EMA: IRIS Document revised

In November 2025 and January 2026, the 'IRIS guide for applicants' was revised again and published in its updated version. The 'IRIS guide to registration and RPIs', on the other hand, has not been revised and remains in version 2.18 from July 2025. Version 3.12 of the IRIS guide for applicants and version 2.18 of the IRIS guide to registration and RPIs are now available on the EMA website.

IRIS guide for applicants

In the new version 3.12, in addition to formal changes, some passages have been updated and added. In line with the document history, the contents of Chapter 2, 'Common operations for all submission types', have been revised. This includes the section '2.3 Create a new submission (general procedure for all submission types, except PLM procedures)'.

In the previous version (3.11), the text of paragraph '13.3 Create an application for modification for Paediatric Investigation Plan (modification of an agreed PIP)' had already been adapted.

The currently valid versions of the IRIS documents can be found at:

• IRIS guide to registration and RPIs (version 2.18)
  
• IRIS guide for applicants (Version 3.12)