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

According to the Presidential decree of the Republic of Kazakhstan of August 6, 2014 No. 875 "About reform of system of public administration of the Republic of Kazakhstan" and 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 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" 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. In the procedure established by the legislation to provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan (further - Committee):

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

2) within ten calendar days after state registration of this order its direction on official publication in mass media and information system of law of Ad_let;

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

3. This order becomes effective from the date of state registration and is subject to official publication.

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of October 17, 2014 No. 147

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"

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 in 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. Place finding of Committee: 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 - republican 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.

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) 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 purposes or received in the course of carrying out biomedical researches;

2) development of provision and procedure for activities of the form commission on questions of rational use of medicines;

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

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;

7) development of forms of the obligatory departmental reporting, checking sheets, criteria for evaluation of risk degree according to the Law of the Republic of Kazakhstan "About the state control and supervision in the Republic of Kazakhstan";

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

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

10) suspension of operations or separate types of activity of the individual entrepreneur or legal entity according to the legislation of the Republic of Kazakhstan on administrative offenses;

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

12) implementation within the competence of the activities connected with licensing for the types of activity which are subject to licensing and ensuring the state control of observance by licensees of the legislation of the Republic of Kazakhstan;

13) 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;

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

15) 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;

16) issue of permissions to performing preclinical (not clinical) and clinical trials pharmacological and medicines, and also clinical trials of medical technologies;

17) 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;

18) determination of compliance of the subject of health care to requirements to rendering highly specialized medical care;

19) development and approval of the State pharmacopeia of the Republic of Kazakhstan;

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

21) the organization of holding qualification examinations in the field of health care;

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

23) carrying out certification on professional competence of heads of local authorities of public administration by health care, the republican organizations of health care and their deputies (having medical education);

24) implementation of acceptance of notifications on the beginning or the termination of implementation of activities in the field of health care according to the procedure provided by the Law of the Republic of Kazakhstan "About permissions and notifications" and also maintaining the state electronic register of permissions and notifications;

25) organization and carrying out accreditation of subjects of health care;

26) accreditation of physical persons for conducting independent examination of activities of subjects of health care;

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

28) issue of permissions to advertizing of medicines, products of medical appointment and medical equipment, dietary supplements to food;

29) implementation of state regulation of the prices of medicines and the medical services rendered by the state organizations of health care;

30) control of activities of subjects of health care, including of 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;

31) control of implementation of new methods of prevention, diagnostics, treatment and medical rehabilitation;

32) 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;

33) control of advertizing of medical services, medicines, products of medical appointment and medical equipment;

34) determination of the list of medicines, the products of medical appointment which are purchased from the single distributor on purchase and ensuring with medicines, products of medical appointment;

35) 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;

36) control of rational prescription of medicines at all levels of delivery of health care;

37) control of effective use of medical equipment in the organizations of health care;

38) control of activities of subjects of rendering services of traditional medicine, traditional medicine (healing);

39) 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;

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

7) to exercise coordination and control of activities of territorial subdivisions of Committee;

8) to perform other obligations provided by the existing legal acts.

3. Organization of activities of Committee

16. Management of Committee is performed of the Chairman (further - the Chairman) who bears the personal responsibility for accomplishment of the tasks assigned to Committee and implementation of the functions by it.

17. The chairman of Committee is appointed to position and dismissed according to the legislation of the Republic of Kazakhstan.

18. The chairman of Committee has deputies who are appointed to positions and are dismissed according to the legislation of the Republic of Kazakhstan.

19. Powers of the Chairman of Committee:

1) according to the legislation, appoints and dismisses employees of Committee, except for workers whose questions of employment relationships according to legal acts are carried to competence of the higher official;

2) determines obligations and powers of vice-chairmen of Committee;

3) determines obligations and powers of heads of structural divisions of Committee;

4) determines obligations and powers of heads and deputy managers of territorial subdivisions of Committee;

5) in the procedure established by the legislation resolves issues of sending, provision of leaves, rendering financial support, preparation (retraining), advanced training, encouragement, payment of allowances and awarding of employees of Committee, heads of territorial subdivisions and their deputies;

6) resolves issues of imposing of authority punishments on employees of Committee, except for workers whose questions of employment relationships according to legal acts are carried to competence of the higher official;

7) is represented by Committee in state bodies and other organizations, irrespective of patterns of ownership;

8) according to the legislation makes decisions on presentation on behalf of Committee of claims and claims to legal entities and physical persons;

9) makes decisions on the questions entering competence of Committee;

10) approves regulatory legal acts on the questions entering competence with direct competence on their approval of acts of the ministry, except for the regulatory legal acts affecting rights and freedoms of man and citizen;

11) takes the measures directed to anti-corruption in Committee.

Execution of powers of the Chairman of Committee in the period of its absence is performed by person replacing it according to the current legislation.

20. The chairman of Committee determines powers of the deputies according to the current legislation of the Republic of Kazakhstan.

4. Property of Committee

21. The committee has on the right of operational management the isolated property, in cases, stipulated by the legislation the Republic of Kazakhstan.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info