Highest permitted wholesale price of a medicinal product and exceptional increase of the price

The highest permitted wholesale price of a medicinal product shall be calculated for each strength, dosage form and packaging of the medicinal product, and shall be determined by HALMED based on the request of the marketing authorisation holder or a wholesaler with an authorisation for the parallel import/entry of the medicinal product (for medicinal product packaging intended to be marketed for the first time in the Republic of Croatia) or ex officio in the annual medicinal product price calculation process (for packaging of medicinal products already in distribution in the Republic of Croatia).

The criteria for determining the highest permitted wholesale price of a medicinal product, regulated by the Ordinance on the criteria for determining the highest permitted wholesale price of a medicinal product, the exceptional increase in the maximum permitted wholesale price of a medicinal product and the annually calculated price of a medicinal product and Ordinance on amendments to the Ordinance on the criteria for determining the highest permitted wholesale price of a medicinal product, the exceptional increase in the maximum permitted wholesale price of a medicinal product and the annually calculated price of a medicinal product (Official Gazette, No. 33/19 , 72/23) (hereinafter: Ordinance), are as follows:

the average comparative wholesale price of a medicinal product (comparative wholesale price of a medicinal product)
the valid highest permitted wholesale price of a medicinal product
the wholesale price of a medicinal product in other countries of the European Union / European Economic Area
the substantiated price proposal for a medicinal product based on the manufacturer’s price of the medicinal product.

The criteria shall be applied successively in the order listed above, and the following criterion shall be considered provided that none of the previous criteria is applicable.

The average comparative price of a medicinal product is the basic criterion for determining the highest permitted wholesale price of a medicinal product, and shall be calculated in accordance with the provisions of the Ordinance, following the guidelines set out in the document "Instructions for Applicants — Calculation of the Average Comparative Wholesale Price of a Medicinal Product”, which can be found below in the Download Centre (available in Croatian).

Where an average comparative wholesale price cannot be calculated for a medicinal product for which a highest permitted wholesale price is being determined, HALMED shall set the highest permitted price of the medicinal product based on the valid highest permitted price of that medicinal product and, should such a price not exist, the wholesale prices of the medicinal product in question (the medicinal product of the same manufacturer) in at least three Member States of the European Union or the European Economic Area shall be taken into account.

Furthermore, where the price of the medicinal product is not available in at least three EU or EEA Member States, HALMED shall set the highest permitted wholesale price of the medicinal product by considering a substantiated price proposal based on the manufacturer's price.

Where the medicinal product meets one of the defined criteria related to the optimum supply of medicinal products necessary for the provision of health care to the population, and the set highest permitted wholesale price is not sufficient to ensure the supply of the Croatian market with the medicinal product in question, the marketing authorisation holder may request an exceptional increase of the highest permitted wholesale price of the medicinal product.

An exceptional increase of the highest permitted wholesale price of a medicinal product may be requested only for a medicinal product that meets at least one of the following criteria:

the medicinal product is intended for use in exceptional circumstances, emergencies and critical situations
the medicinal product is an orphan medicinal product
the medicinal product is in the interest of public health
there are no therapeutic alternatives to the medicinal product (there is no medicinal product with the same authorised indication in distribution in the Republic of Croatia or such a medicinal product is not authorised in the Republic of Croatia)
the medicinal product contains a specific active substance (there is no medicinal product with the same active substance in distribution in the Republic of Croatia or such a medicinal product is not authorised in the Republic of Croatia)
the medicinal product has a specific formulation and/or administration route and/or strength
another criterion related to the optimum supply of the medicinal product to the population.

Along with the request for an exceptional increase of the highest permitted wholesale price of a medicinal product, an overview of the price of the medicinal product based on the manufacturer's price shall be submitted, as well as an explanation of why the set highest permitted wholesale price is not sufficient to ensure the supply of the Croatian market with the medicinal product in question.

HALMED shall decide on an exceptional increase of the highest permitted wholesale price of a medicinal product with the prior consent of the minister in charge of health.

Where the marketing authorisation holder is not granted an exceptional increase of the highest permitted price of a medicinal product, HALMED will not publish the highest permitted wholesale price of that medicinal product without the prior consent of the marketing authorisation holder.