Applying for a permit to maintain lower obligatory storage levels

Application for exemption to maintain lower stock levels

Parties subject to storage obligation must actively monitor their compliance with their obligatory storage. If a party has reason to believe that it cannot fulfil its obligation, it must promptly apply for a permit to maintain lower obligatory storage levels. The stock level may only fall under the obligatory storage level when the Finnish Medicines Agency Fimea has granted a permit to maintain lower obligatory storage levels. The situations in which parties subject to storage obligation may apply for a permit to maintain lower storage levels are listed in Section 15 of the Act on Obligatory Storing of Medicines (Laki lääkkeiden velvoitevarastoinnista, 979/2008). 

Grounds for maintaining lower storage obligation

Fimea may grant the permit if there is a chance that a product in obligatory storage or another product included in the obligatory storage may become unfit for purpose during the storage period for example due to its short shelf life. Fimea may also grant the permit if the operations of a party subject to storage obligation are at risk of disruption due to a temporary shortage or if the party’s stock levels may drop significantly if the obligatory storage is not used. The permit may only be granted if there is no risk to the security of supply. 

If a shortage lasts more than three months, the application for a permit to maintain lower stock levels must be submitted with a written assurance of the shortage prepared by the manufacturer, contract manufacturer or supplier. The assurance shall also be submitted in a timely manner if the duration of the permits applied for during the year due to the same reason is more than three months in total. 

Who can apply for a permit to maintain lower obligatory storage levels?

Pharmaceutical companies in Finland, importers of medicinal products and the National Institute for Health and Welfare may apply for a permit to maintain lower obligatory storage levels for a set period.

The permit process does not apply to health care units that are allowed to reduce their storage obligation if the unit’s operations cannot continue without using the obligatory storage due to a shortage. Once the shortage has ended, the health care unit must restore the required volume of their obligatory storage without delay.

Instructions for applicants

The permits are applied for individual medicinal products or medicinal substances (pharmaceutical companies). For more detailed information about what needs to be declared in the application, please refer to the Fimea Administrative regulation 1/2017.

Carefully completed applications require fewer follow-ups and shorten the processing time at Fimea. Signed applications are submitted to the Registrar's office of Fimea via secure email.

Further information and application form

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

Form: Alituslupahakemus (pdf, in Finnish)