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

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".

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, and also cross-industry coordination in spheres:

1) protection of public health;

2) medical and pharmaceutical science, education and industry;

3) drug circulation, medical products and control of its address;

4) control of quality of rendering medical services (help);

5) sanitary and epidemiologic wellbeing of the population, control and supervision of observance of the requirements established by technical regulations and regulating documents;

6) safety of food products at stage of its realization;

7) biological safety.

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 of the Republic of Kazakhstan and 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 with the image of the State Emblem of the Republic of Kazakhstan and stamps with the name in Kazakh, forms of the established sample, accounts in bodies of treasury according to the legislation of the Republic of Kazakhstan.

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 of the Republic of Kazakhstan.

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 legislation of the Republic of Kazakhstan.

9. Ministry location: The city of Astana, Esilsky district, Prospekt Mang_l_k ate 010000,, the house 8, the office building "The house of the ministries", 5 entrance.

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

11. Financing of activities of the Ministry is performed from the republican budget according to the legislation of the Republic of Kazakhstan.

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

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

Chapter 2. Tasks and powers of the Ministry

13. Tasks:

1) forming and realization of state policy, implementation of cross-industry coordination and public administration in spheres:

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

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

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

medical and pharmaceutical industry;

2) implementation of other tasks assigned to the Ministry within the competence.

14. Powers:

1) rights:

adopt legal acts, obligatory for execution, within the competence;

request and receive in the procedure established by the legislation from state bodies, other organizations, their officials necessary information and materials;

create advisory and consultative and commissions of experts within the competence;

take a legal action, make claims for the purpose of protection of the rights and interests of the Ministry and its departments according to the legislation of the Republic of Kazakhstan;

create priorities of scientific developments of fundamental and applied nature, coordinate scientific maintenance in the sphere of sanitary and epidemiologic wellbeing of the population;

delegate part of the powers and functions to departments;

perform other powers provided by legal acts, acts of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan;

2) obligations:

observe the legislation of the Republic of Kazakhstan, it is right also the interests of physical persons and legal entities protected by the law;

accept and consider appeals of physical persons and legal entities according to the procedure and the terms established by the Administrative procedural Procedure Code of the Republic of Kazakhstan;

provide timely and high-quality execution of orders of the Head of state, Administration of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan, and also plans of bill works of the Government of the Republic of Kazakhstan for the corresponding years;

not disclose information, component commercial, office, other, the secret protected by the law received when implementing the powers, except as specified, established by the laws of the Republic of Kazakhstan;

exercise coordination and control of activities of departments, their territorial authorities, and also subordinated organizations of the Ministry.

15. Functions:

1) forming and realization of state policy in the field of health care, in spheres of rendering medical services (help), drug circulation and medical products, sanitary and epidemiologic wellbeing of the population, and also safety of products which are subject to the state sanitary and epidemiologic control and supervision, biological safety;

2) development and program implementation in the field of health care, in spheres of rendering medical services (help), sanitary and epidemiologic wellbeing of the population, drug circulation and medical products;

3) development and approval within the competence of regulatory legal acts and forms of accounting and reporting documentation in health care;

4) implementation of international cooperation in the field of health care, including concerning educational and scientific activities;

5) No. 307 is excluded according to the Order of the Government of the Republic of Kazakhstan of 14.04.2023

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

7) implementation of the organization of medical care;

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

8-1) development and approval of standards of rendering special social services in the field of health care in coordination with authorized bodies in spheres of social protection of the population and education;

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

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

11) approval of rules of application of new methods of diagnostics, treatment and medical rehabilitation;

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

12-1) control in the sphere of provision of special social services;

12-2) coordination of rules of assessment and determination of need for special social services;

13) approval of rules of preparation of medical personnel in internship;

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

15) approval of rules of target training with postgraduate education in the field of health care;

16) approval of the list of programs of the life-long integrated education for clinical specialties;

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

18) recognition acting in the territory of the Republic of Kazakhstan of requirements of the leading pharmacopeias of the world;

19) 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;

20) 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;

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

22) 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;

