Iopromide NO/H/xxxx/WS/049  Date of publication: 03/08/2022 NO/H/xxxx/WS/055 Date of publication 25/10/2022

Iomeprol Date of publication: 03/08/2022

Iodixanol NO/H/xxxx/WS/052 Date of publication: 03/08/2022 NO/H/xxxx/WS/056 ​​​​​​​Date of publication: 04/08/2022

The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of the DADI project.

The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration on the DADI website

The preparations for the external UAT are almost finalised and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). The link to the test system and details on how to send test submissions will be published as soon as they [...]

The recordings from both DADI public webinars held in January are now available here for the 18th and here for the 25th of January 2022.

Updated versions 1.26.0.0 eAFs are now available on the eAF website. An updated human and veterinary MAA forms, Renewal form and veterinary variation form are ready for immediate use. The changes implemented in this version are minor bug fixes only and they do not affect most users. The use of the v1.26.0.0 is mandatory since [...]

Please find the presentation and the FHIR mapping and examples the webinar on "Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF". Please note that the recording from the webinar will be published as soon as it becomes available.

The Digital Application Dataset Integration (DADI) Network Project team is pleased to announce that an updated version of the DADI Questions and Answers documents is now available.