Article 1. The basic concepts used in this Code are the Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

     1. The following basic concepts are used in this Code:

     1) human habitat (hereinafter referred to as habitat) is a set of natural, anthropogenic and social environmental factors (natural and artificial) that determine the conditions of human life;

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

     3) Certified first aid trainer – a person who has completed additional training in first aid and basic cardiopulmonary resuscitation;

     4) anonymous examination is a voluntary medical examination of a person without identification;

     5) disaster medicine is a field of medicine aimed at preventing and eliminating the medical and sanitary consequences of emergencies of a social, natural and man–made nature (hereinafter referred to as emergencies), including the prevention and treatment of diseases of the population, sanitary and anti-epidemic and sanitary preventive measures, preservation and restoration of the health of participants in emergency situations, as well as medical assistance to emergency services personnel;

     6) social health insurance fund is a non–profit organization that accumulates deductions and contributions, as well as purchases and pays for services of healthcare entities providing medical care in the amounts and on the terms stipulated by the contract for the purchase of medical services, and other functions defined by the laws of the Republic of Kazakhstan;

     7) military medicine is a field of medicine and public health, which is a system of scientific knowledge (a complex of scientific and practical disciplines) and practical activities of the military medical service, aiming at comprehensive medical support for troops, units and departments of special state and law enforcement agencies, civil protection agencies in peacetime and wartime;

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

     9) military medical (medical) units – structural units of the central executive bodies and other central state bodies and their territorial divisions, as well as military medical (medical) institutions (organizations), other units providing military medical (medical) support;

     10) enrichment (fortification) – the introduction of vitamins, minerals and other substances into food products during their production or processing in order to increase nutritional and biological value, as well as the prevention of diseases caused by their deficiency in humans;

     11) child (children) – a person who has not reached the age of eighteen (majority);

     12) specialized specialist – a medical professional with higher medical education, who has a certificate in the field of healthcare;

     13) the established (final) sanitary protection zone is the territory of the sanitary protection zone, determined on the basis of the results of a one–year cycle of field studies and measurements to confirm the calculated (preliminary) sanitary protection zone.;

     14) a list of medicines and medical devices for free and (or) preferential outpatient care for certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions) – the list of medicines, medical devices and specialized medical products purchased at the expense of budgetary funds and (or) assets of the social health insurance fund within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance for the provision of primary health and specialized medical care in outpatient settings, including names and characteristics medicines, medical devices and specialized medical products in the context of certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions);

     15) a biosimilar medicinal product (biosimilar, biosimilar) is a biological medicinal product that contains a version of the active ingredient of a registered biological original medicinal product or reference medicinal product and for which similarity has been demonstrated based on comparative studies in terms of quality, biological activity, safety and efficacy;

     16) biobank – a specialized repository of biological materials for scientific and medical purposes;

     17) biologically active substances – substances of natural origin or their synthetic analogues that normalize pathologically altered body functions in animals and humans;

     18) biological medicinal product – a medicinal product, the active substance of which is produced or isolated from a biological source and in order to describe the properties and quality control of which it is necessary to combine biological and physico-chemical methods of analysis with an assessment of the production process and methods of its control;

     19) medicinal products of biological origin – preparations containing biological substances (hormones, cytokines, blood clotting factors, insulins, monoclonal antibodies, enzymes, colony-stimulating factors, preparations based on tissue cells, and others obtained using biotechnological methods);

     20) biomedical research is research aimed at obtaining new knowledge by scientific methods about life, human health, diseases, their diagnosis, treatment or prevention, as well as genetic and environmental factors related to life processes, diseases and health;

     21) biotechnological medicinal product – a medicinal product produced using biotechnological processes and methods using recombinant deoxyribonucleic acid technology, controlled expression of genes encoding the production of biologically active proteins, hybridomic technologies, monoclonal antibodies or other biotechnological processes;

     22) bioethics is an interdisciplinary scientific field that combines biomedical and humanitarian sciences in order to analyze the moral, social, and legal aspects of applying the latest achievements of the life sciences;

     23) delivery – natural or artificial (instrumental, manual, medical) completion of the birth act;

     24) the marginal price for the trade name of a medicinal product for retail sale is the price for the trade name of a medicinal product included in the list of medicinal products subject to price regulation, above which its retail sale cannot be carried out.;

25) original medicinal product – a medicinal product with a new active substance, which was the first to be registered and placed on the global pharmaceutical market on the basis of a dossier containing the results of complete preclinical (non-clinical) and clinical studies confirming its safety, quality and effectiveness.;

     26) co–payment - payment of the difference in the cost of medicines, medical devices and the established marginal price of their reimbursement within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance at the outpatient level, carried out on a voluntary basis;

     27) a single distributor is a legal entity operating within the guaranteed scope of free medical care and (or) in the system of compulsory social health insurance in accordance with Article 247 of this Code.;

     28) vaccines are drugs for the specific prevention of infectious diseases that have a preventive effect through the immune system;

     29) hematopoietic stem cells are hematopoietic cells of the human bone marrow that have polypotence and are in the process of life in the bone marrow, peripheral blood and umbilical cord blood;

     30) the register of hematopoietic stem cell (bone marrow) donors is a list of persons who agree to donate hematopoietic stem cells (bone marrow) free of charge and are typed according to the HLA system;

     31) genetically modified objects – raw materials and products of plant and (or) animal origin obtained using genetic engineering methods, including genetically modified sources, organisms;

     32) homeopathic medicinal product – a medicinal product produced using homeopathic technology using homeopathic raw materials in accordance with the requirements of the pharmacopoeias of the Republic of Kazakhstan and (or) the Eurasian Economic Union or, in the absence thereof, in accordance with the requirements of homeopathic pharmacopoeias;

     33) medicinal product – a product that is or contains a substance or a combination of substances that comes into contact with the human body, intended for the treatment, prevention of human diseases or the restoration, correction or modification of its physiological functions through pharmacological, immunological or metabolic effects, or for the diagnosis of diseases and human conditions;

     34) the marginal price of a medicinal product is the price above which the sale of a medicinal product cannot be carried out.;

     35) circulation of medicines – an activity involving the processes of development, preclinical (non-clinical) research, testing, clinical trials, expertise, registration, pharmacovigilance, quality control, production, manufacture, storage, transportation, import and export, release, sale, transfer, use, destruction of medicines;

     36) good pharmaceutical practices in the field of drug circulation (hereinafter referred to as good pharmaceutical practices) are healthcare standards that apply to all stages of the life cycle of medicines: good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP), good distribution practice (GDP), good Pharmacy Practice (GPP), Good Pharmacovigilance Practice (GVP) and other good pharmaceutical practices;

     37) manufacturer of medicines – an organization engaged in the production of medicines and licensed to manufacture medicines;

     38) the register of authorized persons of manufacturers of medicines is an electronic information resource of the authorized body containing information about authorized persons of manufacturers of medicines;

     39) authorized person of a manufacturer of medicines – a person responsible for ensuring and controlling the quality of medicines produced by the manufacturer in accordance with the legislation of the Republic of Kazakhstan in the field of healthcare, and included in the register of authorized persons of manufacturers of medicines;

