Posted Fri, 18 Feb 2022 14:43:20 GMT by Silvia Scocca
Reading the last version of the IRIS guidance, some doubts on the correct interpretation remain. 
If the presentation is not marketed in some of the EU member states (that means: marketed in at least 1 member state), the value should be changed from “no data provided” to “not marketed”, or to "never marketed"? If the value "not marketed" should be used, for a presentation that has never been marketed in some of the EU Member States, the date of "marketing status change" and "reason for cessation" will not apply. Therefore, can the date and "reason for cessation" be left blank as well, or this will lead to a validation error in the system? 
Posted Mon, 28 Feb 2022 09:22:41 GMT by Virginia Rojo Guerra
The Marketing Status value Never marketed should be used for presentations that have never been on the market in that particular MS. In this case, the fields Date of marketing status change and Reason for cessation do not apply (since the product has never been on the market, it has never been launched on that particular MS). The fields can be left blank and this should not trigger a validation error.

The value Not marketed should only be used for presentations that have been on the market before (they were launched in the past in a particular MS) but have been removed from the market (i.e. withdrawal, temporary cessation) and are no longer marketed. In this case the fields Date of marketing status change and Reason for cessation are mandatory and should be reported.

Example:
Presentation 001 has never been launched in Austria. Marketing Status value should be reported as Never marketed in Austria. Date of marketing status change and reason for cessation should be left blank.
Presentation 002 was launched in France and later removed for commercial reasons. Marketing Status should be reported in 2 steps. An initial reporting as Marketed with the Date of marketing status change when it was initially launched in France and once that is reflected in the IRIS report (as date of initial placing on the market), then a second reporting as Not marketed with the Date of marketing status change when the product was removed from the market and Reason for cessation as Commercial reasons.

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