The European Medicines Agency (EMA) published a revised version of its IRIS Guide for Applicants on 15 June 2026, updating the instructions for creating, submitting, and managing regulatory applications through the IRIS platform. Since January 2025, submission of Article 61(3) notifications — which cover updates to labeling, Summary of Product Characteristics (SmPC), and Patient Information Leaflets (PIL) for centrally authorised products — has been mandatory through IRIS. The revised guide reflects the latest procedural updates and system changes that applicants and Marketing Authorization Holders (MAHs) must follow. Companies that continue to use non-IRIS channels for labeling notifications are non-compliant. Regulatory teams managing EU product labeling updates, lifecycle variations, and artwork-triggering changes must ensure full alignment with IRIS workflows, including updated registration requirements and the Regulatory Procedure Management (RPM) module. The companion IRIS Guide to Registration and RPIs was also simultaneously updated on 15 June 2026.
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