Council of Ministers Adopts Changes to the Ordinance on Medicinal Product Prices

The Council of Ministers adopted a Decree amending and supplementing the Ordinance that determines the conditions, rules, and procedures for the regulation and registration of medicinal product prices.

The primary objectives of these changes include the implementation of Regulation (EU) 2021/2282, which introduces joint clinical assessments of health technologies within the European Union. This will help improve access to innovative therapies and reduce administrative burdens. Additionally, the changes aim to harmonize terminology and procedures related to the registration of medicinal product prices, including those imported via parallel trade, to avoid regulatory inconsistencies.

An additional objective is to prevent the circumvention of price restrictions for over-the-counter medicines through the abuse of administrative procedures.

The amendments also guarantee access to vital medications for the cytotoxic and hormonal treatment of oncological diseases included in the World Health Organization’s Model List of Essential Medicines. This will be ensured through mandatory price referencing every 24 months.

Pricing mechanisms and external price referencing will be refined. The goal: to prevent legal disputes and ensure more transparent regulation.

The expected results of the adopted amendments include: better control over medicinal product prices and improved access to medications for the treatment of oncological diseases. Furthermore: compliance with European regulatory requirements—without additional burden on the state budget.