LAW OF UKRAINE

of February 4, 2021 No. 1206-IX

About veterinary medicine

This Law determines legal and organizational basis of implementation of activities in spheres of ensuring protection of health and wellbeing of animals, veterinary practice, production, the address and use of veterinary medicines, and also addresses of by-products of animal origin.

Section І General provisions

Article 1. Determination of terms

1. In this Law terms are used in such value:

1) aquaculture - content of water animal (aquatic organisms) in property of one or more physical persons or legal entity during stage of cultivation or cultivation before their collection inclusive, except collection or catch for consumption purposes the person of wild water animal (aquatic organisms) which temporarily contain for slaughter without feeding;

2) risk analysis - the process including danger identification, risk assessment of disease of animals, risk management and the notification on risk;

3) arbitral laboratory research (testing) - laboratory research (testing) conducted by authorized referens-laboratory with use of the methods confirming (referens) upon the demand of person who disputes results of the main laboratory research (testing);

4) autogenic immunobiological veterinary medicine - the means of specific prevention made of isolate of the microorganism allocated from sick animal, and intended for this purpose animal or for livestock of the animals contacting to this sick animal within one economy;

5) balance "advantage risk" - assessment of positive effect of veterinary medicine concerning any risk for health of animals or the person connected with quality, safety or efficiency of veterinary medicine, and also any risk of undesirable effect for the environment and risk of development of resistance to veterinary medicine;

6) biological safety - security from risk of drift and spread of diseases in, from or within animal population, capacity, the territory, zone, the region or kompartment, the vehicle or any other objects, rooms or places;

7) biological product (material) - microorganisms, cultures of cages, RNA, DNA, fabric, cage, the biological liquids, secrets and waste products, physiological allocations, dabs, scrapings, washouts, biopsy material received from animals;

8) biocides (biocidal products) - any substances or mixes in shape, to the available user, consist from, contain or will form one or more active agents for the purpose of destruction, control, neutralization, prevention of action or making of other controlling impact on harmful organisms by all means, except net physical or mechanical impact. Any substances or mixes received from the substances or mixes which are not carried to biocides (biocidal products) are also considered as biocides (biocidal products) if they are used for the purpose of destruction, control, neutralization, prevention of action or making of other controlling impact on harmful organisms by all means, except net physical or mechanical impact;

9) wellbeing of animals - condition of ensuring physiological and ethological needs of animals by creation of proper conditions for their cultivation, content and transportation, including systematic leaving, proper feeding, poyeniye and humane treatment of animals which excludes fear, pain and sufferings, including during slaughter and provides freedom of manifestation to animals of behavior, typical for it;

10) buffer zone - the territory which is established within the territory of Ukraine along frontier of Ukraine on which veterinary and sanitary measures are applied to prevention to penetration of pathogenic agents with or on the territory of foreign states and/or quarantine zones;

11) veterinary medicine - branch of science and practical knowledge of physiology and diseases of animals, their prevention, diagnostics and treatment, preserving health and productivity of animals, protection of people against zoonoz and prionny diseases, and also the practical activities connected with it;

12) veterinary practice - activities for rendering the services connected with prevention, diagnostics and treatment of diseases of animals, consultation on questions of veterinary medicine which is performed by organizations of veterinary medicine and specialists of veterinary medicine based on the corresponding license;

13) veterinary attendance - the activities of specialists of veterinary medicine including information collection about signs of availability of diseases of animals, laboratory and other diagnostic testings (testing), application of preventive measures and treatment of diseases of animals, consultation of owners of animals concerning biological safety, protection of health and wellbeing of animals;

14) veterinary certificate - the document issued by the state veterinary inspector, the official veterinarian or the licensed veterinarian, confirming veterinary and sanitary condition of batch of animals, reproductive material, by-products of animal origin, biological materials (products) in case of their movement on the territory of Ukraine in which, in case of need, results of survey, laboratory and other diagnostic testings (testing), data on vaccination, preventive karantinirovaniye of animals, and also the veterinary and sanitary status of capacity (territory) of origin of animals are specified;

15) veterinary medicine - any substance (substance) or combination of substances (substances) with the declared property of treatment or prevention of diseases of animals or any substance (substance) or combination of substances (substances) which can be applied to animals for the purpose of recovery, correction or change of physiological functions, showing pharmacological, immunological or metabolic action, or for the purpose of establishment of the diagnosis or euthanasia of animals;

