Submission of documentation for determining the price of a medicinal product
Marketing authorisation holders for a medicinal product or wholesalers with a parallel import / distribution authorisation for a medicinal product shall request the determination of the highest permitted wholesale price of the medicinal product for the packaging of the medicinal product they intend to market for the first time in the Republic of Croatia by submitting a request to HALMED for determining the highest permitted wholesale price of a 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 highest permitted wholesale price in question for the packaging that it intends to market and shall inform HALMED thereof.
Furthermore, 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.
Requests and notices in accordance with the provisions of 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 (Official Gazette, No. 33/19 , 72/23; hereinafter: Ordinance) shall be submitted to HALMED via the forms published on the HALMED website. The appropriate form shall be completed separately for each packaging of the medicinal product.
The completed form shall be printed as a memorandum, signed as well as stamped and, together with the accompanying enclosed documentation, delivered in person to the HALMED office or by mail to the following address: Agency for Medicinal Products and Medical Devices, 4 Ksaverska cesta, 10 000, Zagreb, Republic of Croatia.
The manner in which the highest permitted wholesale price of a medicinal product is determined, on the basis of a request received from the marketing authorisation holder or a wholesaler with a parallel import / distribution authorisation for a medicinal product, is described in section Highest permitted wholesale price of a medicinal product and exceptional price increase. HALMED encourages applicants to submit, as a proposal for the calculation of the highest permitted wholesale price of a medicinal product, a completed Excel spreadsheet appropriate for the calculation of the medicinal product price with regard to the criterion used to determine the price, in written and electronic form. An electronic version of the completed Excel spreadsheet for calculating the price of the medicinal product shall be sent to the following e-mail address: cijene.lijekova@halmed.hr. Where the average comparative wholesale price of a medicinal product is used as a criterion for determining the highest permitted wholesale price of the medicinal product, the sources of prices stipulated in Article 7 of the Ordinance shall be used, and their data shall not be older than 30 days on the date of submitting the request. The conversion of foreign currencies into EUR, regardless of the criterion used to determine the price, is performed using the middle exchange rate of the EUR according to the exchange rate list of the Croatian National Bank valid on 1 January of the current year. Additional instructions for applicants for filling in the spreadsheets for calculating the price of a medicinal product are available below in the Download Centre. In the process of determining the highest permitted wholesale price of a medicinal product, HALMED will verify the accuracy of the price calculation proposed by the applicant.
The costs of calculating the highest permitted wholesale price of a medicinal product shall be paid according to the Price list for the Agency’s services.
HALMED shall issue a decision within 30 days of receiving a valid request and, in case of need to supplement the documentation, the deadline shall be extended to 45 days following the receipt of a valid request. Based on the notice of the use of the highest permitted wholesale price of a medicinal product, HALMED will issue a certificate on the determination of the highest permitted wholesale price of the medicinal product within 10 days of its receipt.
Marketing authorisation holders for a medicinal product or wholesalers with a parallel import / distribution authorisation for a medicinal product may send any additional questions related to the determination of the highest permitted wholesale price of a medicinal product to HALMED to the following e-mail address: cijene.lijekova@halmed.hr.
