EMA: Update of the IRIS Guide

In December 2024 and January 2025, the "IRIS guide for applicants" was updated once more and is now valid in version 3.6. Like the "IRIS guide to registration and RPIs", the latest version of this document can be checked on the EMA website.

In addition to formal changes, some passages have been revised and re-linked with the latest updates. In line with the document history, minor adjustments have been made to the content of chapters 2. Common operations for all submission types, 7. Inspections and 12. Product Lifecycle Management (PLM) procedures. In contrast, chapters 4. Scientific Advice, 11. Parallel distribution notifications and 13. Paediatric medicines development were subject to more extensive revisions.

The latest versions of the IRIS documents can be found here:

• IRIS guide to registration and RPIs (Version 2.16)
• IRIS guide for applicants (Version 3.6)