Posted Thu, 09 Dec 2021 10:02:22 GMT by Stephen Mackenzie
Hi,

In the guidance there are 8 reasons for cessation but when creating a draft submission in IRIS there are 11.  We have built our own internal data collection processes around the 11 items in IRIS, as this would make sense to us to mirror IRIS.

Is it 8 or 11, if 8 why are 11 presented in IRIS?  I see in some other responses on the forum you are advising people of 8 reasons for cessation but IRIS itself presents 11, including "down prioritisation due to Covid-19" and "Other" not listed in the guidance.

Regards

Stephen
Posted Thu, 09 Dec 2021 10:50:06 GMT by Virginia Rojo Guerra
Only 8 reasons are applicable to Marketing status, which are the ones included in the IRIS guide for applicants. Other reasons may be applicable to other procedures within IRIS. We are working to ensure that only the applicable ones are visible in the system when reporting a Marketing status.
Posted Thu, 09 Dec 2021 10:51:44 GMT by Stephen Mackenzie
Hi, So the 11 we see in IRIS now is not the final 11 we will see when making an IRIS submission for a single or bulk upload of a marketing status?
Posted Fri, 10 Dec 2021 10:00:59 GMT by Paolo Tomasi EMA
Please report any bugs you see in the system via a EMA Servicedesk ticket, rather than in the Forums. Regarding the issue at hand, this is indeed a regression bug, and EMA is aware of it: there should be 8, not 11 reasons. We are working to solve it in the next release of IRIS (new releases are deployed fortnightly).

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