ABOUT THE HEALTH OF THE PEOPLE AND THE HEALTHCARE SYSTEM
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 received additional training in first aid and basic cardiopulmonary resuscitation;
4) anonymous examination – 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) the 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 provided for 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 the field of medicine and healthcare, 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 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 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 their 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 in the provision of primary health care 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 a reference medicinal product and for which similarity (similarity) has been demonstrated based on comparative studies in terms of quality, biological activity, safety and efficacy;
16) biobank is 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 for the description of properties and quality control of which a combination of biological and physico-chemical methods of analysis with an assessment of the production process and methods of its control is necessary;
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 – research aimed at obtaining new scientific knowledge 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 the application of 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 combining biomedical and humanitarian sciences in order to analyze the moral, social, and legal aspects of the application of the latest achievements of life sciences;
23) delivery – natural or artificial (instrumental, manual, medical) completion of the labor 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 medicines subject to price regulation, above which its retail sale cannot be carried out;
25) original medicinal product – a medicinal product with a new active ingredient, which was the first registered and placed on the world 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 volume of free medical care and (or) in the system of compulsory social health insurance in accordance with the Article 247 of this Code;
28) vaccines are medicines 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 polypotency and are in the process of life in the bone marrow, peripheral blood and umbilical cord blood;
30) register of hematopoietic stem cell (bone marrow) donors – a list of persons who agree to donate hematopoietic stem cells (bone marrow) free of charge and typed according to the system-HLA;
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 their absence, 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 restoration, correction or modification of its physiological functions through pharmacological, immunological or metabolic effects, or for the diagnosis of human diseases and 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 – activities involving the processes of development, preclinical (non-clinical) research, testing, clinical trials, examination, 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) – health 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) a manufacturer of medicines is an organization that carries out activities for the production of medicines and has a license for the production of 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 the 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 contract concluded by a single distributor for 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, having the intention to establish production or modernize the existing production of medicines and medical devices located on 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 (except import), storage, distribution, sale (except export) to the end user, destruction of medicines and medical products;
43) contract production of medicines and medical products (hereinafter – contract production) – 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 standard management system quality (ISO 13485) for manufacturers of medical devices;
44) the web portal for the purchase of medicines and medical devices, services from healthcare entities is 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 products, services from healthcare entities (hereinafter referred to as the single operator) is a legal entity determined 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 limitation of volumes, transportation and destruction of medicines and medical products;
47) state body in the field of circulation of medicines and medical products – a state body that provides guidance in the field of circulation of medicines and medical products, control over the circulation of medicines and medical products;
48) the state expert organization in the field of circulation of medicines and medical products is a subject of a state monopoly engaged in production and economic activities in the field of healthcare to ensure the safety, effectiveness and quality of medicines and medical products;
49) facilities in the field of circulation of medicines and medical products – a pharmacy, including one that sells 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 products, an optics store, a medical products store, a medical warehouse products, organizations for the production of 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 on 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 products is a civil service agreement concluded by a single distributor with a subject in the field of circulation of medicines and medical products – a resident of the Republic of Kazakhstan that meets the requirements of good distribution practice (GDP);
53) state re–registration of a medicinal product or medical device is a procedure for extending the validity period of state registration of a medicinal product or medical device 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 Devices;
54) state registration of a medicinal product or medical device is a procedure for obtaining permission to use medicinal products or medical devices on the territory of the Republic of Kazakhstan and entering a medicinal product or medical device into the State Register of Medicinal Products and Medical Devices for a certain period of time;
55) the expiration date of a medicinal product is the date after which the medicinal product is not subject to use;
56) packaging of a medicinal product is a means or complex of means that ensure the process of 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 device – a dosed finished medicinal product or a finished medical device that has passed all stages of the technological process, except for 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 validity period 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) regulatory document on the quality of a medicinal product – a document establishing requirements for quality control of a medicinal product in the post-registration period on the basis of an examination of a medicinal product during its registration and containing a specification, description of analytical methods and tests of a medicinal product or references to such tests, as well as appropriate 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 – the name of a medicinal product recommended by the World Health Organization;
63) quality of drug supply – 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 state 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 medicines – pharmaceutical activities related to the manufacture of medicines in pharmacies, the purchase of pharmaceutical substances (active pharmaceutical substances) for pharmaceutical use, storage, quality control, registration and sale of manufactured medicines;
68) safety of a medicinal product – 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 restoration, correction or modification of physiological function;
70) medicinal raw materials – substances of vegetable, mineral, animal origin or products of the chemical industry used for the production and manufacture of medicines;
71) disinsection – 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 set 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) health care is a system of measures of a political, economic, legal, social, cultural, 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, providing him with medical care in case of loss of health;
