The Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) team is pleased to announce the
1st roll-out of Variations, Article 61.3 Notifications, and Marketing Authorisation Transfers on the IRIS platform today, on 23 January 2024.
Please note the transition only affects a subset of human (67) and veterinary (44) medicinal products with low regulatory complexity.
Impacted Industry and Network stakeholders have already been provided with the final list of products.
This significant achievement follows a
meticulous testing phase, including a successful second round of testing in November 2023, building upon initial testing conducted in May and June 2023.
Throughout 2024, the RPM team will concentrate on the
incremental delivery of additional system functionalities and the
development of additional procedures. In particular, the work will focus on Periodic Safety Update Reports (PSURs), Post-Authorisation Measures (PAMs), Line extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Study (PASS), and Referrals. The
roll-out for these procedures on IRIS is scheduled for Q4 2024. More details on 2024-2025 plans can be found in the attached RPM roadmap.
The long-term aim of onboarding end-to-end human and veterinary regulatory procedures on IRIS is to increase automation and efficiency, improve knowledge management and data security, and enhance transparency.
For further information or inquiries about RPM for PLM, please contact
iris@ema.europa.eu.
