The procedure for calculating marginal selling prices for medicines has been established

MART adopted the Resolution No. 45 dated 11.07.2023, which approves the Instruction on the methodology of calculation of manufacturers’ marginal selling prices for medicinal products.

It should be recalled that the registration of the marginal selling prices of manufacturers of medicines was valid from 2018 to 2020.

This procedure was resumed in April of this year by the adoption of Presidential Decree No. 95 of 10.04.2023 (hereinafter – the Decree).

Resolution of 06.07.2023 No. 444

The Government followed up the Decree by adopting Resolution No. 444 of 06.07.2023, which defines the rules and the list of medicinal products, the marginal selling prices for which must be registered.

• The list includes 37 names of medicines, such as ibuprofen, lactulose, trimetazidine and others.

Methodology for calculating marginal selling prices

MART followed up on the above-mentioned normative legal acts by adopting the relevant Instruction, which defines the methodology for calculating manufacturers’ marginal selling prices for medicines.

In particular, it is established that the marginal selling price is determined as an average value calculated from:

1. weighted average of the manufacturer’s actual selling price for the medicinal product, in circulation in Belarus for the last 6 months preceding the date of application for price registration;
2. the arithmetic average of the manufacturer’s minimum selling prices (excluding production sites involved in the production process) for A drug product in countries according to a specific list of countries.

List of countries: Belgium, Bulgaria, Greece, Hungary, Kazakhstan, Latvia, Lithuania, Poland, Russia, Romania, Slovakia, France, Czech Republic, countries participating in the production – producer of bulk products.

Previously, the list of countries also included Armenia, Kyrgyzstan, Moldova and Estonia.

The document defines

• the procedure for calculating the marginal selling price in case of changes in the registered marginal selling price;
• procedure for calculating the arithmetic average of the manufacturer’s minimum selling prices for a medicinal product in the countries on the list.

The marginal selling prices for medicinal products must be registered by 1 December 2023.

The regulation came into force on 19 July 2023.

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