Following the training session held on 12 November 2024, EMA is organising pre-go-live Q&A Clinics to answer any open questions from Marketing Authorisation Holders on the transition of EMA-led post-authorisation procedures to IRIS.
Background
In January 2025, the following EMA-led procedures will transition to IRIS for all Centrally Authorised Products (CAPs) (and involved non-CAPs) for procedures submitted on/ after 20 December 2024 via the current submission systems (i.e. Gateway and PSUR repository):
- Post-Authorisation Measures
- Line Extensions
- Renewals
- Annual Reassessments
- Post-Authorisation Safety Studies/Post-Marketing Surveillance Studies
- Referrals
The first transition of post-authorisation procedures to IRIS took place on 23 January 2024, onboarding variations, Article 61.3 notifications, and marketing authorisation (MA) transfer procedures for a subset of human and veterinary CAPs with low regulatory complexity.
Note: Periodic Safety Update Reports will transition to IRIS with the procedures starting on the 6 February 2025 and onwards as per PSUR procedural timetable published on EMA website.