16) veterinary medicine of ex-temporal compounding - the veterinary medicine prepared according to the veterinary recipe for certain animal;

17) the veterinary passport of animal - the identification document on animal issued by the state veterinary inspector, the official veterinarian or the licensed veterinarian, containing information on the animal owner, the description of animal (nickname, type, breed, sex, age, color, etc.), data on its origin, the state of health, diagnostics, vaccination, treatment, antiepizootic actions concerning animals, and also veterinary and sanitary condition of economy in which it contains;

18) veterinary pharmacological supervision - scientific and practical activities on identification, assessment, studying and prevention of emergence of the collateral reactions or other problems connected using veterinary medicines;

19) veterinary medicines - veterinary medicines and biocides (biocidal products);

20) veterinary and sanitary examination - complex of necessary laboratory and special researches (virologic, bacteriological, chemical and toxicological, pathoanatomical, histologic, parasitological, radiological) which are conducted by specialists of veterinary medicine for the purpose of confirmation of safety of animal products, reproductive material, biological products, substances, including the analysis of production technology, processing equipment on compliance to veterinary and sanitary measures;

21) veterinary and sanitary and epizootic wellbeing - condition of security of life and human health and animals from the risks connected with diseases of animals including zoonozam, and also providing optimal conditions of life of animals which prevent disease and adverse effect of factors of the environment on health of animals and their productivity;

22) veterinary and sanitary condition - availability or absence of disease of animals which is subject to the notification, and/or the level of pollutants of the relatively most admissible level;

23) the veterinary and sanitary status - the status of the country, its separate territory (zone, the region or kompartment) or capacities due to illness animals which is determined by the criteria established by relevant international organizations;

24) veterinary and sanitary measures - any measures, stipulated by the legislation and/or decisions of competent authority or the state extraordinary antiepizootic commissions, in particular, antiepizootic actions, procedures of the state control (inspection, sampling, laboratory researches (testing), certification and allowing (conciliatory) procedures; quarantine actions, including requirements for transportation of animal and other goods, requirements for providing information, procedures of sampling and evaluation methods of risk of disease of the animals applied for:

a) protection of life and health of animals against the risks arising owing to drift, rooting or spread of diseases of animals, the organisms transferring diseases, and also pathogenic organisms;

b) protection of life and human health and animals against the risks resulting from effect of additives, pollutants, toxins or pathogenic organisms which contain in animal products and sterns;

c) protection of life and human health against the risks resulting from the diseases transferred by animals or products made from them;

25) production site - part of production capacity on which production of separate pharmaceutical forms of veterinary medicines is performed;

26) relevant international organizations - The World Health Organization of animals and other international organizations developing the international standards, instructions and recommendations connected with health protection of animals and safety of goods;

27) the owner of the registration certificate - the legal entity according to whose statement the state registration of veterinary medicine is performed;

28) the animal owner - the physical person or legal entity performing care of animal who belongs to it on the property right and bears responsibility according to the law for condition and actions of animal;

29) water animal (aquatic organisms) - the animals belonging to stated below types including their eggs, sperm and gametes:

a) fish who treats Agnatha superclass and classes Cartilaginous fishes (Chondrichthyes), Sarcopterygii and Actinopterygii;

b) the water mollusks belonging to type mollusks (Mollusca);

c) the water Crustacea belonging to the Crustacea subtype;

30) secondary package of veterinary medicine - packaging in which the primary package of veterinary medicine is located;

31) generic veterinary medicine (generic) - the veterinary medicine having the same high-quality and quantitative composition of active ingredients and the same dosage form, as reference veterinary medicine, bioequivalence (interchangeability) of which with reference veterinary medicine it was shown;

32) the genetically modified organism (GMO) - any organism, except human which genetic material was changed by means of artificial acceptances which do not result under natural conditions from pairing and/or natural recombination;

33) hybrid veterinary medicine - veterinary medicine which does not fall under determination of generic veterinary medicine or bioequivalence of which cannot be proved by bioavailability research or which has such distinctions with reference veterinary medicine: changes in active ingredients, therapeutic indications, dosage, dosage form or way of introduction;

34) the main sowing culture - the culture of microorganism packed from one container in containers which are processed together during single transaction by method which provides uniformity, stability and prevents pollution of microorganism;

