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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of February 17, 2017 No. 71

About some questions of the Ministries of Health and national economy of the Republic of Kazakhstan

(as amended on 29-09-2021)

According to the Presidential decree of the Republic of Kazakhstan of January 25, 2017 "About further enhancement of system of public administration of the Republic of Kazakhstan" the Government of the Republic of Kazakhstan DECIDES: No. 412

1. Reorganize:

1) Committee on consumer protection of the Ministry of national economy of the Republic of Kazakhstan by allocation of Committee of protection of public health of the Ministry of Health of the Republic of Kazakhstan from it;

2) Committee on regulation of natural monopolies and protection of the competition of the Ministry of national economy of the Republic of Kazakhstan and Committee on consumer protection of the Ministry of national economy of the Republic of Kazakhstan by merge in Committee on regulation of natural monopolies, protection of the competition and the rights of consumers of the Ministry of national economy of the Republic of Kazakhstan.

2. Rename:

1) Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan in Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan;

2) Committee of payment of medical services of the Ministry of health and social development of the Republic of Kazakhstan in Committee of payment of medical services of the Ministry of Health of the Republic of Kazakhstan;

3) public institutions - territorial subdivisions of Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan, Committee of payment of medical services of the Ministry of health and social development of the Republic of Kazakhstan, Committee on consumer protection of the Ministry of national economy of the Republic of Kazakhstan according to appendix 1 to this resolution;

4) the state legal entities according to appendix 2 to this resolution;

5) the state legal entities of Committee on consumer protection of the Ministry of national economy of the Republic of Kazakhstan according to appendix 3 to this resolution.

3. Determine:

1) the Ministry of Health of the Republic of Kazakhstan authorized body on management of the corresponding industry (sphere) of public administration concerning the state legal entities provided by the subitem 4) of Item 2 of this resolution;

2) Committee of protection of public health of the Ministry of Health of the Republic of Kazakhstan by authorized body on management of the corresponding industry (sphere) of public administration concerning the state legal entities provided by the subitem 5) of Item 2 of this resolution.

4. Approve enclosed:

1) Regulations on the Ministry of Health of the Republic of Kazakhstan (further - the Provision);

2) changes and additions which are made to some decisions of the Government of the Republic of Kazakhstan.

5. Recognize invalid some decisions of the Government of the Republic of Kazakhstan according to appendix 4 to this resolution.

6. This resolution becomes effective from the date of its signing, except for subitems 152-3), 152-4), 152-5), 152-6), 152-7), 152-8), 152-9) of functions of central office and the subitem 20) of function of departments of Item 16 of the Provision which become effective since April 11, 2019 according to the laws of the Republic of Kazakhstan of October 5, 2018 "About standardization" and "About modification and amendments in some legal acts of the Republic of Kazakhstan concerning ensuring unity of measurements and standardization".

Prime Minister of the Republic of Kazakhstan

B. Sagintayev

Approved by the Order of the Government of the Republic of Kazakhstan of February 17, 2017 No. 71

Regulations on the Ministry of Health of the Republic of Kazakhstan

Chapter 1. General provisions

1. The Ministry of Health of the Republic of Kazakhstan (further - the Ministry) is the state body of the Republic of Kazakhstan performing management in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, drug circulation, medical products, control of drug circulation and medical products, control of quality of rendering medical services (help), sanitary and epidemiologic wellbeing of the population, control and supervision of observance of the requirements established by technical regulations and regulating documents and also in the field of safety of food products at stage of its realization (further - the regulated sphere), cross-industry coordination in the field of protection of public health of the Republic of Kazakhstan, strategic, regulating, control and supervising, realizable and allowing functions.

2. The ministry has the following departments:

Committee of sanitary and epidemiologic control of the Ministry of Health of the Republic of Kazakhstan;

Committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan.