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

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

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

26) 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) coordination of appointment to positions and releases from positions of heads of local authorities of public administration as health care of areas, cities of republican value and capital;

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

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

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

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

33) 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;

34) development and approval of rules of providing with medicines and medical products within the guaranteed amount of free medical care, additional amount of medical care of persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance;

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

36) development and entering of offers into authorized body in the field of the state material reserve according to the nomenclature and amounts of storage of material values of the state reserve;

37) 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) 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, submission of information on accounting of medicines and medical products of mobilization reserve to 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) development and approval of the qualification requirements imposed to medical and pharmaceutical activities;

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

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

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

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

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

47) development and approval of rules of delivery of health care according to types, stipulated in Clause 120 Codes of the Republic of Kazakhstan "About health of the people and health care system" (further – the Code);

48) development and approval of procedure for rendering medical rehabilitation;

49) determination of procedure for development, registration, coordination, approval and modification and amendments in the State pharmacopeia of the Republic of Kazakhstan;

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

51) 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;

52) coordination of activities of subjects of health care;

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

53-1) development of the program of certification of social workers according to the professional standard;

54) 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;

55) 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;

56) development and approval of rules of performing medical examinations of persons applying for receipt of the right of control of vehicles;

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

57-1) determination of the list and amount of medical care within the guaranteed amount of free medical care to the foreigners and stateless persons revealed and identified as the victims of human trafficking in the territory of the Republic of Kazakhstan;

57-2) taking measures to the prevention of human trafficking;

57-3) participation in risks assessment in the sphere of counteraction to human trafficking and the introduction of offers on their minimization according to the procedure established by the legislation of the Republic of Kazakhstan;

57-4) participation in the redirection of the victims of human trafficking for rendering to them the help and provision of special social services according to the procedure established by the legislation of the Republic of Kazakhstan;

57-5) informing law-enforcement bodies on the facts which became known the preparing or committed crimes connected with human trafficking;

57-6) informing the public on results of activities in the sphere of counteraction to human trafficking;

57-7) coordination of work on provision to the victims of human trafficking of the guaranteed amount of free medical care;

57-8) participation in actions for the prevention of human trafficking together with other state bodies and the organizations;

58) development and approval of rules of fence, storage and use of blood and tissues of persons who were affected by ionizing radiation;

59) determination of procedure and conditions of making and transfer of health care of anatomic gift to the organizations;

60) development and approval of the state standard rate of network of the organizations of health care;

61) 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;

62) development and approval of the standard of rendering palliative medical care;

63) development and approval of the standard of the organization of performing laboratory diagnostics;

64) development and approval of the standard of the organization of rendering pathoanatomical diagnostics;

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

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

67) development and approval of rules of interaction on contractual fractionation;

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

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

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

71) 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;

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

73) 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;

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

75) 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;

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

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

78) 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;

79) 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;

80) 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;

81) setting standards and the limits providing financial stability of fund of social medical insurance;

82) development of the 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;

82-1) annual establishment of size of interest rate of commission fee of fund of social medical insurance within the extreme size established by the Government of the Republic of Kazakhstan;

83) development and determination of procedure and terms of calculation (deduction) and transfer of assignments and (or) fees in fund of social medical insurance;

84) establishment of the size of reserve of fund of social medical insurance on covering of contingencies;

85) 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;

86) forming of the list of the guaranteed amount of free medical care;

87) determination of the list of financial instruments for investment of assets of fund of social medical insurance in coordination with National Bank of the Republic of Kazakhstan, the central authorized bodies on the state and budgetary planning;

87-1) development and approval of rules of collection of commission fee by fund of social medical insurance;

88) approval of forms and terms of provision by fund of social medical insurance of the reporting under funds for delivery of health care;

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

90) 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;

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

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

93) 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;

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

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

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

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

97-1) determination of criteria for evaluation of availability of the ill treatment which led to social disadaptation and social deprivation together with the Ministry of Internal Affairs of the Republic of Kazakhstan and authorized bodies in spheres of social protection of the population and education;

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

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

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

101) creation advisory and consultative and commissions of experts;

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

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

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

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

106) 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;

107) 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;

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