75) the health care system is a set of state bodies and subjects of health care, whose activities are aimed at ensuring the rights of citizens of the Republic of Kazakhstan to health protection;
76) regional long–term plan for the development of healthcare infrastructure – a long-term plan for the development of the region’s infrastructure, reflecting 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 – 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 areas of training “Healthcare” and (or) “Interdisciplinary programs related to healthcare and social security (medicine)”;
79) clinic of the organization of education in the field of healthcare – a structural subdivision of the organization of education or a healthcare organization, on the basis of which educational programs of technical and professional, post-secondary, higher, postgraduate and additional medical education are implemented on the basis of modern achievements of science and practice;
80) scientific organization in the field of healthcare – a national center, scientific center or research institute carrying out 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 qualification, content, quality and working conditions of healthcare professionals;
82) certification of a healthcare professional is a procedure for determining whether an individual’s qualifications meet 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) certificate of a specialist in the field of healthcare – a standard document confirming the qualifications 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 manager in the field of health care is the first head who manages a state medical organization;
85) the certificate of the manager in the field of health care is a document of the established sample for engaging in activities related to the management of a state medical organization;
86) expertise in the field of healthcare – 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 health care, 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 activities, 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 the characteristics of processes, technologies and health services by developing, implementing and ensuring compliance with 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 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 products, 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) health technology assessment – a comprehensive assessment of the comparative proven clinical and clinico-economic (pharmacoeconomical) effectiveness and safety of health technologies, as well as the economic, social and ethical consequences of their use, conducted for decision-making in the field of health;
92) health technology – the application of knowledge and skills that are used to promote health, prevention, diagnosis, treatment of disease, rehabilitation of patients and palliative care, including vaccines, medicines and medical devices, procedures, manipulations, operations, screening, preventive programs, including information systems;
93) a healthcare organization is a legal entity that carries out 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 health 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 participants of the society: the state, the employer and the citizen himself for the preservation and strengthening of individual and public health, reducing the risks of 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 observation;
100) donor – a person, a human corpse, an animal from which donor blood, its components, other donor material (including sperm, eggs, tissues of reproductive organs, germ cells, embryos) are taken, as well as the removal of organs (parts of an organ) and (or) tissues (parts of tissue) 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 corpses are removed and preserved for the purpose of transplantation;
102) donor function – voluntary passing of a medical examination by a donor and performing 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 devices – medicines, medical devices unlawfully and intentionally supplied 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 mark of admission to work;
110) high–tech medical service – a service provided by specialized specialists in diseases requiring the use of innovative, resource-intensive and (or) unique methods of diagnosis and treatment;
111) artificial termination of pregnancy – termination of pregnancy before the term of viability of the fetus using medicinal or surgical methods, carried out by medical professionals with higher medical education of the appropriate profile;
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 sexual identification disorders is a person who aspires to live and be accepted as a person of the opposite sex;
115) immunological medicinal product (immunobiological medicinal product) – 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 a system of antigens located on human leukocytes and determining the tissue compatibility of the donor and recipient during organ transplantation (part of the organ) and (or) tissues (part of the tissue);
117) invasive methods – methods of diagnosis and treatment 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 activities, the introduction 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 – an association of organizations of higher and (or) postgraduate medical education 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 subject of research, in which a research physician, 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 – the activities of state bodies and organizations of the sanitary and epidemiological service to monitor risk factors from exposure to environmental objects 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 factors of the environment on it and the possibility of transmission of the disease 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 exposure to harmful production factors on an employee in connection with the performance of his/her 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 – chemical, physical, biological, microbiological, pharmacological, toxicological and other experimental research or a series of studies on the study of the investigated substance (drug) by applying 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 personnel in the field of healthcare 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 on patient care, 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 “medicine”, “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;
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 medicines subject to price regulation, above which its wholesale sale cannot be carried out;
136) The Kazakhstan national Medicinal 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 medicinal formularies of 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 systematized 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 an active substance are recognized as the same active substance if their safety and effectiveness do not differ significantly. Various dosage forms for oral administration with immediate release of substances are recognized as part of bioavailability studies with 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 infection with 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 by 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 – 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 health system, developing methods of directed 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 incorrectness 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 status 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 leaf, and in which 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 hookah;
151) auxiliary substance – a substance, with the exception of pharmaceutical substances (active pharmaceutical substances), which is part of a medicinal product to give it the necessary properties;
152) confidential medical examination – an examination based on the observance of the secrecy of a medical worker and the preservation of information about the identity of the person being examined;
