On 26 July 2021, EMA has launched the IRIS platform, a secure online platform to report marketing status changes and withdrawn product notifications of centrally authorised medicinal products (CAPs) to EMA.
The marketing status overview will provide to EMA and EU/EEA National Competent Authorities data on actual marketing and temporary/permanent marketing cessations in each Member State for all the authorised presentations of a CAP.
From launch, the IRIS platform will be the reporting system for the Marketing status changes for CAPs not yet marketed in any EU/EEA countries.
For marketed CAPs, the regulatory deadline for companies to populate the marketing status of their products is six months after this public launch (by 31st January 2022). However, EMA strongly recommend to start using this feature as early as possible. During this implementing period, the current reporting system via email will co-exist with the new IRIS reporting system for marketed CAPs only.