Questions and answers clinic on post-authorisation procedure management in IRIS - 17 Jan 2025
EventHumanVeterinary
- The original event time is:
- Friday, January 17, 2025 - 10:00 - 11:00 Amsterdam time (CET)
Date
- , -
Location
- Online
Event summary
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.
Video recording is published after the event.