Europe – IRIS guide to registration

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 pre-requisite 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 EMA systems, such as SPOR.

The instructions in this guide involve visiting three 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.

1.1. Registration steps for applicants of scientific procedures (e.g. orphan designation procedures or Innovation Task Force briefing meeting requests)

1.1.1. EMA user account
Applicants including Sponsor2 of an orphan designation or persons acting on their behalf, must have an active EMA user account and must be registered with an IRIS user access role of “IRIS Industry Manager” (affiliated to one or more organisations), or “IRIS Individual User” (see sections EMA user account and Access to IRIS).

1.1.2. Organisation registration in OMS

The ‘Organisation’ for which the OD or ITF briefing meeting application is being submitted must be already listed in the EMA’s Organisation Management Service (OMS) (see section ‘Organisation registration in OMS (SPOR)’).

• If the organisation is not listed, the registration process takes from eight to ten working days.
• Registration is OMS is not required if a new application is being prepared by an individual not affiliated to any organisation…