Updated IRIS Guide to Registration

On 15 April 2021 the EMA announced the availability of the updated IRIS guide on preliminary requirements for all IRIS submissions, including substance and research product identifier registration (version 2.6).

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 instructions in this guide involve visiting different web portals, all of which appear, for data security reasons, outside the EMA website.

This document is primarily focused on industry and academic stakeholders but may also be of use to regulatory users.

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