The Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) team is hosting a public webinar to offer Marketing Authorisation Holders an update on the progress of RPM plans, providing insights into the strategic direction, key milestones and implementation approach for the coming months. The webinar will also include a live demonstration of the Industry Portal, enabling participants to discover the new features and functionalities developed. Do not miss this valuable opportunity to enhance your understanding and stay informed about the latest developments in this area.
 

The 1st transition of RPM for PLM to IRIS took place on 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 44 veterinary centrally authorised medicinal products (CAPs) with low regulatory complexity.
The products for this roll-out have been selected by reviewing the intended submission plans from the selected MAHs, who have received already the final list of products.
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 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