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LAW OF UKRAINE

of June 25, 1992 No. 2498-XII

About veterinary medicine

(as amended on 01-12-2022)

Section I General provisions

Article 1. Determination of the main terms

In this Law terms are used in the following value:

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

arbitral research - the laboratory researches conducted upon the demand of person appealing results of preliminary laboratory research;

safety of subjects to veterinary health control and supervision - providing the fact that subjects to veterinary health control and supervision will not do harm to human health and animals if they are grown up, made and/or used for designated purpose. Safety is ensured by observance of the requirements established present By the law, other veterinary and sanitary measures and/or technical regulations;

wellbeing of animals - condition of ensuring physiological and ethological needs of farm animals by creation of proper conditions for their content and transportation, including systematic leaving, proper feeding, poyeniye and humane treatment of animals that excludes fear, pain and sufferings, including during killing, and provides freedom of manifestation with farm animals of behavior, typical for them;

buffer zone - the zone established in limits and along border of the infected zone using the measures which are based on epizootic characteristics of the corresponding disease of animals for the prevention of distribution of the pathogenic agent to the country or zone which is free from such disease of animals. Such measures are not limited to vaccination of animals;

veterinary administration - the public service of veterinary medicine having powers in all territory of the country on coordination, the organization and implementation of veterinary and sanitary measures, check of compliance of goods to the requirements determined by the country of destination, issue of the international veterinary certificates according to recommendations and instructions of relevant international organizations and also for supervision and check of their accomplishment;

veterinary dispensary - organization of veterinary medicine - the drugstore, pharmaceutical Item, pharmaceutical booth performing turnover of veterinary medicines and providing consultations concerning their application;

the veterinary reference - the one-time document issued by the state inspector of veterinarna or the licensed doctor of veterinary medicine, confirming veterinary and sanitary condition of batch of animals, animal products, reproductive material, biological products including obligatory specifying of results of laboratory researches and the veterinary and sanitary status of the territory (capacity) of origin, and for animals - certification of performing vaccination and diagnostic testings;

veterinary documents - documents to which the international veterinary certificate, veterinary certificate, veterinary card, the veterinary reference and the veterinary and sanitary passport of animal issued by the state veterinary inspectors or authorized or licensed doctors of veterinary medicine who confirm veterinary and sanitary condition of animal, quality and safety of animal products, reproductive material, biological products, pathological material belong;

veterinary immunobiological means - the means received with use of biological agents by means of biotechnology which therapeutic and/or diagnostic action is directed to correction (stimulation, modulation), and also diagnostics of immune system and identification of causative agents of infectious diseases of animals;

veterinary card - the document issued by the state doctor of veterinary medicine or the official veterinarian in which data on veterinary and sanitary condition of economy, diagnostics, vaccination, treatment and other antiepizootic actions of rather certain animal are entered, being appendix to the passport of this animal;

veterinary medicines - substances or their combinations intended for treatment and/or prevention of diseases of animals or recovery, correction or change of physiological functions, exchange processes at animals;

veterinary medicine - the field of science and practical knowledge of physiology and diseases of animals, their prevention, diagnostics and treatment, determination of safety of products of animal, and in the agrofood markets - and plant origin; the activities directed to preserving health and productivity of animals, the prevention of their diseases and to protection of people against zoonoz and prionny diseases;

veterinary practice - the activities for rendering the services connected with prevention, clinical diagnostics and treatment of diseases of animals and consultation on questions of veterinary medicine, performed by organizations of veterinary medicine including licensed doctors of veterinary medicine, public institutions of veterinary medicine;

veterinary medicines - veterinary medicines, veterinary immunobiological means, antiseptic agents, disinfectants, insectoacaricides, deratizatsida, diagnostikuma with the declared properties of treatment or prevention of diseases of animals or which can be applied by animal for the purpose of recovery, adjustment or change of physiological functions, showing pharmacological, immunological or metabolic action, or establishments of the diagnosis or euthanasia of animals;

veterinary certificate - the one-time document issued by the state inspector of veterinarna, confirming veterinary and sanitary condition of batch of animals, animal products, reproductive material, biological products including obligatory specifying of results of laboratory researches and the veterinary and sanitary status of the territory (capacity) of origin, and for animals - certification of performing vaccination and diagnostic testings;