3. The ministry performs the activities according to the Constitution and the laws of the Republic of Kazakhstan, acts of the President, the Government of the Republic of Kazakhstan, other regulatory legal acts, and also this Provision.

4. The ministry is legal entity in form of business of public institution, has seals and stamps with the name in state language, forms of the established sample, according to the legislation of the Republic of Kazakhstan of the account in bodies of treasury.

5. The ministry enters the civil relations from own name.

6. The ministry has the right to act as the party of the civil relations on behalf of the state if it is authorized on it according to the legislation.

7. The ministry of questions of the competence of the procedure established by the legislation makes the decisions which are drawn up by orders of the head of the Ministry and other acts, stipulated by the legislation the Republic of Kazakhstan.

8. The structure and limit of the number of staff of the Ministry affirm according to the current legislation.

9. Ministry location: 010000, Nour-Sultan's city, Esilsky district, Prospekt Meng_l_k El 8, office building "House of the ministries", 5th entrance.

10. Full name of the Ministry - public institution "Ministry of Health of the Republic of Kazakhstan".

11. This Provision is the constituent document of the Ministry.

12. Financing of activities of the Ministry is performed from the republican budget.

13. The ministry is forbidden to enter contractual relations with subjects of entrepreneurship regarding accomplishment of the obligations which are functions of the Ministry.

If the Ministry by legal acts is granted the right to perform the activities which are bringing in incomes, then income gained from such activities go to the income of the government budget if other is not established by the legislation of the Republic of Kazakhstan.

Chapter 2. Mission, main objectives, functions, prava of obligation of the Ministry

14. Mission of the Ministry:

improvement of health of citizens of Kazakhstan by effective forming and realization of state policy, implementation of cross-industry coordination and state regulation of provision of services in the field of health care.

15. Tasks:

forming and realization of state policy, implementation of cross-industry coordination and public administration in the area:

1) protection of public health of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, quality control of rendering medical services (help);

2) providing according to the legislation of the Republic of Kazakhstan receipts of free medical care by citizens within the amount guaranteed by the state;

3) organizations of providing population and organizations of health care with safe, effective and high-quality medicines;

4) implementation of cross-industry coordination of activities of state bodies for ensuring realization of state policy in the sphere of protection of sanitary and epidemiologic wellbeing of the population;

other tasks assigned to the Ministry by the legislation of the Republic of Kazakhstan.

16. Functions:

functions of central office:

1) forming and realization of state policy in the field of health care, in the sphere of sanitary and epidemiologic wellbeing of the population and protection of public health;

2) development and program implementation in the field of health care, in the sphere of sanitary and epidemiologic wellbeing of the population;

3) development and approval within the competence of regulatory legal acts, forms of accounting and reporting documentation, legal acts, including methodical recommendations in health care, of the sphere of sanitary and epidemiologic wellbeing of the population; regulating documents in the field of safety of the food products which are subject to sanitary and epidemiological surveillance;

4) it is excluded

5) implementation of international cooperation in the field of health care;

6) the conclusion of memorandums with heads of local executive bodies of areas, cities of republican value and the capital, directed to achievement of resulting effects of activities in the field of health care and the sphere of sanitary and epidemiologic wellbeing of the population;

7) implementation of monitoring in the field of health care;

8) organization of medical care;

9) development and approval of standards and regulations in the field of health care;

10) organization of forming of healthy lifestyle and healthy food;

11) implementation of activities for forming, realization, monitoring of realization and assessment of the state social order in the field of protection of public health for non-governmental organizations, including for core groups of the population;

12) implementation of new methods of prevention, diagnostics, treatment of diseases and conditions of medical rehabilitation, and also control of them;

12-1) determination of rules of application of new methods of diagnostics, treatment and medical rehabilitation;

13) ensuring development of medical and pharmaceutical science, medical and pharmaceutical education and coordination of scientific and educational activities in the field of health care;

14) approval of rules of preparation of medical personnel in internship and residency;

