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Non-registered medicinal product subject to special licence – applicant: private person

These instructions apply when a patient or a pharmacy on behalf of the patient applies for reimbursement status for a medicinal product subject to special licence.

In order the reimbursement specified in the Health Insurance Act (1224/2004) can be paid for the medicinal product, the product must have valid reimbursement status and a wholesale price approved by the Pharmaceuticals Pricing Board. Decisions by the Pharmaceuticals Pricing Board on reimbursement status and wholesale price for a medicinal product subject to special licence are fixed-term in nature.

A patient or a pharmacy on behalf of the patient may apply from the Pharmaceuticals Pricing Board for reimbursement status and a reasonable wholesale price for a medicinal product dispensed subject to a special licence referred to in section 21 f of the Medicines Act (395/1987). If reimbursement status and reasonable wholesale price is applied for by the manufacturer, importer or pharmaceutical wholesaler of the medicinal product subject to special licence, separate instructions are applicable to the application procedure.

Medicinal product subject to special licence does not have any marketing authorisation in Finland granted by the marketing authorisation authority. The Finnish Medicine Agency Fimea may in individual cases, when there is not on the market any product with marketing authorization suitable for the treatment of the patient, grant special licence for the use of such a product on the basis of an application written by a physician. Costs of a medicinal product subject to special licence can only be reimbursed under the health insurance scheme when the Pharmaceuticals Pricing Board has approved reimbursement status and a reasonable wholesale price the product. The Pharmaceuticals Pricing Board processes matters regarding reimbursement status and reasonable wholesale price for medicinal products on the basis of applications. The medicinal product in question must have valid special licence granted by the Finnish Medicines Agency Fimea when the application is submitted to the Pharmaceuticals Pricing Board.

A patient may only apply for basic reimbursement status for a medicinal product subject to special licence. The serious and long-term diseases in regard to which special reimbursement status can be granted for the medicinal products used for treating them are specified by Government Decree. If a product containing the same active pharmaceutical ingredient has or has had special reimbursement status in the treatment of a patient’s disease, granting special reimbursement status for it will be considered on the initiative of the authorities, if necessary. In the application for basic reimbursement status, the applicant may propose that the Pharmaceuticals Pricing Board considers the special reimbursement status of a medicinal product for the treatment of the disease referred to in the Government Decree.

The application consists of an application form and specifications.

Instructions for completing the application form

1. Applicant

The applicant can be a patient or a pharmacy on behalf of the patient.

Fill in the following information about the applicant on the form:

  • the applicant
  • the business identity code of the pharmacy, if the applicant is a pharmacy,
  • a contact person whom the Pharmaceuticals Pricing Board may contact,
  • contact information, and
  • the patient’s name and personal identity code.

2. Medicinal product

Fill in the following medicinal product information on the form:

  • name, strength, pharmaceutical form and package size of the product,
  • active substance and ATC class (based on the classification system for medicinal products; not mandatory information),
  • manufacturer, and
  • wholesaler.

3. Wholesale price

Fill in the following wholesale price information on the form:

  • wholesale price of the product (pharmacy’s purchase price without tax) in euro.

4. Attachments to the application

Tick the specifications that you have attached to the application on the form.
See below for more information on the documents that must be attached to the application.

5. Invoicing details

The fee laid down in the Decree of the Ministry of Social Affairs and Health on the priced services of the Pharmaceuticals Pricing Board are charged for the processing of the application. The fee for a patient-specific application is 30 euros.

The following invoicing details must be provided in the application:

  • name of the person to whom the invoice is sent,
  • invoicing address, and
  • telephone number of the person responsible for the invoice.

6. Signature

The application must be dated and signed.

Specifications

The following documents must be attached to the application for reimbursement status and a reasonable wholesale price of a medicinal product subject to special licence:

  • Copy of the application for special licence
    • A copy of the application for special licence or a medical report attached to the application for a special licence showing the therapeutic indication and the grounds for using the medicinal product subject to special licence.
  • Copy of the special licence
    • A copy of the valid special licence granted by the Finnish Medicines Agency Fimea.
  • Copy of the prescription
  • Other specifications
    • Other documents considered necessary by the applicant, such as:
      • medical record,
      • more extensive medical report,
      • summary of product characteristics approved for the product in another country, or
      • publications describing studies performed with the product.
    • If the applicant is a pharmacy that itself imports the product, the application must include a specifications and calculation of the factors affecting the price formation of the product.

Submitting the application

The application and its attachments to it must be submitted to the Pharmaceuticals Pricing Board

Pharmaceuticals Pricing Board
PO Box 33, 00023 Government, Finland

This page was updated on 25 March 2026.