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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 5, 2018 No. 228

About some questions of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan

(as amended of the Order of the Minister of Health of the Republic of Kazakhstan of 05.11.2018 No. 610)

According to the order of the Government of the Republic of Kazakhstan of December 29, 2017 No. 942 "About reorganization of departments of the Ministry of Health of the Republic of Kazakhstan", PRIKAZYVAYU:

1. Approve Provisions:

1) republican public institution "Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan" according to appendix 1 to this order;

2) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on the city of Astana" according to appendix 2 to this order;

3) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on the city of Almaty" according to appendix 3 to this order;

4) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on Akmola area" according to appendix 4 to this order;

5) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on the Aktyubinsk region" it agrees appendix 5 to this order;

6) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan across Almaty region" according to appendix 6 to this order;

7) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on Atyrau area" according to appendix 7 to this order;

8) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan across the East Kazakhstan region" according to appendix 8 to this order;

9) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on Jambyl area" according to appendix 9 to this order;

10) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan across the West Kazakhstan region" according to appendix 10 to this order;

11) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan across the Karaganda region" according to appendix 11 to this order;

12) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan across the Kostanay region" according to appendix 12 to this order;

13) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on Kyzylorda area" according to appendix 13 to this order;

14) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan across Mangystau Region" according to appendix 14 to this order;

15) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan across the Pavlodar region" according to appendix 15 to this order;

16) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on the North Kazakhstan area" according to appendix 16 to this order;

17) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on the Turkestan region" according to appendix 17 to this order;

18) republican public institution "Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan on the city of Shymkent" according to appendix 18 to this order.

2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan:

1) within ten calendar days from the date of adoption of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after official publication.

3. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Tsoi A. V.

4. This order becomes effective from the date of its first official publication.

Minister of Health of the Republic of Kazakhstan

E.Birtanov

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of May 5, 2018 No. 228

Provision of republican public institution "Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan"

Chapter 1. General provisions

1. Republican public institution "Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan" (further - Committee) is the department of the Ministry of Health of the Republic of Kazakhstan (further - the Ministry) performing within the competence regulating, realizable, control functions in the sphere of drug circulation, products of medical appointment and medical equipment. The committee has territorial subdivisions.

2. The committee performs the activities according to the Constitution and the laws of the Republic of Kazakhstan, acts of the President and 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 of the account in bodies of treasury.

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 of the Republic of Kazakhstan.

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 and its territorial subdivisions affirms according to the current legislation.

8. Committee location: Republic of Kazakhstan, 010000, city of Astana, Esilsky district, Prospekt Mang_l_k El, house 8, office building "House of the ministries", 5th entrance.

9. Full name of Committee - republican public institution "Committee of pharmacy of the Ministry of Health 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 goes to the income of the government budget.

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

13. The main objectives of Committee are:

1) realization of state policy, implementation of cross-industry coordination and public administration in the field of the organization of providing the population and the organizations of health care with safe, effective and high-quality medicines with products, medical appointment and medical equipment;

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

14. Functions of Committee:

1) realization of state policy in the field of health care within the competence;

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

3) implementation of issue of the conclusions (allowing documents) for 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;

4) acceptance of the notification on carrying out preclinical (not clinical) researches of biologically active agents;

5) issue of permissions to performing preclinical (not clinical) and clinical trials pharmacological and medicines, products of medical appointment and medical equipment;

6) 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;

7) 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 you will lock medical application and retirement or suspension of medical application of series (batch) of medicines, products of medical appointment and medical equipment;

8) implementation of state regulation of the prices of medicines, products of medical appointment within the guaranteed amount of free medical care (further - GOBMP) and in system of compulsory social medical insurance (further - OSMS);

9) 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 pharmaceutical activities, and also notifying procedure in the field of health care;

10) 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;

11)  No. 610 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 05.11.2018;

12)  No. 610 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 05.11.2018;

13)  No. 610 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 05.11.2018;

14) 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;

15)  No. 610 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 05.11.2018;

16)  No. 610 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 05.11.2018;

17) coordination of import (export) of the medicines registered and not registered in the Republic of Kazakhstan, products of medical appointment and medical equipment;

