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I.O'S ORDER. MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of August 2, 2016 No. 684

About some questions of Committee of control of medical and pharmaceutical activities of the Minister of health and social development of the Republic of Kazakhstan

According to the order of the Government of the Republic of Kazakhstan of September 23, 2014 No. 1005 "About some questions of the Ministry of health and social development of the Republic of Kazakhstan", PRIKAZYVAYU:

1. Approve the Provision:

1) public institution "Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan" (further - the Provision) according to appendix 1 to this order;

2) public institution "Department of Committee of control of medical and pharmaceutical activities for the city of Astana of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 2 to this order;

3) public institution "Department of Committee of control of medical and pharmaceutical activities for the city of Almaty of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 3 to this order;

4) public institution "Department of Committee of control of medical and pharmaceutical activities for Akmola area of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 4 to this order;

5) public institution "Department of Committee of control of medical and pharmaceutical activities for the Aktyubinsk region of the Ministry of health and social development of the Republic of Kazakhstan" it agrees appendix 5 to this order;

6) public institution "Department of Committee of control of medical and pharmaceutical activities for Almaty region the Ministries of health and social development of the Republic of Kazakhstan" according to appendix 6 to this order;

7) public institution "Department of Committee of control of medical and pharmaceutical activities for Atyrau area of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 7 to this order;

8) public institution "Department of Committee of control of medical and pharmaceutical activities for the East Kazakhstan region of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 8 to this order;

9) public institution "Department of Committee of control of medical and pharmaceutical activities for Jambyl area of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 9 to this order;

10) public institution "Department of Committee of control of medical and pharmaceutical activities for the West Kazakhstan region of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 10 to this order;

11) public institution "Department of Committee of control of medical and pharmaceutical activities for the Karaganda region the Ministries of health and social development of the Republic of Kazakhstan" according to appendix 11 to this order;

12) public institution "Department of Committee of control of medical and pharmaceutical activities for the Kostanay region the Ministries of health and social development of the Republic of Kazakhstan" according to appendix 12 to this order;

13) public institution "Department of Committee of control of medical and pharmaceutical activities for Kyzylorda area of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 13 to this order;

14) public institution "Department of Committee of control of medical and pharmaceutical activities for Mangystau Region the Ministries of health and social development of the Republic of Kazakhstan" according to appendix 14 to this order;

15) public institution "Department of Committee of control of medical and pharmaceutical activities for the Pavlodar region the Ministries of health and social development of the Republic of Kazakhstan" according to appendix 15 to this order;

16) public institution "Department of Committee of control of medical and pharmaceutical activities for the North Kazakhstan area of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 16 to this order;

17) public institution "Department of Committee of control of medical and pharmaceutical activities for the Southern Kazakhstan area of the Ministry of health and social development of the Republic of Kazakhstan" according to appendix 17 to this order.

2. Declare invalid the order of the Minister of health and social development of the Republic of Kazakhstan of October 17, 2014 No. 147 "About some questions of Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan" (registered in the Register of state registration of regulatory legal acts on October 25, 2014 at No. 9833, it is published in information system of law of Ad_let on January 13, 2015).

3. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan in the procedure established by the legislation:

1) in week time from the date of its signing the direction of the copy of this order in the Ministry of Justice of the Republic of Kazakhstan, information system of law of Ad_let and periodic printing editions;

2) the direction of the copy of this order within five working days from the date of its signing in the Republican state company on the right of economic maintaining "The republican center of legal information" of the Ministry of Justice of the Republic of Kazakhstan for inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan.

4. To impose control of execution of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

5. This order becomes effective from the date of its signing.

The subitem 35) of Item 14 of the Provision is effective till January 1, 2017.

Acting minister of health care and social development of the Republic of Kazakhstan

A. Tsoi

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of August 2, 2016 No. 684

Provision of public institution "Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan"

Chapter 1. General provisions

1. Public institution "Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan" (further - Committee) is the department of the Ministry of health and social development of the Republic of Kazakhstan (further – the Ministry) performing regulating, realizable and control functions in the sphere of rendering medical services and drug circulation, products of medical appointment and medical equipment within competence.

2. The committee 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.

3. The committee 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.

4. The committee enters the civil relations from own name.

5. The committee 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.

6. The committee on questions of the competence of the procedure established by the legislation makes the decisions which are drawn up by orders of the chairman of Committee.

7. The structure and limit of the number of staff of Committee affirm according to the legislation of the Republic of Kazakhstan.

