Law No. 1513-XII on sanitary and epidemiological provision of population

Unofficial translation 1 Law On Sanitary and Epidemiological Provision of Population The Law of the Republic of Moldova No 1513-XII dated June 16, 1993 I. General Provisions Article 1. Basic notions For the purpose of this law, the following notions shall be defined: Sanitary and epidemiological welfare of the population – a state of health, life style where there is no negative and dangerous action and factors that affect human health, thus offering favourable life conditions. National sanitary and epidemiological monitoring - actions of prevention, detection and elimination of violation of normative acts or other regulatory provisions on sanitary and epidemiological welfare of the population in order to protect human health and its life style; Epidemiologic control (sanitary and epidemiological) – the scientific control system of public health and its determinant factors that ensures the adequate diagnosis and forecasting of the unfavourable conditions, as well as develops the adequate measures for disease prevention and mortality reduction and disease eradiation; Public health – a set of measures focused on disease prevention, health promotion, increase the human physical and psychological potential by directing the society efforts on the life environment sanitation, communicable disease control, health education and healthy life style promotion, health care and assistance organisation, improvement of social mechanism in order to ensure the public accessibility to an adequate standard life style which will assure a healthy life; Life style – the total amount of objectives, phenomena and environment factors (natural and manmade) which have a direct effect on vital human activity; Life style factors - biological factors (viruses, bacteria, parasites, etc.), chemical, physical (noise, vibrations, ultrasound, infrasound, ionized and non-ionized radiation, thermal and of other nature), social (water supply, nutrition, life conditions, work, education and vacation), psychic and factors of other nature that have or can have a direct influence on public health of the present and next generation; Dangerous actions for man – the life style factors influence, which threatens the human life and health of the present and next generation; Adequate conditions for the vital human activity – a life conditions state with no life and health threatening factors influence; National sanitary and epidemiological regulations and normative acts, named hereinafter-sanitary regulations – normative acts and directives that establish sanitary and epidemiological conditions (including security criteria and/or human life Unofficial translation 2 conditions factors harmlessness criteria, hygienic norms, etc.), the violation of which endanger the human health and life, determines the disease outbreak and spreading; Hygienic norm – the accepted minimum and/or maximum index of quality and quantity established by the risk estimation research, which reveals the values of the life conditions factors from the point of view of their security for the human life and health; Social-hygienic monitoring – a set of organisation, sanitary and epidemiological and scientific-technical measures at national level that ensure the sanitary and epidemiological welfare and life conditions quality control, analysis, evaluation and forecasting of the indexes that characterise and define the relation cause-effect in order to develop the measures focused on the prevention, reduction and eradication of dangerous factors impact on human life and health; Sanitary and epidemiological notice – a document that confirms the correspondence (or non-correspondence) of life conditions factors, production activity, performance and services, as well as development projects of normative acts, construction, reconstruction and renovation projects, evaluation and accreditation of object functioning acts, urban and land planning, to sanitary regulations; Sanitary measure – any measure applied for:  Health and life protection of population against risks aroused by pollutants, contaminants, additives, toxins, natural toxic components, pathogenic and conditional pathogenic organisms present in the raw material, semi-prepared and finished foods, food products (including beverage), environment factors, as well as against risks aroused by the unawareness of some legal entities and individuals at national level;  National territory protection against the risk of communicable conventional disease contamination, which are extremely dangerous for the health and life of people; Sanitary and epidemiological measures – organisational, administrative, technical and engineering, medico-sanitary, veterinary measures, as well as measures of any other type that are oriented toward diminishing or eradicating harmful action over people, over their life style factors, as well as toward prevention of occurrence and spreading of mass communicable, contagious and non-communicable diseases, intoxications and their eradication; Quarantine measures – administrative and extraordinary measures, those of medico sanitary and veterinary character, and any other measures oriented toward prevention of spreading and localisation of contagious and extremely dangerous diseases, which need special conditions of activity, isolation, restriction of people and vehicles movement, of goods and animals; Unofficial translation 3 Communicable disease – human disease caused by life environment biological factors or by internal biological factors; Contagious disease – infectious human disease, which is spread among people or from human to animal by human life conditions; Conventional and dangerous contagious disease – infectious human disease with a high spreading rate (epidemic) among people which manifests itself by critical clinical state, high mortality and invalidity rate, and is regulated by the international conventions and International Medical-Sanitary regulations (plague, cholera, hemorrhagic fever and other diseases regulated by WHO); Non-communicable disease (non-contagious, non-transmitted) – human disease caused by physical, chemical, biological and social factors of human life conditions; Harmonization – establishment, approval and implementation of sanitary and anti epidemic measures common for all member states of WHO, WTO(World Trade Organization) and other international organizations; Risk - the possibility of a dangerous effect on health and seriousness of this effect; Risk evaluation – evaluation of the possibility of introduction, outbreak and spreading of a disease on the territory of a country, taking into account the sanitary measures that could be applied, and of possible biological and economic consequences of these phenomena, or the evaluation of the possible effect of dangerous factors on human health; Appropriate level of sanitary protection – a protection level considered being appropriate by the Ministry of Health, that establishes the sanitary measure for human life and health protection; No disease outbreak area – the country territory, a part or the territory of several states where, according to authorities opinion, do not register any specific disease; Disease low-spreading area – the territory of a state, a part or the territory of several states, where, according to the authorities opinion, registers a low spreading level of specific disease based on the implementation of monitoring, control and eradication measures; Human consumption – products and goods provided for maintenance of human life and health; The product and goods harmlessness - the absence of risk to cause prejudice to human health, life and life conditions by using products and goods; Products sanitary authorization (notification) – evaluation of sanitary-hygienic, epidemiological and efficiency conditions of sanitary protection measures against dangerous and unfavourable factors of life, work and environment conditions aimed at dangerous factors prevention, prevention of professional, contagious, non-transmitted, alimentary poisoning diseases and complications provoked by disease, physical and psychic malformations in children; Unofficial translation 4 Sanitary authorization for objectives implementation – sanitary authorization act, issued by State Sanitary and Epidemiological Services, that enables the hygienic and judicial activity of economic entities; Hygienic certifying of the products, goods, processes and services - the research procedure, developed by the State Sanitary and Epidemiological