Law on animal health, Law No. 79/2015/QH13

ORDER

On promulgation of law[1]

THE PRESIDENT OF THE SOCIALIST REPUBLIC
OF VIETNAM

Pursuant to Articles 88 and 91 of the Constitution of the Socialist Republic of Vietnam;

Pursuant to Article 91 of the Law on Organization of the National Assembly;

Pursuant to Article 57 of the Law on Promulgation of Legal Documents,

PROMULGATES:

The Law on Animal Health,

Which was passed on June 19, 2015, by the XIII^thNational Assembly of the Socialist Republic of Vietnam at its 9^thsession.

President of the Socialist Republic of Vietnam
TRUONG TAN SANG

LAW

On animal health[2]

Pursuant to the Constitution of the Socialist Republic of Vietnam;

The National Assembly promulgates the Law on Animal Health.

Chapter I

GENERAL PROVISIONS

Article 1.Scope of regulation

This Law prescribes animal disease prevention and treatment, animal epidemic combat; quarantine of animals and animal products; control of animal slaughter, preliminary processing and processing of animals and animal products; veterinary sanitation inspection; management of veterinary drugs; and veterinary practice.

Article 2.Subjects of application

This Law applies to domestic and foreign organizations and individuals involved in animal health activities in Vietnam.

Article 3.Interpretation of terms

In this Law, the terms and phrases below are construed as follows:

1. Animals include:

a/ Terrestrial animals that are cattle, poultry, wild animals, reptiles, bees, silkworms and a number of other animal species living on the ground;

b/ Aquatic animals that are fishes, crustaceans, mollusks, amphibious animals, aquatic mammals and a number of other species of aquatic animals.

2. Animal products mean products of animal origin, including:

a/ Terrestrial animal products that are meat, egg, milk, bee honey, beeswax, royal jelly, semen, embryo, blood, innard, skin, feather, hair, bone, horn, ivory, claw and other products of terrestrial animal origin.

b/ Aquatic animal products that are aquatic animals preliminarily processed or processed, in whole; embryo, egg, semen and other products of aquatic animal origin.

3. Preliminary processing or processing of animals and animal products means cleaning, cutting, slicing, classifying, freezing, salting, smoking, drying, packaging or other methods of processing animals and animal product for instant use or for use as materials for processing food, animal feed or for other purposes.

4. Animal health activities include state management of animal health and activities of animal disease prevention and treatment and animal epidemic combat; quarantine of animals and animal products; control of animal slaughter, preliminary processing and processing of animals and animal products; veterinary sanitation inspection; management of veterinary drugs and veterinary practice.

5. Animal epidemic-free zone or establishment means an animal husbandry, aquaculture or animal breeding zone or establishment which is determined as being free from infectious diseases on the list of animal diseases subject to epidemic announcement, for a period of time specified for each disease or animal species and in which animal health activities can control epidemics.

6. Infectious disease means the disease that can directly or indirectly spread between animals or between  animal and human and is caused by infectious pathogens.

7. Infectious pathogen means a virus, bacterium, parasite, fungus and another pathogen that may cause an infectious disease.

8. Animal epidemic means the outbreak of an infectious disease on the list of animal diseases subject to epidemic announcement.

9. Animal epidemic focus means a place where exists an infectious disease on the list of animal diseases subject to epidemic announcement.

10. Epidemic zone means a zone where exists an animal epidemic focus or exist new infectious pathogens as determined by an animal health management agency.

11. Epidemic-threatened zone means a zone surrounding an epidemic zone or zone adjacent to an epidemic zone of a neighboring country as determined by an animal health management agency.

12. Buffer zone means a zone surrounding an epidemic-threatened zone as determined by an animal health management agency.

13. List of animal diseases subject to epidemic announcement includes dangerous infectious diseases of animals which may cause great socio-economic damage or dangerous zoonotic diseases.

14. Quarantine of animals and animal products means the inspection and application of technical measures to detect, control and contain objects of animal and animal product quarantine.

15. Animal slaughter control means the pre-slaughter and post-slaughter inspection to detect, deal with and contain elements that cause disease in animals or  harm human health and the environment.