153) compulsory treatment – 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 in 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 – a set of measures to restore the health of patients and persons with disabilities using medical, social and professional work activities for inclusion in work, family and social life;
160) a biomedical experiment is 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 clarify the causes, conditions and mechanisms of the occurrence of the condition or development of the disease, the development of treatment and prevention methods;
161) medical devices – medical devices 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, manufacturer’s service manual;
163) circulation of medical devices – design, development, creation of prototypes, conducting technical tests, research (tests) evaluating the biological effect of medical devices, clinical studies, safety, quality and effectiveness of medical devices, registration, production (manufacture), storage, transportation, sale, installation, commissioning, application (operation), maintenance, repair and disposal of medical devices;
164) research (testing) evaluation of the biological effect of medical devices – research (testing) conducted to determine the compliance of medical devices with the general safety and effectiveness requirements of medical devices, the requirements for their labeling and operational documentation for them;
165) Global Nomenclature of medical devices (GMDN) is a systematized nomenclature classifier of types of medical devices used for the identification of medical devices;
166) type of medical devices – a group of medical devices having a similar purpose, similar application technologies, design features and a common digital designation in the nomenclature of medical devices 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 – an entity 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) component of a medical device – a part of a medical device that is not an independent medical device, including blocks, parts, product elements, materials, spare parts provided by the manufacturer for use in accordance with the functional purpose, operational characteristics, manufacturer’s service manual;
170) safety of a medical device – the absence of unacceptable risk when using a medical device associated with harm to life, human health, as well as the environment;
171) The quality of a medical device is the degree to which a set of properties and characteristics of a medical device correspond to the purposes of its intended use;
172) trade name of a medical device – the name under which the medical device 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 – 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 knowledge and skills of students in medical education programs – assessment of the quality of learning by students of educational programs and the formation of knowledge, skills and abilities in accordance with the stage of training;
176) assessment of the professional readiness of graduates of medical education programs is a procedure for assessing knowledge and skills carried out 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 the agreement;
178) organization of medical education – an educational organization that implements educational programs in the areas of training “Healthcare”;
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 medical care provided with the standards of medical care;
181) medical services – actions of healthcare entities that have a preventive, diagnostic, curative, rehabilitative and palliative orientation 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 level of quality of medical services (assistance) provided by healthcare entities using indicators reflecting the indicator of effectiveness, completeness and compliance of medical services (assistance) provided with standards;
183) medical examination – 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 – 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 carries out management 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 the functional purpose and manufacturer’s instructions;
187) medical rehabilitation is a complex of medical services aimed at preserving, partially or completely restoring impaired and (or) lost functions of the patient’s body;
188) medical trains – 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 territories 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 nurses of extended practice to persons of all ages, groups and communities, sick or healthy, including health promotion, disease prevention and care for the sick, persons 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 a state body exercising state control in the field 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 medicines – medicines obtained biotechnologically or bioengineered, which offer new opportunities for the treatment of diseases and injuries, including funds for gene therapy, somatic cell therapy, 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 undergone special multidisciplinary training in providing primary health care to family members and has a certificate of a healthcare specialist;
199) focal disinfection – disinfection carried out in foci in order to prevent and (or) eliminate 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 maximum wholesale and retail prices for the trade name of a medicinal product included in the list of medicines subject to price regulation, in accordance with the Rules for Regulating Prices for Medicines, as well as for medical devices within the guaranteed the volume of free medical care and (or) in the system of compulsory social health insurance;
201) production site – a geographically isolated complex of a manufacturer of medicines, medical devices, designed to perform the entire production process of medicines, medical devices or its specific stages;
202) production control – 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 compliance of products (goods) with technical regulations and (or) unified sanitary-epidemiological and hygienic requirements of the Eurasian Economic Union and issued by a 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 meet 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, progression in the early stages of diseases and 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;
209) Mental health is a state of well–being in which everyone can realize their own potential, cope with the usual stresses of life, work productively and fruitfully, and contribute to the life of their community;
210) medical care 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) – 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, resolving psychological problems, overcoming difficult life and crisis situations and their consequences, contributing to the maintenance of mental and somatic health, optimizing mental development, adaptation and improving the quality of life, including by activating a person’s own capabilities;
informing people about the causes of psychological problems, ways to prevent and resolve them;
personal 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, the situation in the family 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 – a doctor who studies within the framework of the educational residency 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 qualification of a doctor in the relevant specialty for admission to independent clinical practice;
217) residency base – a clinic of the organization of education in the field of healthcare, a university hospital, a national center, a scientific 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 infection;
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 certain field of laboratory diagnostics;
221) a reference medicinal product is a medicinal product that is used as a comparison drug and is a standard by which the properties of a medicinal product are determined (normalized);