8. Committee location: Republic of Kazakhstan, 010000, city of Astana, Esilsky district, Ulitsa Orynbor, house 8, office building "House of the ministries", 5-6 entrances.

9. Full name of Committee - Public institution "Committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan".

10. This Provision is the constituent document of Committee.

11. Financing of activities of Committee is performed from the republican budget.

12. The committee is forbidden to enter contractual relations with subjects of entrepreneurship regarding accomplishment of the obligations which are functions of Committee.

If the Committee 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.

Chapter 2. Main objectives and functions, rights and obligations of Committee

13. Main objectives of Committee:

1) realization of state policy in the field of the state control in the sphere of rendering medical services and drug circulation, products of medical appointment and medical equipment;

2) monitoring of providing population and organizations of health care with safe, effective and high-quality medicines, products of medical appointment and medical equipment;

3) quality assurance and availability of the state services in the sphere of medical and pharmaceutical activities.

14. Functions of Committee:

1) consideration of appeals of physical persons and legal entities concerning entering competence of Committee;

2) development of procedure for issue of the conclusions (allowing documents) for import to the territory of the Republic of Kazakhstan and export from the territory of the Republic of Kazakhstan of haematopoietic stem cells, marrow in case of their movement for the purpose of performing unrelated transplantation, and also samples of cages, fabrics, biological liquids and secrets, including the waste products of the person, physiological and pathological allocations, dabs, scrapes, washouts intended for the diagnostic scientific purposes or received in the course of carrying out biomedical researches;

3) development of structure and regulations on the form commission of the Ministry of health and social development of the Republic of Kazakhstan (further – the Ministry);

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

5) development of the qualification requirements imposed to medical and pharmaceutical activities;

6) development of standards and regulations of the state services in the sphere of medical and pharmaceutical activities;

7) development of the State pharmacopeia of the Republic of Kazakhstan;

8) development of checking sheets, criteria for evaluation of risk degree according to the Entrepreneurial code of the Republic of Kazakhstan;

9) development of procedure for providing citizens with medicines, including rational use of medicines;

10) development of the list of orphan medicines;

11) development of rules of pricing on medicines and products of medical appointment within the guaranteed amount of free medical care;

12) development of procedure for development and approval of the Kazakhstan national medicinal form, and also procedure for development and coordination of medicinal forms of the organizations of health care;

14) realization of state policy in the field of control in the sphere of drug circulation, products of medical appointment and medical equipment;

15) hearing of cases about administrative offenses and imposing of administrative punishments according to the legislation of the Republic of Kazakhstan on administrative offenses;

16) taking measures to suspension of operations or separate types of activity in the field of health care of individual entrepreneurs or legal entities according to the legislation of the Republic of Kazakhstan on administrative offenses;

17) implementation within the competence of the state control of observance by licensees of the legislation of the Republic of Kazakhstan;

18) implementation of the subject state control of evaluating safety and quality of the registered medicines and the products of medical appointment registered in the Republic of Kazakhstan;

19) implementation of the state control of activities of subjects of health care, including behind observance of standards in the field of health care, rules of licensing on occupation medical and pharmaceutical activities, and also notifying procedure in the field of health care;

20) implementation of the state control of implementation of new methods of prevention, diagnostics, treatment and medical rehabilitation;

21) implementation of the state control in the sphere of drug circulation, products of medical appointment and medical equipment, and also behind drug trafficking, psychotropic substances and precursors in the field of health care;

22) implementation of the state control of advertizing of medical services, medicines, products of medical appointment and medical equipment;

23) implementation of the state control of rational prescription of medicines at all levels of delivery of health care;

24) implementation of the state control of effective use of medical equipment in the organizations of health care;

25) implementation of the state control of activities of subjects of rendering services of traditional medicine, traditional medicine (healing);

26) rendering within the competence of the state services of the sphere of medical and pharmaceutical activities;

27) licensing of import to the territory of the Republic of Kazakhstan from the countries which are not entering into the Customs union and export from the territory of the Republic of Kazakhstan to these countries of bodies (part of bodies) and (or) tissues of the person, blood and its components;

28) issue of the conclusions (allowing documents) for import to the territory of the Republic of Kazakhstan and export from the territory of the Republic of Kazakhstan of haematopoietic stem cells, marrow in case of their movement for the purpose of performing unrelated transplantation, and also samples of cages, fabrics, biological liquids and secrets, including the waste products of the person, physiological and pathological allocations, dabs, scrapes, washouts intended for the diagnostic scientific purposes or received in the course of carrying out biomedical researches;