     40) rational use of medicines – medical treatment appropriate to clinical indications, in doses that meet the individual needs of the patient, for a sufficient period of time and at the lowest cost;

     41) long-term contract for the supply of medicines and medical devices – a civil law contract concluded by a single distributor for a period of up to ten years with the right to extend up to three years with a manufacturer of medicines or medical products located in the territory of the Republic of Kazakhstan, or with a customer for the contract production of original patented medicines, as well as with customers for the contract production of medical products for the supply of medicines or medical products, or with a subject in the field of circulation of medicines and medical devices, intending to establish production or modernize the existing production of medicines and medical devices located in the territory of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan;

     42) retail sale of medicines and medical products – pharmaceutical activities related to the acquisition (other than import), storage, distribution, sale (other than export) to the end user, destruction of medicines and medical products;

     43) contract manufacturing of medicines and medical products (hereinafter referred to as contract manufacturing) is the production of medicines and medical products on a contractual basis at the production facilities of manufacturers of medicines and medical products located in the territory of the Republic of Kazakhstan, which ensure full compliance with the requirements of good manufacturing practice (GMP) for medicines and the international management system standard Quality Assurance (ISO 13485) for medical device manufacturers;

     44) web portal for the purchase of medicines and medical devices, services from healthcare entities - an information system that provides a single point of access to electronic services for the purchase of medicines and medical devices, services from healthcare entities within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

     45) a single operator in the field of procurement of medicines and medical devices, services from healthcare entities (hereinafter referred to as the single operator) is a legal entity designated by the authorized body in coordination with the authorized body in the field of public procurement.;

     46) wholesale sale of medicines and medical products – pharmaceutical activities related to the purchase (acquisition), storage, import (import), export (export), sale (except for sale to the public) without volume restrictions, transportation and destruction of medicines and medical products;

     47) the state body in the field of circulation of medicines and medical devices is a state body that carries out management in the field of circulation of medicines and medical devices, control over the circulation of medicines and medical devices;

     48) state expert organization in the field of circulation of medicines and medical devices is a state monopoly entity engaged in production and economic activities in the field of healthcare to ensure the safety, effectiveness and quality of medicines and medical devices;

     49) facilities in the field of circulation of medicines and medical devices – a pharmacy, including those selling via the Internet, a pharmacy in healthcare organizations and a mobile pharmacy for rural settlements, a pharmacy (distributor) warehouse, a temporary storage warehouse for medicines, medical devices, an optics store, a medical device store, a medical device warehouse organizations that manufacture medicines and medical devices;

     50) subjects in the field of circulation of medicines and medical devices – individuals or legal entities engaged in pharmaceutical activities;

51) The State Register of Medicines and Medical Devices is an electronic information resource containing information about medicines and medical devices registered and approved for medical use in the Republic of Kazakhstan;

     52) a long–term contract for the storage and transportation of medicines and medical devices is a civil service contract concluded by a single distributor with a subject in the field of circulation of medicines and medical devices - a resident of the Republic of Kazakhstan that meets the requirements of good distribution practice (GDPR);

     53) state re–registration of a medicinal product or medical product is a procedure for extending the validity period of a state registration of a medicinal product or medical product with the issuance of an indefinite document certifying state registration (hereinafter referred to as the registration certificate) under the same registration number and making an appropriate entry in the State Register of Medicines and Medical Products;

     54) state registration of a medicinal product or medical product is a procedure for obtaining permission for the circulation of medicinal products or medical products in the territory of the Republic of Kazakhstan and entering a medicinal product or medical product into the State Register of Medicines and Medical Products for a certain period of time.;

     55) the expiration date of a medicinal product is the date after which the medicinal product cannot be used.;

     56) packaging of a medicinal product is a product or a complex of products that ensure the circulation of medicines by protecting them from damage and loss, as well as protecting the environment from pollution;

     57) bulk-a product of a medicinal product or a medical product – a metered-dose finished medicinal product or a finished medical product that has passed all stages of the technological process, with the exception of the final packaging;

     58) making changes to the registration dossier of a medicinal product or medical device is a procedure carried out on the basis of an examination of changes made to the registration dossier during the period of validity of the registration certificate;

     59) the quality of a medicinal product is a set of properties and characteristics of a pharmaceutical substance (active pharmaceutical substance) and a medicinal product, ensuring their compliance with the intended purpose;

     60) a regulatory document on the quality of a medicinal product is a document that establishes requirements for quality control of a medicinal product in the post–registration period based on an examination of the medicinal product during its registration and contains a specification, description of analytical methods and tests of the medicinal product or references to such tests, as well as relevant acceptance criteria for quality indicators;

     61) trade name of a medicinal product – the name under which the medicinal product is registered;

     62) international nonproprietary name of a medicinal product is the name of a medicinal product recommended by the World Health Organization;

     63) quality of drug provision – the level of compliance with the requirements of health standards governing the production, import, storage, timely delivery of medicines and pharmacovigilance;

     64) dosage form – the condition of a medicinal product corresponding to the methods of its administration, application and ensuring the achievement of the necessary therapeutic effect;

     65) medicinal plant raw materials – fresh or dried plants, algae, fungi or lichens or parts thereof, whole or crushed, used for the production of medicines;

     66) medicinal product – a medicinal product in the form of a dosage form;

     67) manufacture of medicinal products – pharmaceutical activities related to the manufacture of medicinal products in pharmacies, the purchase of pharmaceutical substances (active pharmaceutical substances) for pharmaceutical use, storage, quality control, registration and sale of manufactured medicines;

     68) the safety of a medicinal product is the absence of an unacceptable risk when using a medicinal product associated with the possibility of harming human life, health and the environment.;

     69) the effectiveness of a medicinal product is a set of characteristics of a medicinal product that ensure the achievement of a preventive, diagnostic or therapeutic effect or the restoration, correction or modification of a physiological function.;

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

     71) disinsection is a complex of preventive and extermination measures for the destruction of insects and arthropods in order to protect humans, animals, premises and territories from them.;

     72) disinfection is a complex of special measures aimed at the destruction of pathogens of infectious and parasitic diseases in the external environment;

     73) health is a state of complete physical, spiritual (mental) and social well–being, and not only the absence of diseases and physical defects;

     74) healthcare is a system of measures of a political, economic, legal, social, cultural, and medical nature aimed at preventing and treating diseases, maintaining public hygiene and sanitation, preserving and strengthening the physical and mental health of every person, maintaining his active long–term life, and providing him with medical care in case of loss of health;

     75) the healthcare system is a set of state bodies and subjects of healthcare, whose activities are aimed at ensuring the rights of citizens of the Republic of Kazakhstan to health protection.;

     76) regional long–term healthcare infrastructure development plan - a long-term regional infrastructure development plan that reflects information on the existing network of healthcare organizations, planned restructuring (opening, consolidation, closure, redevelopment), as well as information on the need for new healthcare facilities and investment planning;

     77) certification of scientific and pedagogical personnel of educational organizations in the field of healthcare is a procedure for determining the level of pedagogical and professional competence of scientific and pedagogical personnel of educational organizations in the field of healthcare;

     78) organization of education in the field of healthcare – an educational organization that implements educational programs in the fields of "Healthcare" and (or) "Interdisciplinary programs related to healthcare and social security (medicine)";

