ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of June 8, 2016 No. 485

About modification and amendments in the order of the acting minister of health care and social development of the Republic of Kazakhstan of July 30, 2015 No. 639 "About approval of Rules of pricing on medicines and products of medical appointment within the guaranteed amount of free medical care"

According to the subitem 112) of Item 1 of article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" of September 18, 2009 I ORDER:

1. Bring in the order of the acting minister of health care and social development of the Republic of Kazakhstan of July 30, 2015 No. 639 "About approval of Rules of pricing on medicines and products of medical appointment within the guaranteed amount of free medical care" (it is registered in the Register of state registration of regulatory legal acts at No. 11887, it is published in information system of law of Ad_let on August 25, 2015) the following changes and amendments:

in the Rules of pricing on medicines and products of medical appointment within the guaranteed amount of free medical care approved by the specified order:

state Item 2 in the following edition:

"2. In these rules the following basic concepts are used:

1) the import price - the price specified in invoice when importing medicines and products of medical appointment to the Republic of Kazakhstan;

2) selling price (retail price within GOBMP) - the price of the provided medicines, products of medical appointment established by results of purchase of pharmaceutical services within one administrative and territorial unit (area, the city of republican value, the capital);

3) wholesale markup (allowance) - the markup on the registered price of medicine, product of medical appointment including the expenses and profit connected with implementation of wholesale of medicines, products of medical appointment;

4) state body in the field of drug circulation, products of medical appointment and medical equipment - the state body exercising the state control in the field of drug circulation, products of medical appointment and medical equipment (further - state body);

5) the State register of medicines, products of medical appointment and medical equipment - the document of accounting of the medicines registered and allowed for medical application in the Republic of Kazakhstan, products of medical appointment and medical equipment (further - the State register);

6) the state expert organization in the field of drug circulation, products of medical appointment and medical equipment (further - the expert organization) - the organization performing production economic activity in the field of health care on safety, efficiency and qualities of medicines, and also scientific research in the field of development of new original medicines, pharmacy, pharmacology;

7) internal reference pricing on medicinal means - price analysis on medicines by (wholesale, retail) the prices of trade names of medicines within one international non-proprietary name taking into account dosage form, dosage;

8) external reference pricing on medicines - price analysis on medicines by (wholesale, retail) the prices of trade names of medicines within one MNN taking into account dosage form, dosage in the countries with similar level of living of the population and common economic space;

9) the international reference price - arithmetic average value by (wholesale, retail) the prices of trade names of medicines within one MNN taking into account dosage form, dosage in the countries with similar level of living of the population and common economic space;

10) authorized body in the field of health care (further - authorized body) - the state body performing management in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation, products of medical appointment and medical equipment, control of quality of medical services;

11) wholesale price - the price of medicine, product of medical appointment according to the trade name in case of wholesale;

12) retail markup (allowance) or markup (allowance) for pharmaceutical service - the markup on marginal price of medicine, product of medical appointment including the expenses and profit connected with implementation of retail sale of medicines, products of medical appointment or pharmaceutical service;

13) subjects of monitoring - the physical persons and legal entities performing medical and pharmaceutical activities;

14) average wholesale price - arithmetic average value of wholesale price of trade names of medicines within one international unlicensed name of medicine (further MNN) taking into account dosage form, dosage

15) the price of the producer - the price of leave of the producer of medicine and product of medical appointment including all types of production costs, delivery notes and all-administrative expenses;

16) the applicant - the developer, the producer, the owner of the registration certificate, the legal entity having the status of the official manufacturer representative authorized to submit the application, documents and materials for carrying out state registration, re-registration of medicines and products of medical appointment, registration/change of the registered prices;

17) the registered price - the price of medicine, product of medical appointment according to the trade name taking into account the price of the producer, the incurred expenses on evaluating safety and quality, logistics, customs duties in cases, stipulated by the legislation, approved by authorized body;

Marginal 18) the price for medicine, product of medical appointment within GOBMP - the price established by authorized body above which the purchase cannot be made;

19) the form commission of authorized body - the collegiate, advisory and consultative and expert organ which is supporting and enhancing form system, rational use of medicines, ethical promotion of medicines and taking part in forming and price approval on medicines in the Republic of Kazakhstan (further - the form commission);

20) the international unlicensed name of medicine - the name of medicine recommended by the World Health Organization.";

add with Item 4-1 of the following content:

"4-1. Marginal price is determined by 4 criteria:

1) original medicines;

2) biosimilyara;

3) generics;

4) products of medical appointment.";

6, 7 to state Items in the following edition:

"6. For state registration of the price of medicines and (or) products of medical appointment, the applicant provides in the expert organization the registration application of the prices of medicines in form according to appendix 2 (further - appendix 2) and (or) the registration application of the prices of product of medical appointment in form according to appendix 3 (further - appendix 3) to these rules. The prices provided in the statement are analyzed taking into account reference pricing.

Are enclosed to the application:

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