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

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

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

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

22) participation in development of the list of medicines and products of medical appointment for providing citizens within GOBMP and in the OSMS system, including separate categories of citizens with certain diseases (conditions) of free and (or) preferential medicines, products of medical appointment and specialized medical products at the out-patient level;

23) coordination of information company on increase in medicinal literacy of health, pharmaceutical workers and the populations;

24) development of rules of pricing on medicines and products of medical appointment within GOBMP and OSMS;

25) coordination of activities of the Form commission of the Ministry within competence;

26) development of structure and regulations on the Form commission of the Ministry;

27) development of the list of orphan medicines;

28) development of rules of 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;

29) development of the Kazakhstan national medicinal form;

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

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

32) development of technique of implementation of expert evaluation of optimum technical characteristics and kliniko-technical reasons for medical equipment;

33) development proper pharmaceutical practician;

34) marginal forming of prices for purchase of medicines and products of medical appointment within GOBMP and OSMS;

35) development of procedure for wholesale and retail sale of medicines, products of medical appointment and medical equipment;

36) development of rules of the organization and carrying out purchase of medicines, preventive (immunobiological, diagnostic, disinfecting) medicines, products of medical appointment and medical equipment, pharmaceutical services in rendering GOBMP and medical care in the OSMS system;

37) development of the list of the medicines, products of medical appointment and medical equipment which are purchased from the single distributor;

38) development of the qualification requirements imposed to pharmaceutical activities;

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

40) development of checking sheets and criteria for evaluation of risk degree in the sphere of drug circulation, products of medical appointment and medical equipment;

41) development of rules of conducting inspection in the sphere of drug circulation, products of medical appointment and medical equipment;

42) implementation of pharmaceutical inspections on compliance to proper pharmaceutical practicians;

43) excitement, hearing of cases about administrative offenses and imposing of administrative punishments according to the procedure, established by the Code of the Republic of Kazakhstan about administrative offenses;

44) taking measures to 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;

45) participation in the course of Eurasian integration in the sphere of drug circulation and medical products within the Eurasian Economic Union;

46) participation in tariff setting on the medical services provided within GOBMP at the expense of means of the republican budget and in the OSMS system regarding ensuring with medicines and products of medical appointment, and also their planning and accounting;

47) participation in forming of reference books of medicines and products of medical appointment in information systems of health care;

48) forming of requirement and planning of budgetary funds for purchase of medicines and medical products, according to the list of medicines and products of medical appointment for providing citizens within GOBMP and in the OSMS system, including separate categories of citizens with certain diseases (conditions) of free and (or) preferential medicines, products of medical appointment and specialized medical products at the out-patient level;

49) development of rules of implementation of field service of medical equipment in the Republic of Kazakhstan;

50) consideration of appeals of physical persons and legal entities within competence;

51) implementation of other functions provided by the laws and other regulatory legal acts adopted by the President of the Republic of Kazakhstan, the Government of the Republic of Kazakhstan and the Ministry.

15. Rights and obligations of Committee:

1) to adopt regulatory legal acts, obligatory for execution, within the competence;

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

3) 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;

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

5) to 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;

6) to take a legal action in case of failure to carry out or inadequate accomplishment by physical persons and legal entities of the legal requirements or instructions issued by officials of Committee and its territorial subdivisions;

To create 7) advisory and consultative and commissions of experts within the competence;

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

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

10) to make offers on development of programs in the field of 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;

11) to develop regulatory legal acts on the questions carried to competence of Committee;

12) to perform other rights provided by the existing legal acts.

Chapter 3. Organization of activities of Committee

16. Management of Committee is performed of the Chairman - the chief state pharmaceutical inspector of the Republic of Kazakhstan 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:

Appoints 1) according to the legislation 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 heads and employees of structural divisions of Committee;

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

4) carries out annual assessment of activities of employees of Committee for determination of efficiency and quality of their work, except for workers whose questions of employment relationships according to legal acts are carried to competence of the higher official;

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, deputy managers of territorial subdivisions;

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;

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