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CODE OF THE REPUBLIC OF KAZAKHSTAN

of September 18, 2009 No. 193-IV ZRK

About health of the people and health care system

(as amended on 19-04-2019)

General part

Section 1. General provisions

Chapter 1. Basic provisions

Article 1. The basic concepts used in this Code

1. In this Code the following basic concepts are used:

1) the authorized generic - the medicine identical to original medicine issued by the same producer, but differing in the trade name and the price;

1-1) habitats of the person (further - the habitat) - set of natural, anthropogenous and social factors, the environments (natural and artificial) determining conditions of activity of the person;

2) HIV - human immunodeficiency virus;

3) anonymous inspection - voluntary physical examination of person without identification of the personality;

4) medicine of catastrophic crashes - the industry of medicine and health care directed to the prevention and liquidation of medical and sanitary consequences of emergency situations of social, natural and technogenic nature (further - emergency situations), including the warning and treatment of diseases of the population, sanitary and anti-epidemic and sanitary and preventive actions, preserving and recovery of health of participants of liquidation of emergency situations, and also medical care to the staff of rescue services;

5) potentially dangerous chemical and biological substances - substances which under certain conditions and in certain concentration can exert adverse effect on health of the person or future generation which application and use is regulated by regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population and hygienic standard rates;

5-1) fund of social medical insurance - the non-profit organization making accumulation of assignments and fees, and also performing purchase and fee of the subjects of health care providing medical care in amounts and on the conditions provided by the agreement of purchase of medical services and other functions determined by the laws of the Republic of Kazakhstan;

6) military medicine - the industry of medicine and health care representing system of scientific knowledge (complex of scientific and practical disciplines) and practical activities of military-medical service, aiming at comprehensive medical support of troops in peace and wartime;

7) the military-medical help - the medical care provided by specialists of military-medical service to the military personnel and persons injured with use of military weapon;

8) military-medical service - set of military-medical (medical) divisions in which the laws of the Republic of Kazakhstan provide the military or special service intended for medical support of activities of these bodies;

9) military-medical (medical) divisions:

the structural divisions of the central executive bodies and other central state bodies performing the organization and coordination of activities of military-medical (medical) organizations (organizations);

military-medical (medical) organizations (organizations) and other divisions of the central executive bodies and other central state bodies providing rendering military-medical and medical care to the corresponding contingent;

10) military-medical (medical) providing - complex of actions for logistics, and also the organization of delivery of health care in troops, divisions and the departmental organizations for the purpose of recovery of fighting capacity and working ability of staff;

11) the child - person who did not reach eighteen-year age (age of majority);

12) irreversible death of brain - the complete loss of integrated function of cells of brain which is followed by death of all substance of brain;

13) the profile specialist - the health worker with the higher medical education having the certificate on certain specialty;

13-1) list of medicines and medical products for free and (or) preferential out-patient ensuring separate categories of citizens with certain diseases (conditions) - the list of medicines, medical products and the specialized medical products bought at the expense of budgetary funds and assets of fund of social medical insurance within the guaranteed amount of free medical care and in system of compulsory social medical insurance for rendering the out-patient and polyclinic help, including names and characteristics of medicines, medical products and specialized medical products by separate categories of citizens with certain diseases (conditions);

13-2) biosimilar medicine (bioanalogue, biosimilar medicine, biosimilyar) - biological medicine which contains the version of active ingredient of the registered biological original medicine or reference medicine and on which similarity (similarity) on the basis of comparative researches on indicators of quality, biological activity, safety and efficiency is shown;

13-3) biobank - specialized storage of biological materials for the scientific and medical purposes;

14) biologically active agents - the substances of various origin normalizing pathologically changed functions of organism at animals and the person which are potential sources of receipt of medicines;

15) dietary supplements - natural and (or) identical natural biologically active agents, and also the pro-biotic microorganisms intended for the use along with food or introductions in structure of food products;

15-1) biological medicine - medicine which active ingredient is made or emitted from biological source and the description of properties and which quality control requires combination of biological and physical and chemical methods of the analysis to assessment of production process and methods of its control;

15-2) biotechnological medicine - the medicine made by means of bioengineering procedures and application of methods with use of technology of recombinant deoxyribonucleic acid, controlled expression of the genes coding development of biologically active proteins, gibridomny technologies, monoclonal antibodies or other bioengineering procedures;

15-3)  No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

15-4) ceiling price for the trade name of medicine for retail sale - the price of the trade name of medicine above which its retail sale cannot be enabled;

15-5) certificate on assignment of qualification category - the document of the established sample confirming assignment of the corresponding qualification category;

15-6) original medicine - medicine with new active ingredient which was registered and placed by the first in the world pharmaceutical market based on the file containing results of the complete preclinical (not clinical) and clinical trials confirming its safety, quality and efficiency;

16) No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

16-1) single distributor - the legal entity performing within the guaranteed amount of free medical care and in system of compulsory social medical insurance activities according to article 77 of this Code;

16-2) haematopoietic stem cells - the part of fabric of the internal circle of organism, cells of marrow of the person having polipotentnost which are in process of life in marrow, peripheral blood (after stimulation) and umbilical blood;

16-3) homeopathic medicine - the medicine made on homeopathic technology with use of homeopathic raw materials according to requirements of pharmacopeias of the Republic of Kazakhstan and (or) the Eurasian Economic Union or in case of their absence according to requirements of homeopathic pharmacopeias;

17) genetically modified objects - the raw materials and products of vegetable and (or) animal origin received with use of methods of genetic engineering, including genetically modified sources, organisms;

18) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

18-1) long-term agreement of supply of medicines and medical products - the civil agreement signed by the single distributor for up to ten years with producers of medicines, medical products of the Republic of Kazakhstan or the customer of the contract manufacturing of medicines and medical products located in the territory of the Republic of Kazakhstan on supply of the medicines and medical products made according to requirements of proper production practice (GMP) for medicines and requirements of the international standard of quality management system (ISO 13485) for medical products, except for medical products of class of safety of potential risk of application 1 and 2a (except sterile); or with the subject in the sphere of drug circulation and medical products having intention to create and modernize production of medicines and medical products or contract manufacturing of medicines and medical products with the producer of medicines located in the territory of the Republic of Kazakhstan, according to requirements of proper production practice (GMP) for medicines, and for medical products according to requirements of the international standard of quality management system (ISO 13485), except for medical products of class of safety of potential risk of application 1 and 2a (except sterile), according to the procedure, established by the legislation of the Republic of Kazakhstan;

18-2) long-term agreement on storage and transportation of medicines and medical products - the civil agreement of rendering services signed by the single distributor with the subject in the sphere of drug circulation and medical products - resident of the Republic of Kazakhstan, to relevant requirements of proper distributor practice (GDP);

18-3) ceiling price for medicine - the price above which the realization of medicine cannot be enabled;

18-4) producer of medicines - the organization which is performing activities for production of medicines and having the license for production of medicines;

18-5) register of authorized persons of producers of medicines - the information resource of authorized body in the field of health care containing data on authorized persons of producers of medicines;

18-6) rational use of medicines - the drug treatment corresponding to clinical indications in the doses meeting individual needs of the patient during the sufficient period of time and in case of the smallest costs;

18-7) web portal of purchase of medicines and medical products - the information system providing single point of access to electronic services of purchase of medicines and medical products within the guaranteed amount of free medical care and in system of compulsory social medical insurance;

18-8) single operator in the sphere of purchases of medicines and medical products (further - the single operator) - the legal entity determined by authorized body in the field of health care in coordination with authorized body in the sphere of public procurements;

19) No. 299-V ZRK is excluded according to the Law of the Republic of Kazakhstan of 06.04.2015

20) retail sale of medicines and medical products - the pharmaceutical activities connected with acquisition (except import), storage, distribution, realization (except export) to the final consumer, destruction of medicines and medical products, performed according to the rules approved by authorized body in the field of health care;

20-1) contract manufacturing of medicines and medical products (further - contract manufacturing) - production of medicines and medical products on contractual basis on production capacities of producers of the medicines and medical products located in the territory of the Republic of Kazakhstan which provide full compliance with requirements of proper production practice (GMP) for medicines;

21) wholesale of medicines and medical products (distribution) - the pharmaceutical activities connected with purchase (acquisition), storage, import (import), export (export), realization (except for realization to the population) without restriction of amounts, transportation and destruction of medicines and medical products, performed according to the rules approved by authorized body in the field of health care;

21-1) proper pharmaceutical practicians in the sphere of drug circulation (further - proper pharmaceutical practicians) - the standards in the field of health care extending to all stages of lifecycle of medicines: proper laboratory practice (GLP), proper clinical practice (GCP), proper production practice (GMP), proper distributor practice (GDP), proper pharmaceutical practice (GPP), proper practice of pharmakonadzor (GVP) and other proper pharmaceutical practicians;

21-2) No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

21-3) regulating documents on quality of medicine - the document establishing requirements to quality control of medicine during the post-registration period based on the carried-out expertize of medicine in case of its registration and containing the specification, the description of analytical techniques and testing of medicine or the reference to such testing, and also the corresponding eligibility criterions for quality indicators;

22) drug circulation - the activities including processes of development, preclinical (not clinical) researches, testing, clinical trials, examinations, registration, pharmakonadzor, quality control, production, production, storage, transportation, import and export, leave, realization, transfer, application, destruction of medicines;

23) objects in the sphere of drug circulation and medical products - drugstore, pharmaceutical Item in the organizations of health care rendering primary medical and sanitary and (or) consulting and diagnostic help, the mobile pharmaceutical unit for the remote rural zones organized from drugstore, pharmaceutical (distributor) warehouse, warehouse of temporary storage of medicines, medical products, shop of optics, shop of medical products, warehouse of medical products, the organizations for production of medicines and medical products;

24) subjects in the sphere of drug circulation and medical products - the physical persons or legal entities performing pharmaceutical activities;

24-1) No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

24-2) safety of medicine - lack of unacceptable risk in case of use of the medicine connected with possibility of harming of life, to health of the person and the environment;

25) the State register of medicines and medical products - the information resource containing data about the medicines and medical products registered and allowed for medical application in the Republic of Kazakhstan;

25-1) efficiency of medicine - set of the characteristics of medicine providing achievement of preventive, diagnostic or medical effect or recovery, correction or modification of physiological function;

25-2) pharmakonadzor of medicines - watch system, the analysis and assessment of information on safety of the registered medicines;

26) No. 299-V ZRK is excluded according to the Law of the Republic of Kazakhstan of 06.04.2015

27) medicine expiration date - date after which expiration medicine is not subject to application;

28) medicine packaging - means or complex of the means providing process of drug circulation by their protection against damages and losses, and also protecting the environment from pollution;

29) quality of medicine - the set of properties and characteristics of pharmaceutical substance (active pharmaceutical substance) and medicine providing their compliance to purpose;

29-1) balk-product of medicine or medical product - the dosed ready medicine or finished medical product which passed everything stages of engineering procedure, except for final packaging;

30) the international unlicensed name of medicine - the name of medicine recommended by the World Health Organization;

30-1) dosage form - the medicine condition corresponding to methods of its introduction, application and providing achievement of necessary medical effect;

30-2) medicinal vegetable raw materials - the fresh or dried-up plants, seaweed, mushrooms or lichens or their parts, integral or crushed, used for production of medicines;

31) medicine - the medicine in the form of dosage form applied to diagnostics, treatment and prevention;

32) production of medicines - the pharmaceutical activities connected with production of medicines in drugstores with acquisition of pharmaceutical substances (active pharmaceutical substances) for pharmaceutical application, storage, quality control, registration and realization of the made medicines;

32-1)  No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018

32-2) No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018

33) No. 80-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 30.06.2017;

33-1) medicinal raw materials - substances of vegetable, mineral, animal origin or the products of the chemical industry used for production and production of medicines;

34) traditional medicine - the Section of medicine and activities of health workers based on the methods and warning facilities which are saved up by society and treatments of the diseases which affirmed as centuries-old traditions of medical practice;

34-1) disinsection - complex of preventive and destructive actions for extermination of insects and arthropods for the purpose of protection from them of the person, animals, rooms and the territory;

34-2) disinfection - complex of the special events directed to destruction of causative agents of infectious and parasitic diseases in the external environment;

35) health - condition of complete physical, spiritual (mental) and social wellbeing, and not just absence of diseases and physical defects;

36) health care - system of the measures of political, economic, legal, social, cultural, medical nature directed to the prevention and treatment of diseases, maintenance of public hygiene and sanitation, preserving and strengthening of physical and mental health of each person, maintenance of his active long life, provision to it medical care in case of loss of health;

36-1) health care system - set of state bodies and subjects of health care which activities are aimed at providing the rights of citizens to health protection;

36-2) manager of health care - the specialist in management of the state legal entity in the field of health care or heading separate activities of the state legal entity in the field of health care;

36-3) qualification category in the field of health care (further - qualification category) - the skill level of the specialist which is characterized by amount of the professional knowledge, skills necessary for performance of work within the corresponding medical and pharmaceutical specialty;

37) assessment of research and educational personnel of the scientific organizations and organizations of education in the field of health care - the procedure of determination of level of pedagogical and professional competence of research and educational personnel of the scientific organizations and organizations of education in the field of health care;

37-1)  No. 208-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

37-2) professional standard in the field of health care - the standard determining requirements to skill level, content, quality and working conditions of specialists in the field of health care;

37-3) certification of specialists in the field of health care - compulsory procedure for determination of compliance of health workers of clinical specialty and their admission to clinical practice (work with patients), managers of health care with issue of the appropriate certificate of the specialist to them;

37-4) standard of the state service in the field of health care - the regulatory legal act which is establishing requirements to rendering the state services in the field of health care, and also including characteristics of process, form, content and result of rendering the state services in the field of health care;

38) examination in the field of health care - set of the organizational, analytical and practical actions directed to establishment of level and quality of means, methods, technologies, educational programs, services in various fields of activity of health care according to the legislation of the Republic of Kazakhstan;

39) the standard in the field of health care (further - the standard) the regulatory legal act establishing rules, the general principles and characteristics in the sphere of medical, pharmaceutical activities, medical and pharmaceutical education;

40) standardization in the field of health care (further standardization) - the activities directed to achievement of optimum extent of streamlining of characteristics of processes, medical technologies and services by development, implementation and ensuring compliance with standards, requirements, regulations, instructions, rules;

41) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, control of quality of medical services;

42) National holding in the field of health care - the joint-stock company created according to the decision of the Government of the Republic of Kazakhstan, performing activities in the field of health care, including in the field of nuclear medicine;

42-1) assessment of technologies of health care - complex assessment of the comparative proved clinical and kliniko-economic (pharmakoekonomichesky) efficiency and safety of technologies of health care, and also economic, social and ethical consequences of their application;

43) the organization of health care - the legal entity performing activities in the field of health care;

43-1) medicinal form of the organization of health care - the list of medicines for delivery of health care within the guaranteed amount of free medical care and in system of compulsory social medical insurance, created on the basis of the Kazakhstan national medicinal form and approved as the head of the organization of health care according to the procedure, determined by authorized body;

43-2) deratization - complex of the preventive and destructive actions directed to destruction or decrease in number of rodents;

43-3) detoxication - complex of the medical actions directed to removal from human body of toxic substances of endogenous or exogenous origin;

44) diagnostics - complex of the medical services directed to factual determination of availability or absence of disease;

45)  No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

46) dynamic observation - systematic observation of the state of health of the population, and also rendering necessary medical care by results of this observation;

47) the donor - the person, corpse of the person, animal from which are made donor blood sampling, its components, other donor material (including sperm, ova, gametes, tissues of reproductive organs, embryos), and also fabric withdrawal (part of fabric) and (or) bodies (part of bodies), haematopoietic stem cells for transplantation to the recipient;

47-1) donor function - the voluntary act of the donor including physical examination and accomplishment of the procedure of giving blood and its components for the medical purposes;

48) treatment - complex of the medical services directed to elimination, suspension and (or) simplification of course of disease, and also the prevention of its progressing;

49) voluntary treatment - the treatment performed with the consent of the patient or his legal representative;

49-1) undesirable reaction - the inadvertent, adverse reaction of organism connected using the medicinal (researched) medicine and assuming availability of possible interrelation using this medicinal (researched) medicine;

50) counterfeited medicine and medical product - medicine, medical product, illegally and purposely supplied with unreliable information and the counterfeit label about their composition or picking and (or) producers of medicines and medical products;

51) the personal medical book - the personal document in which results of obligatory medical examinations with mark about the admission to work are entered;

51-1) sanitary and epidemiologic examinations of projects - the part of examination of projects which is carried out as a part of complex non-departmental examination of projects (feasibility statements and the design estimates) intended for construction new or reconstruction (expansions, modernization, upgrade) and capital repairs of the existing objects, complex town-planning examination of town-planning projects;"

51-2) high-technology medical services - the services rendered by profile specialists in case of the diseases requiring use of innovative, resource-intensive and (or) unique methods of diagnostics and treatment;

51-3) planned medical care - medical care in case of the preventive actions, diseases and conditions which are not requiring emergency and emergency medical service;

52) No. 208-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

52-1) immunological medicine (immunobiological medicine) - the medicine intended for forming of active or passive immunity or diagnostics of availability of immunity, or diagnostics (development) of the specific acquired change of the immunological answer to allergiziruyushchy substances;

52-2) system of carrying out immunological typing (further - sistema-HLA) - the system of anti-genes located on leukocytes of the person and determining fabric compatibility of the donor and recipient in case of transplantation of fabrics (part of fabric) and (or) bodies (part of bodies);

53) invasive methods - the methods of diagnostics and treatment performed by way of penetration into the internal circle of human body;

54) innovative medical technologies - set of methods and means of scientific and scientific and technical activities which implementation in the field of medicine (biomedicine), pharmacy and informatization in the field of health care is cost-efficient and (or) socially important;

54-1) integrated academic medical center - merging of the medical organization of the higher and (or) postgraduate education with the scientific organizations and the organizations of health care for the purpose of joint use of resources for improvement of quality of medical services by integration of education, researches and clinical practice;

55) infectious and parasitic diseases - diseases of the person which emergence and distribution is caused by impact on it biological factors of the habitat and possibility of transfer of disease from the sick person, animal to the healthy person;

56) iodine-deficiency diseases - the pathological process of organism caused by the dysfunction of thyroid gland connected with insufficient intake and digestion of iodine in organism;

57) occupational disease - the chronic or acute disease caused by impact on the worker of harmful production factors in connection with accomplishment of the labor (office) obligations by it;

57-1) emergency medical service - medical care in case of sudden sharp diseases, injuries, sharp deterioration in the state of health, exacerbation of chronic diseases, without strong indications of threat of life of the patient;

57-2) biological material of preclinical (not clinical) and clinical trials - samples of biological liquids, fabrics, secrets and waste products of the person and animals, the biopsiyny materials, histologic cuts, dabs, scrapes, washouts received when performing preclinical (not clinical) and clinical trials and intended for laboratory researches;

58) preclinical (not clinical) research - chemical, physical, biological, microbiological, pharmacological, toxicological and other pilot study or series of researches on studying of the researched substance (medicine) by application of scientific evaluation methods for the purpose of studying of specific action and (or) receipt of proofs of safety for health of the person;

59) clinical trial - the research with participation of the person as the subject conducted for identification or confirmation of safety and efficiency of means, methods and technologies of prevention, diagnostics and treatment of diseases;

59-1) clinical protocol - the document establishing general requirements to delivery of health care to the patient in case of certain disease or clinical situation;

59-2) clinical pharmacologist - the specialist with the higher medical education in the profiles "medical case", "pediatrics", "general medicine" who studied residency or retraining in clinical pharmacology and having the certificate of the specialist of the clinical pharmacologist;

59-3) ceiling price for the trade name of medicine for wholesale - the price of the trade name of medicine above which its wholesale cannot be enabled;

59-4) daily medical conference - planned meeting of the medical organization for the purpose of summing up for last days, discussions and analysis of clinical cases, and also informing collective on new achievements of medical science and clinical practice;

60) consultation - research of person for the purpose of establishment of the diagnosis, determination of tactics of treatment and the forecast of disease with participation at least three doctors;

61) contraception - methods and warning facilities of undesirable pregnancy;

61-1) The Kazakhstan national medicinal form - the list of medicines with the proved clinical safety and efficiency, and also orphan (rare) medicines which is obligatory basis for development of medicinal forms of the medical organizations and forming of lists of purchase of medicines within the guaranteed amount of free medical care and in system of compulsory social medical insurance;

61-2) nomenclatures of medical products of the Republic of Kazakhstan - the systematized nomenclature qualifier of types of medical products harmonized with the global nomenclature of medical products (GMDN) and used in the Republic of Kazakhstan;

61-3) registers of pharmaceutical inspectors of the Republic of Kazakhstan - the information resource of authorized body containing the information about pharmaceutical inspectors of the Republic of Kazakhstan;

62) the State pharmacopeia of the Republic of Kazakhstan - the code of the minimum requirements to safety and quality of medicines and medical products;

62-1) reproduced medicine (generic) - medicine which has the same quantitative and high-quality composition of active ingredients and the same dosage form, as original medicine and which bioequivalence to original medicine is confirmed by the corresponding researches of bioavailability. Various salts, air, isomers, mixes of isomers, complexes or derivatives of active ingredient are recognized the same active ingredient if their safety and efficiency significantly do not differ. Various dosage forms for intake with immediate release of substances are recognized within the bioavailability researches the same dosage form;

63) public health - the complex characteristic of mental, physical and social wellbeing of the population reflecting efforts of society on maintaining healthy lifestyle by citizens including healthy food, on prevention of diseases and injuries, and also on prevention of influence of adverse factors of the habitat;

63-1) research in the field of public health - the research conducted on the basis of collection and generalization of kliniko-epidemiological data and other medical information for identification of the major factors influencing health and determining development of health care system, development of methods of directed influence and management of these factors;

63-2) unfavorable event (incident) - any defect and (or) deterioration in characteristics or violation of functioning of medical product, either insufficiency or incorrectness of accompanying information (documentation) on the medical product, side effects or undesirable reaction which are not specified in the instruction for application or the operation manual which directly or indirectly brought or could lead to death or serious deterioration in the state of health of users or the third parties;

63-3) excipient - substance, except for pharmaceutical substances (active pharmaceutical substances), being part of medicine for giving of necessary properties to it;

64) confidential physical examination - the inspection based on preserving medical secret and information on the identity of the examined person;

64-1) assessment of professional readiness and confirmation of conformity of qualification of specialists - the assessment procedure of knowledge and skills which is carried out for the purpose of confirmation of conformity of qualification of the specialist to requirements of the professional standard in the field of health care;

65) the certificate of the specialist - the document of the established sample confirming qualification of physical person on compliance:

clinical specialty and for its admission to clinical practice (work with patients);

manager of health care;

66) forced treatment - the treatment of the patient performed based on the judgment;

67) health workers - the physical persons having professional medical education and performing medical activities;

68) medico-social resettlement - recovery of health of patients and disabled people with complex use of medical, social and labor actions for familiarizing with work, inclusion in family and public life;

68-1) medicobiological experiment - the research based on reproduction (modeling) of structurally functional complex of the studied condition or disease in the simplified form on laboratory animals for clarification of the reasons, conditions and origins of condition or development of disease, development of methods of treatment and prevention;

68-2) medical education - system of preparation, retraining and advanced training of health workers, and also set of the knowledge and skills necessary for the health worker received during training in programs of preparation, the retraining and advanced training in medical specialties supported by the official document about the end of training;

68-3) strategic partnership in the sphere of medical education and science - form of medium-term or long-term cooperation between the scientific organizations and the organizations of education in the field of health care, and the foreign organizations of the higher and (or) postgraduate education, and the medical organizations in the sphere of medical education and science for implementation and adaptation of international standards of education, science and clinical practice on the basis of the agreement;

68-4) address of medical products - designing, development, creation of prototypes, carrying out technical testing, researches (testing) of assessment of biological effect of medical products, clinical trials, examinations of safety, quality and efficiency of medical products, registration, production (production), storage, transportation, realization, installation, adjustment, application (operation), maintenance, repair and utilization of medical products;

68-5) researches (testing) of assessment of biological effect of medical products - researches (testing) conducted for the purpose of determination of compliance of medical products to general requirements of safety and efficiency of medical products, to requirements to their marking and operational documentation on them;

68-6) global nomenclature of medical products (GMDN) - the systematized nomenclature qualifier of types of medical products used for the purpose of identification of medical products;

68-7) monitoring of safety, quality and efficiency of medical products - collection, registration, information analysis about unfavorable events (incidents);

68-8) type of medical products - group of the medical products having similar appointment, similar technologies of application, constructive signs and general digital designation in the nomenclature of medical products of the Republic of Kazakhstan;

68-9) producer of medical product - the subject in the sphere of drug circulation and medical products, responsible for development and production of medical product, making it available for use on its own behalf irrespective of, it is developed and made by this person or from his name other person (persons), and bearing responsibility for its safety, quality and efficiency;

68-10) safety of medical product - lack of unacceptable risk when using the medical product connected with damnification of life, to health of the person, and also the environment;

68-11) quality of medical product - degree of compliance of set of properties and characteristics of medical product to the purposes of its intended use;

68-12) trade name of medical product - the name under which the medical product is registered;

68-13) efficiency of medical product - set of the properties and characteristics of medical product providing goal achievement of purpose, established by the producer of medical product and confirmed with practice of its use;

68-14) medical research - research which purpose is obtaining by scientific methods of new knowledge about health of the person, diseases, about their diagnostics, treatment or prevention;

69)  No. 299-V ZRK is excluded according to the Law of the Republic of Kazakhstan of 06.04.2015

70) medical care - complex of the medical services including the medicinal help, directed to preserving and recovery of population health, and also simplification of heavy displays of incurable diseases;

71) quality of medical care - the level of compliance to the standards approved by authorized body and established on the basis of the modern level of development of the medical science and technology provided to medical care;

72) medical examination - inspection of physical person for the purpose of establishment or confirmation of the fact of availability or absence at it of disease, determination of the state of health, and also temporary disability, professional and other suitability;

73) medical activities - the professional activity of the physical persons who got the higher or secondary professional medical education, and also legal entities, directed to protection of public health;

74) medical services - the actions of subjects of health care having preventive, diagnostic, medical, rehabilitation or palliative orientation in relation to the specific person;

75) medical products - any tools, devices, devices, the equipment, materials and other products which are applied in the medical purposes separately or in combination among themselves, and also with the accessories necessary for application of the specified products to destination, including the special software are intended by the producer of medical product for prevention, diagnostics, treatment of diseases, medical rehabilitation and monitoring of condition of human body, carrying out medical researches, recovery, replacement, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy and which functional purpose is not implemented by pharmacological, immunological, genetic or metabolic impact on human body and can be supported by use of medicines;

76) medical rehabilitation - complex of the medical services directed to preserving, partial or complete recovery of the broken and (or) lost functions of organism of patients and disabled people;

77) products of medical optics - the products and materials used in medicine and pharmaceutical activities for correction of sight and phototherapy;

78) No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

78-1) No. 211-VI ZRK is excluded according to the Law of the Republic of Kazakhstan of 28.12.2018;

79) the medical organization - the organization of health care which main activities is delivery of health care;

79-1) sisterly leaving - complex of the medical services rendered by average health workers to persons with serious illness needing leaving in the cases which are not requiring medical observation;

80) the state sanitary and epidemiological surveillance - activities of bodies of sanitary and epidemiologic service for the prevention, identification, suppression of violations of the law of the Republic of Kazakhstan in the sphere of sanitary and epidemiologic wellbeing of the population, and also control of observance of regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population and hygienic standard rates for the purpose of health protection, the habitat of the population and safety of products, processes, services;

80-1) certificate on state registration - the document confirming safety of products (goods), certifying compliance of products (goods) to requirements of regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population and hygienic standard rates;

80-2) state pharmaceutical inspector - the official of authorized body exercising the state control in the sphere of drug circulation and medical products directed to the prevention, identification, suppression of violations of the law of the Republic of Kazakhstan in the field of health care;

81) nicotine - the alkaloid containing in tobacco leaves and tobacco smoke;

82) nutritsevtik - dietary supplements as a part of which there are various set combinations of the essentsialny (irreplaceable) food components (some amino acids, vitamins, mineral substances and minerals, polynonsaturated fatty acids, bioses and food fibers) which are not exceeding their recommended daily requirement;

83) orphan (rare) medicine - the medicine intended for diagnostics, etiopatogenetichesky or pathogenetic treatment of orphan (rare) diseases which frequency does not exceed officially certain level in the Republic of Kazakhstan;

84) orphan (rare) diseases - rare serious illnesses, life-endangering the person or resulting in disability which frequency does not exceed officially certain level;

84-1) focal disinfection - the disinfection which is carried out in the centers for the purpose of prevention and (or) liquidation of infectious and parasitic diseases;

84-2) production supervision - complex of actions, including laboratory researches and testing of the made products, the works and services which are carried out by the individual entrepreneur or the legal entity, aimed at safety and (or) harmlessness for the person and the habitat;

84-3) monitoring of safety of products - system of the actions directed to identification, the prevention and suppression of import, production, application and the sales of products which is not conforming to requirements of regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population, hygienic standard rates and technical regulations;

84-4) authorized person of the producer - the person who is responsible for providing and quality control of the medicines made by the producer according to the legislation of the Republic of Kazakhstan in the field of health care, and entered the register of authorized persons of producers of medicines;

84-5) production site - territorially isolated complex of the producer of medicines, medical products intended for accomplishment of all production process of medicines, medical products or its certain stages;

84-6) palliative care - complex of the medical services directed to improvement of quality of life of patients with incurable diseases in terminal (final) stage;

85) parapharmaceutics - biologically active agents of natural origin or their synthetic analogs in medical doses having pharmacological action and directed to prevention of diseases, auxiliary therapy and regulation of functional activity of bodies and systems;

86) the patented medicines - the medicines which received legal protection according to the legislation of the Republic of Kazakhstan in the field of intellectual property;

87) the patient - the physical person which is (being) the consumer of medical services;

88) prevention - complex of the medical and not medical actions directed to the prevention of emergence of diseases, progressing at early stages of diseases and monitoring already developed complications, damages of bodies and fabrics;

89) psychoactive agents - substances of synthetic or natural origin which in case of single acceptance make impact on mental and physical functions behavior of the person, and in case of the long use cause mental and physical dependence;

90) mental disturbances (diseases) - the disorders of mental activities of the person caused by violation of work of brain;

90-1) psychological assistance - complex of the actions directed on:

assistance to the person in the prevention, permission of psychological problems, overcoming the difficult life and crisis situations and their consequences promoting maintenance of mental and somatic health, optimization of mental development, adaptation and improvement of quality of life including by activization of own opportunities of the person;

informing people on the reasons of psychological problems, methods of their prevention and permission;

development of the personality, its self-improvement and self-realization;

90-2) psychological problem - the condition of sincere discomfort of the person caused by dissatisfaction with, the activities, the interpersonal relations, situation in family and (or) other problems of private life;

90-3) radio pharmaceutical medicine - the medicine containing in condition, ready for application, one or several radionuclides (radioactive isotopes) as active ingredient or as a part of active ingredient;

90-4) reference medicine - medicine which is used as medicine of comparison and are standard by which are determined properties of medicine (are normalized);

91) the recipient - the patient to whom transfusion of donor blood or the components and (or) medicines allocated from it, introduction of men's or women's donor material (sperm, ovum, embryos) or fabric transplantation (part of fabric) and (or) body (part of body) from the donor is made;

91-1) sanatorium treatments - type of recovery treatment and (or) medical rehabilitation, the faces which are carried out in the conditions of temporary stay in the sanatorium organization;

92) sanitary and quarantine control - the control of sanitary and epidemiologic condition of freight and the state of health of people when moving people and freights through the Frontier of the Republic of Kazakhstan matching customs border of the Eurasian Economic Union which is carried out for the purpose of non-admission of delivery on the territory of the country of infectious and parasitic diseases, and also substances and products potentially hazardous to health of the person;

93) the sanitary protection zone - the territory separating zones of special purpose, and also industrial bodies and other production, municipal and warehouse facilities in the settlement the nearby selitebny territories, buildings and constructions of construction engineering appointment for the purpose of weakening of impact to them adverse factors;

93-1) sanitary and preventive actions - the measures taken for the purpose of prevention of infectious, parasitic, occupational and other diseases among the population, and also the prevention of delivery (drift) on the territory of the Republic of Kazakhstan of infectious, parasitic diseases among the population;

94) sanitary and epidemiologic situation - the state of health of the population and the habitat in certain territory in certain time;

94-1) sanitary and epidemiologic audit - check epidemic the significant objects which are subject to the state sanitary and epidemiological surveillance, regarding identification and assessment of sanitary and epidemiologic risks and development of recommendations about reduction of the specified objects in compliance with requirements of regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population;

94-2) sanitary and epidemiologic conclusion - the document certifying compliance (discrepancy) to regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population, to hygienic standard rates and (or) technical regulations of objects of the state sanitary and epidemiological surveillance;

95) sanitary and anti-epidemic actions - the measures taken for the purpose of localization and liquidation of the arisen centers of infectious, parasitic diseases, poisonings among the population;

95-1) sports medicine - the industry of medicine and health care which is responsible for medico-biological ensuring training of athletes and including medical and functional control in sport, functional and medical rehabilitation of athletes, increase in sports working capacity, therapy of somatic diseases of athletes, sports traumatology, emergency aid in sport and hygiene of sport;

95-2) marrow - the central body of blood formation located in spongy substance of bones and marrowy cavities;

95-3) standard sample - the identified uniform substance or mix of substances, held for use in chemical, physical and biological researches in which his (her) properties are compared to properties of the researched medicine, and having purity degree, sufficient for the corresponding application;

96) enrichment (fortification) of food products - introduction of vitamins, minerals and other substances in food products in the course of its production or conversion for the purpose of increase in nutrition and biological value, and also prevention of the diseases caused by their deficit at the person;

97) risk assessment - reasons for probability of penetration and distribution of activators or carriers of infectious and parasitic diseases, and also negative impact of factors of the environment on the state of health of the population and the potential medicobiological and economic consequences connected with it;

98) independent examination - the procedure which is carried out by independent experts within external examination for the purpose of pronouncement of the conclusion about the quality level of the rendered medical services provided by subjects of health care with use of the indicators reflecting performance indicator, completeness and compliance of the rendered medical services to standards;

98-1) independent expert - the physical person having the higher medical education and conforming to requirements to the physical persons applying for conducting independent examination, certain authorized body;

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