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eSubmission Gateway and eSubmission Web Client

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Home

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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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Veterinary eSubmission
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eSubmission expert group
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP

Paediatric submissions

SPOR

eSignatures

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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

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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