Fixed-term special permits

Fixed-term special permits

Based on its own assessment, Fimea may grant a special permit for a medicinal product on its own initiative, without an application (a fixed-term special permit). In that case, medicinal products may be released for consumption without a patient or institution-specific special permit granted by Fimea if they are prescribed and supplied in accordance with the terms of the fixed-term permit. In other case, the release for consumption requires a special permit from Fimea.

If the medicinal product has a fixed-term special permit for a medicinal product under Section 10f of the Medicines Decree (693/1987), the prescription is sufficient in itself, and an application for a special permit including justifications is not necessary.

Electronic prescriptions can be used for medicinal products with a fixed-term special permit, and they may be valid for one year. In Finland, generic substitution is not allowed for unauthorised medicinal products. The prescription must indicate the trade name of the product. A medicinal product may also be released for consumption based on an order for a medicinal product.

Medicinal products that can be released for consumption with a fixed-term special permit granted by Fimea can be found in the search for medicinal products requiring a special permit (Erityislupaa edellyttävät lääkevalmisteet, in Finnish). Please note that search is only in Finnish and search terms are also in Finnish. In the web search, you can select “Määräaikainen erityislupa” as a search term from the drop-down menu. 

The releasing party (a pharmacy, subsidiary pharmacy, hospital pharmacy, pharmaceutical wholesaler, medicinal product manufacturer) must keep a record of medicinal products supplied under a fixed-term special permit. The records must be kept for 5 years.

Marketing or promoting the product is not allowed.

Fixed-term special permits for veterinary products

Products which have been granted a fixed-term special permit and found in the search for products for human use requiring a special permit cannot be used for animals without a separate special permit for use in animals.
Products with a fixed-term special permit for use in animals are listed here: fixed-term special permits for veterinary medicinal products (in Finnish).

More information about special permits for veterinary medicines.