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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 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.

Current procedures on IRIS include:

  • 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.


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