35) homeopathic veterinary medicine - any veterinary medicine prepared from homeopathic raw materials according to the homeopathic production technology provided by the State pharmacopeia of Ukraine or the European pharmacopeia or, in the absence of that, other pharmacopeia which according to the requirements does not yield to specified;

36) the State pharmacopeia of Ukraine - the regulation which contains general requirements to medicines and veterinary medicines, pharmacopoeian Articles, and also techniques of quality control of medicines;

37) the state veterinary inspector - the veterinarian who works in system of competent authority and authorized to issue veterinary documents and to perform measures of the state control of compliance with law about veterinary medicine and wellbeing of animals;

38) wild animals are animal, other than pets which native habitat is the wild nature, including those which are in bondage or semi-free conditions;

39) diagnostics - complex of laboratory researches (testing) and/or other actions directed to establishment of the diagnosis;

40) diagnostic means which is applied by in vitro, - the means intended by the producer for application of in vitro with research purpose of samples only (or with main objective) for receipt of information concerning diagnostics of immune system and identification of causative agents of infectious diseases of animals or monitoring of epizootic situation;

41) active ingredient - any substance (substance) or mix of substances (substances) which are held for use in production of veterinary medicine and are its active pharmaceutical ingredient;

42) preclinical researches (testing) - researches (testing) which are not covered by determination of clinical trials (testing) and include studying of safety or efficiency of veterinary medicine for the purpose of its state registration or change of conditions of its state registration;

43) pets - dogs (Canis lupus familiaris), cat (Felis silvestris catus), polecats (ferrets) (Mustela putorius furo), invertebrates (except bees, bumblebees, mollusks (Mollusca) and cancroid (Crustacea), decorative water animal (aquatic organisms), amphibians, reptiles, birds (except hens, turkey-cocks, guinea fowls, ducks, geese, quails, pigeons, pheasants, partridges and beskilevy (strausoobrazny) (Ratitae) which contain for production of foodstuff), the rodents and rabbits (except the rodents and rabbits intended for production of foodstuff) intended for personal non-commercial purposes, including for satisfaction of esthetic requirements and needs for communication;

44) excipient (ekstsipiyent) - any component of veterinary medicine which is not its active ingredient (active pharmaceutical ingredient) or packaging material;

45) the expert opinion - the report on results of laboratory researches (testing) certifying compliance or discrepancy of indicators on which the research (testing), to the requirements established by the legislation was conducted;

46) epizootic unit - animal, group of animals who with identical probability are affected by infecting agent;

47) pollutant - any biological substance, in particular, microorganisms and their parts, or chemical (pesticides, toxins), remaining balance of veterinary medicines, including the hormones comforting and thyreostatic substances, antibiotics, salts of inorganic substances, radioactive materials and products of their disintegration or other substances which content exceeds the maximum limit of remaining balance set by the legislation or international standards, instructions and recommendations which can be hazardous to health of animals and people;

48) organization of veterinary medicine - organization, the company or the organization, irrespective of pattern of ownership in which, at least, one veterinarian works and which performs veterinary practice, carries out disinfection, disinsection, deratization works or carries out other veterinary and sanitary actions;

49) capacities - stationary capacities which have accurately certain, including geographically, border (on the map, the plan and/or in system of geographical coordinates) are closed in which animals answer set of such signs:

a) contain or get divorced for the educational, research, exhibition purposes or for the purpose of preserving animal species;

b) are isolated and delimited from the surrounding environment;

c) are subjects to observation of health of animals and measures of biological safety;

50) means of veterinary medicine - materials, the equipment, tools, special equipment vehicles and other mechanisms and devices, held for use in veterinary medicine;

51) animals care products - the means intended for content of animals and care of them which have no medical or preventive action;

52) collection of animals (transaction on collection of animals) - collection of domestic land animals who occur from more than one livestock capacity, and their content in one place during the period, smaller, than the period of preventive quarantine for the corresponding type of animals;

53) infecting agent - the pathogenic microorganism which is transferred to animals or people capable to cause disease in animals;