16. Veterinary sanitation means the satisfaction of requirements to protect animal and human health, the environment and eco-system.

17. Veterinary sanitation inspection means the inspection and application of technical measures to detect, control and contain objects of veterinary sanitation inspection.

18. Objects of animal and animal product quarantine include microorganisms, parasites, eggs and larvae of parasites that cause disease in animals and harm to human health.

19. Objects of veterinary sanitation inspection include contaminating microorganisms and microorganic toxins; physical and chemical elements; hazardous and radioactive substances; and environmental elements that cause bad impacts to animal and human health, the environment and eco-system.

20. Goods owner means the owner of animals and animal products or his/her representative who manages, escorts, transports and cares for animals and animal products.

21. Veterinary drug means a single substance or a mixture of substances, including pharmaceutical, vaccine, biological, microorganism and chemical approved for animal use to prevent, treat, diagnose, regulate or rehabilitate growth or reproductive functions of animals.

22. Finished veterinary drug means a veterinary drug which has undergone all stages of the manufacture process, including also end-packaging, labeling and quality control, and satisfies the quality criteria according to its registration dossier.

23. Veterinary drug materials mean substances in the ingredients of a veterinary drug.

24. Veterinary-use vaccine means an antigen-containing biological which prompts the animal body to develop an immune response needed to prevent a disease.

25. Veterinary-use biological means a product of biological origin used for prevention, treatment and diagnosis of animal disease or regulation of growth and reproduction in animals.

26. Veterinary-use microorganism means a bacterium, virus, unicellate parasite, must, yeast and some other microorganisms used for diagnosis, prevention and treatment of animal diseases, or research, production, testing and assay of veterinary drugs.

27. Veterinary-use chemical means a product of chemical origin used for disease prevention, treatment and diagnosis, disinfection and decontamination of the environment for animal husbandry, aquaculture, slaughter, preliminary processing and processing of animals and animal products.

28. Testing of veterinary drugs means the examination and determination of technical standards of veterinary drugs.

29. Assay of veterinary drugs means the examination and determination of characteristics, efficacy and safety of veterinary drugs on animals at an assaying establishment.

30. Quality inspection of veterinary drugs means the inspection and reassessment of the quality of veterinary drugs which have been tested or assayed or are in circulation when there is a dispute or complaint, or an expert examination request of a competent state agency.

Article 4.Principles of animal health activities

1. Animal health activities shall be unified from the central to local level to care for and protect animal health, improve socio-economic efficiency and sustainability of animal husbandry and aquaculture, guarantee food safety, and protect human health and the eco-environment.

2. Disease prevention must be the key, disease treatment must be timely, and epidemic combat must be expeditious in order to quickly and accurately detect and  thoroughly treat animal epidemic foci and infectious sources; promptly prevent the infection and spread of objects of animal and animal product quarantine.

3. Animal epidemic prevention and combat must first of all rest with owners of domestic animals and animal husbandry or aquaculture establishments; state management agencies must be responsible for guiding and applying animal epidemic prevention and combat measures in a timely and effective manner.

4. Trading of animals and animal products shall be facilitated; harmony of interests of the State and community and lawful rights and interests of organizations and individuals shall be ensured.

5. Scientific and technological advances shall be applied and modern science and technology shall be combined with people’s traditional experiences in animal epidemic prevention and combat and animal disease treament.

Article 5.Animal health policies of the State

1. In each period, the State shall adopt specific policies to invest in and provide financial support for the following activities:

a/ Conducting scientific research, technology development and transfer in animal disease diagnosis, testing and treatment; building establishments to diagnose and test animal diseases and assay and inspect the quality of veterinary drugs to serve state management; building quarantine isolation zones;

b/ Building a system for tracing origin of animals and animal products; planning establishments to slaughter animals, preliminarily process and process animal products on an industrial scale associated with animal husbandry areas;

c/ Developing the animal epidemic information, surveillance, forecasting and warning system;

d/ Preventing and combating animal epidemics and remedying damage caused by animal epidemics;

dd/ Preventing and combating diseases on the list of animal diseases subject to epidemic announcement; controlling, containing and eliminating dangerous infectious animal diseases and zoonotic diseases;

e/ Improving physical and technical foundations for animal health management agencies; and the environment monitoring and warning system;

g/ Manufacturing veterinary drugs and vaccines for the prevention and combat of dangerous animal diseases;

h/ Establishing animal epidemic-free zones.

