Regulation of prices and reimbursements for pharmaceuticals

Decision-making in the area of maximum prices of medicinal products and the amounts and conditions of reimbursements for medicinal products. The process of determining the maximum prices and amounts and conditions of reimbursements is individual and may be re-visited, it is conducted in the mode of an administrative procedure with fixed timelines and fully complies with the European transparency directive. Applications and initiatives will be reviewed in particular on the basis of efficacy, safety, and cost efficiency assessments. The parties to the administrative procedure are, pursuant to the law, health insurance companies and marketing authorisation holders. Initiatives may be submitted also by patient organisations or professional associations.