54) zone - accurately certain part of the territory of the state with the separate veterinary and sanitary status, in particular:

a) for land animals - the territory of the country or other geographically certain territory with certain subpopulation of animals which has the separate veterinary and sanitary status of rather certain disease (diseases) of animals which is subject to control measures of incidence and biological safety;

b) for water animal (aquatic organisms) - the general hydrological system with the separate veterinary and sanitary status by certain disease (diseases) of animals including the territory:

all reservoir from source of water channel to the estuary of the lake;

it is more than one reservoir;

parts of reservoir from source of water channel to the barrier interfering spread of certain disease (diseases) of animals;

geographically certain part of the coast;

geographically certain estuary;

55) zone, free from disease of animals which is subject to the notification, - zone in which absence of certain disease of animals which is subject to the notification is confirmed by fulfillment of requirements, established by relevant international organizations and the legislation of Ukraine;

56) protection zone - the territory around unsuccessful Item (the outbreak of disease of animals) on which veterinary and sanitary measures for the purpose of non-admission of spread of disease out of limits of this territory are applied;

57) observation zone - the territory established around protection zone for its department from zone, free from disease of animals which is subject to the notification, within which supervision measures, other veterinary and sanitary actions for the purpose of non-admission of spread of disease out of protection zone limits are performed;

58) zoonoza - the diseases which are transmitted to people from animals;

59) identification - identification of animal or group of animals with not repeating individual or group identification number (identifier) according to the legislation on identification and registration of animals;

60) danger identification - process of identification of causative agents of diseases of animals which can potentially get on the territory of Ukraine during import into Ukraine of animal and other goods and the accompanying objects;

61) immunobiological veterinary medicine - the veterinary medicine intended for introduction to animal for the purpose of forming of active or passive immunity or diagnostics of its condition;

62) hatchery (the incubatory workshop) - capacity on which are performed collection, storage, incubation of eggs for the purposes of conclusion and delivery of hatchable eggs, daily young growth of poultry and baby birds of other types of bird;

63) hatchable eggs - the eggs intended for incubation, laid by the poultry or birds containing in bondage conditions;

64) quarantine of animals - the particular legal regime which is introduced in unsuccessful Item, protection zone, and in case of need - in zone of observation and buffer zone, and provides application of quarantine actions (quarantine) for the purpose of localization of outbreak of disease of animals which is subject to the notification, its liquidations and non-admission of distribution according to the legislation;

65) quarantine zone - the territory within which the quarantine of animals is applied and includes unsuccessful Item, protection zone, and in case of need - both zone of observation and buffer zone;

66) the quarantine station - the place (the site of the area) which is under the supervision of competent authority or its territorial authorities in which groups of animals contain in isolation, without direct or indirect contact with other animals, during the certain period of time, specially equipped for carrying out inspection of animals, sampling for carrying out laboratory researches (testing), and in case of need - treatment of animals;

67) quarantine post - the temporary, specially equipped place on the verge of unsuccessful Item, zone of protection, zone of observation, buffer zone established according to the decision of the state extraordinary antiepizootic commission of appropriate level for the purpose of localization and non-admission of spread of diseases of the animals who are subject to the notification;

68) quantitative risk assessment - risk assessment which results can be expressed in digits;

69) clinical trials (testing) - researches (testing) which include studying in field conditions on target animal species of safety and/or efficiency of veterinary medicine in usual conditions of livestock production or part to customary veterinary practice for the purpose of the state registration or modification of the decision on the state registration of veterinary medicine;

70) kompartment - animal subpopulation of one or several farms (capacities) with single system of management of the biological safety having the separate veterinary and sanitary status concerning one or several diseases of animals concerning which measures of supervision, control or biological safety are entered;

71) compartmentalization - determination by competent authority of the veterinary and sanitary status of kompartment declared by the operator of capacities concerning one or several diseases of animals;

72) competent authority - the central executive body realizing state policy in the field of veterinary medicine;

73) concentration - the content of active ingredient (active pharmaceutical ingredient) expressed quantitatively on dose, unit of volume or weight according to dosing form;

74) leaf tab (the instruction for application) - the instruction accompanying veterinary medicine and containing information for the user, necessary for ensuring safe and effective application of this means;

75) medical forage - the mix of veterinary medicine and forage ready to direct feeding by animal without further conversion which constitutes uniform mix of one or several veterinary medicines or intermediates of their production with fodder materials or fodder mixes;

76) licensed organization of veterinary medicine - the organization of veterinary medicine having the license for implementation of veterinary practice;

77) the licensed specialist of veterinary medicine - the veterinarian or other specialist of veterinary medicine who has the license for implementation of veterinary practice;

