Distribution, Manufacturing and Inspection

Annual calculation of medicinal product prices

HALMED carries out the procedure of annual calculation of maximum permitted wholesale prices of medicinal products for packs of approved prescription medicinal products that have been placed on the market in the Republic of Croatia before the beginning of the annual calculation, i.e. that have a set maximum permitted wholesale price. The annual calculation of medicinal product prices starts on the first working Monday in February, and the notice on the date of commencement of the annual calculation is published on HALMED’s website.

The method HALMED uses to set the maximum permitted wholesale price of a medicinal product in the annual calculation procedure is as follows:

  1. The maximum permitted wholesale price of a medicinal product is calculated following the guidelines described in the section Maximum permitted wholesale prices of medicinal products and exceptional price increases. When the average comparative wholesale price of a medicinal product is used as a criterion for setting the maximum permitted wholesale price, the sources set out in Article 7 of the Ordinance on the criteria for setting maximum permitted wholesale prices of medicinal products and exceptional increase in the maximum permitted wholesale prices of medicinal products and the annual calculation of medicinal product prices (OG 33/19; hereinafter referred to as the Ordinance) shall be used, namely the one applicable on 1 January of the year when the calculation is performed. The conversion of foreign currencies into HRK, regardless of the criterion used to set the price, is performed using the average exchange rate for HRK of the Croatian National Bank ruling on 1 January of the current year. For medicinal products for which the average comparative wholesale price cannot be set, and the current maximum permitted wholesale price does not exist, the marketing authorization holder or wholesaler with a parallel import/marketing authorization must submit to HALMED the data and documents required to set the maximum permitted wholesale price of the medicinal product in question in accordance with the applicable criterion. If the wholesale medicinal product price criterion is applied in other European Union/European Economic Area countries as well, the table "Proposed calculation of the maximum permitted wholesale price of a medicinal product based on its wholesale prices in other EU countries” shall be completed and submitted, namely for at least three EU/EEA countries, and so shall copies of sources demonstrating the type, structure, and amount pertaining to the price of the medicinal product in question in each Member State of the European Union or country of the European Economic Area (printed website, electronic version, etc.). If the criterion of a reasoned price proposal based on the manufacturer’s price of the medicinal product is applied, the table "Reasoned wholesale price proposal based on the manufacturer’s price of the medicinal product” shall be completed and submitted along with a statement of the marketing authorization holder or the wholesaler with a parallel import/marketing authorization, namely attesting to the fact that the price of the medicinal product is not available in at least three Member States of the European Union or countries of the European Economic Area. Additional instructions for completing the said tables for the calculation of medicinal product prices are available in the Download Centre below.
  2. The maximum permitted wholesale price of a medicinal product calculated as described above is compared to the existing maximum permitted wholesale price. If the existing maximum permitted wholesale price of a medicinal product is higher than the maximum permitted wholesale price of that medicinal product calculated in the annual calculation procedure, the price shall be reduced to the maximum permitted wholesale price of the medicinal product calculated in the annual calculation procedure. If the existing maximum permitted wholesale price of a medicinal product is equal to or lower than the maximum permitted wholesale price of that medicinal product calculated in the annual calculation procedure, the price shall not change, and it shall be viewed as the price calculated in the annual calculation procedure.

Within 40 days of the date of commencement of the annual calculation, HALMED will inform marketing authorization holders of the maximum permitted wholesale price amount for the medicinal product calculated in the annual calculation procedure.

Should they hold that the price of a medicinal product has not been calculated in accordance with the provisions of the Ordinance, the marketing authorization holder or the wholesaler with a parallel import/marketing authorization may request its harmonization within 15 days of the date of notice of the calculation of the maximum permitted medicinal product price. The proposal for harmonization of the maximum permitted wholesale price of a medicinal product shall be submitted to HALMED by means of the form published on HALMED’s website. The form in question shall be completed for each marketing authorization holder or wholesaler with an authorization for parallel import/marketing of the medicinal product separately, and the list of medicinal product packs for which price harmonization is requested must be provided. The completed form shall be printed on the company’s headed paper, signed, stamped, and, along with any related attachments, delivered in person to the HALMED clerk’s office or to the following address by post: Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, 10 000 Zagreb, Republic of Croatia. HALMED encourages the applicants requesting price harmonization to submit their price calculation in support of the proposed maximum permitted wholesale medicinal product price amount using the appropriate Excel table for the calculation of the price of a medicinal product with regard to the criterion used to set the price, namely in writing and electronically. The electronic version of the completed Excel spreadsheet for the calculation of the price of a medicinal product shall be delivered to the following e-mail address: cijene.lijekova@halmed.hr. Additional instructions for completing the said tables for the calculation of medicinal product prices are available in the Download Centre below.

If the marketing authorization holder or the wholesaler with a parallel import/marketing authorization does not request the harmonization of the maximum permitted wholesale price of the medicinal product, they shall be deemed to have agreed with the price set by HALMED in the annual calculation procedure.

If, in the process of harmonizing the price of a medicinal product, no agreement is reached between HALMED and the marketing authorization holder or the wholesaler with a parallel import/marketing authorization, HALMED shall issue a decision in accordance with Article 189 of the Medical Products Act.

Maintaining the maximum permitted wholesale price of a medicinal product set in the previous annual calculation procedure for wholesale medicinal product prices is considered to be an exceptional increase in the maximum permitted wholesale price of a medicinal product, and it shall be requested by submitting an application in accordance with the instructions referred to in the section Submission of documentation for setting the price of a medicinal product.

The procedure of annual calculation of maximum permitted wholesale prices shall last a maximum of 100 days and end with the publication of prices on HALMED’s website.

The maximum permitted wholesale price of a medicinal product set in the annual calculation procedure shall take effect on the sixtieth day of the date the prices are published on HALMED’s website.

The annual calculations completed so far are available in the Medicinal Product Price Lists section.

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