     79) the clinic of the organization of education in the field of health care is a structural subdivision of the organization of education or the organization of health care on the basis of which educational programs of technical and professional, post-secondary, higher, postgraduate and additional medical education on the basis of modern achievements of science and practice are realized;

     80) scientific organization in the field of healthcare – a national center, scientific center or scientific research institute engaged in scientific, scientific, technical and innovative activities in the field of healthcare, as well as medical, pharmaceutical and (or) educational activities;

     81) professional standard in the field of healthcare – a standard that defines the requirements for the level of qualifications, content, quality and working conditions of healthcare professionals;

     82) certification of a healthcare professional is a procedure for determining whether an individual's qualification level meets the qualification requirements established by the industry qualifications framework and professional standards in the field of healthcare, as well as determining readiness for professional activities in the field of healthcare, including readiness for clinical or pharmaceutical practice, or activities in the field of sanitary and epidemiological welfare of the population.;

     83) the certificate of a specialist in the field of healthcare is a standard document confirming the level of qualification of an individual and his readiness for professional activity in the field of healthcare, including readiness for clinical or pharmaceutical practice, or activities in the field of sanitary and epidemiological welfare of the population.;

     84) the health care manager is the first head who manages the state medical organization.;

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

     86) expertise in the field of healthcare is a set of organizational, analytical and practical measures aimed at determining the effectiveness and quality of tools, methods, technologies, educational and scientific programs, services in various fields of healthcare, as well as determining temporary disability, professional fitness for health reasons in accordance with the legislation of the Republic of Kazakhstan;

     87) a standard in the field of healthcare (hereinafter referred to as the standard) is a regulatory legal act that establishes rules, general principles and characteristics for ensuring standardization in the field of healthcare in the field of medical, pharmaceutical, educational and scientific activities in the field of healthcare, digital healthcare;

     88) standardization in the field of healthcare (hereinafter referred to as standardization) is an activity aimed at achieving an optimal degree of streamlining of the characteristics of healthcare processes, technologies and services through the development, implementation and enforcement of standards, requirements, norms, instructions, rules;

     89) the authorized body in the field of healthcare (hereinafter referred to as the authorized body) is the central executive body responsible for the management and intersectoral coordination in the field of health protection of citizens of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiological welfare of the population, circulation of medicines and medical devices, quality of medical services (assistance);

     90) national operator in the field of healthcare – a legal entity engaged in activities in the field of healthcare, including the development of healthcare infrastructure;

     91) assessment of healthcare technologies is a comprehensive assessment of the comparative proven clinical and clinical–economic (pharmacoeconomic) effectiveness and safety of healthcare technologies, as well as the economic, social and ethical consequences of their use, conducted for decision-making in the field of healthcare;

     92) healthcare technology is the application of knowledge and skills that are used to promote health, prevent, diagnose, treat diseases, rehabilitate patients and provide palliative care, including vaccines, medicines and medical devices, procedures, manipulations, operations, screening, preventive programs, including information systems;

     93) healthcare organization – a legal entity engaged in activities in the field of healthcare;

     94) medicinal form of a healthcare organization – a list of medicines for the provision of medical care within the guaranteed volume of free medical care and (or) in the system of compulsory social medical insurance, formed on the basis of the Kazakh national Medicinal form and approved by the head of the healthcare organization in accordance with the procedure determined by the authorized body;

     95) joint and several responsibility for health – the division of responsibility between the members of society: the state, the employer and the citizen himself for the preservation and strengthening of individual and public health, reducing the risks of the disease;

     96) deratization is a complex of preventive and extermination measures aimed at destroying or reducing the number of rodents;

     97) detoxification is a complex of medical measures aimed at removing toxic substances of endogenous or exogenous origin from the human body;

     98) diagnostics – a set of medical services aimed at establishing the presence or absence of a disease;

     99) dynamic monitoring – systematic monitoring of the patient's health status, as well as the provision of necessary medical care based on the results of this monitoring;

     100) donor – a person, a human corpse, an animal from which donated blood, its components, and other donor material (including sperm, eggs, tissues of reproductive organs, germ cells, and embryos) are collected, as well as organs (parts of an organ) and (or) tissues (parts of tissue) are removed for transplantation to the recipient;

     101) donor organization – a healthcare organization in which organs (parts of an organ) and (or) tissues (parts of tissue) from cadavers are removed and preserved for the purpose of transplantation;

     102) the donor function is the voluntary passage of a medical examination by a donor and the performance of an allogeneic donation of blood and its components.;

     103) treatment is a complex of medical services aimed at eliminating, suspending and (or) alleviating the course of the disease, as well as preventing its progression;

     104) attending physician – a doctor who provides medical care to a patient during his observation and treatment in a medical organization;

     105) voluntary treatment – treatment carried out with the consent of the patient or his legal representative;

     106) estimated (preliminary) sanitary protection zone - the territory of the sanitary protection zone, determined on the basis of a project with calculations of the dispersion of atmospheric air pollution, physical (noise, vibration, non–ionizing radiation) and (or) radiation effects on human health;

     107) an undesirable reaction is an unintended, adverse reaction of the body associated with the use of a medicinal (investigational) drug and suggesting a possible relationship with the use of this medicinal (investigational) drug.;

     108) falsified medicines and medical products – medicines, medical products unlawfully and intentionally provided with false information about their composition or configuration and (or) manufacturer, as well as about supplies, including records and documents affecting the used supply channels;

     109) personal medical record – a personal document in which the results of mandatory medical examinations are recorded with a note on admission to work;

110) high–tech medical service - a service provided by specialized specialists for diseases requiring the use of innovative, resource-intensive and (or) unique diagnostic and treatment methods;

     111) artificial termination of pregnancy – termination of pregnancy before the viability of the fetus using medicinal or surgical methods, carried out by medical professionals with higher medical education in the relevant field;

     112) mobile medical complexes – mobile clinics (offices) based on motor transport, equipped with the necessary medical equipment, which are used to ensure accessibility and expand the list of medical services provided to the population of rural areas and remote settlements or in the interests of defense and national security;

     113) sexually transmitted infections are infectious diseases, the most common way of infection of which is sexual contact.;

     114) a person with gender identification disorders is a person who aspires to live and be accepted as a person of the opposite sex.;

     115) an immunological medicinal product (immunobiological medicinal product) is a medicinal product intended for the formation of active or passive immunity or the diagnosis of the presence of immunity, or the diagnosis (development) of a specific acquired change in the immunological response to allergenic substances.;

     116) the immunological typing system (hereinafter referred to as the HLA system) is an antigen system located on human leukocytes that determines the tissue compatibility of the donor and recipient during organ (part of the organ) and (or) tissue (part of the tissue) transplantation;

     117) invasive methods – diagnostic and treatment methods carried out by penetrating into the internal environment of the human body;

     118) innovative medical technologies – a set of methods and means of scientific and scientific-technical activity, the implementation of which in the field of medicine (biomedicine), pharmacy and digitalization of healthcare is socially significant and (or) economically effective;

     119) integrated academic medical center is an association of higher and (or) postgraduate medical education organizations with scientific organizations in the field of healthcare and healthcare organizations in order to share resources to improve the quality of medical services through the integration of education, research and clinical practice.;