78) the maximum limit of remaining balance of active ingredient (active pharmaceutical ingredient) - the most admissible content of active ingredient (active pharmaceutical ingredient), its metabolites (transformation products in live systems) and decay products in foodstuff of animal origin which exceeding can negatively affect health of the person, established by the legislation of Ukraine or, in the absence of relevant requirements in the legislation of Ukraine, recommended by relevant international organizations (The commission of the Code Alimentarius, the European agency of medical supplies and so forth);

79) marking - information which contains on primary and secondary packagings of veterinary medicine and reflects its main characteristics;

80) metafilaktika - introduction of veterinary medicine to group of animals among whom the animal with clinical signs of disease is revealed after establishment of the diagnosis, with the medical purpose for non-admission of spread of disease on the animals who had contact with sick animals both treat risk group and can be infected;

81) the international veterinary certificate - the document which is issued by competent authority of country of source or the exporting country and certifies the state of health of live animals and/or safety of by-products of animal origin, reproductive material, biological products;

82) international standards, instructions and recommendations - the standards, instructions and recommendations developed and accepted by World Organization of health protection of animals and other international organizations who develop recommendations, instructions and standards connected with protection of life and human health and animals against diseases of animals;

83) monitoring - system of observations, measurements and researches (testing) with the subsequent analysis and generalization of information on the state of health of animals and/or veterinary and sanitary statehood, the separate territory (zone, the region or kompartment) or capacities, residual amounts of veterinary medicines and other pollutants in animals, animal products and sterns;

84) extraordinary veterinary and sanitary actions - the veterinary and sanitary actions performed in case of origin or threat of emergence of force epizootic majeure;

85) extraordinary epizootic circumstances - epizootic condition of the state, its separate territory (zone, the region or kompartment), including countries of source, the exporting country or the transit country of goods in case of which the disease availability which is subject to the notification which can do bystry and irreparable harm to health of certain animals in all territory of Ukraine or its part, in particular, in case of commodity importation and the accompanying objects which can transfer disease which is subject to the notification is suspected or proves to be true;

86) the name of veterinary medicine (veterinary medicine) - the fictional name of veterinary medicine (veterinary medicine) which is not similar to its commonly accepted name, either the its commonly accepted or scientific name which is followed by the name of trademark or the name of the holder of the registration file of the appropriate veterinary medicine;

87) land animals - birds, land mammals, bees and bumblebees;

88) proper production practice - organizational technical requirements and rules which are part of system of quality assurance and guarantee that veterinary medicines are constantly made and controlled according to the quality standards which answer their assignment, provisions of the registration file, data of the researched veterinary medicine for clinical testing or their specification;

89) proper clinical practice - system of rules of planning, carrying out, accomplishment, monitoring, audit and documentary registration of clinical testing, and also processings and representations of their results;

90) proper practice of realization - organizational technical requirements and rules which are part of system of quality assurance and guarantee that quality of veterinary medicines is maintained at all stages of supply chain from production site to the operator of the market of veterinary medicines who enables retail sale of veterinary medicines, the licensed veterinarian, licensed organization of veterinary medicine;

91) the proper level of protection of health of animals and the protection of human health connected with it - the protection level which is considered sufficient in case of establishment of veterinary and sanitary measures for protection of health and life of people and animals against the adverse effects connected with diseases of animals;

92) National institution of Ukraine on veterinary medicines - the public scientific institution authorized by competent authority to perform scientific assessment of veterinary medicines, the provision on which affirms the Cabinet of Ministers of Ukraine;

93) unsuccessful Item - the territory in which availability of disease of animals according to the requirements established by the legislation on veterinary medicine and wellbeing of animals or relevant international organizations is confirmed;

94) non-commercial movement of pets - any movement of pets which is performed:

a) without sales objective or other transfer of property on such animals;

b) in maintenance and under the owner's liability of pets or the authorized person;

95) the address - realization, transfer to use, and also storage, movement (transportation) and/or any other actions connected with realization or transfer to use;

96) the operator of capacities - physical person or legal entity in which management there is capacity belonging to it on the property right or uses;

97) the operator of the market - the physical person or legal entity performing production for the purpose of introduction into circulation and/or turnover of goods. Operators of the capacities performing slaughter of animals and/or destruction or utilization of goods also treat operators of the market;

