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.

A medicinal product subject to a special permit does not have a marketing authorisation in Finland. Because of that, there is no package leaflet in Finnish or in Swedish. However, it is still possible to use the medicinal product under a special permit procedure.

The physician prescribing the medicine and the pharmacy dispensing the medicine to the patient must ensure that the patient has sufficient information on the appropriate and safe use of the product, including instructions for storage and other instructions. 

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 renewed FimeaWeb.

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.

In Finland, the marketing or other promotion of a medicinal product without marketing authorisation is not permitted. 

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.

In addition to the ERKKA system, Fimea's FimeaWeb has also been updated, allowing the applicant to also apply for medicinal products for veterinary use requiring a special permit. You can search for medicinal products for which Fimea has already granted special permits for human or veterinary use, with the name of an active substance or trade name. The search result contains basic information about a  medicinal product subject to a special permit, such as its trade name, strength, active substance, pharmaceutical form and package size. New information includes the type of medicinal product (Is it is a medicinal product with a marketing authorisation for humans or animals in the country of origin), the country of the marketing authorisation, the marketing authorisation number and Fimea-ID. The country of the marketing authorisation indicates the language of the package. The search result also shows information related to the special permit, i.e. what types of special permits have been valid or previously granted for the medicinal product applied for, and, in the case of a fixed-term special permit, its period of validity.

More information about special permits for veterinary medicines