Yesterday the European Medicines Agency released updated IRIS guidance on "How to create and submit scientific applications, for industry and individual applicants".
The purpose of this guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application and/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, marketing status reports, inspections and veterinary signal management) and related activities.
For any type of submission in IRIS, you need an EMA account and an appropriate role in IRIS, to login into IRIS. For information on how to request an EMA account and an appropriate IRIS role (these are two separate actions), check the separate IRIS guide to registration and the quick interactive guide to the IRIS registration process on the IRIS home page.
This guide also contains information on how to request or transfer an RPI (Research Product Identifier).
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