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	Important: Restore your IRIS access for post-authorisation submissions	Caterina Scarpati	Klodiana Meyer Regulatory Affairs Manager Mon, 22 Sep 2025 09:48:34 GMT	1
Sticky	Actions, support & training resources for MAHs for procedure management in IRIS	Caterina Scarpati	Cecilia Caputo Fri, 05 Sep 2025 10:29:32 GMT	2
Sticky	PSURs cannot be submitted without IRIS-affiliated contact after 1 September 2025	Irene Mumeni Urbani	Irene Mumeni Urbani Thu, 31 Jul 2025 09:49:26 GMT	0
Sticky	IRIS transition update: revised go-live timeline and updated support materials	Caterina Scarpati	Caterina Scarpati Thu, 24 Jul 2025 15:33:14 GMT	1
	How to link Scientific advices for same product but handled by different organizarion	Shubhangi Argade	Shubhangi Argade Mon, 11 Aug 2025 15:23:21 GMT	2
	Next steps for IRIS transition: Initial MAA and pre-submission procedures & updated roadmap	Caterina Scarpati	Caterina Scarpati Wed, 23 Jul 2025 15:13:25 GMT	1
	PIP compliance Check	Ana Rita Dias	Caterina Scarpati Wed, 23 Jul 2025 15:10:53 GMT	1
	Information on clockstops/restarts for processes implemented in IRIS	Isha Arora	Isha Arora Dr. Thu, 10 Jul 2025 13:23:20 GMT	0
	Your input matters: IRIS for post-authorisation survey (5 mins)	Caterina Scarpati	Caterina Scarpati Wed, 11 Jun 2025 08:41:57 GMT	0
	Paediatric Regulatory entitlements in IRIS (Decisions on PIPs and product-specific waivers)	Paolo Tomasi	Fabiola Federico Fri, 06 Jun 2025 16:07:05 GMT	5
	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

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Important: Restore your IRIS access for post-authorisation submissions

Caterina Scarpati