As part of the transition of Centrally Authorised Products (CAPs) lifecycles to the IRIS platform, planned for January 2025, all Marketing Authorisation Holders (MAHs) are required to register their product contact points in the EMA Account Management System by 31 October 2024.

This is essential to:

·       ensure seamless email communication;

·       gain access to case information;

·       support document management.

Ensuring all the necessary contact points are registered is the first step to gain access to IRIS and ensure your remain informed on trainings, guidance and tools to help you in your case management with EMA.

Important Instructions:

1.    Use of Personal Mailboxes as Product Contacts:

• Security Update: IRIS will no longer accept generic mailboxes as contact points for regulatory procedure application submissions.
• Action Required: Update all product contacts to personal mailboxes associated with responsible individuals within your organisation:
  • Submit the updated form using the template provided here.
  • Instructions to submit the form are available here.

2.    Register All Contacts in EMA Account Management System by 31 October 2024:

• Access Request: Request access via the EMA Account Management System for all affiliated roles. Detailed instructions are available in the IRIS guide to registration and RPIs.
• Organisational Affiliation: Ensure the access is requested for the relevant organisations affiliated with the products you are a contact for here.

Ensure these steps are completed by 31 October 2024 to facilitate a smooth transition to the IRIS platform.

The transition to IRIS began in January 2024 with the onboarding of variations, Article 61.3 notifications, and marketing authorisation (MA) transfer procedures for 67 human and 45 veterinary centrally authorised medicinal products (CAPs). In July 2024, an additional 37 human and 16 veterinary products were also migrated to IRIS. In January 2025, all other post-authorisation regulatory procedures will transition to IRIS, i.e. Periodic Safety Update Reports, Post-Authorisation Measures, Line Extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Studies, and Referrals. This transition will impact all CAPs (and involved Nationally Authorisation Products).