Concepts related to quarterly notifications submitted by pharmaceutical companies
A medicinal product placed on the market by the developer of the active substance or a party authorised by the developer.
A medicinal product whose active substance is produced from organisms or living cells or isolated from a biological source. In terms of their structure, biologics are proteins, such as hormones, growth factors or antibodies.
A biological medicinal product that is put on the market after the patent protection and data exclusivity period of the original product has expired. The product contains a new version of the active substance present in the original product, and it has been developed to be similar to and comparable with the original product.
The Finnish Medicines Agency. A central agency that operates under the Ministry of Social Affairs and Health as the Finnish licensing and supervisory authority for the pharmaceutical industry (e.g. for marketing authorisations). Fimea maintains a list of substitutable medicinal products (fimea.fi).
The Pharmaceuticals Pricing Board. An authority that operates in connection with the Ministry of Affairs and Health and confirms reimbursability and maximum wholesale prices for medicinal products. The Pharmaceuticals Pricing Board also sets reference prices for the medicinal products included in the reference price system four times a year (hila.fi).
A medicinal product for which a quarterly notification must be submitted to Kela. The price notification procedure applies to products included in generic substitution and the reference price system as well as products undergoing a transition period. Check the lists published by the Pharmaceuticals Pricing Board to see which products are subject to the price notification procedure (hila.fi, in Finnish).
See E-service for pharmaceutical companies.
The upper limit set for a price corridor. If the price of a product exceeds the upper limit, the pharmacy must substitute it with a less expensive substitutable product. The upper limit is calculated by adding EUR 0.50 to the VAT-inclusive retail price of the least expensive product in a group of interchangeable products.
If a reference price group is established in addition to the price corridor, the upper limit will be calculated by adding EUR 0.50 to the VAT-inclusive retail price of the least expensive reimbursable product in the group. Products whose prices do not exceed the upper limit of the price corridor are included in the same price corridor.
Kela establishes the upper limit of each price corridor four times a year based on the prices disclosed by pharmaceutical companies to Kela in their notifications. Only products that are generally available can be taken into account when setting the upper limit.
See also Reference price.
An online search portal that provides access to up-to-date information on the prices of medicinal products and their reimbursement status and on which products are interchangeable. The service is based on the data content of the Pharmaceutical Database. Go to the Medicinal Products Database.
A service provided on the website of the Kanta Services that contains up-to-date data on medicinal products available on the market in Finland. Doctors and pharmacies use the product data stored in the Pharmaceutical Database when prescribing and dispensing medicines. Pharmaca Health Intelligence Oy provides technical maintenance for the Pharmaceutical Database.
Substitution of a medicine with a less expensive one at the pharmacy. The aim of generic substitution is to increase the use of less expensive medicines and reduce the medicine expenses for the customers and for society at large. The system for generic substitution was introduced in 2003.
A medicinal product for which equivalent interchangeable products exist. See also Substitutable products.
An e-service maintained by Kela that pharmaceutical companies can use to submit quarterly notifications. The e-service can be accessed with Suomi.fi identification, and it can only be used by pharmaceutical companies with a Finnish business ID (Y-tunnus). The service is only available in Finnish and Swedish.
A price notification regarding a product that is subject to the price notification process for generic substitution and the reference price system. Pharmaceutical companies submit price notifications to Kela, and Kela then forwards them to the Pharmaceuticals Pricing Board. The data disclosed in the price notifications are used by Kela to establish price corridors and by the Pharmaceuticals Pricing Board to establish reference prices.
An original product that a parallel distribution company repackages and imports to Finland. Before the product can be put on the market in Finland, the company must file a parallel distribution notice regarding the product with the European Medicines Agency.
An original product that a parallel import company purchases from another EU or EEA country and then repackages and imports to Finland. Before the product can be put on the market in Finland, the company must apply for a marketing authorisation for the product with Fimea.
A medicinal product that is put on the market after the patent protection and data exclusivity period of the original product has expired. The product contains the same amount of the same active substance as the original product, but it may, for example, contain different excipients.
A medicinal product that has previously been included in a reference price group. Products undergoing a transition period are subject to the price notification process, which means that a quarterly notification for the product must be submitted to Kela. Read more about the termination of a reference price group and the transition period (hila.fi).
A group of interchangeable medicinal products as defined by Fimea. Products in the same substitution group contain equal amounts of the same active substance or of a different version of the same active substance. All pack sizes of the same product are included in the same group. See Fimea’s list of substitutable medicinal products to check the substitution group of individual medicinal products (fimea.fi).
A code used to identify a group of interchangeable medicinal product packs of the same size. The same code is used both in generic substitution and in the reference price system. Kela and the Pharmaceuticals Pricing Board are responsible for establishing the groups. Read more about the grouping of medicinal products.
The upper limit established for a price corridor when no interchangeable product packs of the same size are generally available for the entire duration of the upcoming quarter. This ensures that the pharmacy can include these products in the substitution process when they are available. The same formula is used to calculate both the upper limit and the technical upper limit of a price corridor. See also Upper limit of a price corridor.
Bioequivalent medicinal products that contain the same amount of the same active substance. Read more about the criteria for substitution (fimea.fi).
The highest price determined by the Pharmaceuticals Pricing Board based on the basis of which a reimbursement can be calculated. The reference price is calculated by adding EUR 0.50 to the VAT-inclusive retail price of the least expensive reimbursable medicinal product in the reference price group.
The Pharmaceuticals Pricing Board establishes reference prices for each reference price group four times year based on the prices disclosed by the pharmaceutical companies (hila.fi). Only products that are generally available can be taken into account when establishing the reference prices.
The upper limit set by Kela for each price corridor and the reference price set by the Pharmaceuticals Pricing Board are the same because they are both calculated with the same formula. See also Upper limit of a price corridor and Reference price group.
A system established to curb growth in the expenditure on medicine reimbursement and to promote the use of the least expensive substitutable products. The reference price system applies to reimbursable medicinal products that are included in generic substitution. The reference price system was introduced 2009. More information about the reference price system (hila.fi).
A group comprised of interchangeable medicinal product packs of the same size that includes at least two reimbursable products and where at least one of these two products is a generic, parallel import or parallel distribution product or a biosimilar. The Pharmaceuticals Pricing Board confirms the reference price groups four times a year (hila.fi, in Finnish).