IRIS now live for post-authorisation procedure management & next steps

Submission steps are still to be carried out via the current systems – the Gateway and PSUR repository. IRIS will now serve as the platform for procedure management.

Post-authorisation procedures managed through IRIS are: Variations**; Article 61.3 notifications for human medicinal products; Marketing Authorisation (MA) Transfers; Post-authorisation measures (PAM); Annual reassessments; Referrals; Post-authorisation safety study (PASS)/ Post-marketing surveillance studies (PMSS); Line extensions Renewals.

This transition affects all Centrally Authorised Medicinal Products (CAPs) and non-Centrally Authorised Medicinal Products (non-CAPs, i.e., NAPs, MRPs, DCPs) for procedures where EMA acts as the reference authority.

As part of EMA’s ongoing engagement efforts with IRIS users the regulatory procedure management team conducted a survey in 2024. The results suggest a majority of industry users are new to the system and not existing users. Prospective users seem to have been able to find their way to the various webinars about IRIS and they have bene able to locate support resources. Note that beyond intermittent surveys, feedback on IRIS  can always be shared at quarterly system demo’s.

What is coming next? In the coming months, the IRIS team will focus on developing the transition of initial Marketing authorisation application procedures to IRIS. The most recent Network Portfolio roadmap, updated in November 2024, provides a general overview of these activities, with a detailed roadmap for this transition set to be released later this quarter.

Training resources: please find relevant training resources for MAH here.

* Periodic safety update reports (PSUR) will transition to IRIS with the procedures starting on the 6 February 2025 and onwards as per PSUR procedural timetable published on EMA website

** For veterinary medicinal products, variations not requiring assessment (VNRA) are to continue to be submitted and managed via UPD