EMA Updated IRIS Guide for Applicants

On 17 December 2020 the EMA published the updated version 1.9 of IRIS guide for industry and individual applicants.

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.

For Parallel Distribution procedures separate user access roles are needed and separate guidance is available on the IRIS home page.

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