In 2024, the Regulatory Product Management (RPM) for Product Lifecycle Management (PLM) is set to expand its capabilities by supporting key regulatory procedures through the IRIS Portal. The goal is to manage the majority of these procedures, except for Initial Marketing Authorisation and other pre-submission applications, exclusively in IRIS for all Centrally Authorised Products (CAPs) and by extension, for all Marketing Authorisation Holders (MAHs) with CAPs starting in Q4 2024.
Key Procedures Moving to IRIS:
- Periodic Safety Update Reports (PSURs)
- Post Authorisation Measures (PAMs)
- Line Extensions
- Renewals
- Annual Reassessments
- Post-Authorisation Safety Studies (PASS)
- Referrals
The transition began on January 23, 2024, with the onboarding of variations*, article 61.3 notifications**, and marketing authorisation (MA) transfer procedures for a subset of 67 human and 44 veterinary centrally authorised medicinal products (CAPs). These products were chosen based on their low regulatory complexity.
The selection process for the January rollout involved reviewing the intended submission plans from selected Marketing Authorisation Holders (MAHs), who have already received the final list of products. MAHs who have not been contacted by the European Medicines Agency (EMA) can consider their products not impacted by this initial rollout, and no action is currently required.
Important Notes:
- Variations not requiring assessment (VNRA) for veterinary use products are to be submitted and managed via UPD but will also be recorded in IRIS to ensure a complete overview of the product lifecycle.
- ** For human medicinal products.
For more information and to stay updated on these changes, please refer to the upcoming webinars on regulatory procedure management at the bottom of this newsletter.
Stay tuned for further updates as we continue to enhance our regulatory management processes through the IRIS Portal!
Need help? Contact us for your Regulatory requirements at: [email protected]
