Reporting data on prices of medicinal products

A central base of medicinal products as an electronic database is established for the purpose of monitoring the prices of medicinal products which is managed by the provider of compulsory health insurance. The database includes the following data on medicinal products:

  •  as per items 1 to 4 of Article 187 of the Medicinal Products Act (ZZdr-2);
  • prices of medicinal products and start of the validity of prices of medicinal products as per the first to fifth indents of the second and fourth paragraphs of Article 163 of the ZZdr-2;
  • revocation of the price as per the fifth paragraph of this Article and prices of medicinal products determined on the basis of the act regulating price control;
  • the highest recognised values of medicinal products determined by the provider of compulsory health insurance;
  • financing of medicinal products from public funds; presence of the medicinal product on the market.

 The data referred to in the preceding paragraph are submitted to the central base of medicinal products on the basis of an electronic data exchange by:

  •  the competent authority – for data on medicinal products as per the first indent of the preceding paragraph, data on prices of medicinal products as per the first and second indents of the second and fourth paragraphs of this Article and for data on the presence of the medicinal product on the market as per the fifth indent of the preceding paragraph;
  • entities as per the first to sixth indents of the first paragraph of Article 159 of the Medicinal Products Act (ZZdr-2) – for data on prices of medicinal products as per the third indent of the second paragraph of this Article;
  • marketing authorisation holders as per the second paragraph of Article 159 of the Medicinal Products Act (ZZdr-2) – for data on prices of medicinal products as per the fourth indent of the second paragraph of Article 163 of the Medicinal Products Act (ZZdr-2);
  • the provider of compulsory health insurance – for the highest recognised values of medicinal products as per the third indent and for data on financing medicinal products from public funds as per the fourth indent of the eighth paragraph of Article 163 of the Medicinal Products Act (ZZdr-2);
  • the ministry responsible for health – for data on prices of medicinal products as per the fifth indent of the second paragraph of Article 163 of the Medicinal Products Act (ZZdr-2);
  • the ministry responsible for the control of prices – for data on prices of medicinal products determined on the basis of the act governing the control of prices.

 The bodies referred to in the preceding paragraph submit the data on the price of the medicinal product and the termination of its validity to the central base of medicinal products no later than two business days prior to the start or cessation of the validity of the price of the medicinal product.

Other data under the preceding paragraph must be submitted in eight days of their occurrence. Business entities with retail and wholesale marketing authorisations report on medicinal products used in veterinary medicine or submit a suitable certificate of notification also to the authority responsible for veterinary medicine.

Last updated: 08. 01. 2016