98) the operator the market of veterinary medicines - physical person or legal entity according to which statement it is performed state registration of veterinary medicine (the owner of the registration certificate) and/or which performs production and/or turnover of veterinary medicines, and/or turnover of active ingredients (active pharmaceutical ingredients);

99) the description of enterprise system of pharmacological supervision - the detailed description of internal system of pharmacological supervision of the owner of the registration certificate with one or more registered veterinary medicines which are introduced into circulation;

100) especially dangerous diseases entered in the list of the World Health Organization of animals - infectious diseases of animals which can quickly extend in considerable scales irrespective of frontiers, and can have considerable negative social and economic effects or pose threat for human health or animals, and also to exert considerable impact on international trade in animals and animal products;

101) the official representative - the legal entity created according to the legislation of Ukraine, authorized by the owner of the registration file on veterinary medicine to submit the application for the state registration of the appropriate veterinary medicine, to make other actions necessary for the state registration of veterinary medicine and which acts as the owner of the registration certificate on veterinary medicine after its state registration;

102) risk assessment - assessment of probability of biological and economic effects of penetration, rooting or distribution of the pathogenic agent in the territory of Ukraine;

103) pathological material - the samples received from live or dead animals who contain or may contain pathological changes, activators of infectious or parasitic diseases and intended for sending to authorized laboratory;

104) primary package of veterinary medicine - container or any other form of unit package which is in direct contact with veterinary medicine;

105) the period of removal (expectation) - the minimum period of time between the last introduction of veterinary medicine animal and production of foodstuff from such animals which under normal conditions applications guarantees lack of remaining balance of veterinary medicine in foodstuff in quantity, unhealthy the person;

106) the liquidation plan of disease of animals which is subject to the notification - the complex of the tasks and actions directed to liquidation of infecting agents of animals which is subject to the notification within all territory of Ukraine or its separate territories (zones, regions or kompartment) in which is revealed availability of the corresponding disease or the veterinary and sanitary status of which is indefinite, and also the tasks and actions directed to prevention of reinfection of the specified territories (zones, regions or kompartment);

107) the plan of monitoring of disease of animals which is subject to the notification, - complex of the tasks and actions directed to timely detection of disease of animals which is subject to the notification, by collection and information analysis about epizootic situation by such disease;

108) collateral reaction - reaction to veterinary medicine (veterinary medicine) which is harmful and unintentional and arises in case of application of doses which are usually used for prevention, diagnostics or treatment of disease of animals or for the purpose of recovery, correction or change of physiological function;

109) the notification on risk - exchange of information about risk between the risk assessment specialists, persons exercising risk management, competent authorities of the different states, relevant international organizations and other interested persons;

110) capacities - any territories, buildings, constructions, rooms, the equipment, vehicles used for cultivation, cultivation, content, quarantine, movement (transportation), training, competitions, exhibitions (survey), tenders, catching, slaughter or the address of animals; productions and/or addresses of biological products, reproductive material, veterinary medicines, medical forages; destructions, utilization or other address with by-products of animal origin;

111) animal products - the products received from animals and intended for pharmaceutical, surgical, agricultural or industrial use;

112) intermediate product for production of medical forages - the forage not ready for direct feeding by animal without further processing consisting of uniform mix of one or several veterinary medicines with fodder materials or fodder mixes, intended only for use in production of medical forages;

113) antiepizootic actions - the preventive, diagnostic and other veterinary and sanitary actions directed to prevention of infectious and invasive diseases of animals, their identification and liquidation;

114) prevention - complex of the actions directed to non-admission of emergence of diseases of animals, including introduction of veterinary medicine to animal or group of animals before emergence of clinical signs of disease for the purpose of prevention of disease or infection;

115) preventive quarantine of animals - system of the veterinary and sanitary actions applied before and/or after movement of animals for the purpose of prevention of entering or spread of diseases of animals;

116) process of management of signals - the process of active observation of veterinary medicine providing assessment of data of veterinary pharmacological supervision for determination of any changes of balance "advantage risk" of veterinary medicine for the purpose of identification of risks for health of the person or animals and the surrounding environment;

117) the birds containing in bondage conditions - any birds other than poultry, including birds who contain for entertaining actions, exhibitions, competitions, the breeding purposes or realization;

118) realization - sale, exchange, donation, alienation irrespective of the fact which in the way such alienation is performed, on paid basis or it is non-paid;