222) recipient – a patient who has received a transfusion of donor blood or components and (or) preparations isolated from it, the introduction 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 in 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 junction 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 – the territory 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 of residential and civil use in order to mitigate 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 emerging 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 – 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 provision of athletes’ training and includes medical and functional control in sports, including the admission of athletes to high–performance sports, functional and medical rehabilitation of athletes, improving athletic performance, therapy of somatic diseases of athletes, sports traumatology, medical care in an emergency sports uniform 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 study, and having a degree of purity sufficient 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 occurrence, 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 the elimination of their consequences;
the absence or threat of the absence of medicines or medical products 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 carries out 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 consumption simultaneously with food or introduction into the composition of 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 – a medical worker with at least five years of experience, appointed by the head of a medical organization or organization of medical education to provide practical assistance in the professional adaptation of students in medical education programs and young professionals, carrying out activities based on the trinity of education, science and practice;
241) risk-based approach is a form of quality control of medicines and medical products 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 the health of the population and related potential biomedical and economic consequences;
243) independent expert – an individual who meets the requirements determined by the authorized body and is included in 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 maximum 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 system of compulsory social health insurance;
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 a purchase cannot 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 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 dependence of the human body on nicotine, negatively affecting its health, as well as the health of persons who do not consume tobacco products, and polluting the environment;
250) an ingredient of a tobacco product is a substance (with the exception of a tobacco leaf and other parts of tobacco) used in the manufacture of a tobacco product and present in a 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 product;
252) a pack of tobacco product is a unit of consumer packaging made of cardboard or paper or other material containing a certain amount of tobacco product;
253) consumer packaging of a tobacco product – packaging intended for sale or primary packaging of tobacco products sold to the end 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 appropriate pharmaceutical practices – a person authorized to perform the functions of conducting a pharmaceutical inspection for appropriate pharmaceutical practices and included in the register of pharmaceutical inspectors of the Republic of Kazakhstan;
258) pharmaceutical inspection for appropriate pharmaceutical practices (hereinafter referred to as pharmaceutical inspection) – an assessment of an object in the field of circulation of medicines in order to determine its compliance with the requirements of appropriate pharmaceutical practices of the Republic of Kazakhstan and (or) the Eurasian Economic Union;
259) transplantation – transplantation of organs (parts of an organ) and (or) tissues (parts of tissue) to another place in the body or to another organism;
260) the 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;
262) graduate – a person who has mastered the educational program of medical and (or) pharmaceutical education, other 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 donor and potential recipient tissues by specific antigens of the HLA system, which determines the compatibility of the donor and recipient during organ transplantation (part of the organ) and (or) tissues (part of the tissue);
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 separately 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 certain 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) the center for temporary adaptation and detoxification is a center designed to provide specialized medical care to persons who are intoxicated (intoxicated), and is a structural subdivision of an organization providing medical care in the field of mental health;
268) poisoning is a disease (condition) that occurs with acute (simultaneous) or chronic (prolonged) exposure to chemical, biological and other environmental factors;
269) university hospital is a multidisciplinary therapeutic and preventive structural unit of the organization of higher and postgraduate education or a multidisciplinary therapeutic and preventive organization, on the basis of which educational programs of higher, postgraduate and additional medical education are implemented on the basis of 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 tasks and responsibilities for 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 – a system of training and advanced training of pharmaceutical workers, as well as a set of knowledge and skills necessary for a pharmaceutical worker, obtained during training in training and advanced training programs in pharmaceutical specialties, confirmed by an official document on graduation;
274) pharmaceutical service – the activities of entities in the field of circulation of medicines and medical devices related to outpatient drug provision of 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 – activities 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) certificate for a pharmaceutical product (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 formularies, maintenance of medicinal formularies 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 important for their decision–making. Informed written consent is issued in the form approved by the authorized body;
280) a decreed group of the population – persons working in the public service sector and posing the greatest danger to infecting others with infectious and parasitic diseases;
281) key population groups – groups of the population who are at increased risk of HIV infection due to lifestyle characteristics;
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, hygienic standards; products that do not have manufacturer’s (supplier’s) documents confirming its traceability, safety; marking 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 well-being of the population – the state of health of the population, the 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 – the 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 field of sanitary and epidemiological welfare of the population;
285) state control and supervision in the field of sanitary and epidemiological welfare of the population – the activities of state bodies in the field of sanitary and epidemiological welfare of the population aimed at preventing, identifying, 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 the habitat of the population and the safety of products, processes, 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 man loses reproductive ability;
288) live birth and stillbirth of the fetus – the condition 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 a 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 – 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) potential recipient is a patient who needs tissue (part of tissue) and (or) organ (part of organ) transplantation;
293) Fundamental biomedical research – biomedical research conducted in order to expand basic knowledge and understanding of the physical, chemical and functional mechanisms of life processes and diseases;
294) euthanasia – 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;
295) epidemic – a massive spread of an infectious disease significantly exceeding the usually recorded incidence rate;
296) epidemiologically significant objects – 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 the health of the population 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”, “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.