ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of May 30, 2019 No. 347

About modification and amendments in the order of the Government of the Republic of Kazakhstan of October 30, 2009 No. 1729 "About approval of Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance"

The government of the Republic of Kazakhstan DECIDES:

1. Bring in the order of the Government of the Republic of Kazakhstan of October 30, 2009 No. 1729 "About approval of Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance" (SAPP of the Republic of Kazakhstan, 2009, Art. No. 47-48, 444) the following changes and amendments:

state heading in the following edition:

"About approval of Rules of the organization and carrying out purchase of medicines and medical products, pharmaceutical services";

state Item 1 in the following edition:

"1. Approve Rules of the organization and carrying out purchase of medicines and medical products, pharmaceutical services.";

in Rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance approved by the specified resolution:

state heading in the following edition:

"Rules of the organization and carrying out purchase of medicines, medical products and pharmaceutical services";

in all text of Rules of the word "product of medical appointment and medical equipment", "product of medical appointment and medical equipment", "products of medical appointment and medical equipment", "products of medical appointment and medical equipment", "medical equipment and products of medical appointment", "product of medical appointment", "products of medical appointment", "product of medical appointment", "products of medical appointment", "medical equipment", "medical equipment" to replace respectively with the words "medical product", "medical products", "medical product", to "medical product", "medical product", "medical products", "medical products";

state Item 1 in the following edition:

"1. These rules of the organization and carrying out purchase of medicines and medical products, pharmaceutical services (further - Rules) articles 6, the subitem 7) of article 10 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code), Item 2 of article 7 of the Law of the Republic of Kazakhstan of November 16, 2015 "About compulsory social medical insurance are drafted according to the subitem 12)" and determine procedure for the organization and carrying out purchase of medicines and medical products, pharmaceutical services in rendering the guaranteed amount of free medical care and medical care in system of compulsory social medical insurance.";

in Item 2:

subitems 5) to state 6), 7) and 8) in the following edition:

"5) purchase - acquisition by the customer, single distributor, lessor of medicines, medical products, pharmaceutical services in rendering the guaranteed amount of free medical care and in system of compulsory social medical insurance according to the procedure and the methods established by these rules including with use of the web portal of purchases;

6) expert evaluation - assessment performed by the lessor, individual entrepreneurs and legal entities according to technique of implementation of the expert evaluation of optimum technical characteristics and kliniko-technical reasons for the medical products requiring field service, approved by authorized body in the field of health care;

7) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

8) immunological medicine (immunobiological medicine) - the medicine intended for forming of active or passive immunity or diagnostics of availability of immunity, or diagnostics (development) of the specific acquired change of the immunological answer to allergiziruyushchy substances;";

9) to exclude the subitem;

10) to state the subitem in the following edition:

"10) medical products - any tools, devices, devices, the equipment, materials and other products which are applied in the medical purposes separately or in combination among themselves, and also with the accessories necessary for application of the specified products to destination, including the special software; diagnostics, treatments of diseases, medical rehabilitation and monitoring of condition of human body, carrying out medical researches, recovery, substitution, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy and which functional purpose is not implemented by pharmacological, immunological, genetic or metabolic impact on human body are intended by the producer of medical product for prevention, and can be supported by use of medicines;";

21) to state the subitem in the following edition:

"21) the list of medicines, the medical products which are purchased from the single distributor, (further - the list of the single distributor) - the document developed and approved by authorized body in the field of health care containing:

characteristics of medicines, medical products, their ceiling prices for the international non-proprietary name, possibilities of the conclusion of the long-term agreement of delivery with domestic producers;

specifying for medicines of the international non-proprietary name or structure, for medical product - the name or structure;

the name for the medical products requiring field service, the technical specification and picking, cost for unit and by picking, delivery dates on each description of goods;";

28) to state the subitem in the following edition:

"28) the long-term agreement of supply of medicines and medical products - the civil agreement signed by the single distributor for up to ten years with producers of medicines, medical products of the Republic of Kazakhstan or the customer of the contract manufacturing of medicines and medical products located in the territory of the Republic of Kazakhstan on supply of the medicines and medical products made according to requirements of proper production practice (GMP) for medicines and requirements of the international standard of quality management system (ISO 13485) for medical products, except for medical products of class of safety of potential risk of application 1 and 2a (except sterile); or with the subject in the field of drug circulation and medical products having intention to create and modernize production of medicines and medical products or contract manufacturing of medicines and medical products with the producer of medicines located in the territory of the Republic of Kazakhstan, according to requirements of proper production practice (GMP) for medicines, and for medical products according to requirements of the international standard of quality management system (ISO 13485), except for medical products of class of safety of potential risk of application 1 and 2a (except sterile), according to the procedure, established by the legislation of the Republic of Kazakhstan;";

35) to state the subitem in the following edition:

"35) kliniko-technical reasons - the document containing information on the need for the required medical product requiring field service, and readiness of the organization of health care it to apply;";

39) to state the subitem in the following edition:

"39) the medical products which are requiring field service, subject to unification - the medical products requiring field service, with uniform technical characteristics, the health cares which are purchased by the organizations for rendering homogeneous medical services at the expense of means of the republican budget, including target current transfers to regional budgets, budgets of the cities of Nour-Sultan, Almaty, Shymkent on material equipment of the medical organizations at the local level;";

42) to exclude the subitem;

subitems 43) to state 44) and 45) in the following edition:

"43) the price list of the single distributor - the price offer on goods approved by the single distributor for customers and service providers on accounting and sales of goods, containing list of the goods which were purchased by the single distributor with indication of their characteristic, unit of measure, packing, the name of the producer, the country of the producer, the price which is not exceeding marginal price according to the list of the single distributor taking into account markup of the single distributor for unit and also for medicines trade and the international non-proprietary name or structure, for medical products of the trade name or structure;

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