IRIS: EMA portal for regulatory and scientific procedures

IRIS is the European Medicines Agency's secure portal for the procedures that are not submissions of a marketing authorisation dossier. It was introduced in 2018 for orphan designation applications and has since been extended to scientific advice and protocol assistance, PRIME eligibility requests, paediatric investigation plan applications and modifications, parallel distribution notifications, signal management correspondence, inspection-related exchanges and other interactions with the Agency. Each procedure is run as a submission in IRIS with its own forms, document uploads, status tracking and correspondence, so the applicant and the Agency work from the same record. Access requires an EMA account, and the applicant's organisation must be registered in the Organisation Management Service, with roles assigned in IRIS by the organisation's own administrator.

A central concept in IRIS is the Research Product Identifier (RPI), a number assigned to a development product before it has an authorisation, so that orphan designations, scientific advice and paediatric procedures for the same product are linked. IRIS draws substance and organisation data from the SPOR services, which is why a substance or sponsor that is missing there has to be added before a request can be created. Fees for procedures started in IRIS, such as scientific advice, are governed by Regulation (EU) 2024/568 and invoiced through the Agency's usual process. For centrally authorised products, the marketing authorisation dossier itself still goes through the PLM Portal and eSubmission, not IRIS.

What goes wrong: a sponsor's consultant creates the RPI under the consultant's organisation, so the sponsor cannot see its own procedures later; the affiliate submitting a parallel distribution notice is not linked to the holder in OMS; scientific advice requests are started without the pre-submission steps that the Agency's timetable assumes, so they miss the next cycle; orphan designation applications are filed against the wrong RPI after a change of sponsor; and nobody is set as the organisation's IRIS administrator, so new staff cannot be given access when the previous user leaves. Because every procedure has published submission deadlines tied to committee meetings, an access problem in IRIS can cost a full cycle, and the deadlines for the next cycle are rarely far enough away to absorb the delay.