IRIS Release Notes

Release version 26/05/2026

Overview

This release represents the next iterative update of the IRIS portal. It introduces new enhancements and functionalities outlined in User Stories, along with fixes for reported incidents and resolved bugs.

User Stories

ID	Description
255253	ORPHAN DESIGNATION: The PIP/waiver guidance question has been clarified to “Has a PIP/waiver been submitted that has received a positive EMA/PDCO outcome?”, enabling applicants to understand that only PIP/waiver references with a positive outcome should be selected, thereby reducing confusion and preventing incorrect or incomplete submissions.

Release version 11/05/2026

Overview

User Stories

ID	Description
301333	PhV_VETERINARY SIGNAL MANAGEMENT: Automated notifications for new documents in the “Outcome from EMA” folder have been implemented, enabling MAH contacts (principal sender, managers, and contributors) to be promptly informed, thereby ensuring timely awareness of EMA/NCA outputs and reducing the risk of missed information.

Bug fixes

ID	Description
316208	SCIENTIFIC ADVICE: Incorrect population of the Previous Advice (national) field instead of the Product, Subject, and Regulatory Entitlement fields prevented applicants from retrieving documents from Documents from EMA. Now the correct case fields are populated, enabling applicants to retrieve their EMA documents and ensuring access to the required information.

Release version 29/04/2026

Overview

User Stories

ID	Description
301625	SCIENTIFIC ADVICE: The process now includes a dedicated “Previous Advice” selection specifically for the Clarification on Scientific Advice Submission, enabling users to select relevant previous advice linked to parent organisations. The field has been updated to use a parent organisation–based lookup, with additional filtering, thereby making the submission clearer, more accurate, and easier to complete.

Description

301625

SCIENTIFIC ADVICE: The process now includes a dedicated “Previous Advice” selection specifically for the Clarification on Scientific Advice Submission, enabling users to select relevant previous advice linked to parent organisations. The field has been updated to use a parent organisation–based lookup, with additional filtering, thereby making the submission clearer, more accurate, and easier to complete.

Release version 13/04/2026

Overview

No release notes are available for this release as no updates or improvements have been delivered in this cycle