2. The State shall encourage the following activities:

a/ Building animal epidemic-free establishments; building concentrated animal farming and slaughering establishments;

b/ Organizations’ and individuals’ participation in animal epidemic prevention and combat; mobilizing social resources for animal health and livestock insurance activities.

c/ Researching and applying science and technology, applying good practices and advanced quality management systems in the field of animal health;

d/ Training human resources in the field of animal health;

dd/ Caring for, raising and protecting animals for humantarian purposes.

3. If persons who carry out animal health activities at the request of competent state agencies contract diseases, get injured or die, they shall be considered for enjoying entitlements and policies as war invalids and fallen heroes in accordance with the law on preferential treament of persons with meritorious services to the revolution.

Article 6.System of animal health management agencies

1. The system of animal health management agencies consists of:

a/ The Animal Health Department of the Ministry of Agriculture and Rural Development;

b/ Sub-departments with the animal health management function under provincial-level Departments of Agriculture and Rural Development (below referred to as provincial-level animal health management agencies);

c/ Stations under sub-departments with the animal health management function located in rural districts, urban districts, towns, provincial cities and equivalent administrative units (below referred to as district-level animal health management agencies).

2. Based on animal health requirements and available resources in their localities, provincial-level People’s Committees shall propose the People’s Councils of the same level to consider and decide on arrangement of veterinarians in communes, wards or townships.

3. The Government shall specify this Article and entitlements and policies for veterinarians in communes, wards or townships.

Article 7.Animal health information and communication

1. Animal health information and communication aims to provide knowledge about animal epidemics, measures to prevent and combat animal epidemics and animal health policies and laws.

2. Animal health information and communication shall be conducted in various forms suitable to different subjects and geographical areas. Contents of animal health information and communication must be accurate, timely and easy to understand.

3. Responsibilities of state agencies for animal health information and communication:

a/ The Ministry of Agriculture and Rural Development shall organize and direct the provision of animal health information and conduct animal health information and communication activities;

b/ Ministries, ministerial-level agencies, government-attached agencies and People’s Committees at all levels shall, within the ambit of their duties and powers, conduct animal health information and communication activities.

4. Organizations and individuals engaged in animal health information and communication activities shall comply with this Law and relevant laws.

Article 8.State management responsibilities of the Government and ministries

1. The Government shall exercise the uniform state management of animal health nationwide.

2. The Minister of Agriculture and Rural Development must be responsible before the Government for performing the state management of animal health and shall:

a/ Formulate, and direct the implementation of, strategies, master plans and plans on animal health;

b/ Promulgate policies, legal documents, standards and technical regulations on animal health according to his/her competence or propose them to competent authorities for promulgation, and organize the implementation thereof;

c/ Direct, guide and organize the animal disease prevention and treatment and animal epidemic combat; quarantine of animals and animal products; control of animal slaughter, preliminary processing and processing of animals and animal products; veterinary sanitation inspection; management of veterinary drugs; and veterinary practice;

d/ Prescribe the uniforms, badges, insignia, signs and cards of animal quarantine officers;

dd/ Organize the grant, re-grant, extension and revocation of animal health-related licenses and certificates;

e/ Organize baseline survey, scientific research and application of new technologies; training in animal health;

g/ Organize animal health information and communication, knowledge dissemination and law education;

h/ Determine professional criteria and qualifications for titles in the system of animal health management agencies; criteria for veterinarians in communes, wards or townships;

i/ Direct and organize the inspection and examination of animal health activities; settle complaints and denunciations, and handle violations of the law on animal health according to his/her competence;

k/ Make statistics on animal health;

l/ Direct and conduct international cooperation on animal health.

