The procedures for medicinal product pricing are based on provisions of the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 in 66/19) and the provisions of the Rules on the Pricing of Medicinal Products for Human Use (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 32/15, 15/16, 19/18, 11/19, 26/20, 51/21 in 52/21-popr.). Pricing regulation in Slovenia applies only to those medicinal products that are financed from public revenues. The regulations lay down in detail the criteria and procedures for the determining, amending and publication of regulated prices of medicinal products. The maximum allowed prices (MAP) of medicinal products should be formulated on the basis of the value of the manufacturer’s element of price (MEP) plus the wholesaler’s margin.
The value of the MEP is established on the basis of comparable medicinal product prices in the reference countries: Austria, France and Germany. For original medicinal products the value of the MEP should not exceed permitted percentage of the lowest price of an equivalent medicinal product in any of the three reference countries. For biosimilar medicinal products, the value of the MEP should not exceed permitted percentage of the lowest price of all comparable biosimilar medicinal products in any of the three reference countries. For generic medicinal products, the value of the MEP should not exceed permitted percentage of the average of the highest and the lowest prices of comparable generic medicinal products in reference countries.
Before launching the medicinal product to the market, the applicant must submit an application for the first determination of MAP.
As the MAPs are changing twice yearly, the applicants should submit an application for the change of determined MAPs to the JAZMP twice yearly, i.e.:
· from 1 March up to and including 1 April, and
· from 1 September up to and including 1 October.
The application for MAP must be prepared in accordance with the requirements of the current Rules in written and electronic form. The latter should be enclosed on a CD, USB flash drive or sent by e-mail to: .