Services, on the basis of which the correspondence of control system with current requirements is established, the production, import, selling of products, goods, processes and services is accepted and their innocuity to human life and health confirmed; Hygienic certificate – hygienic certifying act, issued by the State Sanitary and Epidemiological Services; Possible dangerous substance (toxic) – any mixed substance of biological or chemical nature, set for economic use, the presence of which, in some circumstances, can determine functional disturbances of human, animal or vegetable organism. Article 2. Basics of the sanitary and epidemiological provision of population (1) Sanitary and epidemiological provision is a complex system of inter and intra department measures, implemented at the state level by the territorial-administration unit, economic unit, regardless to activity field or the form of property, at family and economic community level, focused on health maintenance, prevention and control of outbreak and spreading of the contagious, non-contagious and professional diseases, poisoning, determined by the dangerous environmental factors, production field, habitat, education and human behaviour. (2) The sanitary – epidemiological provision of the population is performed by: 1) The implementation of Republican and local programs on health promotion and disease prevention, the sanitation of life and activity conditions; 2) The development of the sanitary-hygienic and sanitary and anti-epidemic measures by the state bodies, unions, enterprises, institutions, organizations, cooperatives, associations and other economic agents, regardless to the form of property and subordination, as well as individuals, including foreign and stateless citizens (hereinafter individual and legal entities), measures that are a relevant to their activity, the observation of all regulatory provisions by these entities, as well as the implementation of compulsory provisions of state standards on health and life conditions security indexes; 3) The combination of financial involvement of individual and legal entities in the sanitary legislation fulfilment with their responsibility for violation of sanitary regulations and normative acts requirements on production security indices (performance and services); 4) Health and healthy life style promotion, as well as large in scope public education on health, sanitary and epidemiological situation and prevention measures to be taken; Unofficial translation 5 5) The improvement of sanitary habits of the population by health education, health and healthy life style promotion; 6) State sanitary- epidemiological control, the public and production control; 7) Conducting the social-hygienic monitoring and epidemiologic control; 8) The registration of the chemical, biological and radioactive substances, vaccines, bacterial and viruses diagnosis system, nutrition, chemical reagents, disinfectants, raticides, possible dangerous products, including those imported for the first time in our country; 9) State sanitary and epidemiological settlement; 10) Bring actions against contravention of sanitary regulation on the sanitary and epidemiological provision of the population, established by the state. Article 3. Legislation on sanitary and epidemiological provision of population The legislation on the sanitary and epidemiological provision of the population, named hereinafter sanitary legislation includes this law and other normative acts issued in accordance with this law by the central and local public authorities, within its legal framework, including the sanitary regulations, as well as international acts Republic of Moldova take part in. sanitary legislation is a necessary condition in order to fulfil the human right and interests, health strengthening and maintenance, physical and mental development, to ensure the long life expectancy and life quality. Article 4. Sanitary regulations and norms, hygienic requirements (1) The sanitary regulations and norms, hygienic requirements (named hereinafter – sanitary regulations) are the normative acts according to which the criteria for the human security and innocuity of environment factors and the requirements on the provision of people with favourable life and work conditions are established. (2) The sanitary regulations are binding to all individual and legal entities, regardless to their form of property or subordination. (3) On the territory of Republic of Moldova the national and international sanitary regulations, which will be edited and distributed, are in force. Article 5. Authorities (competence) of the public central and local bodies in the field of sanitary and epidemiological provision of population 1) The following issues are of the administration authorities competence: 1) The development and promotion of the policy on the sanitary and epidemiological provision of the population, sanitary legislation development and adoption, the establishment of judicial status of the bodies that conduct sanitary and epidemiological control at the state level; Unofficial translation 6 2) Coordination of the activity of ministries, departments and local public administration authorities within the frame of sanitary and epidemiological provision of population; 3) Planning, adoption and implementation of a system to control the national and local program implementation on of sanitary and epidemiological provision of population and the introduction of technical-scientific achievements in disease prevention; 4) Establishment and elimination of the special life and work conditions of the population focused on the prevention and eradication of epidemic of contagious and non-communicable disease; 5) Establishment of the principles and solving method the prejudices caused by sanitary legislation violation; 6) International cooperation in sanitary and epidemiological provision of population system; 7) The adoption of normative acts on sanitary and epidemiological provision of the population issues and control of the activity related to this field, at state level; 8) Planning and control of the state sanitary and epidemiological services activity. 2) The following issues are of the local administration authorities competence: 1) Coordination of the individual and legal entities activity on taking some complex hygienic and anti-epidemic measures; 2) Planning and approval of local programs on sanitary and epidemiological provision of the population and control of its implementation, as well as implementation of similar national programs; 3) To develop and implement the intervention measures of prevention and eradication of contagious and non-communicable disease epidemic as well as mass poisonings; 4) Decision-making on setting and cancelling the quarantine or related measures in case if an epidemic of contagious and non-communicable disease outbreaks; 5) To provide adequate conditions for realization and defending the public rights and interests related to sanitary and epidemiological provision; 6) To involve and direct, within the authorization limits, the individual and legal entities activity towards prevention and eradication of dangerous impact of environment factors on public health, disease prevention, improvement of the hygienic conditions at workplace and of living area. II. Rights and obligations of both individual and legal entities. Protection of their rights to sanitary and epidemiological provision Article 6. Rights of individuals Individuals have the right to: Unofficial translation 7 a) A favourable living conditions which are provided by the implementation of a set of measures related to prevention of dangerous environment factors impact on man, compelling the individual and legal entities to fulfil the provisions laid down in sanitary legislation, act in accordance with the normative acts on production security (work and services); b) Receive the complete and true data from legal entities (within their limit of competence): Data on the situation of living conditions and public health, in their activity area or the subordinate area, sanitary and epidemiological situation and radiation and the current sanitary regulations; Data on the implemented measures related to sanitary and epidemiological provision of the population and their results; Data on production quality (work and services), including food staff and drinking water quality; c) To be involved in, either through its direct representative or public organization, the development, control and adoption of decisions on sanitary