3. The Minister of Health shall coordinate with the Minister of Agriculture and Rural Development in preventing and combating zoonotic diseases.

4. The Minister of Industry and Trade shall assume the prime responsibility for, and coordinate with the Minister of Agriculture and Rural Development in, preventing and combating trade fraud and counterfeit goods, and handling violations of the law on trade in animals, animal products and veterinary drugs on the market.

5. The Minister of Science and Technology shall coordinate with the Minister of Agriculture and Rural Development in managing scientific research, technology development and transfer, and developing animal health-related standards and technical regulations.

6. The Minister of Finance shall assume the prime responsibility for, and coordinate with the Minister of Agriculture and Rural Development in, promulgating regulations on conditions for completing customs procedures in inspecting and supervising animals and animal products subject to quarantine, clinical specimens and veterinary drugs upon export, import, temporary import for re-export, temporary export for re-import, border-gate or bonded-warehouse transfer or transit through the Vietnamese territory; combating smuggling and illegal cross-border transportation of animals, animal products and veterinary drugs; guiding localities in allocating and using annual budgets and ensuring funds for animal epidemic prevention and combat.

7. The Minister of Public Security shall coordinate with the Minister of Agriculture and Rural Development in ensuring security related to animal epidemic prevention and combat and animal and animal product quarantine.

8. The Minister of National Defense shall coordinate with the Minister of Agriculture and Rural Development in ensuring national defense and security related to animal epidemic prevention and combat and animal and animal product quarantine; directing the border guard and marine police to coordinate with concerned agencies in preventing and combating smuggling and illegal cross-border transportation of animals, animal products and veterinary drugs.

9. The Minister of Information and Communications shall coordinate with the Minister of Agriculture and Rural Development in directing and guiding the popularization of warnings about animal epidemics and information on animal epidemic prevention and combat.

10. The Minister of Natural Resources and Environment shall assume the prime responsibility for, and coordinate with the Minister of Agriculture and Rural Development in, promulgating regulations on environmental protection and national technical regulations on environment related to animal health.

11. The Minister of Transport shall assume the prime responsibility for, and coordinate with the Minister of Agriculture and Rural Development in, organizing the control of vehicles or vessels transporting animals, animal products and veterinary drugs.

Article 9.Responsibilities of People’s Committees at all levels

1. People’s Committees of provinces and centrally run cities (below referred to as provincial-level People’s Committees) shall:

a/ Promulgate according to their competence or submit to competent authorities for promulgation legal documents guiding the implementation of the law on animal health;

b/ Formulate, and organize the implementation of, master plans on animal epidemic-free zones and establishments; plans on animal epidemic prevention and combat; programs on surveillance, control and elimination of animal epidemics;

c/ Decide on allocation, management and use of funds and mobilization of resources of their localities in accordance with law for animal epidemic prevention, combat and supervision; inspect and supervise the quality of veterinary drugs circulated in their localities; allocate funds for disposal and destruction of abandoned animals, animal products and veterinary drugs in their localities and other animal health-related activities;

d/ Direct and organize animal epidemic prevention and combat; make statistics on and assess damage caused by epidemics; implement policies on support for life stabilization and restoration of animal husbandry and aquaculture after animal epidemics;

dd/ Direct and organize the communication and dissemination of and training in animal health knowledge and education about the law on animal health;

e/ Direct and organize the inspection and examination of animal health activities, settlement of complaints and denunciations and handling of violations of the law on animal health according to their competence.

2. People’s Committees of rural districts, urban districts, towns and provincial cities and equivalent administrative units (below referred to as district-level People’s Committees) shall:

a/ Direct and organize the communication and dissemination of animal health knowledge and education about the law on animal health;

b/ Request district-level animal health management agencies to supervise, forecast and warn animal epidemics;

c/ Allocate funds and organize animal epidemic prevention and combat; make statistics, assess damage and provide support to animal farmers after animal epidemics;

d/ Direct and organize the inspection and examination of animal health activities, settlement of complaints and denunciations and handling of violations of the law on animal health according to their competence.

