Pursuant to the Medicinal Products Act (Official Gazette of the Republic of Slovenia, No. 17/14 and 66/19) and the Rules on more exact donditions and procedure for determining interchangeable medicinal products (Official Gazette of the Republic of Slovenia, No. 102/10 and 17/14 – ZZdr-2), (hereinafter: the Rules), the JAZMP determines those medicinal products that are mutually interchangeable. Mutually interchangeable medicinal products may be bioequivalent, pharmaceutically equivalent and pharmaceutically alternative medicinal products. In this respect, the likelihood of the occurrence of clinically significant differences in the efficacy and safety of a medicinal product should be appropriately low.
The procedure for the determination of mutual interchangeability may be started by JAZMP (oex officio), by the proposal of the marketing authorisation holder or on the initiative of an expert institution, in accordance with the provisions of the current Rules.
The proposal or initiative to initiate the procedure for determining interchangeability of medicinal products must be drawn up in accordance with the requirements of the applicable Rules.
Medicinal products listed among interchangeable medicines may be replaced by persons authorised to prescribe or dispense medicinal products.
Based on the list of mutually interchangeable medicinal products, the Health Insurance Institute of Slovenia (ZZZS) sets the highest recognised values on the level of groups of mutually interchangeable medicinal products, defined by active ingredients, pharmaceutical form and strength. This means that for the mutually interchangeable medicinal products the highest acknowledged value which is covered by health insurance is set.