January 2025 - IRIS now live for post-authorisation procedure management!

The transition to IRIS for managing post-authorisation procedures has successfully gone live as planned.
Post-authorisation procedures submitted to EMA on or after 20 December 2024 are now managed in IRIS*. 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.
* 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
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.
Recap of supporting resources: To assist you during this transition, please find the following resources in the attached PDF document:

Actions for MAHs
Key training resources for MAHs
Service desk triage guidelines for support requests

Upcoming Live Q&A Sessions: We encourage you to attend our live Q&A sessions for additional guidance:

8 January 2025 (14:00 – 15:00 CET): Register here
17 January 2025 (10:00 – 11:00 CET): Register here

For action: last call for user survey! Please be reminded that you have until 7 January EOB to reply to the to the enclosed survey to provide insights on your their level of readiness for the transition to IRIS and on the type of support needed. Based on the feedback received, additional engagement activities may be planned.
If you have questions outside the above or require further assistance, please raise a ticket through the EMA Service Desk.