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

These instructions apply when a company (manufacturer, importer or pharmaceutical wholesaler) 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 manufacturer, importer or a pharmaceutical wholesaler 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). The applicant can also be a patient or a pharmacy on behalf of the patient, in which case separate instructions are applicable to the application procedure. The medicinal product must have valid special licence (patient-specific or temporary) granted by the Finnish Medicines Agency Fimea when the reimbursement status is applied for the product.

See also the general instructions for the application at applying for reimbursement status and reasonable wholesale price.

Application documents

  • Attach the following documents to your application:
    • application memorandum
    • sales data and number of patients
    • information on prices and reimbursement statuses in EEA states
    • summary of product characteristics
    • other information the applicant considers necessary (such as list of sources and sources)
  • Report the following information in the application memorandum:
    • details of special licences and formation of wholesale price
    • statement of the product’s therapeutic value
    • justification for special reimbursement status when applying for it
    • statement of the costs and economic value of medicinal treatment
    • basis for sales and patient number estimates
  • Name the files as follows:
    • Application memorandum
    • Sales data and number of patients
    • Prices in EEA states
    • Summary of product characteristics
    • Name other attachments appropriately, for example: Source_Lastname_Year

Special licences and formation of wholesale price

  • Special licences and formation of wholesale price
    • statement of the number of valid patient-specific special licences granted for the product or information on the temporary special licence
    • specification and calculation of factors affecting the formation of the wholesale price

Therapeutic value

  • summary of product characteristics
    • for instance a summary of product characteristics approved in another country
  • therapeutic indications for which reimbursement status of the medicinal product is being applied
  • statement of the benefits to be achieved with the reimbursement status compared to other medicinal products and treatments used for treating the same disease
    • the applicant may present evidence of how patients benefit from the medicinal product and for which patient groups it is intended
    • a comparison with other medicinal products and/or treatments used for the treatment of the same disease
  • A summary of the product’s indispensability and remedial or replacement effect when applying for special reimbursement status
    • a well-grounded proposal for the necessity of the medicinal product
      • type of the disease
      • why this particular medicinal product needed for the treatment of the chronic and severe disease in question and for which patient group is it needed
    • when 100 per cent is reimbursed for a medicinal product in excess of the product-specific deductible, a specification must be presented on the replacement or remedial effect of the medicinal product.
    • a specification of the medicinal product’s therapeutic value proved in studies and in practice
      • research-based evidence
        • a summary of the findings of clinical studies with the product; publications, reports, assessments, etc. are attached to the application
        • the therapeutic value of the new product is assessed compared to other medicinal products and/or treatments with the same therapeutic indication
      • experience of use
        • information on the extent to which the product is used and experience of use
      • dosage
        • dosage of the medicinal product in the disease or therapeutic indication entitling to special reimbursement status; grounds should be presented if the proposed dosage or way of administration deviates from the information given in the summary of product characteristics or from what is used in the studies attached to the application.
      • treatment recommendations and systematic reviews
        • treatment recommendations and systematic reviews by a reliable, independent source can be used for indicating the therapeutic value if they deal with the product of the application and therapeutic indication in question (such as Current Care Guidelines of Duodecim, NICE and Cochrane)

Costs and economic value

  • statement of the average daily dosage and the resulting cost of medicinal treatment calculated on the basis of the proposed wholesale price and retail price including value added tax
    • most commonly used daily dosage or normal treatment dose
    • the applicant may present a comparison of treatment costs for a period of time essential for the treatment
  • treatment costs for the therapeutic indications being applied for compared to available reimbursable products or treatments for the treatment of the same disease

Health economic evaluation

  • a health economic evaluation can be attached to the application if the applicant considers it necessary
  • the Pharmaceuticals Pricing Board has given further instructions on preparing a health economic evaluation on its website

Sales data and number of patients

  • estimate of the sales of the medicinal product at the proposed wholesale price and a retail price including value added tax, and an estimate of the number of patients expected to use the product
    • present sales estimates for each pharmaceutical form, strength and package as well as by total sales of the product (€)
    • estimates of sales and patient numbers is made for the current year and for the following two years
    • the estimates apply to sales reimbursed under the Health Insurance Act
  • actual sales reimbursed under the Health Insurance Act during the validity period of the decision
    • the sales estimates given in the previous application and the actual sales during the validity period of the decision and in the current year broken down into pharmaceutical form, strength, package and as well as by total sales of the product (€)
    • if the actual sales deviate significantly from those estimated in the previous application, give explanation on the deviation
  • report the sales data and patient numbers using the pre-formatted tables available on the website of the Pharmaceuticals Pricing Board

Prices and reimbursement statuses in other EEA states

  • other trade names of the product in use in other EEA states, valid wholesale prices of the product, reimbursement status of the product and marketing authorizations
    • if wholesale prices, also known as pharmacy purchase prices, are not available, give the ex factory prices of the packages
    • if price information for EEA states is not given, an appropriate explanation for the absence of prices must be included
    • prices must be shown in euros using the exchange rates valid when submitting the application
    • information on packages that are not marketed in Finland must also be given
    • specification on the reimbursement status of the product in the EEA states; specify whether the product is included in the reimbursement system, its reimbursement percentage and the basis for reimbursement
    • present a specification on in which EEA states the product is marketed as a product subject to marketing authorization and in which states subject to special licence
    • report the prices and reimbursement statuses in EEA states using the pre-formatted tables available on the website of the Pharmaceuticals Pricing Board

Other specifications

  • Attach any other specifications you consider necessary to your application, such as
    • an expert opinion, which must clearly state any conflicts of interest (see instructions for preparing an expert opinion and an example of a disclosure form on the website of the Pharmaceuticals Pricing Board)
    • a summary of changes that have taken place during the validity period of the current reimbursement status and reasonable wholesale price; such as information on experience of use, new clinical studies and treatment practices.
    • itemised specification of the medicinal product’s research, product development and production costs to the extent that the applicant wishes to appeal to them
  • If you are submitting a renewal application, attach any other specifications required by the Pharmaceuticals Pricing Board in its previous decision to the application.

List of sources and sources

  • Attach to the application a list containing all the sources referred to in the application. The sources must be presented in a logical order, for instance alphabetical order. If a source publication is extensive, page number, table number or other similar reference should be given.
  • All sources used should be attached to the application.
    • If there is a supplement or an appendix connected with an article, include also the supplementary material.
    • For sources that are only available on the Internet, the precise source reference and hyperlink shall be given. The Internet source must be freely available.

This page was updated on 25 March 2026.