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.

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.Currently, it covers the following:

Orphan designation: You can 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.

Parallel distribution: You can use IRIS to submit notifications of parallel distribution and access EMA's 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.

Innovation Task Force: You can use IRIS to apply for a briefing meeting with EMA’s Innovation Task Force (ITF). To find out more about the ITF, please see Innovation in medicines on the EMA corporate website.

Research Product Identifier: You can use IRIS to request a Research Product Identifier (RPI) for a new medicinal product. RPIs were formerly known as Unique Product Identifiers (UPIs). To find out more about RPIs and how to use IRIS for this purpose, please see the IRIS guide to registration.

Accessing IRIS
To use IRIS as a logged-in user, you need to complete a few registration steps that are explained in detail in the IRIS guide to registration. In summary , you need to ensure that:

1: You have an 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 the Organisation Management Service (OMS). If you are submitting an application as an individual, you do not need to register in OMS. For more information on the OMS, see Organisation Management Service on the EMA's corporate website.

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. If you are submitting an application as an individual, you do not need to be affiliated to an organisation and the ‘User Admin’ role is not applicable.

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

Please see the IRIS guide to registration for more details.

Submitting via IRIS
To be able to submit an application, notification or request via IRIS, please follow the instructions contained in the IRIS guide to industry portal and note the following:

1 For orphan designation and ITF briefing meeting requests, you need a valid RPI
If you wish to discuss anything other than a new medicinal product with the ITF (e.g. a new technology, a group of products or other subject), you cannot use IRIS to request an RPI. Please contact itfsecretariat@ema.europa.eu for assistance in obtaining an RPI.
2 For parallel distribution, you need a valid EMA customer account number
This is a unique reference number for financial matters. For detailed information refer to the IRIS guide to registration.

Support

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.