Medicines that require special permit
As a general rule, medicines sold in Finland have marketing authorisation issued by the marketing authorisation authority.
There can be situations where there are no medicines with marketing authorisation available for treatment of an illness or where the medicines with marketing authorisation do not yield the desired effect. In such a case, your doctor may prescribe you a medicine which requires a special permit from the Finnish Medicines Agency (Fimea).
Search for medicines requiring a special permit (fimea.fi)
Read more about special permits (fimea.fi)
How to get a medicine with a special permit
- The doctor prescribes a medicine available with a special permit for you.
- Visit the pharmacy from which you wish to buy the medicine in the future. The pharmacy in question applies for a special permit from the Finnish Medicines Agency (Fimea).
- The processing time for the application is approximately 30 days. When necessary, the application can also be processed as urgent.
- You will have to pay a fee for the processing of the application for a special permit. Kela does not reimburse the costs related to the application for a special permit.
- If Fimea grants a special permit, you can buy the medicine while the prescription is valid only from the pharmacy that applied for the special permit.
You can get a special permit for up to one year at a time. If the treatment continues for a longer period, you need a new prescription and a new special permit.
Reimbursement status of medicines requiring a special permit
A medicine with a special permit is reimbursable when the confirmed reimbursement status of the medicine is in force. In addition, the sales price of the medicine must not exceed the maximum reimbursable price. The reimbursement status is confirmed by the Pharmaceuticals Pricing Board (Hila).
You can check reimbursability and the maximum reimbursable price in the following list maintained by Kela: Reimbursable medicine dispensed with a special permit (PDF, in Finnish)
f a patient-specific medicine with a special permit is not included in the list maintained by Kela or its reimbursement status has expired, you can apply to Hila for reimbursement status for the medicine (hila.fi). You can also ask a pharmacy to apply for reimbursement status on your behalf.
If Hila confirms a special rate of reimbursement for a medicine, or imposes restrictions on its reimbursement status, so that reimbursement at a basic or special rate is only provided for a specific use, you need a right to reimbursement granted by Kela to get a reimbursement.
Hila processes the application and evaluates whether the medicine can be approved for reimbursement status. The evaluation takes into account the price and therapeutic value of the medicine.
If Hila confirms a reimbursement status for a medicine requiring a special permit, the reimbursement status will take effect in accordance with Hila’s decision. The reimbursement status can also enter into force retroactively.
Hila’s decisions on reimbursement status are always fixed-term. The reimbursement status expires at the end of the fixed term unless an application has been made for an extension.
You will have to pay a fee for the processing of the application for a special permit. Kela does not reimburse the costs of an application for a special permit.
If you buy a medicine with a special permit without reimbursement, ask the pharmacy for a statement about your purchase of medicine. You may need the statement if the medicine is granted reimbursement status retroactively and you want to claim retroactive reimbursement from Kela.
You can check when the reimbursement status entered into force in the following list maintained by Kela: Reimbursable medicine dispensed with a special permit (PDF, in Finnish).