On adoption of the Resolution of the of the Ministry of Antimonopoly Regulation and Trade of the Republic of Belarus of November 19, 2018 No. 83 “On Approval of the Instruction on the Method of Calculating the Maximum Selling Prices of Producers for medic

The Resolution of the Ministry of Antimonopoly Regulation and Trade of the Republic of Belarus of November 19, 2018 No. 83 “On Approval of the Instruction on the Method of Calculating the Maximum Selling Prices of Producers for medicines” was adopted as part of the implementation of the Decree of the President of the Republic of Belarus of August 22, 2018 No. 345 "On Registration of Prices for Medicines".

The basis of the Instruction on the method of calculating the maximum selling prices of manufacturers for medicines (hereinafter referred to as the Instruction) is based on the principle of reference pricing. Thus, the document defines a list of countries for which information on the level of minimum selling prices for medicines is provided.

According to the Instructions, the determination of the maximum selling price of the manufacturer for the original medicine is based on the calculation of the arithmetic average of the manufacturer's minimum prices for the medicine in 14 countries, including the country of the manufacturer of the medicine, and the weighted average selling price and (or) contractual selling price prevailing during the calendar year adjusted for the consumer price index, calculated on an accrual basis for each month.

For a generic, biologically similar medicine, a reduction factor is additionally used in relation to the price of the original medicine.

In this case, registration shall be subject to the smallest (minimum) value obtained in the calculations.

The resolution comes into force after the official publication, i.e. from November 23, 2018 and is valid until December 31, 2020.