and epidemiological welfare provision by the public authorities; d) Receive in time the compensation related to the prejudice caused by sanitary regulations violation, a fact that led to outbreak of some contagious and non communicable diseases and large mass poisoning, as well as professional diseases. Article 7. Rights of legal entities The legal entities have the right to: a) Receive, requiring from public authorities, information on the sanitary and epidemiological situation, environment sate, population morbidity and current sanitary regulations; b) To be involved in the process of decision-making related to project development, understanding and planning the programs on the sanitary and epidemiological provision; c) To establish high prices to national economic production, the quality indices of which proves the lack of chemical, radioactive and microbiological pollution, as well as the performance of services and works that are not dangerous for human body, in accordance with the Sanitary and epidemiological Services or Standardization and Metrology Department notice. Article 8. Protection of rights of both individual and legal entities Public authorities decisions, decision factors, as well as their actions that violate the rights of individual and legal entities, as provided in Article 6 and 7, will be brought against them through their superiors. In case of complain disapproval, the judicial instances will be applied to according to current laws. The complains on an action do not cancel this action or decision upon its solving. Unofficial translation 8 Article 9. Obligations of individuals Individuals are bind to: a) To protect their health and the health of their children, to provide health education to their children using the possibilities offered by the society, as well as to adopt a healthy life style; b) To act in accordance with sanitary regulations; c) To promote and be involved in the promotion of sanitary- epidemiological and anti-epidemic measures; d) To fulfil the decisions of State Sanitary-Epidemiologic Service Article 10. Obligations of legal entities On subordinate territory, the legal entities are bind to: a) To respect the current sanitary legislation and the established sanitary regulations and to control their implementation; b) To develop and implement the sanitary and epidemiological and sanitary epidemic measures focused on prevention and eradication of environment pollution, sanitation of working conditions, living conditions and rest conditions of the population, prevention of disease outbreak and spreading; c) To inform, in time, the State Sanitary-Epidemiologic Service about the situations of accident, production cessation, disturbances of the technological processes that have an dangerous effect on the sanitary and epidemiological state of the population; d) To fulfil the policy-makers decisions of State Sanitary-Epidemiologic Service, including those on activity and financing cassation of the enterprises, institutions, organizations and other economic agents that violate the sanitary legislation; e) To apply the material stimulation measures in order to increase the individual and legal entities interest to act in accordance with the sanitary legislation; f) To provide adequate conditions for the maintenance and improvement of public health in order to prevent the disease outbreak and to promote a healthy life style; g) To develop and implement public health education and instruction programs in order to enhance the capacities of the population in sanitary field; h) To ensure the realisation of individuals’ rights, provided in the Article 6. III. General requirements in the field of sanitary and epidemiological provision of population Article 11. Building and management of living areas Unofficial translation 9 (1) The building and management of living areas shall include the provision of favourable conditions for public health and living, the complex management of urban and other areas, prevention and eradication of dangerous impact of the environment factors on public health. (2) In the development of the general project plans of urban areas, projects of the building and management of living areas, projects on transport and other technical means, projects on issues of positioning the constructions, installations, and other civil industrial and agricultural objects, the selection of the territories for constructions, as well as reconstructions and renovation of the above-mentioned objects the sanitary regulations shall be observed. (3) In case of sanitary regulations violation or the impossibility to follow them, the individual and legal entities responsible for the performance of the projects on construction of buildings, installations and other objects shall suspend or cease the performance and financing of these works. (4) The distribution of territories for construction of different objects, their running, as well as production and use of the transport and other technical means are performed only on the basis of the notice on their correspondence to the sanitary regulations issued by the bodies of the State Sanitary and Epidemiological Service. (5) The projects of building and management of living areas, projects on pollutant objects, projects on construction and renovation of the civil, industrial, public nutrition and commerce buildings shall be obligatory submitted to the state sanitary and epidemiological expertise. Article 12. National economy output and producing technology (1) The peculiarities and quality indices of the national economic output, the production, transport, storage and use of which involve the direct participation of the worker and can have an unfavourable impact on his health, shall be in accordance with the current sanitary regulations. (2) The new technologies, materials, substances and items applied in the economy and household are allowed to be produced, introduced and applied exclusively on the basis of the notice that confirm their accordance with sanitary regulations issued by the bodies of the State Sanitary and Epidemiological Service. (3) The use of the chemicals, biological substances for the protection of vegetation, mineral fertilisers, the stimulus for plants and animals growth, polymer and plastic materials, cosmetic and perfume items is to be allowed only after they have been submitted to the toxicological and hygienic evaluation, only after the establishment of the hygiene norms, regulations of their use, development of the experimental methods and authorization of the bodies of the State Sanitary and Epidemiological Service. (4) In case the production does not correspond to the sanitary regulations, the individual and legal entities responsible for its production and running shall suspend or cease the its production and commercialisation. Unofficial translation 10 Article 13. Alimentary raw material, food products and additives and related materials and items (1) The food products shall fulfil the physiological needs of the man causing any damage to his health. (2) The production, transport, storage and commercialisation of the food products, including the alimentary raw material, food additives shall correspond to the sanitary regulations. (3) The production, use and commercialisation of the food products, including alimentary raw material, food additives, the implementation of the production technologies, including the new ones, shall be allowed on the basis of the notice that confirm their accordance with sanitary regulations issued by the bodies of the State Sanitary and Epidemiological Service. The economic units that produce, process, transport, store and commercialise the food products shall practice their activity on the basis of the sanitary authorisation on the objects functioning. (4) The individual and legal entities that produce (including the public alimentary units, etc.), purchase, store, transport and commercialise food products, including alimentary raw material, food additives shall observe the sanitary regulations ad to take measures to ensure their quality. (5) The food products, including alimentary raw material, food additives that do not correspond to the sanitary regulations and are dangerous for human health and life are drawn out from the market and production and are used by its owners in purposes safe for the people or are destructed, informing the State Sanitary and Epidemiological service on these issues. Article 14. Requirements on imported production (1) The food products, including alimentary raw material, food additives, polymer