14-1) approval of rules of target training with postgraduate education in the field of health care;

15) approval of the list of clinical specialties of internship, residency;

16) placement of the state educational order on preparation and advanced training of personnel in the field of health care;

17) it is excluded

18) determination of procedure for additional and informal education of specialists in the field of health care, qualification requirements to the organizations realizing educational programs of additional and informal education in the field of health care and also rules of recognition of the results of training received by specialists in the field of health care through additional and informal education;

19) approval of the state obligatory standards on the education levels in the field of health care and regulations on university hospital, the integrated academic medical center, clinical bases and requirements imposed to them;

20) approval of standard training programs on medical and pharmaceutical specialties in coordination with authorized body in the field of education;

21) preparation of professional scientific and pedagogical, medical and pharmaceutical personnel, specialists of public health and other specialists for health care system and increase in their qualification;

22) determination of procedure for conducting scientific and medical examination;

23) determination of procedure for issue of the conclusions (allowing documents) for import to the territory of the Republic of Kazakhstan from the states which are not members of the Eurasian Economic Union and export from the territory of the Republic of Kazakhstan to these states of samples of biological materials of the person, haematopoietic stem cells, marrow, donor lymphocytes for the purpose of performing unrelated transplantation, gametes and embryos;

24) it is excluded

25) approval of accreditation standards in the field of health care;

26) approval of rules of carrying out preclinical (not clinical) researches and requirements to preclinical measurement bases of biological effect of medical products;

26-1) approval of rules of performing clinical trials of medicines and medical products, clinical laboratory testing of medical products for diagnostics out of live organism (in vitro) and requirements to clinical bases;

27) development and approval of rules of encouragement of workers of the subjects of health care rendering medical services within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

28) it is excluded

29) it is excluded

30) it is excluded

31) coordination of position assignment and dismissal of heads of local authorities of public administration by health care of areas, cities of republican value and capital;

32) statement of structure and regulations on the Central commission on bioethics;

33) implementation of actions for equipment of the state organizations of health care;

34) ensuring readiness of the subordinated organizations for the prevention and treatment of diseases of the population in case of emergency situations;

35) determination of procedure for rendering paid services by subjects of health care;

36) approval of rules of the direction of citizens of the Republic of Kazakhstan on treatment abroad and (or) involvement of foreign specialists for performing treatment in the domestic medical organizations within the guaranteed amount of free medical care;

37) development and approval of rules of providing with medicines and medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

38) development and approval of rules of evaluating safety and quality of the medicines and medical products registered in the Republic of Kazakhstan;

38-1) introduction of offers on the nomenclature and amounts of storage of material values of the state reserve;

38-2) implementation of functions of the customer on acquisition of delivery services, storage of medicines and medical products of mobilization reserve and their release according to the procedure of refreshening and razbronirovaniye in cases of change of the nomenclature;

38-3) following the results of half-year – till July 15 of accounting year, following the results of year – till January 15 of the year following for reporting provides information on accounting of medicines and medical products of mobilization reserve in authorized body in the field of mobilization preparation;

39) determination of the list of socially important diseases;

40) approval of procedure for conducting examination of temporary disability, and also issue of leaf or certificate of temporary disability;

41) approval of the qualification requirements imposed to medical and pharmaceutical activities;

42) it is excluded

43) it is excluded

44) development and approval of rules of attachment of physical persons to the organizations of health care giving primary health care;

45) approval of rules of rendering specialized medical care in out-patient conditions;

46) approval of rules of rendering specialized medical care in stationary conditions;

47) approval of rules of rendering specialized medical care in hospital-replacing conditions;

48) approval of rules of rendering emergency medical service, including with involvement of medical aircraft;

49) it is excluded

50) development and approval of rules of delivery of health care according to types, stipulated in Clause 120 Codes;

50-1) development and approval of procedure for rendering medical rehabilitation;

51) development, registration, coordination, approval and modification and amendments in the State pharmacopeia of the Republic of Kazakhstan;

