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eSubmission Gateway and eSubmission Web Client

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eSubmission Gateway and eSubmission Web Client

The eSubmission Gateway and the eSubmission Gateway Web Client are electronic submission channels that allow the applicants to submit documents supporting all types of applications for human and veterinary medicines to the Agency securely over the internet in structured and non-structured formats. The web-based Gateway Web Client may be more suitable for small and medium-sized companies, however it is available for all applicants. The Gateway and the Web Client users will benefit from an automated confirmation of the technical validation feedback and an automated upload to the Agency’s eCTD review system. The use of the eSubmission Gateway and the Web Client is mandatory for all human and veterinary submissions.

It is mandatory to use XML delivery files for submissions via the eSubmission Gateway and the Web Client.

News

10-04-2019

The eSubmission Gateway and Web Client online registration guidance has been updated with new contact information.

04-02-2019

Delay in the Formatted Table Template implementation in the XML delivery files – please continue to use the Formatted Table Template until further notice (Human and Veterinary).

There is a delay in the launch of the Formatted Table Template fields in the eSubmission Gateway Delivery file User Interface (UI) due to interdependencies with other systems, extended testing and resource issues due to the move of the agency. We were therefore unable to discontinue the use of the Formatted Table Template as of 1st of February 2019 as previously announced.

The release of the updated eSubmission Delivery file UI for the eSubmission Gateway has been further postponed until a future date. We will provide an update once the timeline for the delivery can be confirmed.

Please continue to provide the Formatted Table Template for Human and Veterinary submissions as a part of the Cover Letter in Module 1 of eCTD submission sequences or Part 1 of VNeeS dossiers.

As usual, users are required to fill in all the submission attributes correctly through the Delivery file UI. The attributes in the XML delivery files are used to support important searches in the Common Repository and they support EMA internal processes. Please note that incorrect submissions may lead to procedural delays of incoming applications.

18-12-2018

Due to a subtle delay in updates to the eSubmission Web User Interface (XML delivery file), the use of the Formatted Letter Template will become obsolete 1st February 2019. This concerns all EMA Human and Veterinary submissions (including PSUSA procedures) and companies should then 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 February 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 theSubmission Web User Interface by creating an XML delivery file as all attributes in the XML delivery file are used to support important searches in the Common Repository. The use of the XMLl will also support EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications. This will ensure continuous and immediate access to up-to-date dossiers.

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

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.

09-07-2018

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce an additional business rule to help users correctly select PASS 107 procedures types. Also, a Purchase Order number attribute for PASS 107 procedure was introduced.

This release of the eSubmission Gateway delivery file UI also fixes the known issue related to Veterinary submissions, users can now select from a predefined list of procedure numbers to reference their ASMF submissions. This is aligning with how Human procedure numbers can be linked to ASMF submission.

Users should note that the delivery files created using the eSubmission Gateway XML delivery file UI prior to the new release on 6st of July 2018 should work following the deployment of the new version. It is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.

Previous news is available here.

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