and plastic materials use in the construction of the drinking water supply and water transportation system, construction of dwellings and public edifices, goods and items of the household chemistry and cosmetic and perfume items imported in the country by the individual and legal entities for commerce and/or use in food industry shall not present any danger for public health and life. These goods can be introduced in the country only on the basis of the sanitary and epidemiologic notice and hygienic certificate on the correspondence to the sanitary regulations. The goods, including the above-mentioned ones, that are imported for the first time in the country and the list of which is approved by the Government shall be submitted to state registration before their introduction in the country. (2) The observance of the sanitary regulations in the import of the food products, including alimentary raw material, food additives, polymer and plastic material used in the construction and use of the drinking water supply system, import of the goods and items of the household chemistry, cosmetic and perfume items means to Unofficial translation 11 guarantee the observance of the sanitary regulations in every batch delivery that is a compulsory condition of every delivery contract. (3) The individual and legal entities that sign contracts on imported products, as well as on its delivery and commercialisation are responsible for the products security and harmlessness. Article 15. Drinking and household water supply for the population (1) The population should be supplied with drinking water of high quality (according to the national standard) in sufficient quantity for the fulfilment of their physiological and household needs. (2) The legal entities are bound to take measures on the development of a centralised water supply system. Article 16. Water sources (1) The quality of water from the sources used for the centralised and decentralised water supply system, for fulfilment of public household, entertainment and hygiene needs, for irrigation of the agricultural crops shall correspond to the current hygiene requirements. (2) For the purpose of prevention and eradication of the pollution of all water sources, the Government and local administration authorities establish zones of sanitary protection around these fields. (3) In case the water quality does not correspond to the sanitary regulations (state standard), the individual and legal entities responsible are bound to forbid the use of these water sources by the population. Article 17. Requirements for atmospheric air, acoustic and electromagnetic background, as well as for other factors regarding living areas and places of permanent or temporary residence of population (1) The atmospheric air, noise, electromagnetic and other factors level from the living areas and places of temporary and permanent residence of the population shall correspond to the sanitary regulations. (2) For the purpose of prevention of the negative impact of the atmospheric air polluted with industrial exhaust emissions, the high level of noise and electromagnetic irradiation on public health, around the industrial enterprises shall be established zones of sanitary protection, the dimension of which shall be determined by calculations, laboratory investigations and measurements. (3) Between the industrial enterprises and the protected areas shall be established zones of sanitary protection, the dimension of which shall be determined by the Ministry of Health on the basis f research on the impact of industrial noxes on public health and life environment. Unofficial translation 12 (4) The individual and legal entities are responsible for the dimensions established for the zones of sanitary protection and are bound to take measures for prevention and eradication of the pollution of atmospheric air, the decrease of noise and electromagnetic irradiation measures that affect public health. Article 18. Requirements on soil, territorial maintenance of living areas and economic units (1) The territories of living areas, enterprises, institutions and organisations shall be maintained in accordance with sanitary regulations. (2) The local public administration authorities establish the method and conditions for the provision of the appropriate sanitary state of the territories of living areas. (3) The industrial and household waste shall be collected. Processed, detoxicated, used and buried in the conditions and methods correspondent to the requirements of the security and harmlessness for public health and life. (4) The content of the chemical and biological substances potentially dangerous for man, biologic organisms, including micro-organisms, as well as the radiation background in the soil of the territories of living areas, economic units, including agricultural, institutions and organisations shall not exceed the maximum allowed value established by the sanitary regulations. Article 19. Dwellings (1) The dwellings for temporary and permanent residence shall provide the favourable conditions for human health and life. (2) The individual and legal entities are bound to forbid the public installation and residence in places that do not correspond to the sanitary regulations. Article 20. Requirements for use of production and public buildings, premises, installations and production equipment. Requirements for working conditions, including physical non-ionised factors (1) The favourable conditions for work, entertainment and living shall be provided for the workers during the exploitation of production and public buildings, indoor spaces, installations and equipment. The measures on environment protection and prevention of disease outbreak and spreading among people shall be taken. (2) In case of the established sanitary regulations violation, the individual and legal entities responsible shall suspend or cease the activity of certain sections and sectors, the exploitation of the public and production buildings, indoor spaces, installations, equipment, technical means, the performance of certain works and services. Unofficial translation 13 (3) The working conditions, place and process shall not negatively influence on the employee. The requirements on working conditions are stipulated in the sanitary regulations and other related normative acts accordingly approved. (4) The individual and legal entities are bound to take sanitary and epidemiological measures in order to provide the best working conditions for the employees, to observe the requirements, as provided for in the sanitary regulations and other related normative acts. The individual and legal entities shall take measures, also, on the processes of production, sanitary-technological and technological installations, the organisations of the working places, the individual and collective means of employees protection, the working, entertainment and socially hygienic service schedule of the prevention of traumas, professional communicable and contagious diseases as well as the diseases determined by the working places. (5) The use of the vehicles, installations, aggregates and equipment that are sources of the physical non-ionised factors that affect human body is allowed only on the basis of the notice on correspondence of the working conditions to the physical factors provided in the sanitary regulations. Article 21. Sanitary and epidemiological requirements on activities involving ionized radiations sources (1) The activities involving ionised radiations sources (generators) shall be performed in accordance with the current legislation and observance of the sanitary regulations. (2) The import, production, use, exploitation, conservation, transportation and storage of the radioactive substances and other sources of ionised radiation shall be allowed only on the basis of the sanitary and epidemiological notice or sanitary work authorisation, issued by the body of the State Sanitary and Epidemiological Service responsible for these activities. Article 22. Public education and training conditions (1) In the preschooler and recovery institutions, in schools, specialised high and medium education institutions, enterprises and organisations that practice education, training and professional training shall provide the conditions for health maintenance and fortification, conduct the education on health and healthy life style promotion among the students and observe the sanitary regulations. (2) The curricula, methods and schedules of the education and training, goods and publications for children, the