Please note that PSUR and eSubmission Gateway File Handler will be unavailable from Friday 12/11/2021 after 18:00, until Monday 15/11/2021 morning 8:00, due to essential maintenance. EMA gateway will, however, remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.
eSubmission Gateway Web Client upgrade – Syncplicity go-live for production environment on this weekend (8th – 10th July 2022)
As previously announced, the EMA is in the process of upgrading our current Axway Gateway solution. Please note that migration of all users in the Production System will be done this weekend, starting from Friday, 8 July 2022, at 17:00 CEST until Sunday, 10 July 2022, at 18:00 CEST. Should this need to be postponed, [...]
The issues relating to preparations for the external UAT have been solved and all eSubmission Web Client XCOMP users are now invited to start user acceptance testing (XCOMP environment). Please refer to the Guidance on how to submit using Syncplicity Web Client.
The issues relating to preparations for the external UAT have been solved 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). Please note that internal testing is still ongoing, and it is recommended that external testers do not start [...]
The updated excel sheet listing all fields in the Variation and Medicinal Product has been published on the DADI website on the 23rd of May. The Conceptual Data Models for the human variation form FHIR message and the medicinal product in a variation FHIR message are now also available on the DADI website. The example [...]
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.
Technical issue on the eAF webpage affecting availability of the latest versions of the eAF v18.104.22.168 has been fixed
The updated versions 22.214.171.124 eAFs (Veterinary MAA and variation, human variation) were published on the eAF website on 20th of January 2022. A technical issue has been identified which means that these latest versions were replaced by earlier versions (at some point around 5th of February). The issue has been now fixed and the latest [...]
Following the announcement on the revised timeline made during the first Digital Application Dataset Integration (DADI) Network Project public webinar held on 18 January 2022, an updated timeline for the release of DADI web-based variations forms for Human medicinal products, including key milestones, is now available.
Veterinary Medicinal Products Regulation (Regulation (EU 2019/6) enters into force – updated eSubmission systems/forms now available for mandatory use
The use of the updated version of 126.96.36.199 eAFs is now mandatory for all new veterinary variations and marketing authorisation applications. Please note that there is no transitional period and the v188.8.131.52 cannot be used for any new procedures starting after 28th January 2022.
Updated versions 184.108.40.206 eAFs are now available on the eAF website. An updated human variation form is ready for immediate use. The change implemented in this version is a minor business rule change only and it will not affect most users. The use of the v220.127.116.11 is mandatory since 1st January 2022 and the users [...]