Updated versions of the PSUR Repository and the eSubmission Gateway user interfaces to create XML delivery files for submissions via the eSubmission Gateway and the Web Client are now available. These new versions will introduce changes in line with the updated EU Module 1 Specification v3.0 and v3.0.1. The updated delivery files should also be used for eCTD submissions created using eCTD specification version 2.0. The changes are implemented to the Gateway XML delivery files also for Veterinary submissions to align the submission process and provide more information on the submission.
Updated user guides and system release notes are available for PSUR Repository users here and for Gateway users here. Slides from the training session held on 21 July 2016 on the use of the updated delivery files are now available here.
Issues have been reported with the latest versions of the electronic Application Forms v220.127.116.11 and, while the issues are fixed the acceptability of the v18.104.22.168 of the eAF has been extended until 15 September 2016. The new versions of all the 4 forms are planned to be published within the coming weeks, exact date of this new release is yet to be confirmed.
If you are experiencing issues with the forms, please contact the EMA IT service desk via the online portal: https://servicedesk.ema.europa.eu.
The formatted table template cover letter has been updated and is now available here.