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? 

For a presentation that was previously marketed in a Country, I need to report a permanent marketing cessation, which also occurred in the past. There is an obligation in IRIS to report if cessations lead to shortage but, since this happened in the past, it is not clear if we can speak of “shortage” actually.

If a marketing cessation took place in the past, should we answer "no" to the question "does cessation lead to shortage"?