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 public service of veterinary medicine or official veterinarians, concerning safety of products of animal, origin of reproductive material, biological products, veterinary medicines, substances, including the analysis of production technology and processing equipment about compliance to veterinary and sanitary measures;

veterinary and sanitary and epizootic wellbeing - ensuring protection of life and human health and animals from the risks connected with diseases of animals including zoonoza, and also providing optimal conditions of life of the animals warning diseases and harmful effects of factors of the environment on their health and productivity;

veterinary and sanitary measures - any measures, including in pursuance of the laws, resolutions, other regulatory legal acts, sets of rules, requirements and procedures, including, in particular, antiepizootic actions, determination of criteria of end product, methods of conversion and production, test procedures, inspections, certifications and acceptances, quarantine actions, including the relevant requirements connected with transportation of subjects to the state veterinary health control and supervision in pursuance of regulations on the corresponding statistical techniques, 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 resulting from entering, rooting or spread of diseases of animals, organisms which transfer diseases, and also pathogenic organisms;

b) protection of life and human health or animals against the risks arising from pollutants, toxins or the pathogenic organisms containing in animal products or sterns;

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

veterinary and sanitary condition - availability or absence of the disease which is subject to the message and/or level of pollutants of the relatively most admissible level;

the veterinary and sanitary status - the status of the country or the territory (capacity) concerning disease of animals determined according to the criteria established by relevant international organizations;

relevant international organizations - the International epizootic bureau (World Organization on health protection of animals) (further - MEB) and other international organizations developing the international standards, instructions and recommendations connected with health protection of animals and safety of goods;

selective veterinary health control - recurring inspection of safety of goods by the expanded control exercised by public service of veterinary medicine;

the conclusion of the state veterinary and sanitary examination (expert opinion) - the document issued by the state or authorized laboratory of veterinary medicine, certifying safety of animal products, reproductive material, biological products, veterinary medicines, substances. Effective period of the expert opinion - no more than one month;

specifying - the information and methodical document which is issued by the chief state veterinary inspectors of Ukraine, the Autonomous Republic of Crimea, areas, cities of Kiev and Sevastopol, cities, areas, regional services of the state veterinary health control and supervision on frontier of Ukraine and transport or their deputies;

the term "ready forages" is excluded according to the Law of Ukraine of 21.12.2017 No. 2264-VIII;

State department of veterinary medicine with the state inspection of veterinary medicine (further - Department) - the state body performing functions of administration of veterinary medicine of Ukraine;

public service of veterinary medicine of Ukraine - system of state bodies of management of veterinary medicine and public institutions of veterinary medicine;

the state veterinary health control - functions which are performed by the state veterinary inspectors and/or official veterinarians and consist in permanent ensuring accomplishment of the veterinary and sanitary measures and technical regulations established by the current legislation;

the state veterinary sanitary inspection - functions which are performed by the state veterinary inspectors and/or official veterinarians and consist in recurring inspection of observance of requirements of the current legislation in the field of veterinary medicine;

the state veterinary inspector - the doctor of veterinary medicine working in public service of veterinary medicine or authorized by Department or if it is the doctor of the foreign country - its veterinary administration, on implementation of inspection of goods, capacities (objects), means of veterinary medicine and the accompanying objects for the purpose of protection of human health and/or health of animals and if necessary - certifications of their veterinary and sanitary condition according to requirements of relevant international organizations and implementation of other functions of the state veterinary health control and supervision;

the state doctor of veterinary medicine - the doctor of veterinary medicine working in state bodies or public institutions of veterinary medicine;

state bodies of veterinary medicine - Department and territorial authorities, regional service of the state veterinary health control and supervision on frontier of Ukraine and transport;

public institutions of veterinary medicine - the organizations of veterinary medicine performing preventive, diagnostic, medical and other antiepizootic actions, laboratory researches concerning safety of goods research and examinations for which control and supervising functions in the field of veterinary medicine, or representatives are assigned to implementation of such functions;

the term the import permit is excluded;

the order - written power on which the chief state veterinary inspectors of Ukraine, the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol, the cities, areas, regional services of the state veterinary health control and supervision on frontier and transport or their deputies grant the right to other person or organization on its own behalf to perform certain legal acts or to receive material values;