     120) non–interventional clinical trial - a study that is conducted after the state registration of a medicinal product or medical device and is prescribed within the framework of medical practice;

     121) interventional research – a study involving a person as a research subject, in which a researcher, based on the protocol of an interventional clinical trial corresponding to the procedure for conducting clinical trials, prescribes a special intervention to the subject of the study.;

     122) epidemiological surveillance of non–communicable diseases is the activity of state bodies and organizations of the sanitary and epidemiological service to monitor risk factors from environmental impacts affecting public health, including occupational factors, occupational diseases with temporary disability, minimization and control over the implementation of management programs for chronic non-communicable diseases.;

     123) infectious and parasitic diseases are human diseases, the occurrence and spread of which are caused by the influence of biological environmental factors on it and the possibility of disease transmission from a sick person, animal to a healthy person.;

     124) iodine deficiency disease is a pathological process of the body caused by a violation of the function of the thyroid gland, associated with insufficient intake and assimilation of iodine in the body.;

     125) occupational disease is an acute or chronic disease caused by the exposure of an employee to harmful industrial factors in connection with the performance of their work (official) duties.;

     126) biological material of preclinical (non–clinical) and clinical studies - samples of biological fluids, tissues, secretions and waste products of humans and animals, biopsy material, histological sections, smears, scrapings, flushes obtained during preclinical (non-clinical) and clinical studies and intended for laboratory research;

     127) preclinical (non–clinical) research is a chemical, physical, biological, microbiological, pharmacological, toxicological and other experimental study or series of studies on the study of the investigated substance (drug) through the use of scientific assessment methods in order to study the specific effect and (or) obtain evidence of safety for human health.;

     128) clinical base – a healthcare organization that is used by an educational organization for the training and advanced training of healthcare personnel under a joint activity agreement;

     129) clinical trial – a study involving a person as a subject, conducted to identify or confirm the safety and effectiveness of means, methods and technologies for the prevention, diagnosis and treatment of diseases;

     130) clinical nursing guidelines – a document containing scientifically proven recommendations for nursing staff in the care of patients, involving the use of preventive, diagnostic, therapeutic and rehabilitative measures in the management of patients;

     131) clinical pharmacologist – a specialist with higher medical education in the fields of "medical science", "pediatrics", "general medicine", who has completed a residency or retraining program in clinical pharmacology and has a certificate of a specialist in the field of healthcare;

133-1) advisory supervision – medical supervision of a person with harmful use of a psychoactive substance and (or) a person with a pathological attraction to gambling;

     132) clinical protocol – scientifically proven recommendations for prevention, diagnosis, treatment, medical rehabilitation and palliative care for a particular disease or condition of the patient;

     133) consultation – examination of a person in order to establish a diagnosis, determine treatment tactics and prognosis of the disease with the participation of at least three doctors;

     134) contraception – methods and means of preventing unwanted pregnancy;

     135) the marginal price for the trade name of a medicinal product for wholesale sale is the price for the trade name of a medicinal product included in the list of medicinal products subject to price regulation, above which its wholesale sale cannot be carried out.;

135-1) potent substances – substances of natural, synthetic and biosynthetic origin (chemical or biological compounds) with high toxicity, the use of which has a harmful effect on human life and health, included in accordance with the legislation of the Republic of Kazakhstan in the list of potent substances that have a harmful effect on human life and health.;

     136) The Kazakhstan National Pharmaceutical Formulary is a list of medicines with proven clinical safety and efficacy, as well as orphan (rare) medicines, which is an obligatory basis for the development of pharmaceutical formularies for medical organizations and the formation of lists for the purchase of medicines within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance.;

     137) the nomenclature of medical devices of the Republic of Kazakhstan is a systematic nomenclature classifier of types of medical devices, harmonized with the global nomenclature of medical devices (GMDN) and used in the Republic of Kazakhstan;

     138) The State Pharmacopoeia of the Republic of Kazakhstan is a set of minimum requirements for the safety and quality of medicines and medical devices;

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

     140) a reproduced medicinal product (generic) is a medicinal product that has the same quantitative and qualitative composition of active ingredients and the same dosage form as the original medicinal product, and the bioequivalence of which to the original medicinal product is confirmed by relevant bioavailability studies. Different salts, esters, isomers, mixtures of isomers, complexes or derivatives of the active substance are recognized as the same active substance if their safety and effectiveness do not differ significantly. Different dosage forms for immediate-release oral administration of substances are recognized in bioavailability studies as the same dosage form.;

141) allogeneic donation of blood and its components – donation of blood and its components for medical use from one person to another;

     142) Pre–exposure prophylaxis - antiretroviral therapy applied to uninfected people to prevent HIV infection;

     143) post–exposure prophylaxis - antiretroviral therapy used to reduce the risk of HIV infection after possible infection;

     144) public health is a comprehensive characteristic of the mental, physical and social well–being of the population, reflecting the efforts of society to lead a healthy lifestyle for citizens of the Republic of Kazakhstan, including a healthy diet, to prevent diseases and injuries, as well as to prevent the influence of adverse environmental factors.;

     145) research in the field of public health is a study conducted on the basis of collecting and summarizing clinical and epidemiological data and other medical information to identify the main factors affecting health and determining the development of the healthcare system, developing methods of targeted influence and management of these factors.;

     146) adverse event – any malfunction and (or) deterioration of the characteristics or malfunction of a medical device, or insufficiency or inaccuracy of the accompanying information (documentation) for a medical device, side effects or an undesirable reaction not specified in the instructions for use or the operating manual, which directly or indirectly led or could lead to death or serious deterioration of the health of users or third parties;

     147) applied biomedical research – biomedical research aimed at achieving specific goals in the field of diagnosis, treatment or prevention of diseases, ensuring public health;

     148) hookah is a device used to inhale aerosol, steam or smoke arising from the smoldering and (or) heating of tobacco, as well as products that do not contain tobacco leaves, and in which the aerosol, steam or smoke pass through a vessel with liquid;

     149) hookah tobacco is a type of smoking tobacco product intended for smoking using a hookah and consisting of a mixture of cut or torn raw materials with or without the addition of non–tobacco raw materials and other ingredients.;

     150) hookah mixture – a product made without using tobacco leaf as a raw material, prepared in such a way as to be used for consumption using a hookah;

     151) auxiliary substance – a substance, with the exception of pharmaceutical substances (active pharmaceutical substances), which is part of a medicinal product to impart the necessary properties to it;

     152) confidential medical examination is an examination based on the observance of the secrecy of a medical professional and the preservation of information about the identity of the person being examined.;

     153) compulsory treatment is the treatment of a patient carried out on the basis of a court decision.;

     154) medical worker – an individual who has a professional medical education and carries out medical activities;

     155) medical aviation – provision of emergency medical care to the population with the involvement of air transport;

     156) medical information – information about patients and diseases arising in the process of providing medical care and reflected in medical documents and medical information systems, as well as information on health issues;

     157) medical intervention – direct or indirect impact and (or) other manipulation performed by a medical professional when providing medical care to patients for the purpose of prevention, prevention, diagnosis, treatment, rehabilitation, research and aimed at restoring or improving health;

     158) medical and social assistance is medical and socio-psychological assistance provided to persons with socially significant diseases, the list of which is determined by the authorized body.;

