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.

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What's New in eSubmission Today?

12-12-2018

Essential maintenance to computer applications

Essential maintenance is scheduled to be carried out to SPOR data services: Referential Management Services (RMS) and Organisations Management Services (OMS) between 08:00 (UK time) on Saturday, 15 December and 18:00 (UK time) on Sunday, 16 December 2018. Applications consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp), and eAF) will be affected during this time. Should you have any questions please contact the EMA IT Service Desk.

The PSUR Repository will be impacted for industry users sending non-EU single assessment PSURs only and the NCA users using performing searches in the non-EU single assessment area of the PSUR Repository. Search attribute MA authorisation type is also unavailable during this period. Please note that if you have submission deadline for non-EU single assessment PSUR on Friday, 14 December, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.

The eAF will be impacted for the ATC code field (MAA human and vet and the renewal form) and for the areas where Organizations 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 continue working during this maintenance activity.

03-12-2018

The final version of the implementation package containing the updated eCTD v4.0 EU M1 Implementation Guide is now released for implementation purpose.

Further details can be found here.

22-11-2018

EMA IT systems unavailable from 30 November to 3 December 2018

All EMA online applications will be temporarily unavailable

All European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable from 18:00 on Friday 30 November to 06:00 on Monday 3 December 2018 (UK time), due to essential maintenance.  The EMA public website will remain available during this period, however it will not be possible to access any other EMA-hosted website or online application. Normal service will resume on 3 December.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.

05-11-2018

The use of the Formatted Letter Template will become obsolete as of 1st January 2019. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and companies should no longer use the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier.

From 1 January 2019, the Formatted Letter Template will not be maintained by EMA and the document and references will be removed from EMA corporate website.

Users are required to fill in all the submissions attributes correctly through the eSubmission Web UI by creating a .XMLdelivery file, as all attributes in the .XML delivery file are used to support important searches in the Common Repository.

Use of the .XML will also support EMA internal processes by significantly reducing the time required for receiving, processing, and validating incoming applications, and ensures continuous and immediate access to up-to-date dossiers.

Please note that incorrect submissions may lead to procedural delays of incoming applications.

03-10-2018

The eAF User Guidance Human & Vet Q&A has been updated and can also be found under the section “Guidance documents / Q&A" here.

02-10-2018

New versions of the 4 electronic Application Forms (eAF v. 1.23.1.0) and the related release notes are now available. This new version is a hotfix release of the forms and can be used as of 28th September 2018.

The current versions (v1.23.1.0) of the forms can be used and will fully replace the version 1.22.0.1 after a transitional period, on 15 October 2018 as detailed in the eAF Release Milestone plan. The version of the form should not be changed during an ongoing procedure.

13-09-2018

Gateway submission of veterinary applications in VNeeS version 2.6.

Please note that the EMAeSubmission Gateway web UI is being updated to reflect in the field “Submission
format” the VNeeS version 2.6 for Pharmaceutical and Immunological products.

For the time being, therefore, please submit your applications in VNeeS version2.6 using the submission format 2.5.

And

Essential maintenance to computer applications on Friday, 14 September

PSUR and eSubmission Web User Interface (to create the delivery file) will be unavailable between 17:30-19:30hrs (UK time) on Friday, 14  September 2018.However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.  

05-09-2018

Essential maintenance to computer applications on Thursday, 6 September

PSUR and eSubmission Web User Interface (to create the delivery file) will be unavailable between 17:30-19:30hrs (UK time) on Thursday, 6 September 2018.However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.  

03-09-2018

Guideline on eSubmissions for Veterinary products – version 2.6 now in force.

Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council came into force on 27 January 2017.

With VNeeS version 2.6 now in force, the structure of the electronic dossier has been brought in line with structure described in the Commission Implementing Regulation.

Previous news is available here