EMA has organised a short Q&A clinic to address specific questions from Network users who are already using IRIS for Regulatory Procedure Management for Product Lifecycle Management.

The first transition of RPM for PLM to IRIS took place 23 January 2024, with the onboarding of variations*, article 61.3 notifications**, and marketing authorisation (MA) transfers procedures for a subset of 67 human and 45 veterinary centrally authorised medicinal products (CAPs) with low regulatory complexity.

This Q&A session is dedicated to Network stakeholders who have already used IRIS following the transition of these procedures.

In 2024, our work is continuing with the development of further regulatory procedures in IRIS:

•    Periodic Safety Update Reports;•    Post Authorisation Measures;•    Line extensions;•    Renewals, Annual Reassessments; •    Post-Authorisation Safety Study/Post-Marketing Surveillance Study and Referrals.

The aim is to manage the majority of procedures, except Initial Marketing Authorisation and other pre-submissions applications, exclusively in IRIS for all CAPs (and, consequently, for all MAHs with CAPs). In this regard, a 2nd roll-out will be performed in Q4 2024.

* Variations not requiring assessment (VNRA) for veterinary use products are to be submitted and managed via UPD however they are also recorded in IRIS (to ensure a complete overview of product lifecycle)

** For human medicinal products