EMA – Advancing regulatory science research – 18 November 2024

In January 2025, the following EMA-led procedures will transition to IRIS for all Centrally Authorised Products (CAPs) (and involved non-CAPs): Periodic Safety Update Reports, Post-Authorisation Measures, Line Extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Studies/Post-Marketing Surveillance Studies, and Referrals. The first transition of Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) 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. EMA is organising this training session to provide Marketing Authorisation Holders with key instructions to be prepared for the transition, showcase the IRIS system and answer questions.

More information on the EMA Website.