Change description : 2026-01-12 13:36:00: Updated MORE submissions guide with added guidance on the new report reassignment functionality, which allows users to reassign reports to the appropriate manufacturer/responsible person within the MORE portal. [Guidance and regulation]
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Details
This user guide provides details on how to use the different functions for report submissions and to manage reports.
Updated the PSR submission process to reflect the resumption of uploads via the MORE portal. Revised the SAE section to include additional guidance on Quarterly Safety Reports (QSRs).
10 June 2025
Updated 'MORE Submissions - user reference guide'.
24 August 2023
Updated Submissions guidance to reflect: Update to screenshots, guidance for draft reports and auto-population of submitter fields.