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Exemptions and special permits

Exemptions and special permits

The use of medicinal products that have been granted marketing authorisation is always the primary option in the patient's pharmacotherapy. If a product with a marketing authorisation is experiencing a shortage of availability or if there is no medicinal productl with a marketing authorisation, the patient's pharmacotherapy is possible to with exemption and special permit procedures.

In situations where a shortage of a pharmaceutical subject to marketing authorisation could otherwise be expected, Fimea may, for justified reasons, grant the marketing authorisation holder a batch-specific exemption from the terms of the marketing authorisation or registration. This kind of exemption can only be granted for a preparation that has valid marketing authorisation or registration Finland. An exemption can only be granted for a product their supply of which is considered critical for Finland's pharmaceutical services.

A special permit refers to Fimea-granted authorisation for the sale of a medicinal product that has no marketing authorisation in Finland in individual cases for special therapeutic reasons. Special permits is limited to compassionate use in exceptional cases where no other treatment is appropriate or yields the desired effect. The treating physician will assess whether it is necessary to use a medicinal product that requires a special permit and, if so, apply for a special permit.

Read more about exemptions and special permits:

Exemptions

Special permits