technical and video terminal means, the school furniture shall be used in the process of education and training only on the basis of the sanitary and epidemiological notice on their correspondence with sanitary regulations. Article 23. Preventive medical examinations Unofficial translation 14 (1) For the purpose of health protection, prevention of disease occurrence and spreading, the workers in the enterprises, institutions, organisations and persons that practice individual activity are bound to pass preventive medical examination (at their employment) and periodic ones according to the legislation. (2) The State Head Sanitary Physician in agreement with state directing syndicate establishes the list of dangerous production factors and workers and the method of the performance of these examinations. (3) In case of necessity, according to the decision of the local public administration authorities in certain enterprises, institutions and organisations shall be introduced additional conditions and indications on the performance of the preventive medical examinations. (4) The chairmen of the enterprises, institutions, organisations and other agents are bound to provide conditions necessary to submit the employees to pass the examination in due time. (5) The employees that refuse to pass the preventive medical examinations at their employment and periodic after shall not be employed until the examination is passed. (6) The results of the preventive medical examinations shall be recorder in the personal medical chart, conforming the employment according to the regulations established by the Ministry of Health. (7) The economic agents support the expenses on the preventive medical examination performance, at the employment and periodic examination; the performance of the preventive medical examinations for employees of the budgetary system is free of charge. Article 24. Prevention of occurrence and spreading, as well as eradication of communicable diseases, non-communicable disease and mass intoxication of population (1) Complex organisation, technical engineering, medical, hygiene and antiepidemic actions shall be taken for the purpose of prevention of occurrence and spreading, as well as eradication of communicable diseases, non-communicable disease and mass intoxication of population. (2) In case of the risk of spreading of communicable, contagious, non communicable diseases and mass intoxication in certain territories of living areas, the Government and local public administration authorities shall provide special conditions and schedules for economic activity and living, proposed by the State Sanitary and Epidemiological Service. (3) The Government and local public administration authorities establish antiepidemic commissions of excellence in order to operatively conduct and coordinate the individual and legal entities activity for prevention and eradication of contagious and non-communicable diseases and mass intoxication of the population. Unofficial translation 15 (4) The people suffering from a contagious disease, people suspected of these diseases and those who have come in contact with contagious patients are submitted to medical examination and medical supervision and in case of necessity to treatment – compulsory hospitalisation and isolation (quarantine). In the central sources of infection shall be taken preventive and antiepidemic measures focused on the impediment of disease spreading(isolation, quarantine, medical monitoring, laboratory investigations, vaccinations, preventive treatment, disinfection, disinsection and diratification), according to the instructions approved by the Ministry of Health. (5) The person carrier of pathogenic agents of contagious diseases are submitted to treatment and temporarily transferred to other work activity if the current activity present a source of disease spreading. In case the transfer is impossible than they are temporarily dismissed, until full recovery, from work providing a material award from the special social insurance fund. (6) For the purpose of prevention of several contagious diseases, the population is provided with preventive vaccinations, of which the compulsory and free of charge for certain age and groups of risk are vaccinations against tuberculosis, poliomyelitis, convulsive cough, diphtheria, tetanus, rubella, measles, viral hepatitis B, Haemophilus Influentzae type b, rabies. The Ministry of Health approves the list of the contagious diseases against which the vaccinations are provided free of charge for the persons of any age and group of risk. (7) In order to take operative sanitary and antiepidemic measures focused on the prevention of contagious diseases spreading, every institutions, regardless to their for of property, all medical staff are bound to keep separate evidence on contagious disease patients and to inform the State Sanitary and Epidemiological Service within 24 hours from their detection. The Ministry of Health approves the list of the contagious diseases that require special registration and urgent information. (8) The measures of the sanitary protection of the state territory against introduction and spreading conventional and of extreme danger diseases, the list of which is approved by the State Head Sanitary Physician, are taken in accordance with sanitary legislation and International Medical and Sanitary Regulations. (9) The sanitary and epidemiological control and supervision is provided at the border points of the Republic of Moldova. (10) The activities that involve biological subdivisions, micro-organisms, toxins shall be performed in accordance with sanitary regulations and only on the basis of the sanitary authorisation, issued by the appropriate body of the State Sanitary and Epidemiological Service. Article 25. Expertise and special consultations (1) The scientific research institutions and organisations, other organisations and institutions, as well as high education institutions are bound to conduct, within the limits of their competence and at the request of the public authorisation, expertises Unofficial translation 16 and special consultations in order to estimate the impact of the environment factors n public health. (2) The institutions, organisations and specialists that perform expertises and give consultations are responsible for the quality, objectivity and character of their activity. Article 26. Health education, health and healthy life style promotion, hygiene training (1) The public health education and hygiene training are conducted in kindergartens, high and medium education institutions by including in the compulsory discipline on health education and health promotion in the study curricula. In the training curricula, professional training curricula and qualification curricula of the specialists of the economic field are included chapters on knowledge of hygiene, current sanitary regulations and sanitary legislation. (2) The chairmen, specialists and other staff from the enterprises, institutions and organisations, the activity of which is related to production, storage, transport and commerce of food products and drinking water supply, education and training of children and household service shall be submitted to compulsory hygiene training and attestation, as provided for by the Ministry of Health. (3) The means of public information (radio, TV, press) are bound to contribute to the increase of the level of public sanitary knowledge and to the propagation of knowledge on healthy life style. Article 27. State sanitary and epidemiological regulation (1) The state sanitary and epidemiological regulation consists of: The development of unique requirements on the scientific research conducting for the argumentation of the sanitary regulations; Development, expertise, approval, accordingly established, and publication of the sanitary regulations; The state supervision on the implementation and observance of the sanitary regulations, the research and generalisation of the implementation results; The registration and systematisation of the sanitary regulations, development and management of a unique database on state sanitary and epidemiological regulation. (2) The bodies and institutions of the State Sanitary and Epidemiological Service are responsible for the state sanitary and epidemiological regulation on the basis of the Regulation approved by the Government. Article 28. Development of sanitary regulations (1) The sanitary regulations are developed by the bodies and institutions of the State Sanitary and Epidemiological Service