Exemptions and special permits
The use of authorized medicinal products is always the primary option in patient medication. If there is a shortage situation of an authorized product or if an authorized medicine is not available on the Finnish market, patient medication can be ensured through Exemption and Special permit procedures.
In situations where shortage of an authorized medicinal product is otherwise expected, Fimea may, for justified reasons, grant the marketing authorization holder a batch-specific exemption from the conditions of the marketing authorization or registration. Such an exemption can only be granted for a product that has a valid marketing authorization or registration in Finland. An exemption can only be granted for a product whose availability is considered critical for Finland's pharmaceutical services.
A special permit refers to an authorization that Fimea may grant in individual cases for specific therapeutic reasons, allowing the use of a medicinal product that does not have a marketing authorization in Finland. Special permits are limited to compassionate use in exceptional cases where no other treatment is appropriate or yields the desired effect. The attending physician assesses whether the use of a medicinal product requiring a special permit is necessary and applies for a special permit if needed.