IRIS Portal: EMA expands digital Procedure Management

The European Medicines Agency (EMA) is continuing to expand its IRIS Portal. Since 18 August 2026, additional functions have been available, allowing further regulatory procedures to be handled directly via the platform in future. In several areas, this replaces the previous contact route via the EMA Service Desk.

IRIS is the EMA's online platform for scientific and regulatory procedures. Initially, the portal was used primarily for centralised marketing authorisation procedures. It now increasingly also covers procedures for nationally authorised medicinal products, including PSUR and referral procedures.

The EMA is continuously expanding the scope of the platform. The Agency provided an outlook on its further development at an IRIS Portal event on 11 June 2026. The roadmap presented there, together with a recording of the webinar, is available on the event page.

New requirements since 18 August 2026

On 18 August 2026, the EMA published several documents providing for the use of the IRIS Portal, instead of the previous procedures via the EMA Service Desk, for various types of procedure. These include:

• Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies (+ version with tracked changes)
• EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
• Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device
• European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (plus version with tracked  changes)
• Marketing authorisation (veterinary medicines)
• Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)

With its continued expansion, IRIS is developing into a central point of contact for the submission and processing of additional scientific and regulatory procedures at the EMA.

Important for companies: The respective updated EMA documents contain practical information on using the IRIS Portal and should be taken into account when preparing the relevant regulatory procedures.