Posted Fri, 08 Apr 2022 14:41:41 GMT by Erasmo Addeo
Hello, this is about withdrawn presentations (neither available in the EMA list of authorized presentations) but which keep appearing in IRIS.
When populating the product marketing status report, withdrawn presentations are still visible and can be selected. However being these presentations withdrawn in the past and no reliable data are available, our concern is how to handle them in IRIS.
Our approach followed so far was to NOT select withdrawn presentations at all, since as per our understanding "never marketed" should be used for registered presentations only but never marketed in any member state at all.
Please advise if a different approach shall be used for withdrawn presentations or if not selecting them at all when populating the marketing status report is the best option.
Posted Mon, 25 Apr 2022 08:00:35 GMT by Virginia Rojo Guerra
The answer will differ depending on what is meant by 'withdrawn' presentations. Presentations that have been removed from the Marketing Authorization via variation and are no longer valid should not be visible in IRIS. If they are, please raise a ticket with EMA HelpDesk to correct it. Presentations that are no longer in the market but are still valid in the MA will be visible in IRIS. In that case, if the presentation was marketed and removed from the market later on, the status should be reported as Not Marketed. This should be done in 2 steps, first the presentation should be reported as Marketed with the date of initial placing in the market for each MS as Date of marketing status change. Once this is completed, the presentation should be reported as Not marketed and the Date of marketing status change, Reason for cessation and Does cessation leads to shortages should be populated. The 2 step approach is to allow for the date of initial placing in the market to be visible in the report. If the presentation was never on the market in a particular MS, it should be reported as Never marketed for that particular country.

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