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eSubmission Gateway and eSubmission Web Client

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eSubmission Gateway & 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.

Previous news is available here

News

15-06-2022

eSubmission Gateway Web Client upgrade - External UAT for all XCOMP users now open

The issues relating to preparations for the external UAT have been solved and all eSubmission Web Client XCOMP users are now invited to start user acceptance testing (XCOMP environment). Please refer to the Guidance on how to submit using Syncplicity Web Client.

There is no need to register for the UAT. Please provide any feedback via the EMA Service Desk as soon as possible, but latest by Wednesday 22nd June 2022.

It is currently anticipated by Axway that the go-live of the new Web Client (Syncplicity) will be in take place in late June 2022. Date is yet to be confirmed. Before the go-live in production, the 'sun Java' which is only available in Internet Explorer is still required.

14-06-2022

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 here. The new version provides an update of the framework for the delivery file user interface for both, the eSubmission Gateway delivery file UI and the PSUR Repository UI. The update is mainly technical, providing a slightly different look and feel.

Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added into the Gateway Delivery file UI human domain. No other functional changes have been introduced in the user interface.

10-06-2022

eSubmission Gateway Web Client upgrade

eSubmission Gateway Web Client upgrade - Migration of all (XCOMP) users to Syncplicity ongoing

The issues relating to preparations for the external UAT have been solved and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). Please note that internal testing is still ongoing, and it is recommended that external testers do not start testing yet.

The migration of all existing XCOMP environment users to Syncplicity was done on Wednesday 8th of June 2022 - please note that registered XCOMP users have received an email from Axway Syncplicity with a link to reset your password for the XCOMP (test) environment. Please note that this resetting of the password has no impact in the password in production eSubmission Gateway Web Client. Please see the guidance on how to reset your password.

The details on how to send test submissions will be published as soon as the user guide becomes available once the migration activities have been finalised.

There is no need to register for the UAT, and the link to the system will be provided via this website.

It is currently anticipated by Axway that the go-live of the new Web Client (Syncplicity) will be in take place in late June. Date is yet to be confirmed. Until then, the 'sun Java' is still required (only available in IE).

eSubmission Gateway Delivery file UI - technical update go-live postponed until Tuesday 14th June 2022

The eSubmissions team has been working on an update of the framework for the delivery file user interface. This updated user interface will be deployed in production on Tuesday 14th of June 2022.

08-06-2022

eSubmission Gateway Web Client upgrade

The EMA is in the process of upgrading our current Axway Gateway solution.
The Gateway tool provider Axway is currently facing some issues with the new tool, however it is expected that the testing by external users can start within next couple of days.
Details and updated user guide will be published to support testing.

eSubmission Gateway Delivery file UI - technical update go-live 10th June 2022

The eSubmissions team has been working on an update of the framework for the delivery file user interface. This is mainly a technical update only providing a slightly different look and feel.

Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added. There are no other functional changes to the MAH user interface.

This updated user interface will be deployed in production on 10th of June 2022.

24-05-2022

eSubmission Gateway Web Client upgrade

Update on the project status

The EMA is in the process of upgrading the current Axway Gateway solution.
The Gateway tool provider Axway is currently facing some issues with the tool and this has caused a delay in the start of the User Acceptance Testing (UAT). Once these Syncplicity issues are resolved, Axway will propose a new timeline for the UAT and a date will be announced for the go-live in production.


Update of IP addresses for Gateway to Gateway connections

As part of an upcoming eSubmission Gateway upgrade which affects the Gateway to Gateway submission, the EMA will be changing the IP addresses of the AS2 Gateway connections. To ensure smooth transition, all current eSubmission Gateway to Gateway users are advised to update firewall rules in line with the gateway connections document. No other configuration changes are required as part of this upgrade.
This IP address range change does not affect the Web Client users.

If you have any questions on the upgrade, contact us using the EMA service desk.


eSubmission Gateway Delivery file UI - technical update

The eSubmissions team has been working on an update of the framework for the delivery file user interface. This is mainly a technical update only providing a slightly different look and feel. Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added. There are no other functional changes to the MAH user interface.

The updated user interface will be deployed in production once the internal user acceptance testing has been finalised (exact date TBC).

An updated user guide and release notes will be published at the time of the go live.

21-04-2022

eSubmission Gateway Web Client upgrade - Migration of all (XCOMP) users to Syncplicity starting now

The preparations for the external UAT are almost finalised and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). The link to the test system and details on how to send test submissions will be published as soon as they become available.

There is no need to register for the UAT, and the link to the system will be provided via this website.

The migration of all existing XCOMP environment users to Syncplicity starting today - please note that you will be receiving an email from Axway Syncplicity with a link to reset your password for the XCOMP (test) environment. This resetting of the password has no impact in the password in production eSubmission Gateway Web Client.

The vgateway (old XCOMP environment) is currently not accessible.

The new Web Client (Axway Syncplicity) will be implemented in production environment in May 2022 following successful user acceptance testing.

User Guidance

Multimedia Tutorials

Technical Documents

Statements of Intent and announcements

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.

 

 

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