The holder of a marketing authorisation or registration, or their representative, must notify Fimea of a temporary withdrawal from the market of a medicinal product intended for human use, i.e. a shortage under section 27 of the Medicines Act (395/1987). The notification must be submitted at least two months before the withdrawal.
Shortage = the amount of a medicinal product available on the Fin ...
If a company has a Finnish business ID, they submit shortage notifications in the e-service. The service is intended for marketing authorisation or registration holders and their representatives as well as parallel importers and distributors.
Users log in to the service with Suomi.fi e-Identification. To submit a shortage notification, the user needs to be granted a Suomi.fi e-Authorization for acting on behalf of the company. In the e-service for shortage notifications identification methods of foreigners has not been enabled and therefore you need Finnish social security number for using the e-service.
The e-service can be used to submit shortage notifications and view and update a company’s own notifications. All current or future shortages reported to Fimea can also be viewed in the service.
If a company does not have a Finnish business ID and personnel who has Finnish social security number, shortage notifications are submitted with a PDF form. The submission should be sent to Finnish Medicines Agency Fimea at shortagesSPOC@fimea.fi. There is no need to send a paper version by letter.