EMA updates IRIS Guide

In June 2024, the "IRIS guide for applicants" was revised and updated again. Now the guide is valid in version 3.2. Like the "IRIS guide to registration and RPIs" and "IRIS guide to parallel distribution applicants", the latest version of this document is available on the EMA website.

The new features and revisions in the guide are set out below.

In version 3.2, section "13. Paediatric medicines development" has been added and contains the following paragraphs:

• 13.1. Create an application for Initial Paediatric Investigation plan (PIP)
• 13.2. Create an application for Product Specific Waiver
• 13.3. Create an application for Modification of Paediatric Investigation Plan (modification of an agreed PIP)
• 13.4. Create an application for Compliance check
• 13.5. Create a submission for Annual Report on paediatric deferred measures
• 13.6. Other paediatric procedures
• 13.6.1. Create a submission for Confirmation request
• 13.6.2. Create a submission for Discontinuation of paediatric development
• 13.6.3. Transfer a paediatric regulatory entitlement
• 13.6.4. Request for a Re-examination of PDCO Opinion
• 13.6.5. Submitting additional information during paediatric procedures

Furthermore, Table 3 in section "6.2 Marketing Status Notification (Bulk Upload)" has been updated and the new features in the "Reason for Cessation" section have been highlighted in yellow.

The latest versions of the IRIS documents can be found at

• IRIS guide to registration and RPIs (Version 2.16)
• IRIS guide for applicants (Version 3.2)
• IRIS guide to parallel distribution applicants