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

of November 19, 2018 No. 83

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

Based on subitem 1.3 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", the paragraph of the third Item 2, of subitems 4.5 and 4.6 of Item 4, of Item 16 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 "About marginal registration of selling prices of producers for 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 "Questions of the Ministry of anti-monopoly regulation and trade of the Republic of Belarus", the Ministry of anti-monopoly regulation and trade of the Republic of Belarus DECIDES:

1. Approve the enclosed Instruction about marginal method of calculation of selling prices of producers on medicines.

2. This resolution becomes effective after its official publication and is effective till December 31, 2020.

Approved by the Resolution of the Ministry of anti-monopoly regulation and trade of the Republic of Belarus of November 19, 2018 No. 83

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

Chapter 1 General provisions

1. This Instruction establishes procedure of payments the organizations performing production of medicines (further, unless otherwise specified, - producers), the marginal selling prices on the medicines registered in the procedure established by the legislation which are subject to registration according to the Presidential decree of the Republic of Belarus of August 22, 2018 No. 345 "About registration of the prices of medicines" (The national legal Internet portal of the Republic of Belarus, 25.08.2018, 1/17898).

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 "About medicines" are used (The national register of legal acts of the Republic of Belarus, 2006, No. 122, 2/1258) and 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 "About marginal registration of selling prices of producers for medicines" (The national legal Internet portal of the Republic of Belarus, 02.11. 2018, 5/45755).

3. Marginal selling price of the producer on original medicine in the forms of release provided according to Item 16 of the Regulations on marginal order of registration of selling prices of producers on medicines is calculated based on the minimum selling prices of the producer (without the production sites participating in production process) on the corresponding forms of release of such medicine in the countries according to the list of the countries on which information on the level of the minimum selling prices on medicines, according to appendix 1 to this Instruction is provided.

If marginal selling price of the producer on original medicine is registered according to Item 16 of the Regulations on marginal order of registration of selling prices of producers on medicines, marginal calculation of selling prices on generic, biologically similar medicine is performed on each form of release taking into account marginal selling prices of producers on medicine (further, unless otherwise specified, - marginal selling price) on the corresponding forms of release of original medicine.

4. For the purpose of implementation of the economic analysis of the made marginal calculations of selling price are constituted:

data on amounts of leave and selling prices concerning the medicines of producers of state members of the Eurasian Economic Union which are in circulation in the Republic of Belarus and (or) the foreign producers performing primary and (or) secondary package of medicine in the Republic of Belarus in form according to appendix 2 to this Instruction;

marginal calculation of selling price of the producer on medicine in form according to appendix 3 to this Instruction;

data on amounts of import and contract price (CIP) 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 on the receipt date of goods on warehouse of the buyer specified in delivery note (if such goods are not subject to customs declaring) (further, unless otherwise specified, - contract price), concerning medicine of the foreign production which is in circulation in the territory of the Republic of Belarus in form according to appendix 4 to this Instruction;

data on availability of the registered marginal selling prices of the declared medicine in form according to appendix 5 to this Instruction;

marginal calculation of selling price on generic, biologically similar medicine in form according to appendix 6 to this Instruction.

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