3. People’s Committees of communes, wards and townships (below referred to as commune-level People’s Committees) shall:

a/ Organize the communication and dissemination of animal health knowledge and education about the law on animal health;

b/ Designate places for and organize the disposal and destruction of diseased animals; animal products carrying pathogens; counterfeit, inferior-quality or smuggled veterinary drugs or veterinary drugs of unclear origin;

c/ Organize surveillance for early detection and announcement of animal epidemics; apply measures to prevent and combat animal epidemics; sum up and report on damage caused by animal epidemics; guide the implementation of policies to support the animal epidemic prevention and combat;

d/ Coordinate with district-level animal health management agencies in conducting surveillance of animal epidemics and making animal health statistics;

dd/ Organize the examination of veterinary activities, settlement of complaints and denunciations and handling of violations of the law on animal health according to their competence.

Article 10.Responsibilities of the Vietnam Fatherland Front, its member organizations, socio-professional organizations and social organizations

1. The Vietnam Fatherland Front and its member organizations shall, within the ambit of their functions and duties, disseminate and mobilize people and their members to implement, policies and law on animal health; give their opinions on law making, conduct supervision and social criticism in the field of animal health in accordance with law.

2. Socio-professional organizations and social organizations shall give their opinions on making the law on animal health; disseminate and popularize animal health knowledge and law; provide consultancy and technical training in animal health.

Article 11.International cooperation on animal health

1. International cooperation on animal health covers:

a/ Conclusion of, accession to, and implementation of, international agreements and treaties on animal health to which the Socialist Republic of Vietnam is a contracting party;

b/ Training and development of human resources; scientific research and technology transfer; exchange of information about and experience in animal health;

c/ Assistance in resources.

2. The Animal Health Department shall act as the focal point for international cooperation on animal health as assigned by the Minister of Agriculture and Rural Development.

Article 12.Animal health charges and fees

Charges and fees shall be paid for animal health-related activities in accordance with the law on charges and fees.

Article 13.Prohibited acts

1. Hiding or failing to report or promptly report on diseased animals, animals which show signs of infection or die of infectious disease, causing transmission of animal diseases and epidemics.

2. Declaring, listing or certifying a untruthful number or volume of diseased or dead animals or infected animal products which are subject to destruction; declaring or certifying a untruthful quantity or volume of materials and chemicals for animal epidemic prevention and combat for self-seeking purposes.

3. Failing to publicly announce or declare animal epidemics in case announcement or declaration is required in accordance with this Law.

4. Providing untruthful information on animal epidemic situations.

5. Failing to apply or unpromptly applying animal epidemic prevention and combat measures as prescribed in this Law.

6. Failing to comply with animal epidemic prevention and combat measures at the request of competent agencies and organizations.

7. Discarding diseased or dead animals and animal products and discharging pathogen-carrying wastewater and waste into the environment.

8. Transporting diseased animals, animal products or wastes carrying pathogens of dangerous infectious diseases, animals susceptible to announced animal epidemics and their products out of epidemic zones without permission of competent animal health management agencies.

9. Improperly destroying or failing to destroy diseased or dead animals or pathogen-carrying animal products which are subject to destruction in accordance with law.

10. Trading in, erasing or tampering with animal health-related licenses or certificates.

11. Fraudulently swapping or changing numbers of quarantined animals or animal products.

12. Shirking quarantine; transporting animals and animal products subject to quarantine without quarantine certificate or those of unclear origin.

13. Importing, temporarily importing for re-export, temporarily exporting for re-import, transferring from border gate to border gate or transiting through the Vietnamese territory animals or animal products from countries or territories where exists a dangerous epidemic on animals susceptible to such epidemic.

14. Importing animals, animal products or clinical specimens without permission of animal health management agencies.

15. Importing or exporting animals or animal products banned by law from import or export.

16. Slaughtering or harvesting animals or animal products for use as food before the end of the withdrawal interval of veterinary drug according to their use instructions.

17. Slaughtering or treating animals infected with diseases on the list of animal diseases with which animals are banned from slaughter or treatment.