52) determination of the list of the medicines and medical products which are purchased from the single distributor;

53) development and approval of rules of use of technical means of control, devices of observation and fixing, photo, the video equipments used in the medical organizations for the purpose of ensuring protection of the rights of patients and health workers;

54) coordination of activities of subjects of health care;

55) determination of procedure for carrying out certification on professional competence of specialists in the field of health care;

56) it is excluded

57) development and approval of rules of forming of the register of the subjects of health care enabling the wholesale and retail realization of medical products in notifying procedure;

58) development and approval of rules of forming of the Kazakhstan national medicinal form, list of medicines and medical products for free and (or) preferential out-patient ensuring separate categories of citizens of the Republic of Kazakhstan with certain diseases (conditions), and also rules of development of medicinal forms of the organizations of health care;

59) development and approval of rules of conducting inspection in the sphere of drug circulation and medical products;

60) approval of rules of carrying out preclinical (not clinical) researches and requirements to preclinical measurement bases of biological effect of medical products;

61) approval of procedure for performing medical examinations of persons applying for receipt of the right of control of vehicles;

62) determination of procedure for accreditation in the field of health care;

63) determination of the list of the diseases constituting danger to people around, and amount of medical care in case of which kandasa, the foreigners and stateless persons which are temporarily staying in the Republic of Kazakhstan persons who are looking for shelter have the right to the guaranteed amount of free medical care;

64) it is excluded

65) it is excluded

66) determination of procedure for fence, storage and use of blood and tissues of persons who were affected by ionizing radiation;

67) approval of procedure and conditions of making and transfer of health care of anatomic gift to the organizations;

68) approval of the state standard rate of network of the organizations of health care;

69) establishment of procedure, criteria and the amount of payments to the donors who are carrying out donation of blood and its components on paid basis;

70) approval of the standard of rendering palliative medical care;

71) approval of the standard of the organization of performing laboratory diagnostics;

72) approval of the standard of the organization of rendering pathoanatomical diagnostics;

73) establishment of procedure for the organization and conducting internal and external examinations of quality of medical services (help);

74) it is excluded

75) development and approval of technique of implementation of expert evaluation of optimum technical characteristics and kliniko-technical reasons for medical products;

76) determination of order of interaction on contractual fractionation;

77) development and approval of procedure for forming of the list of orphan diseases and medicines for their treatment;

78) development and statement of structure of the first-aid kit for first-aid treatment;

79) approval of the list of orphan diseases and medicines for their treatment (orphan);

80) development and approval of the list of medical contraindications for execution of an employment agreement on hard work, works with harmful and (or) dangerous working conditions, underground works, and also for the admission to work of person belonging to dekretirovanny national group;

81) development and approval of rules of marginal forming of prices and markup on medicines and (or) medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

82) development and approval of rules of implementation of field service of medical products in the Republic of Kazakhstan;

83) development and approval of rules of the admission of foreign specialists for implementation of professional medical activity in "Nazarbaev Universiteta" or its medical organizations, in the medical organizations of Administration of the President of the Republic of Kazakhstan, and also training in the organizations of the higher and (or) postgraduate education, national and scientific centers, research institutions and the highest medical colleges which are realizing educational training programs of additional education and underwent institutional accreditation in the accreditation bodies entered in the register of acknowledged accreditation bodies based on accredited university hospitals, clinics of the organizations of education in the field of health care and base of residency;

84) development and approval of standards proper pharmaceutical practician;

85) development and approval of rules of rendering the surdologichesky help to the population of the Republic of Kazakhstan;

86) determination of procedure for giving lifetime declaration of will of the person on posthumous organ donation (part of body) and (or) fabrics (part of fabric) and the notification of the spouse (spouse) or one of close relatives on it;

87) it is excluded

88) development and approval of the instruction, algorithms and regulations in the field of health care;

