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	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
Sticky	Q&As on IRIS registration, login and RPI requests	Paolo Tomasi	Paolo Tomasi EMA Tue, 07 Nov 2023 08:08:18 GMT	6
	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
	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
	Potential performance issues on IRIS portals due to non-CAPs data load until end of Sep 2024	Caterina Scarpati	Caterina Scarpati Mon, 09 Sep 2024 07:37:38 GMT	0
	SPOR & XEVMPD Webinar series - October 2024	Caterina Scarpati	Caterina Scarpati Fri, 06 Sep 2024 10:15:55 GMT	0
	Inquiry: Appointed contact persons per product	Tea Tosic	Paolo Tomasi EMA Fri, 30 Aug 2024 08:07:07 GMT	1
	Marketing Status on NAPs	Elena Cerretini	Paolo Tomasi EMA Fri, 30 Aug 2024 08:06:11 GMT	1
	"EMA Account Management, what's new?" Webinar, 20/09/24 10:00 - 11:00 CEST	Caterina Scarpati	Caterina Scarpati Mon, 26 Aug 2024 08:22:54 GMT	0
	Transferring a Marketing Authorisation does not transfer the corresponding RPI	Paolo Tomasi	Paolo Tomasi EMA Fri, 23 Aug 2024 11:12:41 GMT	0
	Paediatric submissions in IRIS: no need for Letter of Authorization or the Part A PDF form	Paolo Tomasi	Paolo Tomasi EMA Wed, 17 Jul 2024 13:31:36 GMT	0
	Paediatric submissions in IRIS: one condition per submission	Paolo Tomasi	Paolo Tomasi EMA Wed, 17 Jul 2024 10:17:14 GMT	0
	Paediatric submissions in IRIS: how to submit answers to the PDCO request for modification	Andrea Davies	Andrea Davies Thu, 11 Jul 2024 10:18:33 GMT	0
	Submission receipt notifications sent in error by IRIS for old, closed Paediatric procedures	Paolo Tomasi	Adriana Andric Mon, 08 Jul 2024 09:31:49 GMT	4
	Changes to safety update notification procedure for parallel distribution	Caterina Scarpati	Mirweis Ahmadi Tue, 02 Jul 2024 11:43:06 GMT	1
	Save the date: SPOR Status Update Webinar – 10 July 2024	Caterina Scarpati	Caterina Scarpati Mon, 24 Jun 2024 09:42:22 GMT	0
	Paediatric procedures fully onboarded on IRIS	Sara Mancabelli	Sara Mancabelli Tue, 04 Jun 2024 07:47:13 GMT	0

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Activities for MAHs for Jan 2025 post-authorisation procedures transition to IRIS (+ training)

Caterina Scarpati