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eSubmission Gateway and eSubmission Web Client

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Human eSubmission
eCTD v3.2
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eSubmission expert group documents

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

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PSUR Repository

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eCTD v4.0

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Paediatric submissions

SPOR

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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

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.

User Guidance

Multimedia Tutorials

Technical Documents

Statements of Intent and announcements

 

 

 

EMA

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