89) development and approval of technique of forming (calculation) of indicators in the field of health care;

90) development and approval of rules of purchase of goods and services for implementation of examination in case of state registration of medicines and medical products and assessment of their safety and quality;

91) it is excluded

92) determination of procedure for carrying out accreditation of the test laboratories performing exclusive activities for examination and assessment of safety and quality of medicines and medical products;

93) development and approval of rules of carrying out certification of manager of health care, confirmation of action of the certificate of manager in the field of health care and rules of carrying out certification of the specialist of health care, confirmation of action of the certificate of the specialist of health care, including foreign specialists, and also admission conditions to certification of the specialist in the field of health care of person who got medical education outside the Republic of Kazakhstan;

94) it is excluded

95) development of the regulations and limits providing financial stability of fund of social medical insurance;

96) development of the annual offer on limiting establishment of size of interest rate of commission fee from assets of fund of the social medical insurance aimed at providing activities of fund of social medical insurance;

97) it is excluded

98) development and determination of procedure and terms of calculation (deduction) and transfer of assignments and (or) fees on compulsory social medical insurance;

99) development of the size of reserve of fund of social medical insurance on covering of contingencies;

100) development and approval of rates for the medical services provided within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

101) forming of the list of GOBMP;

102) development of the list of financial instruments for investment of assets of fund of social medical insurance;

103) development and approval of the list, forms, terms of submission of financial and other reporting by fund of social medical insurance for ensuring control functions;

104) implementation of the analysis, assessment and control of financial stability of fund of social medical insurance;

105) development and approval of rules and technique of forming of rates for the medical services rendered within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

106) approval of rules of rendering high-technology medical care;

106-1) development and approval of rules of rendering specialized, including high-technology, medical care;

107) it is excluded

108) development and approval of rules of marginal forming of prices and markups on medicines and (or) medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

109) development and approval of rules of wholesale and retail sale of medicines and medical products;

110) approval of procedure for forming of the joint commission on quality of medical services, regulations on its activities;

111) development and approval of rules of purchase of services at subjects of health care in delivery of health care within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

112) price fixation on the goods (works, services) made and (or) realized by the subject of the state monopoly in coordination with antimonopoly authority;

113) establishment of the list of diseases in the presence of which person cannot adopt the child, accept it under guardianship or custody, patronage;

114) it is excluded

115) development and approval of the subordinate regulatory legal acts determining procedure for rendering the state services;

116) approval of checking sheets and criteria for evaluation of risk degree together with authorized body on entrepreneurship;

117) approval of the minimum social standards in spheres of health care;

118) rendering within the competence of the state services, including electronic;

119) placement of the state educational order on preparation and advanced training of personnel in the field of health care;

120) the organization of explanatory work among the population concerning protection of public health, sanitary and epidemiologic wellbeing of the population;

121) creation advisory and consultative and commissions of experts;

122) ensuring departmental statistical observation in the field of health care;

123) interaction with public associations on realization of state policy in the field of health care;

124) implementation of interaction and cooperation with the youth organizations for health care;

125) consideration of appeals of physical persons and legal entities concerning health care;

126) methodical and organizational coordination of work of authorized state bodies, subjects of health care and other organizations in the field of health care, protection of public health;

126-1) development of the list of the state bodies responsible for provision of data on the categories of persons specified in Item 1 of article 26 of the Law of the Republic of Kazakhstan "About compulsory social medical insurance" and on the foreigners who are temporarily staying in the territory of the Republic of Kazakhstan and being labor migrants and also members of their families from state members of the Eurasian Economic Union in the State corporation for further transfer to information system of compulsory social medical insurance;

127) creation and ensuring functioning of electronic information resources and information systems, information and communication networks in the field of health care, in the sphere of sanitary and epidemiologic wellbeing of the population, the organization of access of physical persons and legal entities to them according to the legislation of the Republic of Kazakhstan in the sphere of informatization;

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