This message contains important information to ensure preparedness for the upcoming transition of post-authorisation procedures to IRIS.

1. What will happen as of January 2025?
From January 2025, post-authorisation procedures submitted to the EMA on or after 20 December 2024 will be managed in IRIS. Kindly note that the submissions steps will still be done via the current systems, i.e., Gateway and PSUR repository, while  IRIS will be used for procedure management only.
Post-authorisation procedures transitioning to IRIS are: Variations*; Article 61.3 notifications**; Marketing Authorisation (MA) Transfers; Periodic safety update reports (PSUR)***; Post-authorisation measures (PAM) Annual reassessments; Referrals; Post-authorisation safety study (PASS)/ Post-marketing surveillance studies (PMSS); Line extensions; Renewals.

* For veterinary medicinal products, variations not requiring assessment (VNRA) are to continue to be submitted and managed via UPD
** For human medicinal products
*** 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
The transition will affect all Centrally Authorised Medicinal Products (CAPs) and and non-Centrally Authorised Medicinal Products (non-CAPs, i.e. NAPs, MRPs, DCPs) for those procedures where EMA acts as reference authority.

2. Supporting  documents
Please find in the attachment essential details to support the transition:

1. Actions for MAHs before the transition
2. Key training resources for MAHs
3. Service desk triage to request support

3. MAH readiness survey
We would appreciate to receive insights from each MAH on 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.
Kindly provide your feedback by replying to the enclosed survey by 7 January EOB.

4. Next planned live Q&A sessions:
Q&A clinics on post autorisation procedures are being organised in December 2024 and January 2025 as follows: