Do you Know the about IRIS?

The European Medicines Agency (EMA) has launched a new secure online portal for orphan designation applications.

The portal, named 'IRIS', provides a single space where applicants can submit and manage the information and documents related to their applications for orphan designation. This is expected to reduce the time needed to prepare and submit the applications. During the review process, applicants can check the status of their applications from any device and receive automatic notifications when the status of the application changes.

Iris is part of a longer-term programme that aims to make the handling of product-related applications easier and utilises the domains of master data in pharmaceutical regulatory processes (SPOR).

Applicants will still be able to use the existing submission process until 19 September 2018. However, the Agency strongly encourages companies to start using the new portal from 19-06-18.

You can use this portal for the following activities relating to orphan medicines:

·         Apply for an orphan designation

·         Request a pre-submission meeting

·         Track the progress of your application

·         Respond to requests from EMA for supplementary information

·         View your historic applications

·         Change the name or address of a sponsor

·         Request an Appeal

·         Remove or transfer an orphan designation to a new sponsor

Reference: Modernising the orphan designationprocess