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eSubmission Gateway and eSubmission Web Client

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Human eSubmission
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Systems:

Common Repository

eAF

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eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

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eCTD v4.0

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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

29-06-2020

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The update has introduced a label change to reflect the new Medical Device legislation.

Users should note that the delivery files created prior to the new release deployed in the evening of 23th of June 2020 will not work after the deployment. It is strongly recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues after the deployment.

05-05-2020

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The update has introduced a new radio button to indicate if the submission is relating to Covid-19. This new flag will help to prioritise and indicate urgency of the incoming COVID19 related submissions.

Users should note that the delivery files created prior to the new release deployed in the evening of 5th of May 2020 should continue to work following the deployment of this new version. It is however, recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues. For submissions relating to Covid-19, it is essential to create a new delivery file in order to fill in this information in the delivery file. Please note that in those cases the new radio button should be set to YES.

27-02-2020

An updated version of the eSubmission Gateway XML delivery file user interface for Veterinary ASMF submissions is now available. This update introduces a manual entry for ASMF numbers that are not available from the dropdown list enabling all Veterinary ASMFs to be sent using the XML delivery files.

09-01-2020

Please note that from 1 January 2020, the Formatted Table Template will no longer be maintained by EMA.

The use of the XML delivery files is mandatory and the users are required to fill in all the submission attributes correctly through the eSubmission Delivery File UI since all attributes in the delivery file are used to support important searches in the Common Repository.

The delivery file must be attached to the submission when it is sent via the eSubmission Gateway or the Web Client.

The use of XML delivery files also supports the EMA internal processes by significantly reducing the time required for receiving, processing and validating incoming applications and it ensures continuous and immediate access to up-to-date dossiers for internal and network users.

Please note that below mentioned fields are crucial and must be filled in correctly:

  • Customer reference (Purchase order information) for all relevant fee related submissions
  • Related procedure number for all submissions that already have a procedure number assigned
  • RMP version number where applicable
  • Withdrawal information for consolidating sequence unit type.

Previous news is available here.

User Guidance

Multimedia Tutorials

Technical Documents

Statements of Intent and announcements

 

 

 

EMA

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