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.
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce improvements and new fields to the user interface. This change is a further step towards integration of the XML delivery file and the Formatted Table Template; however this release does not affect yet the use of the Formatted Table Template.
Please note that the delivery files created prior to the new release should work following the deployment of the new versions.
One of the new features will be introduction of Brexit Related procedure indicator.
Users can indicate if the change is a Brexit related procedure. This is applicable to initial submissions for the following submission types:
- Variations Type IA (H & V)
- Variations Type IAIN (H & V)
- Variations Type IB (H & V)
- Variations Type II (H & V)
- Transfer MA (H & V)
- Notification 61-3 (H only)
The eSubmission Web User Interface for creation of the XML delivery files has been updated to include submission description (submission description – Responses to RSI) and updated values in submission format for veterinary PSUR submissions. A procedural change is also being introduced to the submission process for Worksharing (WS) and Internal Grouping (IG) procedures. The User Guide to XML delivery files will be updated shortly.
An updated version of the eSubmission Gateway XML delivery file user interface is now available and effective 29 September. This update introduces additional attributes to the veterinary domain in preparation for the extension of the Common Repository for Veterinary submissions. This release contains number of changes for veterinary users only, such as use of the ‘Submission description’ and selection of ‘procedure numbers’ for post-authorisation procedures where applicable.
Previous news is available here.
Statements of Intent and announcements