     159) medical and social rehabilitation is a set of measures to restore the health of patients and persons with disabilities using medical, social and professional activities for employment, inclusion in family and social life.;

     160) biomedical experiment – a study based on the reproduction (modeling) of the structural and functional complex of the studied condition or disease in a simplified form on experimental (laboratory) animals to determine the causes, conditions and mechanisms of the condition or disease development, to develop methods of treatment and prevention;

     161) medical products – medical products and medical equipment;

     162) consumables for medical devices – products and materials consumed when using medical devices that ensure manipulation in accordance with the functional purpose of the medical device, performance characteristics, and the manufacturer's service manual;

     163) circulation of medical products – design, development, creation of prototypes, conducting technical tests, research (testing) evaluation of the biological effect of medical products, clinical trials, safety, quality and effectiveness of medical products, registration, production (manufacture), storage, transportation, sale, installation, commissioning, application (operation), maintenance, repair and disposal of medical devices;

     164) research (tests) to evaluate the biological effect of medical devices – research (tests) conducted to determine the compliance of medical devices with the general requirements for the safety and effectiveness of medical devices, the requirements for their labeling and operational documentation for them.;

     165) Global Nomenclature of Medical devices (GMDN) is a systematic nomenclatural classifier of types of medical devices used to identify medical devices.;

     166) type of medical products – a group of medical products having a similar purpose, similar technologies of application, design features and a common numeric designation in the nomenclature of medical products of the Republic of Kazakhstan;

     167) monitoring the safety, quality and effectiveness of medical devices – collection, registration, analysis of information about adverse events;

     168) manufacturer of a medical device – a subject in the field of circulation of medicines and medical devices responsible for the development and manufacture of a medical device, making it available for use on its own behalf, regardless of whether it was developed and (or) manufactured by this person or on his behalf by another person(s), and responsible for its safety, quality and efficiency;

     169) a medical device component is a part of a medical device that is not an independent medical device, including blocks, parts, product elements, materials, and spare parts provided by the manufacturer for use in accordance with their functional purpose, performance characteristics, and the manufacturer's service manual.;

     170) the safety of a medical device is the absence of an unacceptable risk when using a medical device associated with harm to human life, health, and the environment.;

     171) The quality of a medical product is the degree to which a set of properties and characteristics of a medical product correspond to the purposes of its intended use.;

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

     173) the effectiveness of a medical device is a set of properties and characteristics of a medical device that ensure the achievement of the intended purpose set by the manufacturer of the medical device and confirmed by the practice of its use.;

     174) medical education is a system of training and advanced training of medical workers, as well as a set of knowledge and skills necessary for a medical worker, acquired during training in advanced training programs in medical specialties, confirmed by an official document on graduation;

     175) assessment of students' knowledge and skills in medical education programs – assessment of the quality of students' learning of educational programs and the formation of knowledge, skills and abilities in accordance with the stage of study;

     176) assessment of the professional readiness of graduates of medical education programs is a procedure for assessing knowledge and skills, conducted in order to determine whether the qualifications of a graduate of a medical education program meet the requirements of a professional standard in the field of healthcare;

     177) strategic partnership in the field of medical education and science is a form of medium–term or long-term cooperation between scientific organizations and organizations of education in the field of healthcare, and foreign organizations of higher and (or) postgraduate education, and medical organizations in the field of medical education and science for the implementation and adaptation of international standards of education, science and clinical practice based on agreement;

     178) organization of medical education – an educational organization that implements educational programs in the areas of "Healthcare" training;

     179) medical care is a complex of medical services aimed at preserving and restoring public health, including drug provision;

     180) quality of medical care – the level of compliance of the provided medical care with the standards of medical care

181) medical services are actions of healthcare entities that have a preventive, diagnostic, curative, rehabilitative and palliative focus in relation to a specific person.;

     182) independent examination of the quality of medical services (assistance) is a procedure conducted by independent experts within the framework of internal and external examinations in order to make a conclusion on the quality level of medical services (assistance) provided by healthcare entities, using indicators reflecting the effectiveness, completeness and compliance of the medical services (assistance) provided to standards.;

     183) medical examination is an examination of an individual in order to establish or confirm the fact of the presence or absence of a disease, to determine the state of health.;

     184) medical activity is the professional activity of individuals who have received technical and professional, post-secondary, higher and (or) postgraduate medical education, as well as legal entities aimed at protecting the health of the population of the Republic of Kazakhstan.;

     185) state body in the field of medical services (assistance) – a state body that provides leadership in the field of medical services (assistance), quality control of medical services (assistance);

     186) medical devices – materials, products, solutions, reagents, kits, kits used to provide medical care in accordance with their functional purpose and manufacturer's instructions;

     187) medical rehabilitation is a complex of medical services aimed at preserving, partially or completely restoring the impaired and (or) lost functions of the patient's body.;

     188) medical trains are mobile clinics on railway transport equipped with the necessary medical equipment, used to ensure accessibility and expand the list of medical services provided to the population living near railway stations (tracks) and in areas close to them.;

     189) medical equipment – devices, devices, equipment, complexes, systems used separately or in combination with each other to provide medical care in accordance with the functional purpose and operational characteristics established by the manufacturer;

     190) medical organization – a healthcare organization whose main activity is the provision of medical care;

     191) nursing care is a complex of medical services provided by nurses and extended practice nurses to people of all ages, groups and communities, sick or healthy, including health promotion, disease prevention and care for the sick, people with disabilities and dying people;

     192) preschool and school medicine is a field of medicine that includes the organization of medical care for children of preschool and school age, aimed at protecting and strengthening health and preventing diseases;

     193) state pharmaceutical inspector – an official of the state body exercising state control in the sphere of circulation of medicines and medical devices;

     194) multidisciplinary group – a group of various specialists, formed depending on the nature of the violation of the functions and structures of the patient's body, the severity of his clinical condition;

     195) nicotine is an alkaloid found in tobacco leaves and tobacco smoke;

     196) advanced therapy drugs – drugs obtained by biotechnological or bioengineered methods that offer new opportunities for the treatment of diseases and injuries, including drugs for gene therapy, somatic cell therapy, and tissue engineering;

     197) rehabilitation potential – a clinically justified probability of the prospect of partial or complete restoration of impaired and (or) lost functions of the patient's body in a certain period of time;

     198) family doctor – a doctor who has received special multidisciplinary training in providing primary health care to family members and is certified as a healthcare specialist;

     199) focal disinfection – disinfection carried out in foci for the prevention and (or) elimination of infectious and parasitic diseases;

     200) manufacturer's marginal price – the price for the trade name of a medicinal product provided by the manufacturer, which is the base price for calculating the marginal wholesale and retail prices for the trade name of a medicinal product included in the list of medicinal products subject to price regulation, in accordance with the Rules for Regulating Prices for Medicinal Products, as well as for medical products within the guaranteed the amount of free medical care and (or) in the compulsory social health insurance system;

     201) a production site is a geographically isolated complex of a manufacturer of medicines, medical products, designed to carry out the entire process of manufacturing medicines, medical products or its specific stages.;

     202) production control is a set of measures, including laboratory studies and tests of manufactured products, works and services performed by an individual entrepreneur or a legal entity, aimed at ensuring safety and (or) harmlessness to humans and the environment.;

