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The document ceased to be valid since May 14, 2019 according to Item 2 of the Order of the deputy. The Minister of Health of the Republic of Kazakhstan of April 19, 2019 No. KR DSM-42

ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of February 8, 2018 No. 53

About introduction of amendments to 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 of September 18, 2009 "About health of the people and health care system" 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:

state heading in the following edition:

"Rules of marginal forming of the prices and markups on medicines and products of medical appointment which are purchased within the guaranteed amount of free medical care and in system of compulsory social medical insurance";

Rules of pricing on the medicines and products of medical appointment within the guaranteed amount of free medical care approved by the specified order to be reworded as follows according to appendix, to this order.

2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) within ten calendar days after state registration of this order the direction it the copy on official publication in periodic printing editions;

4) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

5) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), 3) and 4) of this Item.

3. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Tsoi A. V.

4. This order becomes effective after ten calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

E.Birtanov

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of February 8, 2018 No. 53

Appendix 1

to the Order of the acting minister of health care and social development of the Republic of Kazakhstan of July 30, 2015 No. 639

Rules of marginal forming of prices and markups on medicines and products of medical appointment purchased within the guaranteed amount of free medical care and in system of compulsory social medical insurance

Chapter 1. General provisions

1. These rules of marginal forming of prices and markups on medicines and products of medical appointment purchased within the guaranteed amount of free medical care and in system of compulsory social medical insurance (further - Rules) determine procedure for marginal forming of prices and markups on medicines and products of medical appointment purchased within the guaranteed amount of free medical care (further - GOBMP) and in system of compulsory social medical insurance (further - OSMS).

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

Marginal 1) the price for medicine and product of medical appointment within the guaranteed amount of free medical care and in system of compulsory social medical insurance (further - marginal price) - the price of medicine and product of medical appointment above which the purchase by the single distributor and the organizations of health care providing medical care within the guaranteed amount of free medical care and in system of compulsory social medical insurance cannot be made;

2) external reference pricing on the imported medicines - comparative analysis of ex-works price of the applicant with ex-works prices of the same producer of medicine with the same active agent, taking into account dosage form, concentration and dosage in the reference countries determined by Item 16 of these rules and also, in case of lack of the price in the reference countries, in the countries where medicine is registered;

3) state body in the field of drug circulation and products of medical appointment (further - state body) - the department of authorized body performing within the competence regulating, realizable, executive, control functions in the field of drug circulation and products of medical appointment;

4) the state register of medicines, products of medical appointment and medical equipment (further - the State register) - 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;

5) the state expert organization in the field of drug circulation, products of medical appointment and medical equipment (further - the expert organization) - the republican state company on the right of economic maintaining 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;

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