What's New in IRIS

Forum Info:

EMA will regularly publish updates on new features of IRIS. On the top of the threads list you will find "sticky" threads, containing guidelines and standard information.
IRIS portal users are kindly asked to refrain from creating new threads in this Forum; use the General Discussion and self-help Forum instead. If replying to announcements in this Forum, please do not post confidential information.

	Thread	Author	Last post	Replies
Sticky	Next steps for IRIS transition: Initial MAA and pre-submission procedures & updated roadmap	Caterina Scarpati	Caterina Scarpati Thu, 10 Apr 2025 10:54:17 GMT	2
	Email authentication for EMA applications – Complete your account conversion by 8 May 2025	Caterina Scarpati	Caterina Scarpati Mon, 14 Apr 2025 12:38:10 GMT	0
	"[INACTIVE]" prefix in IRIS after OMS synchronisation – impacts & actions	Caterina Scarpati	Caterina Scarpati Mon, 14 Apr 2025 10:22:24 GMT	0
	Save the date: SPOR & XEVMPD quarterly status update webinars planned in 2025	Caterina Scarpati	Caterina Scarpati Mon, 24 Mar 2025 14:35:50 GMT	0
	Paediatric submissions in IRIS: one condition per submission	Paolo Tomasi	Paolo Tomasi EMA Tue, 25 Feb 2025 08:15:46 GMT	2
	January 2025 - IRIS now live for post-authorisation procedure management!	Caterina Scarpati	Caterina Scarpati Wed, 12 Feb 2025 14:23:40 GMT	1
	Reminder: Email authentication to EMA systems - Timeline to convert your user	Caterina Scarpati	Caterina Scarpati Thu, 30 Jan 2025 13:50:40 GMT	0
	Invoice information - Financial information tab missing	Daria Mari	Paolo Tomasi EMA Wed, 29 Jan 2025 12:08:43 GMT	2
	Upcoming SPOR & XEVMPD Status Update Webinar – 22 January 2025	Caterina Scarpati	Caterina Scarpati Fri, 10 Jan 2025 08:43:31 GMT	0
	How do I submit a request for follow-up scientific advice using the current IRIS interface?	Jorg Schneidereit	Tarita Toufexi Ms Mon, 06 Jan 2025 17:22:49 GMT	1
	RPI contact person	Daria Mari	Paolo Tomasi EMA Mon, 16 Dec 2024 19:44:46 GMT	1
	Email authentication to EMA systems - Timeline to convert your user	Caterina Scarpati	Caterina Scarpati Fri, 13 Dec 2024 11:02:54 GMT	0
	Transition of post-authorisation procedures on IRIS, training materials and feedback request	Caterina Scarpati	Caterina Scarpati Thu, 12 Dec 2024 14:32:20 GMT	0
	Q&A Clinics on post-authorisation procedure management transition to IRIS - Dec 2024	Caterina Scarpati	Caterina Scarpati Mon, 09 Dec 2024 13:27:15 GMT	0
	Impact of Fee Regulation changes to selections available in IRIS	Caroline Brickell	Tarita Toufexi Ms Wed, 04 Dec 2024 10:00:05 GMT	1
	Transition of post-authorisation to IRIS overview + request to register in EMA IAM by Oct 2024	Caterina Scarpati	Sonja Nolte Mon, 11 Nov 2024 14:50:07 GMT	8
	Paediatric submissions in IRIS: Q&A	Paolo Tomasi	Paolo Tomasi EMA Mon, 04 Nov 2024 08:19:45 GMT	0
	Activities for MAHs for Jan 2025 post-authorisation procedures transition to IRIS (+ training)	Caterina Scarpati	Caterina Scarpati Tue, 22 Oct 2024 13:52:27 GMT	0
	Paediatrics: resubmission of PIP applications after clock-stop	Paolo Tomasi	Paolo Tomasi EMA Thu, 19 Sep 2024 07:17:30 GMT	0
	Paediatric Regulatory entitlements in IRIS (Decisions on PIPs and product-specific waivers)	Paolo Tomasi	Paolo Tomasi EMA Wed, 11 Sep 2024 17:29:27 GMT	2

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Next steps for IRIS transition: Initial MAA and pre-submission procedures & updated roadmap

Caterina Scarpati