     203) certificate of state registration of products – a document confirming the safety of products (goods), certifying the compliance of products (goods) with technical regulations and (or) uniform sanitary-epidemiological and hygienic requirements of the Eurasian Economic Union and issued by the state body in the field of sanitary-epidemiological welfare of the population in a single form;

     204) product safety monitoring is a system of measures aimed at identifying, preventing and suppressing the import, production, use and sale of products that do not comply with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

     205) patented medicinal products – medicinal products that have received legal protection in accordance with the legislation of the Republic of Kazakhstan in the field of intellectual property;

     206) patient – an individual who is (has been) a consumer of medical services, regardless of the presence or absence of a disease or condition requiring medical care.;

     207) prevention is a complex of medical and non–medical measures aimed at preventing the occurrence of diseases, the progression of diseases in the early stages and the control of complications that have already developed, damage to organs and tissues.;

     208) psychoactive substances – substances of synthetic or natural origin (alcohol, narcotic drugs, psychotropic substances, their analogues, other intoxicating substances), which, when taken once, have an effect on mental and physical functions, human behavior, and with prolonged use cause mental and physical dependence.;

208-1) harmful use of psychoactive substances – non-medical use that has led to physical and (or) mental and (or) legal consequences without signs of dependence syndrome;

     208-2) medical examination to establish the fact of the use of a psychoactive substance and intoxication – an examination of a person in order to establish the state of narcotic, alcoholic intoxication and intoxication from other psychoactive substances, conducted in public health organizations engaged in activities in the field of mental health protection, in accordance with the procedure determined by the authorized body;

     209) Mental health is a state of well–being in which everyone can realize their own potential, cope with the normal stresses of life, work productively and productively, and contribute to the life of their community.;

     210) medical assistance in the field of mental health – prevention, diagnosis, treatment, medical and social assistance and medical and social rehabilitation of persons with mental and behavioral disorders (diseases);

211) mental and behavioral disorders (diseases) are a group of diseases according to the international classification of diseases characterized by impaired mental activity;

     212) psychological assistance – a set of measures aimed at:

     assistance to a person in preventing and resolving psychological problems, overcoming difficult life and crisis situations and their consequences that contribute to maintaining mental and physical health, optimizing mental development, adapting and improving the quality of life, including by activating a person's own abilities;

     informing people about the causes of psychological problems, ways to prevent and resolve them;

     personality development, self-improvement and self-realization;

     213) psychological problem – a state of mental discomfort of a person caused by dissatisfaction with himself, his activities, interpersonal relationships, family situation and (or) other problems of personal life;

     214) radiopharmaceutical medicinal product – a medicinal product containing, in a ready-to-use state, one or more radionuclides (radioactive isotopes) as an active substance or as part of an active substance;

     215) resident physician is a doctor who studies as part of a residency training program and works in a medical organization under the supervision of a mentor.;

     216) residency – the level of postgraduate medical education, the purpose of which is to acquire or change the professional qualifications of a doctor in the relevant specialty for admission to independent clinical practice.;

     217) residency center – a clinic of a healthcare education organization, a university hospital, a national center, a research center or a research institute accredited as a medical organization on the basis of which residency programs are implemented in accordance with the procedure established by the authorized body;

     218) reproductive health – human health, reflecting his ability to reproduce full-fledged offspring;

     219) antiretroviral therapy is a method of treating HIV infection through the use of short and long courses of antiretroviral drugs in order to restore the immune system, reduce the risk of developing severe life–threatening diseases, reduce the number of complications and prolong the life of those infected with HIV;

     220) reference laboratory is a laboratory of a healthcare organization that carries out organizational and methodological work on the implementation of an external quality assessment system and conducting research in diagnostically complex and expert cases in a specific field of laboratory diagnostics.;

     221) a reference medicinal product is a medicinal product that is used as a reference product and is a standard by which the properties of a medicinal product are determined (normalized).;

     222) recipient – a patient who has undergone transfusion of donated blood or components and (or) preparations isolated from it, injection of male or female donor material (sperm, egg, embryos) or transplantation of organs (parts of an organ) and (or) tissues (parts of tissue) from a donor, as well as artificial organs (parts organs);

     223) sanatorium-resort treatment is a type of medical rehabilitation carried out under conditions of temporary stay of persons in a sanatorium–resort organization.;

     224) sanatorium-resort organizations – organizations providing sanatorium-resort services for the improvement and restoration of human health with the use of medical and other services, natural healing factors, located in resorts or in health-improving areas: sanatorium (for adults, adults and children, children), student sanatorium, children's rehabilitation-wellness center;

     225) sanitary and quarantine control – type of state control and supervision in the field of sanitary and epidemiological welfare of the population in relation to persons, vehicles and products (goods) controlled by the state sanitary and epidemiological control and supervision at checkpoints across the customs border of the Eurasian Economic Union, at interstate railway transfer stations or docking stations in order to prevent the import of products potentially dangerous to human health (goods), importation, occurrence and spread of infectious and mass non-communicable diseases (poisoning);

     226) sanitary protection zone - an area separating special–purpose zones, as well as industrial organizations and other industrial, communal and warehouse facilities in a locality from nearby residential areas, buildings and structures for residential and civil purposes in order to reduce the impact of adverse factors on them.;

     227) sanitary and preventive measures – organizational, administrative, engineering, medical, sanitary, preventive and other measures aimed at assessing the risk of harmful effects of environmental factors on humans, eliminating or reducing such risk, preventing the occurrence and spread of infectious and mass non-communicable diseases (poisoning) and their elimination;

     228) sanitary and epidemiological audit is an alternative form of control of epidemiologically significant facilities subject to state control and supervision in the field of sanitary and epidemiological welfare of the population, in order to identify and assess sanitary and epidemiological risks and develop recommendations for bringing these facilities in line with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

     229) sanitary and epidemiological situation - the state of health of the population and the environment in a certain area at a certain time;

     230) sanitary and epidemiological conclusion – a document certifying compliance with regulatory legal acts in the field of sanitary and epidemiological welfare of the population of objects of state sanitary and epidemiological control and supervision;

     231) sanitary and anti–epidemic measures - measures taken to localize and eliminate the foci of infectious, parasitic diseases, poisoning among the population.;

     232) a point of trust is a specially organized point where preventive services are provided to key groups of the population free of charge on the principle of anonymity, voluntariness and confidentiality;

     233) simulation room (center) is a structural unit of the organization of education in the field of healthcare, on the basis of which students practice and pass practical skills in conditions of imitation of clinical practice in a safe learning environment using simulation technologies: mannequins, simulators, computer modeling, virtual reality technologies and specially trained actors trained to portray patients.;

     234) screening studies are a complex medical examination of the population without clinical symptoms and complaints in order to identify and prevent the development of various diseases at an early stage, as well as risk factors for their occurrence;

235) sports medicine is a field of medicine responsible for the medical and biological support of athletes' training, including medical and functional control in sports, including the admission of athletes to high–performance sports, functional and medical rehabilitation of athletes, early detection of health abnormalities, improvement of athletic performance, therapy and prevention of somatic diseases and injuries of athletes, psychological training, emergency medical care in sports and sports hygiene;

