Belarus introduces manufacturer’s sale price for medicines registration from 2019

Manufacturers of medicines to register maximum selling price based on reference price method.

In order to keep prices for medicines at bay, Belarus is introducing manufacturer’s selling price registration based on the reference prices method.
At first, the measure will affect only some oncological and cardiovascular medicines listed in the legislation and will remain until 2021. If it proves to be effective the measure will cover all medicines and extended.
From 1 January 2019 selling affected medicines without a price limit registration is prohibited in Belarus.
The Ministry of Healthcare together with its subordinate organization, the Centre for Examinations and Tests in Healthcare (RCETH), handles applications and registrations. At the request of the RCETH, the Ministry of Antimonopoly Regulation and Trade (MART) evaluates the price set by the manufacturer according to the set methodology and approves or rejects it.
The right to apply belongs to the holder of the medicine’s state registration certificate or their authorized representative.
Each calculation is detailed and specified for certain types of manufacturer, products (original, generic) and situations in the methodology approved by MART (available in English here).
The reference countries are Armenia, Bulgaria, Hungary, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Poland, Russia, the Czech Republic, Estonia and the country of manufacturer’s residence.
For instance, the manufacturer’s sale price limit for a non-EAEU manufacturer who is not involved in primary or secondary packaging of its products in Belarus for original medicines is established based on comparison of (1) the weighted average of the actual selling price in Belarus for the calendar year preceding application for registration and (2) the average minimal selling price in reference countries, whichever is less. Detailed rules are laid down in the methodology for calculation of each indicator mentioned.
Documents supporting the application among others must include a power of attorney and a list of open information sources with data on manufacturers’ minimum selling prices in the reference countries.
The registered prices are added to the special register publicly available on the web-page of RCETH.
The manufacturer may not sell its products for a price above the registered maximum price.

Source: National legal internet portal of the Republic of Belarus (NLIP) 24.08.2018, 1/17898


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