IRIS Guide to Registration and RPIs

6 February 2023 – the EMA published version 2.12 of the IRIS guide to registration and RPIs.

This guide documents describes preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration. 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, Organization and Referentials (SPOR).

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