     236) a standard sample is an identified homogeneous substance or mixture of substances intended for use in chemical, physical and biological studies, in which its properties are compared with those of the medicinal product under investigation, and having a sufficient degree of purity for appropriate use.;

     236-1) strategically important medicines and medical devices – medicines and medical devices intended for medical use in conditions of:

     military operations and elimination of their consequences;

     occurrence, prevention and elimination of consequences of emergency situations;

     threats of emergence, spread of new especially dangerous infectious diseases and elimination of their consequences;

     prevention, diagnosis, treatment of diseases and lesions resulting from exposure to adverse chemical, biological, and radiation factors, as well as elimination of their consequences;

     the absence or threat of absence of medicines or medical devices on the markets of the member States of the Eurasian Economic Union in the context of the introduction of restrictive economic measures against at least one of the member States;

     237) bone marrow is a tissue that performs hematopoiesis, located in the inner part of bones and includes hematopoietic stem cells, stroma and other components of the microenvironment.;

     238) biologically active food additives – natural and (or) biologically active substances identical to natural ones, as well as probiotic microorganisms intended for simultaneous consumption with food or introduction into food products;

     239) internship is a form of non–formal education aimed at the formation and consolidation in practice of professional knowledge, skills and abilities acquired as a result of theoretical training, as well as the study of the specifics of work, best practices for further professional activity.;

     240) mentor is a medical professional with at least five years of experience appointed by the head of a medical organization or a medical education organization to provide practical assistance in the professional adaptation of students in medical education programs and young professionals who carry out activities based on the trinity of education, science and practice.;

     241) risk-based approach – a form of quality control of medicines and medical devices through annual selection from the market, including in medical organizations;

     242) risk assessment – substantiation of the probability of penetration and spread of pathogens or vectors of infectious and parasitic diseases, as well as the negative impact of environmental factors on public health and related potential biomedical and economic consequences.;

     243) an independent expert is an individual who meets the requirements determined by the authorized body and is on the register of independent experts.;

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

     245) the marginal price for the trade name of a medicinal product or medical device within the guaranteed volume of free medical care and (or) in the compulsory social health insurance system is the price for the trade name of a medicinal product or medical device registered in the Republic of Kazakhstan, above which no purchase can be made within the guaranteed volume of free medical care and (or) in the compulsory social health insurance system;

     246) the maximum price for an international nonproprietary name of a medicinal product or a technical characteristic of a medical device within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance – the price of an international nonproprietary name of a medicinal product or a technical characteristic of a medical device registered in the Republic of Kazakhstan, above which no purchase can be made within the guaranteed volume of free medical care and (or) in the compulsory social health insurance system;

     247) tobacco is a plant of the genus Nicotiana of the family of nightshade species Nicotiana Tabacum and Nicotiana Rustica, used for the production of tobacco products;

     248) tobacco products – products made in whole or in part from a tobacco leaf and (or) other parts of a tobacco plant as raw materials prepared in such a way as to be used for smoking, sucking, chewing, sniffing or other methods of consumption, including using a tobacco heating system or any other device;

     249) tobacco product consumption is the process of consuming tobacco products, hookah mixtures and hookah tobacco, including using hookah, tobacco heating systems and any other consumption systems that cause the human body to depend on nicotine, negatively affecting its health, as well as the health of persons who do not consume tobacco products, and polluting the environment;

     250) tobacco product ingredient – a substance (with the exception of tobacco leaf and other tobacco parts) used in the manufacture of tobacco products and present in the finished tobacco product, including in a modified form;

     251) tobacco product packaging is a unit of group consumer packaging containing a certain number of packs of tobacco products.;

     252) a pack of tobacco products is a unit of consumer packaging made of cardboard or paper or other material containing a certain amount of tobacco products.;

     253) consumer packaging of a tobacco product – packaging intended for sale or primary packaging of tobacco products sold to the final consumer;

     254) tobacco sponsorship – any type of contribution to any event, event or individual for the purpose, result or probable result of stimulating the sale of tobacco products or tobacco use directly or indirectly, with the exception of payments and contributions provided for by the legislation of the Republic of Kazakhstan;

     255) Tobacco heating system – a device used to heat tobacco to form an aerosol containing nicotine;

     256) tobacco products – tobacco products packaged in consumer packaging;

     257) pharmaceutical inspector for good pharmaceutical practices – a person authorized to perform the functions of conducting a pharmaceutical inspection for good pharmaceutical practices and included in the register of pharmaceutical inspectors of the Republic of Kazakhstan;

     258) pharmaceutical inspection for good pharmaceutical practices (hereinafter referred to as pharmaceutical inspection) is an assessment of an object in the field of drug circulation in order to determine its compliance with the requirements of good pharmaceutical practices of the Republic of Kazakhstan and (or) the Eurasian Economic Union;

     259) transplantation is the transplantation of organs (parts of an organ) and (or) tissues (parts of tissue) to another place in the body or into another organism;

     260) a contagious form of tuberculosis is a form of tuberculosis that poses a danger to others due to the release of tuberculosis bacteria into the external environment by the patient.;

     261) electronic consumption systems – electronic nicotine delivery systems and electronic delivery systems for non–nicotine products - devices (including electronic cigarettes) that use electronic technology (battery) to heat liquid (in cartridges, tanks and other containers) with or without nicotine, other chemicals, flavorings with the formation of an aerosol inhaled by the user; - Excluded by the Law of the Republic of Kazakhstan.

262) graduate – a person who has completed an educational program of medical and (or) pharmaceutical education, or another educational program in the field of healthcare;

     263) tissue is a collection of cells and intercellular matter having the same structure, functions and origin.;

     264) tissue compatibility – the similarity of the tissues of the donor and the potential recipient in terms of specific antigens of the HLA system, which determines the compatibility of the donor and the recipient during organ (part of the organ) and (or) tissue (part of the tissue) transplantation;

     265) medical devices for diagnostics outside a living organism (in vitro) – any instruments, apparatuses, devices, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes alone or in combination with each other, as well as together with accessories necessary for the intended use of these products, including special software, and intended by the manufacturer of the medical device for use in research outside of a living organism (in vitro) samples of human biological materials to obtain information about a physiological or pathological condition, congenital pathology, predisposition to a specific clinical condition or disease, tissue compatibility with a potential recipient, prediction of reactions to therapeutic effects, choice of therapeutic agents and (or) control of treatment;

     266) temporary adaptation is the process of removing a person from a state of intoxication and adapting it to environmental conditions;

     267) temporary adaptation and detoxification center – a center designed to provide specialized medical care to people who are intoxicated (intoxicated), and is a structural unit of an organization providing medical care in the field of mental health;

     268) poisoning is a disease (condition) that occurs during acute (simultaneous) or chronic (prolonged) exposure to chemical, biological and other environmental factors.;

     269) university hospital is a multidisciplinary medical and preventive structural unit of an organization of higher and postgraduate education or a multidisciplinary medical and preventive organization, on the basis of which educational programs of higher, postgraduate and additional medical education are implemented based on modern achievements of science and practice.;

     270) pharmacovigilance is a type of activity aimed at identifying, analyzing, evaluating and preventing undesirable effects of the use of medicines;

