The use of medicinal products that have been granted a marketing authorisation is always the primary option in patients' pharmacotherapy. However, in individual cases and for special therapeutic reasons, Fimea may authorise the release for consumption of a medicinal product that has no marketing authorisation in Finland. A special permit is granted for up to one year based on a situation and case-specific overall assessment.
In the Medicines Decree (693/1987), the special permit procedure is limited to use in exceptional cases where no other treatment is appropriate or yields the desired effect. A special permit granted by Fimea safeguards the necessary medicinal treatment for individual patients in exceptional cases.
Special permits may be granted to pharmacies, subsidiary pharmacies, hospital pharmacies, pharmaceutical wholesalers and medicinal product manufacturers etc.
Medicinal products subject to a special permit may be prescribed in accordance with the Ministry of Social Affairs and Health Decree on the prescription of medicines (1088/2010).
- For technological reasons, prescriptions requiring a patient-specific special permit should primarily be issued as written prescriptions. However, if the prescription related to the special permit application has been issued electronically, the releasing party may apply for the special permit based on an electronic prescription (incl. narcotic and PKV medicinal products). A patient-specific special permit is specific to a prescription, and a prescription related to a special permit may be valid for a maximum of one year. A copy of the written or electronic prescription must be attached to the special permit application submitted to Fimea.
- An institutional special permit pertains to several users of the medicine within the institution without the need to list the individual users. When applying for an institutional special permit, you do not need to attach the order for a medicinal product or the prescription to the application.
- A special permit may also be granted to an individual physician for the purpose of practising the profession (pro auctore). In that case, the corresponding pro auctore prescription must be attached to the application for a special permit.
- If Fimea has on its own initiative granted 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 products subject to a fixed-term special permit. The prescription may be valid up to one year.
A special permit granted by Fimea is not a statement on the necessity of the treatment or the therapeutic value of the medicinal product. The responsibility lies with the attending physician.