119) the registration file - set of the documents enclosed to the application for the state registration (change of conditions of the state registration of veterinary medicine (veterinary medicine) based on which it is possible to draw valid conclusion on its safety, quality and efficiency;

120) reproductive material - sperm, zygotes (oocytes), embryos intended for artificial reproduction, hatchable eggs and other biological material intended for reproduction;

121) referens-laboratory - the accredited laboratory authorized by competent authority to carry out arbitral laboratory researches (testing) and to perform other functions determined by the legislation;

122) reference veterinary medicine (veterinary medicine) - veterinary medicine (veterinary medicine) registered in connection with the complete registration file with the proved safety, quality and efficiency to which the researched veterinary medicine (veterinary medicine) is compared;

123) the recipe (the veterinary recipe) - the document of the established sample issued by the licensed veterinarian, the veterinarian of licensed organization of veterinary medicine or in the cases determined by the law - other specialist of veterinary medicine based on whom production and/or the realization of the veterinary medicine or medicine intended for treatment of the person for the purpose of treatment of animals is enabled;

124) risk - possibility of negative event (biological and economic effects of adverse effect on health of animals and/or people or on the surrounding environment), and also probable scales of its effects during the certain period of time;

125) poultry - birds who are grown up and contain on purpose:

a) productions of meat, food eggs and other products;

b) replenishments of livestock of game bird;

c) use for the production purposes;

126) pets are pets and farm animals who contain the person, including animal aquacultures;

127) series of veterinary medicine (veterinary medicine) - the amount of veterinary medicines (veterinary medicines) determined by the producer with the identical name and properties, made for one production cycle or during consecutive production cycles under identical conditions on the same capacity;

128) serious collateral reaction - collateral reaction which leads to death poses threat for life, involves essential viability loss or restrictions of life activity, is inborn anomaly / defect of development or predetermines availability of long or permanent symptoms at the animals undergoing treatment;

129) raw materials (initial stocks) - any substance (substance) of certain quality used in production of veterinary medicines (except packaging materials, washing, disinfection and washing disinfectants);

130) farm animals are animals, including fishes, reptiles and amphibians which are grown up and/or contain the person for production of foodstuff, by-products of animal origin (wool, skins, fur), and also for other agricultural purposes;

131) the outbreak of disease - the confirmed officially case of the disease of animals which is subject to the notification or emerdzhentny disease;

132) the specialist of veterinary medicine - the veterinarian, the paramedic or other specialist with the corresponding education (qualification) who performs activities for prevention, improvement, diagnostics, treatment of animals, accomplishment of veterinary and sanitary examination or other veterinary and sanitary actions;

133) the standard - the document developed on the basis of consensus and approved by authorized body, establishing intended for general and reuse of the rule, the instruction or the characteristic, concerning activities or its results, including products, processes or services which observance is not obligatory. The standard does not contain the requirements to safety of goods established by veterinary and sanitary measures and can include or be entirely devoted to requirements concerning designation, packaging, marking and labeling of goods or process, and also to requirements to terminology which is used concerning process, goods or service;

134) stemping-miss - complex of the antiepizootic actions performed under the leadership of the chief state veterinary inspector, including slaughter of patients and the infected animals of herd, and if necessary - other herd of animals who could have the direct or mediated contact with animals of the infected herd that could lead to transfer of the pathogenic agent. During stemping-miss all animals concerning whose disease there is suspicion irrespective of, they are vaccinated or not, are slaughtered, their hulks are destroyed by burning, burial or in a different way which guarantees non-admission of spread of infection through hulks or other products of the slaughtered animals, and also the actions for cleaning and disinfection recommended by relevant international organizations are performed;

135) substance - any substance (material) of chemical, plant, animal or human origin;

136) the accompanying objects - objects which can transfer or transmit diseases of animals to other animals or people including straw, hay, harness and other objects which accompany animals or are used for animals;

137) animals are all vertebrata and backboneless animals, that is living beings who are other than the person, but are allocated with sensitivity;

138) animal aquacultures - water animal (aquatic organisms), being aquaculture objects;

139) livestock capacities - any territories, buildings, constructions, rooms, the equipment, vehicles used for cultivation, cultivation, content, movement (transportation), training, competitions, exhibitions (review), tenders, catching, slaughter or the address of animals, production and/or turnover of reproductive material;

