Special arrangements for the fulfilment of storage obligation

Pursuant to Section 10 of the Act on Obligatory Storing of Medicines (Laki lääkkeiden velvoitevarastoinnista, 979/2008), a party subject to storage obligation may demonstrate full or partial compliance with their storage obligation by agreeing to provide equivalent security of supply by other means. Section 2 of the Government Decree on Obligatory Storing of Medicines (Valtioneuvoston asetus lääkkeiden velvoitevarastoinnista, 1106/2015) includes more detailed provisions on the alternative arrangements for the fulfilment of storage obligation. 

Fulfilment of the obligation to maintain obligatory storage by stocking a substitute medicinal product included in the obligatory storage

An importer or a health care unit may fulfil their storage obligation partially or in full by stocking another medicinal product that contains the equivalent amount of the same medicinal substance. The product must be suitable for the treatment of the same patient population. If the substitute medicinal product becomes subject to storage obligation during the time period covered by the application, it must be taken into account in the total quantity to be included in the obligatory storage.

Fulfilment of the obligation to maintain obligatory storage of a medicinal product by stocking a medicinal substance or a semi-finished product 

A party subject to storage obligation may fulfil their storage obligation by stocking medicinal products or semi-finished products that pharmaceutical companies operating in Finland can use to manufacture medicinal products in the required dosage forms that meet the acceptable quality requirements. However, the actual medicinal product must account for at least 20% of the quantities required.

When applying for a substitution of the regular obligatory storage by stocking a medicinal substance or semi-finished product, the applicant must provide Fimea with information on the suitability of the medicinal substances and materials to be stocked for the manufacture of the medicinal product, including details and responsibilities regarding the stocks. The application must be accompanied by a copy of the agreement made with the pharmaceutical company. 

Fulfilment of the obligation to maintain obligatory storage of a medicinal substance by stocking a medicinal product 

With Fimea’s permission, a pharmaceutical company may fulfil their obligation to maintain an obligatory storage of a medicinal substance in full or partially by stocking an equivalent quantity of a medicinal product. 

The substitutability between the medicinal substance and the medicinal product depends on the quantity of the medicinal substance contained in the medicinal product. The application submitted to Fimea must include information about the medicinal substance contained in the medicinal product and the volume of the storage obligation of the substitute medicinal product.

Fulfilment of the obligation to maintain obligatory storage by stocking authorized medicinal product not marketed in Finland  

A party subject to storage obligation may apply Fimea’s permission to temporarily fulfil their storage obligation by stocking medicinal product packages other than those that are marketed in Finland Finland in accordance with the medicinal product’s marketing authorisation. The application must provide an explanation of how the obligatory storage of the medicinal product can be accessed if needed. The use of substitutes can be approved if the arrangement does not compromise the security of supply or patient safety.

If Fimea has granted an exemption to a medicinal product included in the obligatory storage, it can be stocked as a substitute to fulfil the obligation to maintain an obligatory storage of the medicinal product in question. In this case, there is no need to submit a separate application to substitute a medicinal product included in the obligatory storage. 

The party subject to storage obligation must bear in mind that the sales of the substitute medicinal product count towards the volume of storage obligation and that it must be taken into account in the storage obligation notification.

Instructions for applicants

For more detailed application instructions, please refer to the Fimea Administrative regulation 2/2017.

To make sure the application can be processed in a timely manner, we recommend submitting the application using the storage obligation substitute form. 

Further information and application form

Fimea Administrative regulation 2/2017 Hakemusmenettelyt varastointivelvoitteen järjestämiseksi erityistapauksissa (pdf, in Finnish)

Form: Velvoitevarastoinnin järjestäminen erityistapauksissa (pdf, in Finnish)