18. Slaughtering animals, preliminarily processing or processing animals or animal products for trading without satisfying veterinary sanitation requirements.

19. Producing, preliminarily processing, processing or trading in animal products containing substances banned from use in animal husbandry or veterinary medicine or containing microorganisms or residues in excess of permitted limits.

20. Soaking in or impregnating with chemicals, injecting water or other substances into, animals or animal products against veterinary sanitation requirements.

21. Using veterinary drug materials for animal disease prevention and treatment; or using veterinary drugs of unclear origin or banned from use, expired veterinary drugs or those not yet permitted for circulation in Vietnam, except the case specified at Point c, Clause 6, Article 15 of this Law.

22. Manufacturing, importing, exporting or trading in counterfeit veterinary drugs; veterinary drugs of unclear origin or banned from use, expired veterinary drugs, veterinary drugs of inferior quality, or those not yet permitted for circulation in Vietnam, except the case specified in Clause 2, Article 100 of this Law.

23. Circulating veterinary drugs whose labels contain contents inconsistent with those registered with the animal health management agency.

24. Advertising veterinary drugs with functions and uses inconsistent with registered ones.

25. Illegally practicing veterinary medicine.

Chapter II

ANIMAL EPIDEMIC PREVENTION AND COMBAT

Section 1

GENERAL PROVISIONS ON ANIMAL EPIDEMIC PREVENTION AND COMBAT

Article 14.Contents of animal epidemic prevention and combat

1. Applying measures to prevent, diagnose and treat diseases; monitoring and warning farming environments; supervising, forecasting and warning epidemics; investigating epidemics; analyzing risks; containing animal epidemics.

2. Sanitizing and disinfecting animal farming and aquaculture environments.

3. Establishing animal epidemic-free zones and establishments; implementing programs and plans to contain and eliminate a number of dangerous infectious diseases in animals and zoonotic diseases.

4. Providing accurate, adequate and timely information about animal epidemics and support policies for animal epidemic prevention and combat.

5. Disseminating and training in animal epidemic prevention and combat measures.

Article 15.Animal disease prevention

1. Animal farms, aquaculture areas and tools used in animal farming or aquaculture shall be sanitized, disinfected or decontaminated and have disease vectors eliminated on a regular basis or after each farming period; animal farms and aquaculture areas must conform to local master plans or obtain permission from a competent agency.

2. Wastes from animal farming and aquaculture shall be disposed of in accordance with the law on environmental protection. For closed aquaculture systems, the quality of water sources shall be ensured; wastewater and waste shall be treated before being discharged in order to ensure veterinary sanitation in accordance with the law on environmental protection.

3. Breeds and feeds used in animal farming and aquaculture must be disease and epidemic free and ensure veterinary sanitation in accordance with the laws on animal breeds and feeds.

4. Animals shall be compulsorily vaccinated against dangerous infectious diseases at the request of animal health management agencies.

5. Vaccines for compulsory disease prevention under programs on containment and elimination of animal diseases and epidemics and urgent disease and epidemic prevention and combat shall be funded by the state budget; animal health management agencies shall make and submit to competent authorities for approval plans on use of vaccines for animal disease prevention, and implement these plans.

6. The Minister of Agriculture and Rural Development shall:

a/ Promulgate the list of animal diseases subject to epidemic announcement; the list of zoonotic diseases; and the list of animal diseases with which animals are banned from slaughter or treatment;

b/ Prescribe compulsory disease prevention measures; veterinary and environmental sanitation requirements in animal farming and aquaculture; conditions for animals and animal products to be transported out of epidemic zones;

c/ Decide on use of veterinary drugs not yet registered for circulation in Vietnam in emergency cases for timely animal epidemic prevention and combat;

d/ Prescribe the order, procedures and dossiers for recognition of animal disease- and epidemic-free zones and establishments.

Article 16.Surveillance of animal diseases and epidemics

1. Surveillance of animal diseases and epidemics aims to early detect diseases and epidemics likely to cause serious socio-economic damage, pathogens of dangerous infectious animal disease and zoonotic diseases.

