Pursuant to the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 in 66/19), 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. EHAP 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 (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.).
The application for EHAP 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: .
The procedure of determining EHAP is carried out with the participation of the Committee for determination of EHAP. 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.