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eSubmission Gateway and eSubmission Web Client

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Human eSubmission
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Systems:

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eAF

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eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

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Projects:

eCTD v4.0

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eSubmission Gateway and eSubmission Web Client

The eSubmission Gateway and the eSubmission Gateway Syncplicity 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

26-10-2022

eSubmission Gateway XML delivery file update for Raw Data submissions

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file (addition of new submission type for 'Raw data submission' (human domain only). Further information on the Raw data pilot submissions can be found here. Please note that this new submission type should only be used when it has been previously agreed that the product is taking part in the pilot. The details on the changes are provided in the related release notes which are available here and the updated user guide is 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.

11-07-2022

eSubmission Gateway Web Client - upgraded Syncplicity portal now in production

The eSubmission Web Client portal has now been upgraded to Axway Syncplicity portal. Please access the new Web Client to send submissions to the EMA here.

All previously registered eSubmission Gateway Web Client users should have now received an email from Axway with a link to reset your password for the production Web Client.

05-07-2022

eSubmission Gateway Web Client upgrade - Syncplicity go-live for production environment on this weekend (8th - 10th July 2022)

As previously published, the EMA is in the process of upgrading our current Axway Gateway solution.
Please note that migration of all users in the Production System will be done this weekend, starting from Friday, 8 July 2022, at 17:00 CEST until Sunday, 10 July 2022, at 18:00 CEST. Should this need to be postponed, an update will be published on this webpage.

Please note that registered production environment users will receive an email from Axway Syncplicity with a link to reset your password for the production environment. Please see the guidance on how to reset your password.

In the view of the update for Gateway to Gateway users only, we have requested you to make the required changes to update your firewall rules in line with the gateway connections document. If you use the Gateway to Gateway connection (not relevant to Web Client users), please implement the required changes by Friday, 8 July 2022, at 17:00 CEST to avoid any business disruption.

User Guidance

Technical Documents 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.

 

 

EMA

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