Basic ointment
These instructions apply when
- reimbursement status and a reasonable wholesale price are sought for a basic ointment for the first time
- renewal of reimbursement status and wholesale price are sought for a basic ointment
- an increase in the wholesale price used as a basis for reimbursement is sought for a basic ointment
Basic ointments can be reimbursed when used for treating a chronic skin disease. When a renewal application is prepared, particular attention should 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
- product specification
- statement of therapeutic value in the treatment of a chronic skin disease
- statement of costs and economic value
- sales volumes and number of patients
- information on prices and reimbursement statuses in EEA states
- any other specifications
- list of sources and sources.
- In the application memorandum, report the following:
- statement of therapeutic value in the treatment of a chronic skin disease
- in the case of a renewal application, statement of changes in the therapeutic value of the product
- statement of the costs and economic value of the treatment
- basis for sales and patient number estimates.
- statement of therapeutic value in the treatment of a chronic skin disease
- Name the files as follows:
- Application memorandum
- Sales data and number of patients
- Prices in EEA states
- Product specification
- List of sources
- Name other attachments appropriately, for example: Source_Lastname_Year.
Therapeutic value
- Describe the role of the ingredients present in the basic ointment if the product is a new basic ointment.
- If the basic ointment contains a new ingredient that is not present in the reimbursable basic ointments, detail the following:
- properties of the new ingredient, such as its therapeutic effect, allergenic properties and any other adverse reactions relevant to the therapeutic value of the basic ointment
- summary of the studies made with the basic ointment in the treatment of a chronic skin disease. Attach the research publications to the application.
- Present a specification of the benefits of reimbursement status compared with other products and treatments used for treating the same disease.
- Describe the treatment of a chronic skin disease in the current situation and attach any treatment recommendations to the application.
- Describe how patients benefit from the product.
- If you are submitting a renewal application, describe any changes in treatment practices and treatment options.
Costs and economic value
- Compare wholesale treatment costs with other reimbursable basic ointments.
Sales and number of patients
- Estimate the future sales of the product at the proposed wholesale price and retail price including VAT per package and as total sales. Estimate the number of patients using 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.
- If you are applying for renewal of reimbursement status and wholesale price, 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.
- 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
- 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 on packages that are not sold in the Finnish market. If no price information for EEA states is given, an appropriate explanation for the absence of prices must be 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.)
- 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 the 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.
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 26 March 2026.