Posted Tue, 26 Jul 2022 07:43:26 GMT by Eva Prokopova
Dear all, I would like to ask you when we change a license in a particular country to temporary unavailable and provide a new date when it will appear on the market again after the stock shortage, does IRIS automatically change the status to marketed again on the date we have put in the system? Or do I have to manually go in and change the status back to marketed? Thank you for your help
Posted Tue, 09 Aug 2022 12:44:29 GMT by Virginia Rojo Guerra
The system does not change status automatically, since the situation may have changed from the initial reporting. Companies are required to submit the new status within 30 days of the reintroduction in the market. For more info, please review Notifying a change of marketing status | European Medicines Agency (europa.eu).

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