Distribution, Manufacturing and Inspection

Medicinal product pricing system

The Act on Amendments to the Medicinal Products Act (Official Gazette, No. 100/18) has adopted a new pricing system for medicinal products which, in accordance with the marketing authorisation for those medicinal products in the Republic of Croatia, are classified as prescription medicinal products with regard to the method of dispensing.

Within the new pricing system for prescriptt permition medicinal products in the Republic of Croatia, the concept of the highest permitted wholesale price of a medicinal product is introduced and, for exceptional circumstances, the concept of the exceptional increase in the maximum permitted wholesale price of a medicinal product, determined by the Agency for Medicinal Products and Medical Devices (hereinafter: HALMED).

The clear and transparent criteria for determining the wholesale price of a medicinal product, in accordance with the requirements of Directive 89/105/EEC, are laid down in the Ordinance on the criteria for determining the highest permitted wholesale price of a medicinal product and 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), which is available here (in Croatian).

For the packaging of medicinal products intended to be marketed for the first time in the Republic of Croatia, the highest permitted wholesale price of a medicinal product shall be determined based on the request of the marketing authorisation holder for the medicinal product or a wholesaler with an authorisation for the parallel import / entry of the medicinal product. In exceptional circumstances, the request is not required if HALMED has already set the highest permitted price for a medicinal product with the same active substance, strength, dosage form and packaging as the medicinal product intended to be marketed for the first time. In that case, the marketing authorisation holder or wholesaler with a parallel import / distribution authorisation shall use the appropriate highest permitted wholesale price for the packaging in question that it intends to market and shall inform HALMED thereof.

The highest permitted wholesale prices of medicinal products for the packaging of medicinal products already in distribution in the Republic of Croatia shall be periodically regulated through the annual price calculation process carried out by HALMED.

Additionally, in cases related to the optimum supply of medicinal products necessary for the provision of health care, HALMED may, based on the request of the marketing authorisation holder and with the prior consent of the minister in charge of health, allow the exceptional increase in the maximum permitted wholesale price of a medicinal product.

The highest permitted wholesale price of a medicinal product or the exceptionally higher price than the highest permitted wholesale price of a medicinal product is the highest possible price at which wholesalers and marketing authorisation holders may sell a medicinal product, as well as the highest possible price that the Croatian Institute for Health Insurance may determine for a medicinal product in the procedure of being included in its medicinal product reimbursement list or in the procedure of harmonising the prices of medicinal products already on its medicinal product reimbursement list. These procedures of the Institute are regulated by the provisions of the ordinance on the criteria for the inclusion of medicinal products in the reimbursement list of the Croatian Institute for Health Insurance as well as the method of determining the prices of medicinal products to be paid by the Croatian Institute for Health Insurance and the method of reporting on them (Official Gazette, No. 33/19).

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