Welcome to IRIS | Regulatory & Scientific Information Management Platform
IRIS is the European Medicines Agency’s (EMA) secure online platform where you can carry out certain regulatory procedures with EMA.
You can use IRIS to apply for orphan designation for a medicine and manage related pre- and post- orphan designation activities.
To find out more about orphan designation and how to use IRIS for this purpose, see Applying for orphan designation on the EMA corporate website.
You can use IRIS to submit notifications of parallel distribution and access the public register of parallel distribution notices.
To find out more about parallel distribution and how to use IRIS for this purpose, see Parallel distribution on the EMA corporate website.
Purpose of IRIS
IRIS aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through integration with other EMA systems such as the substance, product, organisation and referential (SPOR) portal.
IRIS is a core part of EMA’s digital transformation process. EMA plans to extend the platform to cover other regulatory and scientific procedures in future.
Access to IRIS
Please see the IRIS Quick Guide to Registration to use IRIS as a logged-in user. You will need to complete a few registration steps to ensure that:
1: You have active EMA account
Allow up to two working days if you need to reset the password for an account for which you have not set up your security questions.
2: Your organisation is registered in EMA’s Organisation Management Service (OMS)
Allow from five to ten working days to register a new organisation or update organisation data in OMS (one of the domains of SPOR master data).
3: You have the appropriate user access role and affiliation to an organisation
Allow up to two working days for EMA to approve the first 'User Admin' role for your organisation.
Submitting via IRIS
To submit via IRIS you will need to ensure that (for detailed information refer to the IRIS Quick Guide to Registration):
1 (orphan designation only): Your active substance is registered as 'authorised' and 'current' in EUTCT
Allow from four to eight days to register a new active substance.
2 (orphan designation only): You have a valid Research Product Identifier (RPI, formerly called UPI)
Allow up to two working days for EMA to approve a new RPI via IRIS.
3 (parallel distribution only): You have a valid EMA customer account number
This is a unique reference number for financial matters.
Getting started with IRIS
To get started with IRIS, once your registration is complete:
1. Click ‘Sign In’ and then the ‘EMA Account’ button
2. If “Pick an account” appears, click on ‘Use another account’
3. Type your EMA username followed by @id.ema.europa.eu
3. Enter your EMA user account password and you will now return to the IRIS home page as a logged-in user
4. Update your data and add a contact telephone number
If you cannot find the support you need in the IRIS guidance documents, please contact the EMA Service Desk.
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.