Fimea may decide to grant a temporary special permit for a medicinal product. Medicinal products may be released for consumption without a special permit granted by Fimea if ordering and delivery is conducted in accordance with the supply restrictions of a temporary permit. Otherwise, release for consumption requires a special permit granted by Fimea.
Medicinal products that can be released for consumption with a temporary special permit granted by Fimea can be found in the search for medicinal products requiring a special permit. These medicinal products can be searched based on the type of special permit.
The medicinal product may be released for consumption upon prescription or a request for supply.
The party releasing the product for consumption (pharmacy, auxiliary pharmacy, hospital pharmacy, pharmaceutical wholesaler, pharmaceutical company) must keep a record of all medicinal products supplied with temporary special permission for compassionate use. The records must be stored for 5 years.
The products must not be advertised or otherwise promoted.