     271) pharmacovigilance system – a system organized by holders of registration certificates of medicines and an authorized body to perform the tasks and responsibilities of pharmacovigilance, designed to monitor the safety of medicines, timely identify all changes in the assessment of the benefit-risk ratio of medicines, develop and implement measures to ensure the use of medicines when the benefit exceeds the risk.;

     272) pharmaceutical workers – individuals with pharmaceutical education and engaged in pharmaceutical activities;

     273) pharmaceutical education is a system of training and advanced training of pharmaceutical workers, as well as a set of knowledge and skills necessary for a pharmaceutical worker, acquired during training in training and advanced training programs in pharmaceutical specialties, confirmed by an official document on graduation;

     274) pharmaceutical service – the activity of entities in the field of circulation of medicines and medical devices related to outpatient drug provision to the population, including the purchase, transportation, storage, accounting and sale of medicines and medical devices, within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

     275) pharmaceutical activity – an activity carried out in the field of healthcare for the production and (or) manufacture, and (or) wholesale and (or) retail sale of medicines and medical products related to the purchase (acquisition), storage, import, export, transportation, quality control, registration, distribution, use and destruction of medicines and medical devices, as well as ensuring their safety, quality and effectiveness;

     276) Pharmaceutical Product Certificate (CPP) is a document issued by an authorized body for the registration of domestic medicines abroad and their export;

     277) pharmaceutical substance (active pharmaceutical substance) – a medicinal product intended for the production and manufacture of medicinal products;

     278) formulary system – a system of periodic evaluation and selection of medicines for medicinal products, maintenance of medicinal products and provision of information in the form of appropriate guidelines and a list aimed at the rational use of medicines;

     279) informed consent is a procedure for a person to voluntarily confirm in writing their consent to receive medical care and/or participate in a specific study after receiving information about all aspects of medical care and/or research that are relevant to their decision-making. Informed written consent is issued in the form approved by the authorized body.;

     280) designated population group – persons who work in the public service sector and pose the greatest danger to infecting others with infectious and parasitic diseases.;

     281) key population groups – population groups that are at increased risk of contracting HIV infection due to their lifestyle;

     282) products that pose a danger to the life and health of the population – the condition of products indicating the presence of a risk associated with harmful effects on human health during their use or use, recognized as not meeting the safety requirements established by technical regulations, hygiene standards; products that do not have documents from the manufacturer (supplier) confirming its traceability, safety; labeling of which does not comply with the requirements of regulatory legal acts; with an unspecified or expired expiration date; counterfeit products;

     283) sanitary and epidemiological welfare of the population is a state of public health and habitat in which there is no harmful effect of environmental factors on humans and favorable living conditions are provided.;

     284) activities in the field of sanitary and epidemiological welfare of the population – activities of state bodies and organizations in the field of sanitary and epidemiological welfare of the population, aimed at protecting the health of citizens of the Republic of Kazakhstan, including state control and supervision in the field of sanitary and epidemiological welfare of the population, sanitary and epidemiological monitoring, sanitary and epidemiological rationing, state registration of products, sanitary and epidemiological expertise, hygienic training, sanitary and epidemiologicalepidemiological audit, disinfection, disinfection and deratization, assessment of the degree of risks in the sphere of sanitary and epidemiological welfare of the population;

     285) state control and supervision in the field of sanitary and epidemiological welfare of the population is the activity of state bodies in the field of sanitary and epidemiological welfare of the population, aimed at preventing, detecting, suppressing and eliminating violations of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, as well as monitoring and supervision of their observance in order to protect health, the environment human habitation and safety of products, processes, and services;

     286) state body in the field of sanitary and epidemiological welfare of the population - a state body implementing state policy in the field of sanitary and epidemiological welfare of the population, monitoring and supervision of compliance with the requirements established by regulatory legal acts in the field of sanitary and epidemiological welfare of the population and other legislative acts of the Republic of Kazakhstan;

287) surgical sterilization is a method of contraception with the use of medical intervention, as a result of which a woman or a man loses his reproductive ability.;

     288) live birth and stillbirth of the fetus – the conditions of a newborn child (fetus), determined according to the relevant international criteria of the World Health Organization for live birth and stillbirth of the fetus;

     289) non-smoking tobacco (nicotine–containing) products - products containing nicotine, fully or partially made from tobacco leaf and (or) other parts of the tobacco plant as raw materials and their synthetic analogues, prepared in such a way as to be used for sucking, chewing, sniffing;

     290) restrictive measures, including quarantine, are measures aimed at preventing the spread of infectious and parasitic diseases and providing for a special regime of entrepreneurial and (or) other activities;

     291) potentially dangerous chemical and biological substances are substances that, under certain conditions and in certain concentrations, can have a harmful effect on human health or the future generation, the use and use of which are regulated by regulatory legal acts in the field of sanitary and epidemiological welfare of the population.;

     292) a potential recipient is a patient who needs a tissue (part of a tissue) and (or) organs (part of an organ) transplant;

     293) Fundamental biomedical research is a biomedical research conducted with the aim of expanding basic knowledge and understanding of the physical, chemical and functional mechanisms of life processes and diseases.;

     294) euthanasia is the satisfaction of a request to accelerate the death of an incurable patient by any actions or means, including the administration of medicines or other means, as well as the cessation of artificial measures to maintain his life in cases of an unfavorable outcome of the disease.;

294-1) electronic consumption systems (vapes) – electronic nicotine delivery systems and electronic delivery systems for non–nicotine products - devices (including electronic cigarettes) that use electronic technology (battery) to heat liquid (in cartridges, tanks and other containers) with or without nicotine, others chemicals, flavorings with the formation of an aerosol inhaled by the user;

     294-2) flavor for electronic consumption systems (vapes) – any ingredient or combination of substances of natural or artificial origin that are supplied through accessories or other various methods and materials in order to enhance the attractiveness of taste and smell of products of electronic consumption systems (vapes), including the smell of aerosol (smoke, steam);

294-3) energy drink is a non–alcoholic and low-alcohol drink containing caffeine and plants (plant extracts) containing it, taurine, guarana, mate, as well as medicinal plants and their extracts that have a tonic effect, sugar, minerals, easily digestible carbohydrates, vitamins and vitamin-like substances, substrates and stimulants of energy metabolism, which has a negative effect on the human body when consumed excessively, with the exception of coffee and tea;

     295) An epidemic is a massive spread of an infectious disease that significantly exceeds the usually recorded incidence rate.;

     296) epidemiologically significant objects are objects whose products and (or) activities, in violation of the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, may lead to food poisoning and (or) infectious, parasitic diseases among the population and (or) harm public health from physical factors, industrial and radioactive pollution;

     297) nuclear medicine is a field of medicine in which radioactive elements and ionizing radiation are used for the prevention, diagnosis and treatment of various diseases of human organs and systems, including oncological diseases.

     2. The concepts of "mental illness" and "mental disorder" applied in other branches of the legislation of the Republic of Kazakhstan are equivalent to the concept of "mental, behavioral disorder (disease)", unless otherwise provided by this Code.

     3. The content of other terms is determined by separate articles of this Code.

 The Code of the Republic of Kazakhstan dated July 7, 2020 "On the health of the people and the healthcare system

President    

Republic of Kazakhstan     

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