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As part of EMA’s commitment to continuous improvement and transparency, a new release notes section is now available on the IRIS portal.
This page will be updated monthly and will provide information on system developments, including new functionalities, enhancements, and other relevant changes. Users are encouraged to consult it regularly to stay informed about the latest updates.
Important: Restore your IRIS access for post-authorisation submissions
Actions, support & training resources for MAHs for procedure management in IRIS
PSURs cannot be submitted without IRIS-affiliated contact after 1 September 2025
IRIS transition update: revised go-live timeline and updated support materials