Expert Insights

Expert Insights

Using IRIS: the EMA’s Orphan Designation Portal

Using IRIS: the EMA’s Orphan Designation Portal
09 April 2019

As of September 2018, the EMA requires both applicants and sponsors to use the new secure online portal called IRIS for the submission of applications for orphan designation and the management of post-designation activities. The aim is for the portal to be used for all activities relating to orphan designation, including applying for orphan designation, requesting pre-submission meetings, responding to requests for supplementary information and transferring orphan designation to a new sponsor. You also can use IRIS to submit notifications of parallel distribution and access the public register of parallel distribution notices. The goal is that IRIS will provide a “comprehensive procedural and scientific support system for orphan designations.” 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 the future.

Before an application can be drafted on IRIS, the IRIS Quick guide to Registration explains that users must be registered with the EMA Account Management portal. Users will then be asked to select their organization via the Organisations Management System (OMS). All organizations must be registered in OMS, which is part of the SPOR web portal (substance, product, organization and referential portal). Next, users must request access to IRIS via the EMA Account Management portal, before selecting the active substance to which their application relates. New active substances will need to be registered through the EMA Service Desk; only after this has been assigned may the application be drafted and submitted via IRIS.

Access to the database is limited to those with EMA accounts, and currently, users are able to access information only about their own products.

Contact us for more on how we can help in applying for orphan designation for your clinical trial.

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