Applying for a special permit – Information for prescribers
In outpatient care, the prescriber gives the application for a special permit and any attachments to the patient who takes them to the pharmacy of their choosing. In Finland, generic substitution is not allowed for unauthorised medicinal products. The prescription (and the application) must indicate the trade name of the product. The prescription may be valid for a maximum of one year. In the application for a special permit, the quantity of the medicine applied to be released for consumption must correspond the quantity indicated in the prescription, not exceeding the amount required for one year of treatment.
Account of special therapeutic reasons
The use of medicinal products that have been granted a marketing authorisation is always the primary option in patients' pharmacotherapy. The physician prescribing products subject to a special permit for compassionate use is required to supplement the special permit application with an account of the special therapeutic reasons for choosing the product concerned and why no products with a marketing authorisation can be used. The account must substantiate that the case is exceptional and that no other treatments are appropriate or yield the desired effect.
Special therapeutic reasons refer to medical grounds. A special permit is not solution to the cost of a product, and the higher price of an authorised medicinal product or the absence of generic substitution are not acceptable grounds for a special permit.
A condition for prescribing an authorised medicinal product or the absence of an official therapeutic indication are not acceptable reasons as referred to in the law. In Finland, unauthorised medicinal products do not have any therapeutic indications approved by authorities.
Physician’s responsibility
The physician treating the patient is responsible for the treatment they prescribe. A special permit granted by Fimea is not a statement on the necessity of the treatment or the therapeutic value of the product. An authorised medicinal product is always the preferred option.
When applying for a special permit, it should be noted that the medicinal product in question has no marketing authorisation in Finland. In some cases, the product may be still in the development stage, or its marketing authorisation may have been revoked in Finland. This may be due to a lack of efficacy, safety or quality, or a changed perception of the therapeutic value and necessity of the product.
When prescribing an unauthorised medicinal product, the physician must take into account that no national translation approved by the authorities is available of the summary of product characteristics or the package leaflet. The prescriber of the medicinal product must ensure that the user of the product receives sufficient information on the correct and safe use of the product.
When considering an individual treatment plan involving a medicinal product subject to a special permit, the physician should update their knowledge of the product concerned as applicable.
When an unauthorised medicinal product is prescribed, it must also be considered how the continuity of pharmacotherapy can be ensured after the expiry of the special permit. A special permit subject to application is valid for one year, after which the preconditions for granting the permit may not necessarily be valid if, for example, other authorised products become available.
Prescriptions
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).
In Finland, generic substitution is not allowed for unauthorised medicinal products. The prescription (and the application) must indicate the trade name of the product. The prescription may be valid for a maximum of one year. In the application for a special permit, the quantity of the medicine applied to be released for consumption must correspond the quantity indicated in the prescription, not exceeding the amount required for one year of treatment.
- Medicinal products that require a special permit are not included in the Pharmaceutical Database (excluding medicinal products released for consumption under a fixed-term special permit).
- 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).
- Narcotics must be prescribed in writing using a confirmed narcotics prescription form.
- In exceptional situations where the use of a telephone prescription is justified, the legislative amendment restricting their period of validity must be taken into account. As of 1 January 2024, telephone prescriptions may be valid for a maximum of three months.
- European prescriptions are not possible.
- You do not have to attach an order for a medicinal product or a prescription to an application for an institutional permit submitted to Fimea.
- Pro auctore prescriptions are approved as an attachment to a pro auctore application.
E-prescriptions can always be used for medicinal products that have a fixed-term special permit Fimea has granted on its own initiative. The prescription may be valid up to one year.
The form and instructions
In outpatient care, the prescriber gives the application for a special permit and any attachments to the patient who takes them to the pharmacy of their choosing.
The party releasing the medicinal product into consumption is the applicant for a special permit (a pharmacy, hospital pharmacy, pharmaceutical wholesaler, medicinal product manufacturer). The user of the medicinal product and the physician who completed the application must take into account that they cannot send the form to Fimea themselves.
You can complete and sign the special permit application form electronically.
Special permit application form (pdf) (in Finnish)
Instructions for filling the special permit application form (pdf) (in Finnish)