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 Finnish market falls short of demand.
Submitting a shortage notification – Finnish company
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.
Instructions: Granting Suomi.fi e-Authorization for reporting shortages (pdf)
Instructions for using the e-service for reporting shortages
Submitting a shortage notification – Foreign company
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 the registry office of the Finnish Medicines Agency Fimea at firstname.lastname@example.org. There is no need to send a paper version by letter.
Shortage notification, foreign company (pdf)
Other Availability Disruption Labels
Fimea adds the Uncertain Availability label to medicinal products if Fimea has received information of a possible shortage of a medicinal product, but no shortage notification has been submitted to Fimea. The Uncertain Availability label means that the medicinal product may not be available on the Finnish market in a quantity that meets demand.
The Uncertain Availability label is added to a medicinal product on the market if the marketing authorisation or registration holder or their representative does not fulfil their obligation to submit a shortage notification despite a request from Fimea.
The label is removed after one year. The label is replaced with shortage information if Fimea receives an up-to-date shortage notification for the product in question.
Parallel distribution products are medicinal products that have been granted a marketing authorisation through the centralised procedure of the European Medicines Agency (EMA) and that are parallel-distributed in Finland by some other distributor than the original company that was granted the marketing authorisation. The Parallel Distribution label is added to all parallel distribution products.
The availability of parallel distribution products is uncertain because submitting shortage notifications of these products to Fimea is voluntary for the parallel distribution permit holder. Due to there being no obligation to report shortages of parallel distribution products, Fimea does not always receive information on the shortages of these products. The Parallel Distribution label is replaced with shortage information if a shortage notification is submitted for a product.
Questions and support in relation to notification of shortages email@example.com