Posted Wed, 05 Jan 2022 10:29:14 GMT by Silvia Scocca
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"?
Posted Thu, 06 Jan 2022 16:05:47 GMT by Virginia Rojo Guerra
If the cessation actually led to a shortage at that point, you can answer yes. This field is for information only, as an early warning to authorities, so if it happened in the past, this is not that relevant anymore. In the event of a potential future shortage, this still needs to be communicated through the appropriate channels separately.

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