Welcome to IRIS | Regulatory & Scientific Information Management Platform

IRIS is the online web portal through which you can apply to the European Medicines Agency (EMA) for orphan designation for a medicine. 
EMA plans to expand the scope of this portal to cover other regulatory and scientific procedures.
You can use this portal for the following activities relating to orphan medicines:
  • Request a Research Product Identifier (RPI)*
  • Request a pre-submission meeting
  • Apply for an orphan designation
  • Apply for an amendment to an orphan designation
  • Track the progress of your application
  • Respond to a request from EMA for supplementary information
  • Request an appeal
  • Request withdrawal of an application
  • Transfer an orphan designation to a new sponsor
  • Change the name and/or address of the sponsor
  • Submit an annual report
  • Submit a report on the maintenance of the designation criteria
  • Request removal of an orphan designation from the EU register
  • View your draft, ongoing and completed applications
*When submitting an application you also need to request an RPI. If an active substance is not registered, please allow up to 5 days for this step. To find out more about orphan designation and the ‘IRIS quick guide to the portal for industry users’, see ‘Guidance and forms’ under the Applying for orphan designation section of the EMA corporate website.

The IRIS platform uses information held in EMA’s Substance, Product, Organisation and Referential (SPOR) master data management services. For more information on SPOR, visit the SPOR master data page on the EMA corporate website or the SPOR portal.

Access to IRIS
To access IRIS you need an active EMA user account and an “Orphan Industry” user access role.  You can create and request these in the EMA Account Management portal

To get started in IRIS , click on “Sign In” and then click on the “Azure AD” button. In the “Pick an account screen”, click on “Use another account” and type your EMA username followed by @id.ema.europa.eu. Enter your EMA user account password and you will return to this page, ready to carry out the activities described above.
 
For more information and help with accessing IRIS and SPOR, please read the IRIS Quick Guide to Registration first. For anything not covered in the Quick Guide, you can contact us via the EMA Service Desk portal.

Origin of the name:  The Iris, or “Blue Flag”, is a plant used in healing and medicine since ancient times.  In Greek mythology, Iris was a messenger to the Gods who carried the “Caduceus”, or staff, now found at the centre of the international symbol for medicine.  The IRIS platform facilitates the exchange of regulatory and scientific information between EMA and organisations developing medicinal research products for potential use in the European Union.