Applying for a special permit – Information for prescribers
Instructions for the use of the electronic services (in Finnish)
The ERKKA special permit system allows the person prescribing a medication to prepare a special permit application in the e-service. The pharmacy, hospital pharmacy or pharmaceutical wholesaler that releases the product for consumption processes the same electronic special permit application in the e-service and sends the completed application to Fimea for electronic processing. The transparency of the processing of applications will increase when the status of the processing of an electronic application can be monitored directly in e-services.
A patient-specific application is always prepared by a physician or dentist. They prepare an electronic application with grounds for why a medicinal product subject to a special permit is needed for the treatment of the patient.
A institution-specific application for a special permit can be prepared by a physician or dentist, for the use of a medicine with a special permit in the treating unit or operating area. A person authorised to apply for special permits may prepare an institution-specific special permit application for a physician or dentist who will then supplement the medical justification for the application and approve the application.
Logging in to the e-service begins with user identification. Users are identified with strong identification using the suomi.fi service. The user can choose their method of identification, and use e.g. a certificate card, personal online banking codes or a mobile certificate. A person acting in the role of a physician or dentist does not need a mandate to access e-services.
If digitalised application is not possible for some reason, you can apply for a special permit using the old form. Switching to e-services is recommended as soon as possible. A PDF form and instructions for filling in the form can be found at the bottom of the page. If the medicine is intended for 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 user of the medicinal product and the physician who completed the application must take into account that they cannot send the form to Fimea for processing themselves. 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
In Finland, 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, the package leaflet or the medicine package. 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 in Finland, 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 in Finland.
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).
Pharmaceutical substitution is not possible in Finland with unauthorised medicinal products, as the Finnish authority does not assess the foreign medicinal products in question, such as medicinal products subject to marketing authorisation in Finland, in terms of efficacy, safety or quality. 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.
- A special permit may also be granted to an individual physician for the purpose of practising their profession (pro auctore). In that case, a pro auctore that corresponds to a special permit application is drawn up.
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
Fimea recommends that the e-service always be used as the primary form of application. If digitalised application is not possible for some reason, you can apply for a special permit using the old form. 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 for processing 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)