Operational permission - the document of allowing nature which is issued to the operator of capacities on conversion of inedible animal products based on check of compliance of its capacities to requirements of veterinary and sanitary actions and allows the operator of capacities to perform economic activity on conversion of inedible animal products;

export capacities (objects) - the capacities used for production of subjects to the state veterinary health control and supervision which are checked by Department for compliance to the requirements established by the country of destination for such capacities for the purpose of implementation of export of the above-stated objects to this country and have the corresponding operational permission;

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

the nation-wide program of control - the program determining obligations of operators of capacities, operators of the market, operators of the market of forages, operators of the market of foodstuff, state bodies of veterinary medicine and/or public institutions of veterinary medicine by control of the zoonoz and their activators and/or other pollutants, by implementation provided by such program of veterinary and sanitary actions and/or other actions;

the interested trading partners - the states and other subjects of international law who are participants of multilateral and bilateral agreements which regulate application of veterinary and sanitary measures which participant is Ukraine, and also members of relevant international organizations which member is Ukraine;

organization of veterinary medicine - organization, the company, the organization where at least one doctor of veterinary medicine which are founded by legal entity or physical person (the subject of managing) having qualification of the doctor of veterinary medicine and performing veterinary activities, including for veterinary practice, production of veterinary medicines, retail, wholesale trade by veterinary medicines, to carrying out disinfection, disinsection and deratization works works;

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

conditioning agents for animals - the means intended for cultivation of animals and care of them, which do not have medical and preventive action;

the report on results of researches - the document issued by the state or authorized laboratory of veterinary medicine in which the report on results of researches of the state of health of animals and/or detection of activators of infectious and parasitic diseases, antibodies to them or results of pathomorphologic and other researches is submitted. The recommendations and the conclusions provided in the report on results of researches are obligatory to execution;

zone - accurately certain part of the territory of the country with certain veterinary and sanitary status;

zone or kompartment, free from disease of animals which is subject to the notification, - zone or kompartment in which absence of certain disease of animals is confirmed by fulfillment of requirements of rather free status, established by relevant international organizations. In zone or kompartment the relevant activities of control (localization) concerning goods and other objects which can transfer the corresponding diseases of animals, including vehicles shall be held effectively;

zone or kompartment with insignificant presence of disease which is subject to the notification, - zone or kompartment of all country, its part, several countries or their parts where by determination of administration of veterinary medicine disease of animals at a low level and in which effective measures of inspection, control (localization) or liquidation are taken;

observation zone - the zone established in limits and along border of zone, free from the disease which is subject to the message which separates from zone, free the disease which is subject to the message from the infected zone where severe measures of observation are taken;

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

danger identification - process of identification of pathogenic agents of diseases of animals who can potentially get on the territory of Ukraine by import of goods and the accompanying objects;

the infected zone - zone in which absence of disease of animals is not confirmed according to the requirements established by relevant international organizations;

the quarantine zone - zone within which the quarantine of animals is applied and which includes the infected zone, buffer zone and also can include observation zone;

the quarantine station (post) - the place (the site of the area) which is under control of state bodies of veterinary medicine where groups of animals contain in isolation without direct or mediate contact with other animals, specially equipped for carrying out inspection during the certain period of time and in case of need - examinations or treatments;

quarantine of animals - the particular legal regime applied in the infected and buffer zones and in case of need - in observation zone for the purpose of localization of outbreak of disease of animals and liquidation of such disease according to the laws adequate to the veterinary and sanitary measures and regulatory legal acts published according to this Law;

quarantine veterinary post - the temporary specially equipped place on border of quarantine zone established according to the decision of the state extraordinary antiepizootic commission for the purpose of localization and non-admission of spread of the diseases which are subject to the message;