29) implementation of issue of the conclusions (allowing documents), coordination on import to the territory of the Republic of Kazakhstan of medicines, products of medical appointment and medical equipment (including unregistered) as the humanitarian assistance or the help in case of emergency situations;

30) issue of permissions to performing clinical trials pharmacological and medicines;

31) implementation of coordination of questions on carrying out certification of specialists in the field of health care for the admission to clinical practice;

32) implementation of coordination of questions on issue of the certificate on assignment of qualification category for specialists with medical and pharmaceutical education;

33) implementation of state registration, re-registration, modification of the registration file, withdrawal of the decision on state registration of medicines, products of medical appointment and medical equipment, maintaining the State register of medicines, products of medical appointment and medical equipment;

34) decision making about suspension of medical application of medicine, product of medical appointment and medical equipment by suspension of action of the registration certificate of medicine, product of medical appointment and medical equipment, and also about prohibition of medical application and retirement or suspension of medical application of series (batch) of medicines, products of medical appointment and medical equipment;

35) is not effective according to Item 5.

36) the organization and carrying out accreditation of physical persons for conducting independent examination of activities of subjects of health care;

37) forming of databank of accredited subjects and independent experts in the field of health care;

38) accreditation of the organizations performing assessment of professional readiness and confirmation of conformity of qualification of specialists in the field of health care;

39) accreditation of the medical organizations on the right of performing clinical trials pharmacological and medicines, products of medical appointment and medical equipment;

40) accreditation of test laboratories on the right of carrying out preclinical (not clinical) researches of biologically active agents, products of medical appointment;

41) accreditation of the test laboratories performing exclusive activities for examination and assessment of safety and quality of medicines, products of medical appointment;

42) organization and carrying out monitoring of activities of accredited subjects of health care;

43) issue of coordination and (or) the conclusion (the allowing document) for import (export) of the medicines registered and not registered in the Republic of Kazakhstan, products of medical appointment and medical equipment;

44) implementation of coordination concerning issue to foreigners of the certificate of the specialist, for the admission to clinical practice except for persons invited to implementation of professional medical activity in National holding in the field of health care and its affiliated organizations and also in "Nazarbaev Universitet" or its medical organizations, in the medical organizations of Administration of the President of the Republic of Kazakhstan;

45) holding actions for determination of compliance of the subject of health care to requirements to rendering highly specialized medical care;

46) participation in implementation of actions for equipment of the state organizations of health care;

47) implementation of state regulation of the prices of medicines, within the guaranteed amount of medical care;

48) the organization and carrying out the state certification of the organizations of education in the field of health care;

49) carrying out certification of heads of local authorities of public administration of health care of areas, cities of republican value and capital and their deputies, heads of the organizations subordinated to authorized body, their deputies, and also heads of branches;

50) development of lists of medicines, products of medical appointment, within the guaranteed amount of free medical care, including purchased from the single distributor;

51) recognition of standards of the international and foreign pharmacopeias, and also pharmakopeyny Articles (monographs) and other regulating documents on standardization on medicines, products of medical appointment and medical equipment of foreign states;

52) implementation of pharmaceutical inspection;

53) issue of the certificate on pharmaceutical product (SRR);

54) implementation of coordination and monitoring of questions on withdrawal of the certificate on assignment of qualification category for specialists with medical and pharmaceutical education;

55) implementation of monitoring in the sphere of drug circulation, products of medical appointment and medical equipment;

56) determination of degree of satisfaction of citizens with level and quality of the provided medical care;

57) implementation of the state control of conducting examination and assessment of production of medicines, products of medical appointment and medical equipment in case of their state registration;

58) implementation of other functions, stipulated by the legislation Republic of Kazakhstan.

15. Rights and obligations of Committee:

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

2) to make suggestions for improvement of single state policy in the field of public health care, to the development of concepts, strategy, regulatory legal acts, normative and technical documents on questions entering competence;

3) to make offers on development of programs in the field of control in the sphere of rendering medical services and drug circulation, products of medical appointment and medical equipment, and also to participate in development of the state and industry (sectoral) programs on protection of public health, and also programs of intrahospital management and efficiency evaluation of work of the organizations of health care;

4) to make offers when forming the Medicinal form;

5) to perform other rights provided by the current legislation of the Republic of Kazakhstan;

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