Pursuant to the Medicinal Products Act, medicinal products for human use (medicinal products with marketing authorization, authorisation for the entry or importation or provisional marketing authorization for an essential or indispensable medicinal product, parallel import authorization, a certificate of receipt of the notification of parallel distribution of medicinal product) may have an exceptional higher allowed price (EHAP) determined. An exceptional higher allowed price enables the marketing authorisation holders to set a higher price of medicinal products in cases when, owing to the size and other characteristics of the Slovenian market, the maximum allowed price (MAP) does not enable them to supply the market.
The procedure for EHAP determination is based on provisions of the Medicinal Products Act and the provisions of the Rules on the Pricing of Medicinal Products for Human Use.
The procedure of determining EHAP is carried out with the participation of the Committee for determination of EHAP, which drafts an opinion. The committee’s opinion forms the basis for EHAP determination.
The determination of EHAP is not time-sensitive, so deadlines for the submission of applications are not set. EHAP for a medicinal product may be determined for a maximal period of one year. The Rules do not provide basis for an extension of EHAP, which means that a new application for re-determination of EHAP should be submitted at least 90 days prior to the expiry of price validity.