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RESOLUTION OF THE MINISTRY OF ANTI-MONOPOLY REGULATION AND TRADE OF THE REPUBLIC OF BELARUS

of July 11, 2023 No. 45

About approval of the Instruction about marginal method of calculation of selling prices of producers on medicines

(as amended on 19-03-2024)

Based on subitem 1.2 of Item 1 of the Presidential decree of the Republic of Belarus of August 22, 2018 No. 345 "About registration of the prices of medicines", subitem 6.49 of Item 6 of the Regulations on the Ministry of the anti-monopoly regulation and trade of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of September 6, 2016 No. 702, the Ministry of anti-monopoly regulation and trade of the Republic of Belarus DECIDES:

1. Approve the Instruction about marginal method of calculation of selling prices of producers on medicines it (is applied).

2. This resolution becomes effective after its official publication.

First Deputy Minister

I. V. Vezhnovets

It is approved

Ministry of Health of the Republic of Belarus

 

 

Approved by the Resolution of the Ministry of anti-monopoly regulation and trade of the Republic of Belarus of July 11, 2023 No. 45

The instruction about marginal method of calculation of selling prices of producers on medicines

Chapter 1. General provisions

1. This Instruction establishes marginal method of calculation of selling prices of producers on the medicines (further, unless otherwise specified, – marginal selling prices) included in the list of medicines on which marginal selling prices are subject to registration, No. 776 determined by the resolution of Council of Ministers of the Republic of Belarus of October 31, 2018 "About marginal registration of selling prices of producers for medicines".

2. For the purposes of this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation", the Presidential decree of the Republic of Belarus of August 22, 2018 No. 345 are used.

3. For the purpose of implementation of marginal calculation of selling price by the holder of the registration certificate (authorized by it person) are constituted:

data on amounts of leave and selling prices in form according to appendix 1 concerning the medicines which are in circulation in the Republic of Belarus if in contracts based on which leave is performed the payment amount is specified in Belarusian rubles;

data on amounts of import and contract prices in form according to appendix 2 with indication of the contract price converted into Belarusian rubles on the official rate of National Bank of the Republic of Belarus established on date of issue of goods according to customs procedure of release for internal consumption (if such goods are subject to customs declaring) or of the receipt date of goods on warehouse of the buyer specified in commodity-transport delivery note or the consignment note (if such goods are not subject to customs declaring) (further, unless otherwise specified, – contract price), concerning the medicines which are in circulation in the Republic of Belarus if in contracts based on which import is performed the payment amount is specified in foreign currency;

calculation of arithmetic average of value of the minimum selling prices of the producer on medicine in form according to appendix 3.

4. For economic case of data on amounts of leave (import) and the selling (contractual) prices provided by appendices 1 and 2, concerning the medicines which are in circulation in the Republic of Belarus for the period, determined according to Item 5 of this Instruction, are used:

commodity-transport delivery notes and consignment notes on shipped quantity of medicine;

invoices (invoices) on supply of medicine to the Republic of Belarus.

5. For calculation the period equal on duration of six months preceding date of the statement for marginal registration of selling price for medicine in case of marginal registration of selling price according to item 4 of the Regulations on marginal order of registration of selling prices of producers on medicines approved by the resolution of Council of Ministers of the Republic of Belarus of October 31, 2018 No. 776 is accepted (further – the Provision).

In need of change of the registered marginal selling price according to Provision Item 19 for calculation the period from marginal registration date of selling price before date of the statement for marginal registration of selling price for medicine, but no more than in six months prior to date of the statement for marginal registration of selling price for medicine is accepted.

Chapter 2. Marginal calculation of selling price on medicine

6. Marginal selling price is determined as the average size calculated from:

6.1. the weighted actual selling (contractual) average price of the producer on the medicine which is in circulation in the Republic of Belarus, for the period, determined according to Item 5 of this Instruction calculated according to Items 7 and 8 of this Instruction corrected on the consumer price index established in case of determination of the main forecast indicators of social and economic development of the Republic of Belarus for year in which filing of application about marginal registration of selling price for medicine is performed (further, unless otherwise specified, – the predicted consumer price index):

for medicines if in contracts based on which leave is performed the payment amount is specified in Belarusian rubles, – based on data on amounts of leave and selling prices according to appendix 1;

for medicines if in contracts based on which import is performed the payment amount is specified in foreign currency, – based on data on amounts of import and contract prices according to appendix 2;

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