Updated IRIS Guide for Applicants

On 15 October 2020 the EMA updated the IRIS guide on how to create and submit scientific applications for industry and individual applicants.

IRIS is a secure online platform for handling product-related scientific and regulatory procedures with EMA.

This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application for a scientific procedure (e.g. orphan designation application, scientific advice, or ITF briefing meeting request) and related activities.

Read the pdf 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /