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CODE OF THE REPUBLIC OF KAZAKHSTAN

of July 7, 2020 No. 360-VI ZRK

About health of the people and health care system

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

2) HIV infection - the chronic infectious disease caused by human immunodeficiency virus, which is characterized by specific defeat of immune system and leading to its slow destruction before forming of acquired immunodeficiency syndrome;

3) the certified first aid coach - person who had additional training on first aid and basic warm and pulmonary resuscitation;

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

5) medicine of catastrophic crashes - the field of medicine 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;

6) 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 conditions which are provided by the agreement of purchase of medical services, and other functions determined by the laws of the Republic of Kazakhstan;

7) military medicine - the field 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, divisions and departments of special state and law enforcement agencies in peace and wartime;

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

9) military-medical (medical) divisions - structural divisions of the central executive bodies and other central state bodies and their territorial subdivisions, and also military-medical (medical) organizations (organizations), other divisions performing military-medical (medical) providing;

10) enrichment (fortification) - 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;

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

12) the profile specialist - the health worker with the higher medical education having the certificate in the field of health care;

13) the established (final) sanitary protection zone - the sanitary protection zone territory determined based on results of year cycle of natural researches and measurements for confirmation of the settlement (preliminary) sanitary protection zone;

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

15) 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;

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

17) biologically active agents - substances of natural origin or their synthetic analogs normalizing pathologically changed functions of organism at animals and the person;

18) 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;

19) medicines of biological origin - the medicines containing biological substances (hormones, tsitokina, the fibrillation factors, insulin, monoclonal antibodies, enzymes, koloniyestimuliruyushchy factors, medicines created based on cells of fabrics, and other, received by means of biotechnological methods);

20) biomedical research - research which purpose is obtaining by scientific methods of new knowledge of life, health of the person, diseases, their diagnostics, treatment or prevention, and also the genetic and ecological factors connected with processes of life, diseases and health;

21) 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;

22) bioethics - the cross-disciplinary scientific direction uniting biomedical and the humanities for the purpose of the analysis of moral, social, legal aspects of application of the latest developments of sciences about life;

23) rodorazresheniye - natural or artificial (tool, manual method, medicamentous) completion of the patrimonial act;

Marginal 24) the 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;

25) 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;

26) copayment - payment of difference in the cost of medicines, medical products and the established marginal price of their compensation within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance at the out-patient level, performed in voluntary procedure;

27) the single distributor - the legal entity performing activities within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance according to article 247 of this Code;

28) vaccines - the medicines for specific prevention of infectious diseases rendering preventive effect through immune system;

29) haematopoietic stem cells - the haematogenic cells of marrow of the person having polipotentnost and being in process of life in marrow, peripheral blood and umbilical blood;

30) the register of donors of haematopoietic stem cells (marrow) - the list of persons, concordants on non-paid donorship of haematopoietic stem cells (marrow) and typed on sisteme-HLA;

31) 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;

32) 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;

33) 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;

Marginal 34) the price for medicine - the price above which the realization of medicine cannot be enabled;

35) 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;

36) 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;

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

38) the register of authorized persons of producers of medicines - the electronic information resource of authorized body containing data on authorized persons of producers of medicines;

39) the authorized person of the producer of medicines - 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;

40) 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;

41) the long-term agreement of supply of medicines and medical products - the civil agreement signed by the single distributor for up to ten years with producer of medicines, medical products of the Republic of Kazakhstan or the customer of 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;

42) 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;

43) 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 and the international standard of quality management system (ISO 13485) for producers of medical products;

44) the web portal of purchase of medicines and medical products, services at subjects of health care - the information system providing single point of access to electronic services of purchase of medicines and medical products, services at subjects of health care within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

45) the single operator in the sphere of purchase of medicines and medical products, services at subjects of health care (further - the single operator) - the legal entity determined by authorized body in coordination with authorized body in the sphere of public procurements;

46) wholesale of medicines and medical products - 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;

47) state body in the sphere of drug circulation and medical products - the state body performing management in the sphere of drug circulation and medical products, control of drug circulation and medical products;

48) the state expert organization in the sphere of drug circulation and medical products - the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and medical products;

49) objects in the sphere of drug circulation and medical products - the drugstore including enabling the realization on the Internet, pharmaceutical Item in the organizations of health care, 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;

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

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

52) the 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);

53) the state re-registration of medicine or medical product - the procedure of prolongation of effective period of state registration of medicine or medical product with issue of the undated document certifying state registration (further - the registration certificate), at former registration number and entering of the corresponding record into the State register of medicines and medical products;

54) state registration of medicine or medical product - the procedure of receipt of permission to drug circulation or medical products in the territory of the Republic of Kazakhstan and introduction of medicine or medical product for certain term in the State register of medicines and medical products;

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

56) 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;

57) 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;

58) modification of the registration file of medicine or medical product - the procedure performed based on examination of the changes made to the registration file during effective period of the registration certificate;

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

60) the regulating document 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;

61) the trade name of medicine - the name under which medicine is registered;

62) the international non-proprietary name of medicine - the name of medicine recommended by the World Health Organization;

63) quality of provision of medicines - the level of compliance to requirements of the standards in the field of health care regulating production, import, storage, timely supply of medicines and pharmakonadzor;

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

65) 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;

66) medicine - medicine in the form of dosage form;

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

68) 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;

69) 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;

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

71) 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;

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

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

74) 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;

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

76) the regional perspective plan of development of infrastructure of health care - the long-term plan of development of infrastructure of the region reflecting information on the existing network of the organizations of health care, the planned restructuring (opening, consolidation, closing, reshaping), and also information on the need for new health care facilities and planning of investments;

77) certification of research and educational personnel of the 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 organizations of education in the field of health care;

78) the organization of education in the field of health care - the organization of education realizing educational programs for the directions of preparation "Health care" and (or) "The cross-disciplinary programs connected with healthcare and welfare (medicine)";

79) clinic of the organization of education in the field of health care - structural division of the organization of education or the organization of health care based on which educational programs of technical and professional, postsecondary, higher, postgraduate and additional medical education on the basis of modern achievements of science and practice are implemented;

80) the scientific organization in the field of health care - the national center, scientific center or research institution performing scientific, scientific and technical and innovative activities in the field of health care and also medical, pharmaceutical and (or) educational activities;

81) the 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;

82) certification of the specialist in the field of health care - the procedure of determination of compliance of qualification of physical person to the qualification requirements established by industry frame of qualifications and professional standards in the field of health care and also determination of readiness for professional activity in the field of health care, including readiness for clinical or pharmaceutical practice, or activities in the sphere of sanitary and epidemiologic wellbeing of the population;

83) the certificate of the specialist in the field of health care - the document of the established sample confirming qualification of physical person and its readiness for professional activity in the field of health care including readiness for clinical or pharmaceutical practice, or activities in the sphere of sanitary and epidemiologic wellbeing of the population;

84) manager in the field of health care - the first head exercising control of the state medical organization;

85) the certificate of manager in the field of health care - the document of the established sample on occupation activities for management of the state medical organization;

86) examination in the field of health care - set of the organizational, analytical and practical actions directed to determination of efficiency and quality of means, methods, technologies, educational and scientific programs, services in various fields of activity of health care and also determination of temporary disability, professional suitability for health reasons according to the legislation of the Republic of Kazakhstan;

87) the standard in the field of health care (further - the standard) - the regulatory legal act establishing rules, the general principles and characteristics for ensuring standardization in the field of health care in the sphere of medical, pharmaceutical activities, educational and scientific activities in the field of health care, digital health care;

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

89) 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 of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, qualities of rendering medical services (help);

90) the national operator in the field of health care - the legal entity performing activities in the field of health care including on development of infrastructure of health care;

91) assessment of technologies of health care - the 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 which is carried out for decision making in the field of health care;

92) technology of health care - use of knowledge and skills which are used for strengthening of health, prevention, diagnostics, treatment of disease, rehabilitation of patients and rendering palliative medical care, including vaccines, medicines and medical products, procedures, manipulations, transactions, screening, preventive programs, including information systems;

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

94) the 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 (or) 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;

95) joint liability for health - separation of responsibility between members of society: the state, the employer and the citizen for preserving and strengthening of individual and public health, decrease in risks of emergence of disease;

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

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

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

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

100) the donor - the person, corpse of the person, animal from which are made donor blood sampling, its components, other donor material (including sperm, ova, tissues of reproductive organs, gametes, embryos), and also removal of organs (part of body) and (or) fabrics (part of fabric) for transplantation to the recipient;

101) the donor organization - the organization of health care in which withdrawal and preservation of bodies (part of body) and (or) fabrics (part of fabric) from corpses for the purpose of transplantation is performed;

102) donor function - voluntary passing by the donor of physical examination and accomplishment of allogenny donation of blood and its components;

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

104) the attending physician - the doctor providing medical care to the patient during its observation and treatment in the medical organization;

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

106) the settlement (preliminary) sanitary protection zone - the sanitary protection zone territory determined based on the project with calculations of dispersion of pollution of atmospheric air, physical (noise, vibration, not ionizing radiation) and (or) radiative effects on health of the person;

107) 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;

108) counterfeited medicines and medical products - medicines, medical products, illegally and purposely supplied with unreliable information about their structure or picking and (or) the producer, and also about deliveries, including the records and documents mentioning the used supply channels;

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

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

111) abortion - the termination of pregnancy to terms of viability of fruit with use of medicamentous or surgical methods which is carried out by the health workers having the higher medical education of the corresponding profile;

112) portable medical complexes - mobile clinics (offices) based on road transport equipped with the necessary medical equipment which are used for ensuring availability and extension of the list of the rendered medical services to the population of the rural zone and the remote settlements or for the benefit of defense and homeland security;

113) infections, sexually transmitted, - infectious diseases most of which frequent way of infection is the sexual contact;

114) person with disorders of sexual identification - person aiming to live and be accepted as person of opposite sex;

115) 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;

116) 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 organ transplantation (part of body) and (or) fabrics (part of fabric);

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

118) 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 digitalization of health care is socially important and (or) cost-efficient;

119) the integrated academic medical center - merging of the organization of the higher and (or) postgraduate medical education with the scientific organizations in the field of health care 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;

120) not intervention clinical trial - research which is conducted after carrying out state registration of medicine or medical product and is appointed within medical practice;

121) intervention research - research with participation of the person as the subject of research with which the doctor-researcher based on the protocol of the intervention clinical trial corresponding to procedure for performing clinical trials appoints to the subject of research special intervention;

122) epidemiological surveillance behind noninfectious diseases - activities of state bodies and organizations of sanitary and epidemiologic service for monitoring of risk factors from impact of the objects of the environment influencing health of the population, including production factors, occupational diseases with temporary disability, to minimization and control of implementation of management programs chronic noninfectious diseases;

123) infectious and parasitic diseases - diseases of the person which emergence and distribution are 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;

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

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

126) 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;

127) 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;

128) clinical base - the organization of health care which is used by the organization of education for preparation and advanced training of personnel in the field of health care on cooperation agreement;

129) 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;

130) clinical sisterly management - the document containing scientifically proved recommendations for nursing staff about care of patients, assuming use of preventive, diagnostic, medical and rehabilitation actions under the authority of patients;

131) the clinical pharmacologist - the specialist with the higher medical education in the profiles "medical case", "pediatrics", "general medicine" who mastered the program of residency or retraining in clinical pharmacology and having the certificate of the specialist in the field of health care;

132) the clinical protocol - scientifically proved recommendations about prevention, diagnostics, treatment, medical rehabilitation and palliative medical care in case of certain disease or the patient's condition;

133) 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;

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

Marginal 135) the price for the trade name of medicine for wholesale - the price of the trade name of medicine above which its wholesale cannot be enabled;

136) 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 (or) in system of compulsory social medical insurance;

137) the nomenclature 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;

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

139) the register of pharmaceutical inspectors of the Republic of Kazakhstan - the electronic information resource of authorized body containing the information about pharmaceutical inspectors of the Republic of Kazakhstan;

140) the 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;

141) allogenny donation of blood and its components - donation of blood and its components for application in the medical purposes from one person to another;

142) dokontaktny prevention - the anti-retrovirus therapy applied to not infected people to prevention of infection with HIV infection;

143) post-contact prevention - the anti-retrovirus therapy applied for the purpose of decrease in risk of infection with HIV infection after possible infection;

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

145) 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;

146) unfavorable event - 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;

147) applied biomedical research - the biomedical research directed to achievement of specific purposes in the sphere of diagnostics, treatment or prevention of diseases, ensuring health of the population;

148) hookah - the device used for the inhalation of aerosol, vapor or smoke arising from decay and (or) heating of tobacco, and also the products which are not containing tobacco leaf and in which aerosol, vapor or smoke pass through vessel with liquid;

149) tobacco for hookah - type of the smoking tobacco product intended for smoking with use of hookah and consisting of mix of cut or fragmentary raw materials with addition or without addition of not tobacco raw materials and other ingredients;

150) hookah mix - the product made without use of tobacco leaf as raw material, prepared so that to use for consumption with use of hookah;

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

152) confidential physical examination - the inspection based on observance of secret of the health worker and preserving information on the identity of the examined person;

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

154) the health worker - the physical person having professional medical education and performing medical activities;

155) medical aircraft - provision of emergency medical service in the emergency form to the population with attraction of air transport;

156) medical information - the information on patients and diseases arising in the course of delivery of health care and reflected in medical documents and medical information systems and also information on questions of health care;

157) medical intervention - the direct or mediated impact and (or) other manipulation which are carried out by the health worker in case of delivery of health care to patients for the purpose of the prevention, prevention, diagnostics, treatment, rehabilitation, research and directed to recovery or improvement of health;

158) the medico-public assistance is medical and social psychological assistance given to persons with socially important diseases which list is determined by authorized body;

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

160) 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;

161) medical products - products of medical appointment and medical equipment;

162) consumable material to medical products - the products and materials spent when using medical products, providing carrying out manipulations according to functional purpose of medical product, operational characteristics, management on field service of the producer;

163) the 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;

164) research (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;

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

166) 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;

167) monitoring of safety, quality and efficiency of medical products - collection, registration, information analysis about unfavorable events;

168) the 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;

169) the accessory of medical product - the part of medical product which is not independent medical product including blocks, parts, the product elements, materials, spare parts provided by the producer for use according to functional purpose, operational characteristics, management of the producer on field service;

170) 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;

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

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

173) 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;

174) medical education - system of preparation 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 of advanced training in medical specialties, supported by the official document about the end of training;

175) assessment of knowledge and skills of students of programs of medical education - quality evaluation of development by students of educational programs and formation of knowledge, skills according to grade level;

176) assessment of professional readiness of graduates of programs of medical education - the assessment procedure of knowledge and skills which is carried out for the purpose of determination of compliance of qualification of the graduate of the program of medical education to requirements of the professional standard in the field of health care;

177) 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;

178) the organization of medical education - the organization of education realizing educational programs for the directions of preparation "Health care";

179) medical care - complex of the medical services directed to preserving and recovery of population health including provision of medicines;

180) quality of medical care - the level of compliance to the provided medical care to standards of delivery of health care;

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

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

183) 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;

184) medical activities - the professional activity of the physical persons who received technical and professional, postsecondary, higher and (or) postgraduate medical education, and also legal entities, directed to public health care of the Republic of Kazakhstan;

185) state body in the sphere of rendering medical services (help) - the state body performing management in the sphere of rendering medical services (help), control of quality of medical services (help);

186) products of medical appointment - the materials, products, solutions, reagents, sets, sets used for delivery of health care according to functional purpose and the instruction of the producer;

187) medical rehabilitation - complex of the medical services directed to preserving, partial or complete recovery of the broken and (or) lost functions of organism of the patient;

188) medical trains - the mobile clinics on rail transport equipped with the necessary medical equipment, used for ensuring availability and extension of the list of the rendered medical services to the population living near railway stations (ways) and in the territories, blizraspolozhenny to them;

189) medical equipment - the devices, devices, the equipment, complexes, systems applied separately or in combination among themselves to delivery of health care according to the functional purpose and operational characteristics established by the producer;

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

191) sisterly leaving - complex of the medical services rendered by nurses and nurses of expanded practice to the faces of all age, groups and communities sore or healthy, including promotion of health, prevention of diseases and patient care, disabled people and the dying people;

192) preschool and school medicine - the field of medicine including the organization of delivery of health care to children of preschool and school age, directed to protection and strengthening of health and prevention of diseases;

193) the state pharmaceutical inspector - the official of state body exercising the state control in the sphere of drug circulation and medical products;

194) multidisciplinary group - the group of various specialists created depending on nature of violation of functions and structures of organism of the patient, weight of its clinical condition;

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

196) medicines of the advanced therapy - the medicines received in the biotechnological or bioengineering way which offer new opportunities for treatment of diseases and injuries, including means for gene therapy, somatic cellular therapy, fabric engineering;

197) rehabilitation potential - clinically reasonable probability of prospect of partial or complete recovery of the broken and (or) lost functions of organism of the patient in certain interval of time;

198) the family doctor - the doctor who had special multi-profile training on rendering primary health care to family members and having the certificate of the specialist in the field of health care;

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

Marginal 200) price of the producer - the price of the trade name of medicine provided by the producer, which is the basic price for limiting calculation of the wholesale and retail prices of the trade name of medicine according to Regulations of the prices of medicines and also of medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance;

201) the 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;

202) 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;

203) the certificate on state registration of products - the document confirming safety of products (goods), certifying compliance of products (goods) to technical regulations and (or) single sanitary and epidemiologic and hygienic requirements of the Eurasian Economic Union and issued by state body in the sphere of sanitary and epidemiologic wellbeing of the population in single form;

204) 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;

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

206) the patient - the physical person which is (being) the consumer of medical services irrespective of availability or absence at it of the disease or condition requiring delivery of health care;

207) 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;

208) psychoactive agents - substances of synthetic or natural origin (alcohol, drugs, psychotropic substances, their analogs, other stupefying substances) 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;

209) mental health - condition of wellbeing in case of which each person can realize own potential, copes with regular vital stresses, productive and fruitful work, and also make contribution to life of the community;

210) medical care in the field of mental health - prevention, diagnostics, treatment, the medico-public assistance and medico-social resettlement of persons with mental, behavioural disturbances (diseases);

211) mental, behavioural disturbances (diseases) - group of diseases according to the international classification of the diseases which are characterized by violation of mental activities;

212) 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;

213) 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;

214) 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;

215) the resident doctor - the doctor studying within the educational program of residency and working in the medical organization under the supervision of the mentor;

216) residency - the level of postgraduate medical education which purpose is acquisition or change of professional qualification of the doctor on the corresponding specialty for the admission to independent clinical practice;

217) base of residency - clinic of the organization of education in the field of health care, the university hospital, the national center, scientific center or research institution accredited as the medical organization based on which programs of residency according to the procedure are implemented, established by authorized body;

218) reproductive health - the health of the person reflecting its capability to reproduction of full-fledged posterity;

219) anti-retrovirus therapy - method of treatment of HIV infection by application of short and long rates of acceptance of anti-retrovirus medicines for the purpose of recovery of immune system, decrease in risk of development of the heavy diseases threatened to life, reduction of number of complications and the prolongation of life infected with HIV infection;

220) referens-laboratory - the laboratory of the organization of health care which is carrying out organizational and methodical work on implementation of system of external quality evaluation and carrying out researches in diagnostic complex and expert cases in certain area of laboratory diagnostics;

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

222) 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 organ transplantation (part of body) and (or) fabrics (part of fabric) from the donor, and also artificial organs (part of bodies) is carried out;

223) sanatorium treatment - type of the medical rehabilitation which is carried out in the conditions of temporary stay of persons in the sanatorium organization;

224) the sanatorium organizations - the organizations providing the sanatorium services in improvement and recovery of health of the person using medical and other services, natural medical factors located in resorts or in medical and improving areas: sanatorium (for adults, adults and children, children), student's sanatorium dispensary, the children's rehabilitation and improving center;

225) sanitary and quarantine control - type of the state control and supervision in the sphere of sanitary and epidemiologic wellbeing of the population concerning persons, vehicles and under control to the state sanitary and epidemiologic control and supervision of products (goods) at check points through customs border of the Eurasian Economic Union, at interstate transfer railway stations or butt stations for the purpose of prevention of import of products (goods) potentially hazardous to health of the person, delivery, origin and spread of infectious and mass noninfectious diseases (poisonings);

226) 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;

227) sanitary and preventive actions - the organizational, administrative, technical, medical and sanitary, preventive and other measures directed to risk assessment, harmful effects per capita of habitat factors, elimination or reduction of such risk, prevention of origin and spread of infectious and mass noninfectious diseases (poisonings) and their liquidation;

228) sanitary and epidemiologic audit - alternative form of control epidemic the significant objects which are subject to the state control and supervision in the sphere of sanitary and epidemiologic wellbeing of the population, 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;

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

230) the sanitary and epidemiologic conclusion - the document certifying compliance to regulatory legal acts in the sphere of sanitary and epidemiologic wellbeing of the population of objects of the state sanitary and epidemiologic control and supervision;

231) 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;

232) trust Item - specially organized Item where preventive services are provided to core groups of the population on free basis on the principle of anonymity, voluntariness and confidentiality;

233) simulyatsionny office (center) - structural division of the organization of education in the field of health care based on which working off and delivery of practical skills by students in the conditions of imitation of clinical practice in the safe circle of training using simulyatsionny technologies are performed: dummies, exercise machines, computer simulation, technologies of virtual reality and specially trained actors trained to represent patients;

234) screening researches - complex of physical examination of the population which does not have clinical symptoms and claims for the purpose of identification and the prevention of development of various diseases at early stage, and also risk factors of their origin;

235) sports medicine - the field of medicine which is responsible for biomedical support of training of athletes and including medical and functional control in sport including the admission of athletes to sports of the highest achievements, functional and medical rehabilitation of athletes, increase in sports working capacity, therapy of somatic diseases of athletes, sports traumatology, medical care in urgent form in sport and hygiene of sport;

236) 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;

237) marrow - the fabric performing blood formation, located in internal part of bones and including haematopoietic stem cells, to Strom and other components of microenvironment;

238) dietary supplements to food - 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;

239) training - the form of informal education directed to forming and fixing in practice of professional knowledge, the skills received as a result of theoretical preparation and also studying of specifics of work, the best practices for further professional activity;

240) the mentor - the health worker with years of service at least five years appointed by the head of the medical organization or organization of medical education for rendering the practical help in professional adaptation of students according to programs of medical education and young specialists, performing activities on the basis of trinity of education, science and practice;

241) risk - the oriented approach - form of control of quality of medicines and medical products by annual selection from the market, including in the medical organizations;

242) 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 habitat on the state of health of the population and the potential medicobiological and economic consequences connected with it;

243) the independent expert - the physical person conforming to the requirements determined by authorized body, and consisting in the register of independent experts;

244) the guaranteed amount of free medical care - amount of the medical care provided at the expense of budgetary funds;

Marginal 245) the price for the trade name of medicine or medical product within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance - the price of the trade name of medicine or medical product above which the purchase within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance cannot be made;

Marginal 246) the price for the international non-proprietary name of medicine or technical characteristic of medical product within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance - the price of the international non-proprietary name of medicine or technical characteristic of medical product above which the purchase within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance cannot be made;

247) tobacco - the plant of the family Nicotiana of family of solanaceous types of Nicotiana Tabacum and Nicotiana Rustica used for tobacco products manufacture;

248) tobacco products - the products fully or partially made of tobacco leaf and (or) other parts of tobacco plant as the raw materials prepared so that to use for smoking, sucking, chewing, shuffing or different ways of consumption, including by means of system for heating of tobacco or any other device;

249) consumption of tobacco products - process of consumption of tobacco product, hookah mix and tobacco for hookah, including with use of hookah, systems for the heating of tobacco and any other systems of consumption causing dependence of human body on nicotine, negatively influencing his health, and also health of persons which are not consuming tobacco products, and polluting the environment;

250) ingredient of tobacco product - the substance (except for tobacco leaf and other parts of tobacco) used in case of production of tobacco product and which is present at finished tobacco product, including at the changed form;

251) packaging of tobacco product - unit of group consumer pack containing certain quantity of packs of tobacco product;

252) pack of tobacco product - the unit of consumer pack made of cardboard or paper or other material, containing certain quantity of tobacco product;

253) consumer packaging of tobacco product - packaging, held for sale or primary package of the tobacco products realized to the final consumer;

254) tobacco sponsorship - any kind of contribution to any event, action or the individual on purpose, result or probable result of sales promotion of tobacco product or the use of tobacco directly or indirectly, except for payments and fees, stipulated by the legislation the Republic of Kazakhstan;

255) system for tobacco heating - the device used for heating of tobacco with formation of the aerosol containing nicotine;

256) tobacco products - the tobacco product packed into consumer packaging;

257) the pharmaceutical proper pharmaceutical practicians inspector - the face authorized on implementation of functions on conducting pharmaceutical inspection on proper pharmaceutical practicians and included in the register of pharmaceutical inspectors of the Republic of Kazakhstan;

258) pharmaceutical inspectorate for proper pharmaceutical practicians (further - pharmaceutical inspection) - object assessment in the sphere of drug circulation for the purpose of determination of its compliance to requirements proper pharmaceutical the practician of the Republic of Kazakhstan and (or) the Eurasian Economic Union;

259) transplantation - organ transplantation (part of body) and (or) fabrics (part of fabric) on other place in organism or in other organism;

260) infectious form of tuberculosis - the tuberculosis form constituting danger to people around in connection with allocation sick to the external environment of bacteria of tuberculosis;

261) electronic systems of consumption - electronic systems of delivery of nicotine and electronic systems of the product delivery, not being nicotine, - devices (including electronic cigarettes) which by means of electronic technologies (accumulator) heat liquid (in cartridges, reservoirs and other containers) with nicotine content or without it, other chemicals, fragrances with formation of the aerosol inhaled by the user;

262) the graduate - person who mastered the educational program of medical and (or) pharmaceutical education, other educational program in the field of health care;

263) fabric - set of the cages and intercellular substance having identical structure, functions and origin;

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