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Clinical nutritional preparation

These instructions apply when the following is sought for a clinical nutritional preparation:

  • reimbursement status and a reasonable wholesale price for the first time (new product, new dosage form or new package size/package type)
  • extension of reimbursement status
  • renewal of reimbursement status and wholesale price
  • increase in the wholesale price used as a basis for reimbursement.

When a renewal application is prepared, particular attention must be paid to the changes that have taken place during the period of validity of the current decision.

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 volumes and number of patients
    • information on prices and reimbursement statuses in EEA states
    • product specification
    • any other information (such as sources, other information required by the Pharmaceuticals Pricing Board in the previous decision).
  • In the application memorandum, report the following:
    • table of contents and list of sources of the application
    • a summary of the grounds for product reimbursement status and the proposed reasonable wholesale price
    • statement of the intended use of the product
    • statement of the therapeutic value of the product in the proposed disease specified in the Government decree
    • statement of costs
    • basis for sales and patient number estimates.
  • Name the files as follows:
    • Application memorandum
    • Sales data and number of patients
    • Prices in EEA states
    • Product specification
    • Name other attachments appropriately, for example: Source_Lastname_Year.

Therapeutic value

  • Present a statement of the therapeutic value of the product in the proposed disease specified in the Government decree.
    • Note that clinical nutritional preparations are reimbursable when they are used in the treatment of a severe disease to replace or supplement a diet or part of it. Provisions on diseases in the treatment of which 40 % or 65 % of the costs of clinical nutritional preparations are reimbursed are laid down in a Government decree.

Sales and number of patients

  • Estimate the future sales of the product at the proposed wholesale price per package and as total sales. Estimate the number of patients using the product. The sales forecast concerns the sales reimbursed under the Health Insurance Act and must be provided for the current year and the three years following it.
  • In a renewal and extension application, include the sales estimates given in the previous applications as well as the actual sales during the period of validity of the decision and in the current year per package and as total sales of the product.
  • If the actual sales volumes differ significantly from the estimate given in the previous application, state the reasons for this difference and refer to a notification of exceeding sales submitted to the Pharmaceuticals Pricing Board.
  • Report the sales volume 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

  • List any other trade names of the medicinal product used in other EEA states.
  • State the existing wholesale prices in euros, using the exchange rates valid at the time of submitting the application. Give wholesale prices (pharmacies’ purchase prices). Do not give ex factory prices. Also provide this information for packages that are not sold in the Finnish market.
  • Give an explanation for the absence of prices in EEA states if no price information is provided.
  • State if the product is reimbursed in other EEA states and if the reimbursement status is general or patient specific. Also give any restrictions and conditions for reimbursement.
  • 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)
    • list of sources and sources in logical order (for example, alphabetically)
    • detailed specification of the research, product development and manufacturing expenses for the product if you wish to refer to them.
  • If you are submitting a renewal application, attach to the application any other specifications required by the Pharmaceuticals Pricing Board in its previous decision.
  • When applying for an increase in the approved reasonable wholesale price, in addition to the aforementioned attachments, submit a detailed and reasoned proposal for a new reasonable wholesale price and details of the permanent changes in the factors affecting the price formation of the product during the validity of the wholesale price. Explain how the price increase would change sales estimates, for example.

This page was updated on 25 March 2026.