and other bodies and institutions competent in the necessity of regulating the life style factors and working conditions, necessity of Unofficial translation 17 improvement of the diagnosis, prevention and eradication means of contagious diseases. (2) The development of the sanitary regulations consists of: The conducting the research for the detection and evaluation of the impact of the life style factors on public health; The establishment of the sanitary and epidemiological requirements on the prevention of the negative influence of the life style factors of public health; The establishment of the criteria of harmlessness and security, hygiene and other kind of norms for life style; The analysis of the international experience on the sanitary and epidemiological regulation; The argumentation of the necessity of review of sanitary and antiepidemic measures, hygiene and other types of norms; The forecast of the socio-economical consequences of the implementation of the sanitary regulations; The argumentation of the terms and conditions of the implementation of the sanitary regulations. Article 29. Approval and observance of sanitary regulations (1) On the territory of the Republic of Moldova, the sanitary regulations approved by the State Head Sanitary Physician are in force. (2) The observance of the sanitary regulations is compulsory for the individual and legal entities, including foreign and stateless citizens. (3) The normative acts on the sanitary and epidemiological provision of the population, adopted by the local and central public authorities, the decisions of the legal entities on the same issue, the state standards, norms and regulations in construction, rules of protection of work and wor security technique, veterinary and fitosanitary regulations shall not contradict sanitary regulations. Article 30. Hygiene labelling of products, goods, and services that are of potential danger for human health and life (1) The hygiene labelling of products, goods, and services that are of potential danger for human health and life is performed on the basis of the sanitary and epidemiological expertise on their correspondence to the sanitary regulations. (2) The economic units, regardless to their form of property, shall practice only on the basis of the sanitary work authorisation. Article 31. Expertise, investigations, examinations, researches, experiments and sanitary and epidemiological tests, toxicological, hygiene and other evaluations (1) The bodies and institutions of the State Sanitary and Epidemiological Service, authorised experts shall conducts the expertise, investigations, examinations, Unofficial translation 18 researches, experiments and sanitary and epidemiological tests, toxicological, hygiene and other evaluations, using method and procedures of investigation and measure, approved by the Ministry of Health in order to: Detect and prevent the dangerous impact of the life style factors on human health; Determine the causes of occurrence and spreading of contagious, communicable and non-communicable diseases, including the poisoning; Determine the correspondence (non-correspondence) of the urbanisation and land management documentation to the sanitary regulations; Determine the correspondence (non-correspondence) of documentation of projects on construction, economic activity and other type of activity, products, goods, processes and services to the sanitary regulations. (2) On the basis of the results of expertises, investigations, research examinations, experiments and sanitary and epidemiological test, toxicological and hygiene and other type of evaluations presented according the establishment and in accordance with this law, the state head sanitary physicians and their deputies shall issue appropriate decisions and notices, hygiene certificates and sanitary work authorisations. (3) The authorised body on state sanitary and epidemiological supervision shall establish the method of conducting the expertises, investigations, research examinations, experiments and sanitary and epidemiological test, toxicological and hygiene and other type of evaluations (4) The bodies and institutions of the State Sanitary and Epidemiological Service and experts, authorised accordingly, that conduct the expertises, investigations, research examinations, experiments and sanitary and epidemiological test, toxicological and hygiene and other type of evaluations are fully responsible for the quality and objectivity of their work in accordance with the current legislation. Article 32. State registration of substances and products (1) To the state registration are submitted the following: a) The chemical, radioactive and biological substances and their preparations, named hereinafter substances, of potential danger for the human health and life, used for the first time in the country; b) The products that are of potential danger for human health and life; c) The products, including food products, imported in the country for the first time; d) The vaccines, serums, diagnosis, bacteriological and virus diagnosis systems, nutrition environments, chemical re-agents, disinfectants, disinsectants, raticides and other preparations and ingredients used for the prevention, detection and elimination of contagious and communicable diseases. (2) The state registration of the substances and products, mentioned in paragraph (1), shall be performed on the basis of: Unofficial translation 19 a) Evaluation of substances and products dangerous for human health, life and life style; b) Establishment of the hygiene and other related kind of norms on the contents of the substances and of certain product components; c) Development of the protection measures, establishment of the conditions of use, neutralisation and destruction of the substances and certain types of products in order to avoid the dangerous influence on human health, lifestyle and life. (3) The state registration of the substances and products, mentioned in paragraph (1), shall be performed by the bodies authorised by the Government. IV. LIABILITY FOR VIOLATION OF SANITARY LEGISLATION Article 33. Liability for violation of sanitary legislation (1) The violation of the regulations provided in the sanitary legislation attracts the disciplinary, administrative, civil (material) and criminal liability, in accordance with this law and other related normative acts. (2) The individual and legal entities that violated the sanitary regulations, produced, delivered, stored or commercialised products, the use of which lead to the contagious and non-communicable diseases outbreak and mass intoxication of the population shall pay a fine, in the appropriate amount, in the Republican Epidemiological fund. Article 34. Civil (material) liability (1) The individual and legal entities, responsible for the occurrence of certain contagious and non-communicable diseases and mass intoxications of the population and pollution of the public life style and exceeding maximum allowed values established in the state sanitary and epidemiological norms on pollutants, are bound to reimburse the expenses for medical assistance provision for the patients and performance of the sanitary, hygiene and antiepidemic actions, as well the expenses of the affected persons. (2) In case of refusal to compensate the caused prejudice, the litigation shall be discussed in judicial instance. (3) The government establish the method of compensation of the expenses of curative and preventive institutions, sanitary and epidemiological institutions and persons affected of the sanitary legislation violation. Article 35. Competence for bringing to administrative liability in case of sanitary legislation violation The entities authorised to examine the cases of administrative conventions and to apply administrative penalties in the name of State Sanitary and Epidemiological Service are the following: Unofficial translation 20 The State Head Sanitary Physician of the Republic of Moldova and his deputies; The State Head Sanitary Physicians of the municipalities and their deputies; The State Head Sanitary Physicians of the regions and their deputies; The State Head Sanitary Physicians of the autonomic territorial unit of Gagauzia and their deputies; The State Head Sanitary Physicians of the eastern regions of Moldova and their deputies; The Head Sanitary Physicians of the ministries and departments that have in their structure the department sanitary and epidemiological service (in the subordinate divisions). Article 36. Suspension of the economic entity activity (1) In case the economic entity, regardless to its form of property and judicial litigation form, violates the established by the sanitary regulations, the head sanitary physicians of any profile and their deputies have the right to suspend the activity of this entity upon the liquidation of all violations and its consequences. (2) The decision of activity suspension of the policy-maker of the State Sanitary and Epidemiological Service shall be performed within the time limit established by him. (3) One can bring actions against the decision of activity suspension in court. The litigation of the decision does not cease its implementation within the established time limit. (4) The refusal of implementation of the decision on activity suspension within the time limit implies the administrative or criminal liability, established by the sanitary legislation. (5) The decision on activity suspension ceases the force of the sanitary work authorisation of the unit. V. STATE SANITARY AND EPIDEMIOLOGICAL SUPERVISION, PUBLIC AND PRODUCTION CONTROL Article 37. State sanitary and epidemiological supervision (1) The State Sanitary –Epidemiological Service within the Ministry of Health, performs the sanitary and epidemiological supervision. (2) The state sanitary and epidemiological supervision consists of: (1) Supervision, research, evaluation and prognosis of the public health versus their life conditions; (2) Detection and establishment of the causes and conditions of the contagious and non-communicable disease, a well as mass poisoning outbreak and spreading; (3) Development of the compulsory measures to be taken that will ensure the public sanitary and epidemiological welfare; Unofficial translation 21 (4) To control the sanitary-antiepidemic measures implementation and the individual and legal entities’ observation of the current sanitary regulations (5) To take measures on the eradication of the sanitary legislation violations and bring action against the persons that violate it; (6) To conduct the evidence and analysis on the contagious and non communicable diseases and mass poisoning, as well as professional diseases; (3) The State Sanitary and epidemiological Service, within the Ministry of Health, was appointed as a central body for notification. The State Sanitary and epidemiological Service shall inform the World Trade Organisation Secretary on the sanitary measures amendments and shall present information on sanitary activity. (4) The ministry of Health accepts the sanitary measures implemented in other countries, members of the World Trade Organisation, as equivalents, even if they are different than the export country will objectively prove the import country that the implemented measures lead to the increase of the sanitary protection level in republic of Moldova. Consequently, the Ministry of Health shall have access, at its request, to the inspection, testing and other procedures. Article 38. Sanitary and epidemiological supervision of the ministerial and departmental units having departmental sanitary and epidemiological service (1) The sanitary and epidemiological service within the ministries and departments perform the sanitary and epidemiological supervision at these particular ministries and departments. The bodies and institutions of the sanitary and epidemiological service are authorised by the correspondent ministries and departments. (2) The appropriate ministries and departments approve the list of the institutions and bodies of the sanitary and epidemiological service. (3) The ministries and departments in agreement with Ministry of Health develop and approve the Regulation on the sanitary and epidemiological supervision at ministries and department. (4) The Ministry of Health is responsible for the coordination of the organisation and process of the departmental sanitary and epidemiological services. (5) The ministries and departments perform the accreditation of the institutions within the sanitary and epidemiological services and specialists attestations, as provided by the Ministry of Health. Article 39. Control over production The administration, chiefs of the institutions, enterprises and organisations as well as persons that practice individual activity are authorised to control the observation of the sanitary regulations established in the process of [production (activity) and the measures taken focused on the prevention and control of environment pollution, life Unofficial translation 22 conditions, working conditions and public health education and public instruction and control of the quality indices of the production (works and services). Article 40. Public control The public organisations, according to their status, have the right perform the public control on the current sanitary regulations observation and to inform the bodies of the State Sanitary- Epidemiological Service on the results achieved. VI. STATE SANITARY AND EPIDEMIOLOGICAL SERVICE Article 41. Structure of the state sanitary and epidemiological service (1) The state sanitary and epidemiological service is a unique system of the bodies and institutions lead by the Ministry of Health consequently subordinate to each other. (2) The parts of the state sanitary and epidemiological service are the following: The State Head-Sanitary Physician, the Deputy Minister of Health; The National Scientific and Applied Center of Preventive Medicine; The municipal, regional centres of preventive medicine and those from the autonomous territorial unit of Gagauzia and eastern part of republic of Moldova. (3) The coordination of the bodies and institutions of state sanitary and epidemiological service is the task of State Head-Sanitary Physician and its deputies, as well as the task of the appropriate head-sanitary physicians of the regional and municipal centres. (4) The functions of the head-physician, doctors and assistance that conduct the sanitary –epidemiological supervision, are attended by the persons with special training, including those from the hygienic and epidemiological fields, in the institutions of high and medium education. (5) The preventive measures for the sanitary – epidemiological provision of the population financing is performed according to a state and local administrations budgetary limits, annually established for each field. The financing of the state sanitary and epidemiological service is performed from the state budget and extra budgets as provided in the sanitary legislation. (6) For the purpose of financing the sanitary-epidemiological and sanitary antiepidemic measures for prevention, eradication and control the spreading of contagious and non-communicable disease and mass poisoning, in critical situations the National Epidemiological Fund shall be set by the Ministry of Health. Unofficial translation 23 (7) The State Head-Sanitary Physician, Deputy Minister of Health, is appointed and dismissed from Government function at the recommendation of Minister of Health. (8) The deputies of the State Head-Sanitary Physician and chief – physicians of regional and municipal centres are appointed and dismissed by the Minister of Health in agreement with regional and municipal councils. Article 42. Rights of decision-makers of the state sanitary and epidemiological service (1) The State Head-Sanitary Physician of the republic of Moldova and its deputies, chief – physicians of regional and municipal centres have the right to: 1) To submit to the public authorities proposals in the establishment of the sanitary legislation and development of plans of social and economic development projects, the complex programs on health protection, environment protection, enhancement of the working and life conditions, focused on the sanitary epidemiological provision of the population; 2) To visit (by presenting identity card) and control the enterprises, institutions, organisations, other economic agencies involved regardless to their form of property, as well as working conditions of the individual entrepreneurs in order to control the observation of sanitary legislation, current sanitary regulations by theses units and taking the hygienic and antiepidemic measures; 3) To acquire the individual and legal entities to take necessary hygienic and antiepidemic measures and liquidation of sanitary legislation violations, sanitary protection of the territories with high risk of infiltration and spreading the dangerous disease (which acquire establishment of quarantine) and other diseases, as well as to control the implementation of theses measures; 4) To conduct the expertise