EMA – Publication of the IRIS guide for applicants (creation of submissions) and the guide to Registration, Substances and RPIs
The EMA issued two updated guidance for the IRIS Platform:
This guide has been produced to help new users of IRIS to complete the prerequisite steps before accessing the platform. Most of these steps are independent from the IRIS platform and are similar to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).
- The EMA issued its updated IRIS guide for applicants (How to create, submit and manage IRIS applications, for industry and individual applicants).
This guide has been produced to show applicants how to use the IRIS platform to prepare, submit and manage an application and/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, PRIME, marketing status reports, inspections and veterinary signal management) and related activities, or applications for Parallel Distribution procedures.
More guidance and trainings on the IRIS Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (1 juin 2024). EMA – Publication of the IRIS guide for applicants (creation of submissions) and the guide to Registration, Substances and RPIs. ELSIBI. Consulté le 18 janvier 2026 à l’adresse https://doi.org/10.58079/11rn6





