IRIS portal release notes

IRIS is EMA’s secure online platform for handling product-related regulatory procedures. First launched in 2018 for orphan designation, EMA is progressively transferring all regulatory procedures to IRIS.

The IRIS portal provides a single space for applicants to communicate, share information, and deliver documents for EMA-led procedures. It also allows NCAs to access procedure-related information. The IRIS portal currently includes the following procedures:

• Innovation Taskforce Consultation

• Inspections

• Marketing Status

• Orphan Designation

• Paediatric Procedures

• Parallel Distribution

• PRIME

• Product Lifecycle Management (e.g., variations)

• Scientific Advice

• Veterinary Signal Management

This document lists and briefly describes the new features and fixed issues included in the release of the IRIS Portal. The most recent release appears first.