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

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

the term "stern" is excluded according to the Law of Ukraine of 21.12.2017 No. 2264-VIII;

the term "stern of plant origin" is excluded according to the Law of Ukraine of 21.12.2017 No. 2264-VIII;

the term "stern of animal origin" is excluded according to the Law of Ukraine of 21.12.2017 No. 2264-VIII;

the term "feed additives" is excluded according to the Law of Ukraine of 21.12.2017 No. 2264-VIII;

laboratory of veterinary medicine - the laboratory which is properly equipped and accredited by National accreditation agency or relevant organ on accreditation of the foreign country staffed by specially prepared personnel, competent to perform the corresponding technical procedures and headed by the doctor of veterinary medicine;

medical forage - any mix of veterinary medicines, including vitamins, amino acids, microelements, etc. or medical premixes and forage made under control of the specialist of veterinary medicine ready to turnover and intended for feeding to animals without preprocessing for the purpose of prevention and treatment;

the licensed doctor of veterinary medicine - the doctor of veterinary medicine who is constantly working in organization of veterinary medicine or veterinary dispensary, or the physical person - the entrepreneur, the license for the implementation of certain types of activity having qualification of the doctor of veterinary medicine and obtained in the field of veterinary medicine;

the maximum border of remaining balance (the most admissible level of remaining balance) - the most admissible content of active ingredient of veterinary medicines and their metabolites (transformation products in live systems) and toxicants in live animals, inedible animal products and sterns which exceeding can negatively affect health of animals and people that is established by veterinary and sanitary actions or if such indicators in actions do not exist, is established at the levels recommended by relevant international organizations;

the international veterinary certificate - the certificate which form and content correspond to recommendations of relevant international organizations which is issued in the country of export according to instructions of relevant international organizations and certifies the state of health of animals and/or observance of requirements for health protection of the person which were fulfilled concerning the exported goods;

international standards, instructions and recommendations - the standards, instructions and recommendations developed and accepted by MEB and other international organizations developing the recommendations, instructions and standards connected with protection of health and life of people and animals against diseases of animals;

the minimum quality factors - organoleptic, chemical, biological and physical indicators to which there shall correspond certain object to be considered acceptable for proper use;

monitoring - system and the procedure of observations of veterinary and sanitary condition of subjects to veterinary health control and supervision;

force epizootic majeure - the epizootic condition of the country confirmed or the suspected availability in country of source or transit of the disease which is subject to the message which can do bystry and irreparable harm to health of certain animals in all territory of Ukraine or its part in case of commodity import and the accompanying objects which can transfer the disease which is subject to the message;

proper practice of production (for veterinary medicines) - the system concerning all aspects of production process for ensuring the approved production and the control according to the quality standards for the purpose of risk minimization connected with safety and other risks connected with production of veterinary medicines, feed additives, premixes and ready-made feeds which cannot be eliminated by testing/check of end product. Such practice can be based on international standards, the principles and recommendations and is necessary for ensuring compliance with the adequate veterinary and sanitary measures, technical regulations and other requirements established present By the law. If there are no relevant international standards, instructions or recommendations or they do not provide the proper level of protection, veterinary and sanitary measures shall be based on objective scientific criteria, including proceeding from the analysis of risk assessment by the technique developed by relevant international organizations;

proper level of protection of health of animals and the protection of human health connected with it - the protection level which is considered the state sufficient in case of establishment of veterinary and sanitary measures for protection of health and life of people and animals against adverse effects to which overcoming veterinary and sanitary measures are directed;

diseases - the condition of animals which is not disease, but requiring leaving by the owner or treatment from the specialist of veterinary medicine;

inedible animal products - the by-products of animal origin which are not intended for consumption by the person, and also those which are not used for consumption by the person, but are used for the pharmaceutical, surgical, agricultural and industrial purposes;

subjects to the state veterinary health control and supervision - goods, capacities (objects), means of veterinary medicine, conditioning agent for animals and the accompanying objects;

turnover - movement (transportation) or the storage and any other actions connected with change of the property right or ownership including trade, exchange or donation;

the operator of capacities - the physical person or legal entity performing the activities provided by this Law, using capacities (objects) belonging to it on the property rights or uses;

especially dangerous diseases entering the MEB list - infectious diseases of animals which can quickly extend in considerable scales irrespective of frontiers which can have considerable social and economic effects or pose threat for health of the person or animal and it is essential to influence international trade in animals and animal products;

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

the batch - any goods quantity determined by the producer with the identical name and properties made during the period of time determined by the producer in identical conditions on the same capacity (object), is transported by the same vehicle and if necessary is followed by the same relevant veterinary document;

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