Notifying the obligatory storages

Those required to maintain obligatory storage must notify the quantities to be stocked to the Finnish Medicines Agency Fimea annually. The notification shall be submitted by the last day (31 December) of the year preceding the storage year. The notification shall be submitted in a tabulated format in line with the Fimea Administrative regulation 1/2017. The obligation to maintain obligatory storage lasts the entire calendar year.

The obligation to maintain obligatory storage is not tied to any specific package size. If a product is available in Finland in several package sizes under the same marketing authorisation, the overall obligation can be maintained with one   package size or some of the available package sizes. In this case, the package sizes must be suitable for the same indication and the treatment of the same patient population and the same number of patients. The overall obligation is reported as units (such as tablets or millilitres) in stock. 

Pharmaceutical companies and importers

The size of the obligatory storage is calculated on the basis of the sales figures of the medicinal product in question in Finland between the beginning of March and the end of August preceding the storage year. Depending on the medicine group, the quantity to be stocked is the number of products equivalent to the average sales over a period of 10, 6 or 3 months.

Health care units

The size of the obligatory storage is calculated on the basis of consumption of the pharmaceutical product between the beginning of January and the end of September preceding the storage year. Depending on the medicine group, the quantity to be stocked is the number of products equivalent to the average consumption over a period of 6 months, 3 months or 2 weeks.

National Institute for Health and Welfare

The National Institute for Health and Welfare is obliged to maintain an obligatory storage of vaccines that belong to the national vaccination programme. The size of the obligatory storage is calculated on the basis of consumption between the beginning of January and the end of June in the preceding year. Influenza vaccines are not included in the obligatory storage.

Updating the notification of obligatory storages, pharmaceutical companies and importers

If the sales of a medicinal product included in the obligatory storage have increased by at least 30% between the October preceding the storage year and the end of March of the storage year, the obligatory storage must be updated to match the increase in sales. If the sales have gone down by at least 30%, the party obliged to maintain an obligatory storage may decrease the size of the obligatory storage to match the decrease in sales. Any changes shall be reported to the Finnish Medicines Agency Fimea by the end of May of the storage year. The change in the quantity to be stocked shall enter into force on 1 July.

Submitting notifications to Fimea

Signed obligatory storage notifications and changes to the notifications shall be submitted to the Registrar's office of Fimea via email, [email protected]. We recommend submitting the report also as an Excel spreadsheet. Notifications may also be posted to P.O. Box 55, FI-00034 FIMEA, Finland.

Further information and notification form:

Fimea Administrative regulation 1/2017 Velvoitevarastoinnin lupa- ja ilmoitusmenettelyt (pdf, in Finnish)

Form: notifying the obligatory storages (xls, in Finnish)