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Authorised medicinal product – renewal

These instructions apply when the marketing authorisation holder applies renewal of reimbursement status and wholesale price for an original product. Reimbursement status is applied to the same extent as has previously been approved for the product. When a renewal application is prepared, particular attention should be paid to changes that have taken place during the period of validity of the current decision.

If you are applying for different reimbursement statuses for different packages of the same medicinal product and/or their therapeutic indications differ from each other, the indications and the reimbursement status you are applying for must be separately detailed for each package.

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:
    • valid summary of product characteristics
    • valid marketing authorisation decision (if the marketing authorisation was granted in a centralised authorisation procedure, also attach the information published by the European Medicines Agency on the different product packages and their marketing authorisation numbers)
    • information on the therapeutic value
    • information on the costs and economic value
    • market forecast
    • sales information and number of patients
    • information on prices and reimbursement statuses in EEA states
    • specifications required by the Pharmaceuticals Pricing Board in its previous decision
    • other information the applicant considers necessary
    • list of sources and sources
  • In the application memorandum, report the following
    • changes relevant to the product’s therapeutic value
    • information on the costs and economic value of medicinal treatment
    • basis for the market forecast and the estimates of sales volumes and patient numbers
    • summary of prices in EEA states and changes in them
    • specifications required by the Pharmaceuticals Pricing Board in its previous decision
  • Name the files as follows:
    • Application memorandum
    • Summary of product characteristics
    • Marketing authorisation decision
    • Sales data and number of patients
    • Market forecast
    • Prices in EEA states
    • List of sources
    • Name other attachments appropriately, for example: Source_Lastname_Year

Therapeutic value

  • Describe the therapeutic indications for which reimbursement status is applied.
  • Provide information on changes in the preconditions for reimbursement status and the product’s relative effectiveness during the current decision’s period of validity. Among other things, report
    • changes in the summary of product characteristics and a reference to a notification of change in the summary of product characteristics submitted to the Pharmaceuticals Pricing Board
    • new research-based evidence of the effectiveness and/or safety of the product relevant to the therapeutic indication for which reimbursement status is applied (research publications attached)
    • changes in treatment practices, such as updated treatment guidelines
    • changes in treatment options
    • changes in the benefits of the medicinal product compared to other medicinal products used for treating the same disease and other treatments

Costs and economic value

  • Provide a statement of the average daily dosage and the resulting medicinal treatment costs calculated on the basis of the proposed wholesale price and retail price including VAT for the therapeutic indication for which reimbursement status is applied.
  • Compare treatment costs to other reimbursed products used for treating the same disease in the market based on the treatment dosages given in the summaries of product characteristics.
  • Provide a summary of changes associated with the product’s costs and economic value during the period of validity of the current decision.
  • A health economic evaluation must be included in renewal application whenever the Pharmaceuticals Pricing Board has requested one in its previous decision. A health economic evaluation may be included in the application in other cases too, if the applicant considers it necessary. Prepare a health economic evaluation in accordance with the instructions published on the Pharmaceuticals Pricing Board’s website.

Market forecast

  • Describe the group of medicinal products with similar therapeutic indications within which the medicinal product will be marketed, what similar products there already are within the group, how the use of medicinal products is expected to change within the group, and what changes are expected to take place in the market situation.
  • Provide a forecast of the total sales of the group of medicinal products using retail prices including VAT and the shares of the product/products in total sales in euros and percentages for the current year and the four years following it.
  • Submit the market forecast using the pre-formatted tables available on the website of the Pharmaceuticals Pricing Board.

Sales and number of patients

  • Include the sales estimates given in the previous application and actual sales over the validity period of the previous decision and the current year per package and as total sales of the product.
  • If the actual sales deviate significantly from the estimate given in the previous application, give explanation on the deviation and refer to the notification of exceeding the sales estimates submitted to the Pharmaceuticals Pricing Board.
  • Estimate the sales of the product based on the proposed wholesale price and retail price including VAT per package and as total sales. Estimate the number of patients expected to use the product. The estimate must be based on sales reimbursed under the Health Insurance Act and cover the current year and the four years following it.
  • 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

  • List 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. If no wholesale prices are available, give the ex factory prices of the packages. Also provide this information for packages that are not sold in the Finnish market.
  • State if the product is reimbursed in other EEA states and if the reimbursement status is general or patient specific. Also give information on the 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 information

  • When an application concerns a product with confirmed conditional reimbursement status and the applicant proposes a continuation of the conditional reimbursement status, the application must include the ordinary application documents and a separate document containing a proposal for conditional reimbursement. The Pharmaceuticals Pricing Board has issued instructions on the procedure for conditional reimbursement status on its website (Other instructions).
  • Attach any other specifications required by the Pharmaceuticals Pricing Board in its previous decision to the application.
  • Attach any other information the applicant considers necessary, such as
    • an expert opinion that must clearly state the expert’s conflicts of interest (see instructions on the website of the Pharmaceuticals Pricing Board for drawing up an expert opinion and example of declaration of interests)
    • itemised specification of the medicinal product’s research, product development and production costs to the extent that the applicant wishes to appeal to them.

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 alphabetically. 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.