EEA countries are listed).

This version also includes a change in the Variation form, form validation rules for National Authorisation applications for grouping of a single variation scopes for multiple products.

More details can be found from the release notes and a presentation on changes available here.

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.

New version of the PSUR repository is now available

A new version of the PSUR Repository (industry and NCA user interfaces) is now available. Minor changes have been introduced to both industry and NCA user interfaces due to the end of the Brexit transitional period on 31st of December.

The changes relate to use of terms United Kingdom (Northern Ireland) and new country code XI for UK(NI) in the product selection tables in the industry user interface.

Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.

03-12-2020

eAF issues with webservices fixed

The issue affecting the ‘Substance Type’ field in both, human and veterinary MAA forms has now been fixed and all the previously available substance types are
now again available.

As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.

EMA
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