DADI Project Update
Human variations forms updated timeline & revised go-live scope
Following the news published in February 2022 on the updated timeline for the release of DADI web-based variations forms for Human medicinal products further details on the timeline leading to go-live and go-live scope are now available here.
Updated FHIR mapping is now available
An updated excel sheet listing all fields in the Variation form and the Medicinal Product is now available here. The FHIR messages relating to the latest mapping will be published on the EU Network website and once all confidential data has been redacted, they will also be published on the DADI website (timing TBC).
For any questions, please contact the DADI project team via the EMA Service Desk. (Please select the option “Ask a question” and include in the subject “DADI Q&A”).
Presentation from the public webinar “Variations Form for Human Medicinal Products - What will happen at Go-Live” held on 16th May 2022
The presentation from the public webinar is now available.
eSubmission Gateway Web Client upgrade
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 a 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.
PSUR Repository MAH user interface - technical update
The PSUR Repository team has been working on an update of the framework for the user interface. This is a technical update only providing a slightly different look and feel. It should also be noted that the option to select submission format NeeS has been disabled in the view of mandatory use of eCTD for all procedure types since 1st January 2019. 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.