Applying for an exemption

Applying for an exemption

After reviewing the application, Fimea may exempt a party subject to storage obligation from maintaining obligatory storage either partially or in full. The grounds for exemption from the storage obligation are listed in Section 11 of the Act on Obligatory Storing of Medicines (Laki lääkkeiden velvoitevarastoinnista, 979/2008) and in Section 3 of the Government Decree on Obligatory Storing of Medicines (Valtioneuvoston asetus lääkkeiden velvoitevarastoinnista, 1106/2015). 

Exemption from the storage obligation may be granted on the condition that the security of supply of the medicinal product in question will not be compromised. Exemption may also be granted, if compliance with the storage obligation causes special problems for the party subject to storage obligation, if the volume of storage obligation is low or if the storage is otherwise no longer needed due to a reason such as a change in the importer of the medicinal product. 

If exemption is applied for more than one medicinal product, applications shall be submitted for each individual medicinal product.

The decision is valid from the date on which the application is reviewed or from a specifically requested date at most until the end of the calendar year in question at a time.

Who can apply for an exemption?

Pharmaceutical companies in Finland, importers of medicinal products and health care units may apply for an exemption.

Instructions for applicants

For more detailed information about what needs to be declared in the application, please refer to the Fimea Administrative regulation 1/2017. 

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

Further information and application form

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

Form: Velvoitevarastoinnin vapautus (pdf, in Finnish)