in sanitary-epidemiological provision of the population and according to the results achieved to present the individual and legal entities reasoning notifications; 5) To reveal and establish the causes and conditions of contagious and non communicable diseases and mass poisoning as well as professional diseases outbreak and spreading; 6) To cease until the necessary measures are not taken and the liquidation of the existing violations of the sanitary regulations and in case the observation of the rules is not possible than the following should cease: a) Planning and construction works as well as the operation of finished and renovated objects; b) The operation of enterprises, institutions, existing organisations, some production sections and sectors, indoor spaces, plans, equipment, technical Unofficial translation 24 means, as well as the operation of some works, production activities and service performance; c) Development, production, manufacturing and use the national economic production; d) Production, storage, transport and selling the raw material and food stuff, water (water sources) consumption for the household, ménage, cultural and sanitation purposes; 7) To submit draft of proposals to public authorities and financial-crediting bodies on the following issues: a) Interdiction and introduction of, in certain regions, special life and working conditions for population or the development of public economic activity focused on the prevention of contagious, non-communicable diseases and mass poisoning spreading and eradication of these diseases; b) To cease the financing (crediting) of the planning and construction activities, as well as economic activity of individuals or legal entities, in case the sanitary regulations and the regulations established by the State Sanitary and Epidemiological Service on the cessation of the related works and activities are violated; 8) Decision-making on the following issues: a) To dismiss temporarily the infected persons with contagious diseases that can become the disease spreading source despite of their of activity or the process of production they are involved in; b) To direct the persons that have been in contact with an infected person to have a medical examination and monitoring; c) To hospitalise immediately the infected persons and persons that are suspected of infection with contagious diseases, which are dangerous for other people health; d) To conduct the disinfection, disinsectisation and disratisation of the infected points as well as the indoor and outdoor spaces of the high risk of infection outbreak and spreading e) To conduct the public vaccination and the vaccination of the groups according to epidemic indications; (9) To invite the individual and legal entities at the State Sanitary-Epidemiologic Service in order to examine the materials on the sanitary legislation violation; (10) To examine the cases on the sanitary regulations violation and to give penalty payments in accordance with Articles 42, 42.1, 43 and 53 of the Code on administrative contraventions, to submit the acts to investigation bureaus to intent an action at law, to present to the policy-makers draft of proposals on the discipline sanction implementation; (11) To acquire the following issues: a) The compensation of the damages caused to public health; Unofficial translation 25 b) The reimbursement, by the curative-preventive and sanitary-epidemiological institutions, of the expenses of the hygienic, antiepidemic and curative measures taken in case of communicable and non-communicable disease and mass poisoning outbreak; c) To carry out penalty payments; (12) To receive, without any impediments, from the individual and legal entities, the necessary documents for the fulfilment of the State Sanitary Epidemiologic Service tasks; (13) To take samples of materials, substances, articles, food staff, air, water and soil for the laboratory research and hygienic expertise; (14) To develop regulations on the liquidation of the production considered of low quality after the expertise and is dangerous for the public health; (15) The State Head-Sanitary Physician has the right to approve, promote and to implement, in accordance with current sanitary legislation, the sanitary indices and method recommendations; (16) The State Head-Sanitary Physician and its deputies have also the right to empower the specialists in order to conduct the expertise and consultancy and to present to individual and legal entities notifications on the project norms, technical and normative documents on the technology and use of the new equipment of the national economy, and the technology of its production, notifications on the contract delivery documentation of the imported food products, raw material destined for economic and household use, as well as notifications on programs and curricula of education, instruction and intellectual and physical requirements. (17) The right provided in the paragraph (1) point 2), 3), 5), 12) and 13) of this law are also addressed to the decision-makers and specialists of State Sanitary Epidemiologic Service. Article 43. Obligations and liabilities of decision-makers and specialists of the state sanitary and epidemiological service (1) The State Head-Sanitary Physician, the head-sanitary physicians of the regional centres and other decision-makers of the State Sanitary-Epidemiologic Service provide the sanitary-epidemiological supervision within the limits of their competence, are bind to: 1) To use in time and at the full extent their empowerment for the prevention, identification and elimination of the sanitary legislation violations; 2) To collaborate in their activity with interested public authorities and organisations in order to defend the individual and legal entities rights and interests, to protect and fortify the public health and to ensure the sanitary epidemiological provision of the population; Unofficial translation 26 3) To ensure the confidentiality to state and commercial information achieved in the process of their activity; (2) The decision-makers and the specialists of the State Sanitary-Epidemiologic Service are responsible for the inappropriate fulfilment of their duties as provided in the current sanitary legislation. Article 44. Advancing claims against activity (or inactivity) of decision-makers and specialists of the state sanitary and epidemiological service (1) The actions (inactivity) of the state head-sanitary physicians and other decision makers and specialists of the State Sanitary-Epidemiologic Service related to the prevention, identification and repressing the sanitary legislation violations will be claimed from the superior State Head-Sanitary Physician. In case of disapproval with the decision taken the actions against decision-makers should be brought in the trial. (2) The claim submitted does not cease the complained action. Article 45. Legal status and social protection of decision-makers and specialists of the state sanitary and epidemiological service (1) The State Head-Sanitary Physicians, other decision makers and the specialists of the State Sanitary-Epidemiologic Service who conduct the sanitary-epidemiological supervision are representatives of the state bodies and are protected by the state. (2) They are independent in their activity and act in accordance with Constitution, the current laws of republic of Moldova, the decrees of the President of Republic of Moldova, Government decisions and sanitary legislation. (3) Any interfering in the activity of the decision-makers and specialists that conduct the sanitary-epidemiological supervision is forbidden. The individual and legal entities that make any pressure (of any kind) on the decision-makers and specialists that conduct the sanitary-epidemiological supervision are sued according to the current legislation. (4) The local administration authorities are bind to provide the state head-sanitary physicians with a place to live and telephone line within a year after their appointment. VII. INTERNATIONAL COMPACTS Article 46. International compacts in the field of sanitary and epidemiological provision of population In case the international treaty on the sanitary and epidemiological provision of the population, a part of which the Republic of Moldova is, establish regulations other than those established in the sanitary legislation of Republic of Moldova, than the regulations of the international treaty are implemented. Unofficial translation 27 PREZIDENT OF THE REPUBLIC OF MOLDOVA Mircea SNEGUR Chişinău, 16 June 1993 Nr.1513-XII.