140) goods - animals, by-products of animal origin, reproductive material, biological products, pathological material, veterinary medicines, active ingredients (active pharmaceutical ingredients), other substances and means of veterinary medicine;

141) authorized laboratory - accredited laboratory to which the competent authority confers powers to conduct laboratory researches (testing) for the purpose of the state control;

142) risk management - process of identification of danger, the choice and implementation of measures which are applied for the purpose of decrease in risk;

143) the holder of animals - physical person or legal entity, including the operator of capacities (the operator of the market) performing content and/or turnover of animals;

144) counterfeited veterinary medicine - counterfeit veterinary medicine which does not correspond to data (to one or several, including on marking) about veterinary medicine with the corresponding name entered in the State register of veterinary medicines of Ukraine;

145) disease of animals - the pathological condition of animals caused by different etiology, including origin in animal infections and invasions with clinical and pathological manifestations or without them, caused by one or several infecting agents;

146) disease of animals which is subject to the notification - the disease of animals brought in the list approved by the central executive body providing forming and realization of state policy in the field of veterinary medicine about cases of identification or suspicion about availability of which need to be notified immediately territorial authority of competent authority;

147) strains of microorganisms - genetically homogeneous populations of microorganisms within type with certain stable specific morphological features and biological properties;

148) quality standard of risk - assessment which results concerning probability of approach of events or scales of their effects connected with risk assessment subject are determined by such high-quality terms as "high", "average", "low", "insignificant";

149) quality of veterinary medicine (veterinary medicine) - set of the properties providing to veterinary medicine (veterinary medicine) capability to satisfy users according to the assignment and meeting the requirements of the legislation on veterinary medicine and wellbeing of animals.

2. Other terms are used in this Law in the values given in the laws of Ukraine "About the state control of compliance with law about foodstuff, sterns, by-products of animal origin, veterinary medicine and wellbeing of animals" and "about the by-products of animal origin which are not intended for consumption by the person".

Article 2. Legislation on veterinary medicine and wellbeing of animals

1. The legislation on veterinary medicine and wellbeing of animals consists of the Constitution of Ukraine, this Law, the laws of Ukraine "About the state control of compliance with law about foodstuff, sterns, by-products of animal origin, veterinary medicine and wellbeing of animals", "About the by-products of animal origin which are not intended for consumption by the person" and the regulatory legal acts published according to it.

2. If the international treaty of Ukraine which consent to be bound is provided by the Verkhovna Rada of Ukraine establishes other regulations, than those which are provided by this Law are applied regulations of the international treaty of Ukraine.

Article 3. Law coverage

1. Operation of this law extends to the public relations relatively:

1) ensuring health of animals;

2) ensuring wellbeing of animals;

3) veterinary practice;

4) addresses of by-products of animal origin;

5) productions, addresses and use of veterinary medicines, active ingredients (active pharmaceutical ingredients), medical forages and intermediates for production of medical forages, and also substances with anabolic, antimicrobic, antiparasitic, anti-inflammatory, hormonal or psychotropic properties which can be used as veterinary medicines.

2. Operation of this law does not extend to the public relations relatively:

1) foodstuff of animal origin;

2) forages of animal origin (except medical forages).

3. Operation of this law extends to veterinary medicines of ex-temporal compounding only regarding requirements concerning ownership, assignment, realization and use of the corresponding medicines.

4. Action of provisions of the Section X of this Law does not extend to production and turnover of the autogenic immunobiological veterinary medicines, biocides and diagnostic means applied by in vitro.

Production and turnover of the autogenic immunobiological veterinary medicines, biocides and diagnostic means applied by in vitro are regulated according to the requirements approved by the central executive body providing forming and realization of state policy in the field of veterinary medicine.

Article 4. The main directions of state policy in the field of veterinary medicine

1. The main directions of state policy in the field of veterinary medicine are:

1) development, approval and application of veterinary and sanitary actions;

2) elimination or reduction of risks of distribution of zoonoz and disease of the population on them;

3) protection of the territory from penetration of diseases of animals from quarantine zones or the territories of other states;

4) protection of animals and the population from diseases of animals and their activators by implementation of preventive, diagnostic and medical actions;

5) development and implementation of effective measures for identification, localization of control and, whenever possible, liquidation of local diseases of animals and liquidation of exotic diseases of the animals brought on the territory of Ukraine;

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