2. Animal disease and epidemic surveillance programs shall be announced by competent agencies in response to a number of dangerous infectious animal diseases and epidemics aim to encourage owners of domestic animals and owners of animal farming or aquaculture establishments to take the initiative in preventing and combating animal diseases and epidemics.

3. Owners of animal farming or aquaculture establishments shall:

a/ Build their establishments and conduct surveillance of animal epidemics at their establishments under the guidance of the animal health management agency;

b/ When participating in an animal epidemic surveillance program mentioned in Clause 2 of this Article, comply with instructions of the animal health management agency and may transport aminals and aminal products out of epidemic zones under the guidance of the animal health management agency;

c/ Monitor and record the process of animal farming or rearing, disease prevention and treatment and epidemic combat;

d/ Report to local administrations and the animal health management agency on results of inspection and identification of animals carrying pathogens of diseases on the list of animal diseases subject to disease announcement or the list of zoonotic diseases; take handling measures as prescribed.

4. Animal disease diagnosis and testing establishments shall report to the animal health management agency on results of testing of diseases on the list of diseases subject to epidemic announcement and the list of zoonotic diseases.

5. The animal health management agency shall conduct surveillance of animal diseases as follows:

a/ Based on development of animal diseases or epidemics, to develop programs on animal disease surveillance in the course of farming, transportation, slaughter, trading or import of animals and animal products;

b/ To take the initiative in conducting investigation and collecting specimens for surveillance of animal diseases and epidemics;

c/ To conduct surveillance on a regular or an irregular basis of infectious diseases transmittable between wild animals and domestic animals at establishments keeping wild animals, zoos, bird gardens, biodiversity reserves and nature reserves;

d/ Based on results of surveillance and epidemiological characteristics of animal diseases, to forecast or warn about a number of dangerous infectious animal diseases and epidemics and guide measures to prevent and combat these diseases and epidemics. When discovering a zoonotic epidemic, to promptly notify it to the same-level health agency and give warnings to farmers and communities so as to take active measures to isolate diseased animals and prevent and combat the transmission of the disease from animal to humans;

dd/ To build and manage a database on surveillance of animal diseases and epidemics and animal epidemic forecasting and warning information; to receive information on animal diseases and epidemics and give feedback;

e/ To certify that establishments participating in the animal epidemic surveillance program are safe.

Article 17.Animal epidemic-free zones and establishments

1. A zone or an establishment that satisfies the following conditions shall be recognized as animal epidemic-free:

a/ Having taken the animal disease prevention measures prescribed in Article 14 and Clauses 1, 2, 3, 4 and 5, Article 15 of this Law;

b/ Conducting surveillance of animal diseases and epidemics under Clause 3 of Article 16 of this Law;

c/ Letting none of animal epidemics registered for recognition occur during a period of time specified for each animal disease or animal species;

d/ Ensuring that animal health activities in the zone or establishment can control animal diseases and epidemics.

2. Animal epidemic-free zones and establishments may be prioritized for supply of animal breeds, animals and animal products.

3. The Minister of Agriculture and Rural Development shall detail this Article.

Article 18.Containment and elimination of a number of dangerous infectious diseases in animals and zoonotic diseases

1. The containment and elimination of a number of dangerous infectious diseases in animals and zoonotic diseases shall be programed and planned for each period.

2. The containment and elimination of a number of dangerous infectious diseases in animals cover the following activities:

a/ Conducting research and investigation to discover pathogens and vectors of these diseases; analyzing and assessing risks of causing and infection of these diseases;

b/ Early discovering these diseases for timely eradication, thus preventing their transmission on a wide area;

c/ Taking compulsory measures to prevent diseases for animals, including vaccination, sanitization, disinfection and decontamination in farming areas, compulsory destruction or slaughter of diseased animals and other compulsory technical measures as requested by the animal health management agency;

d/ Conducting epidemic surveillance and warning the risk of infection ;

dd/ Mobilizing, training and guiding organizations and individuals to actively prevent and combat a number of dangerous infectious diseases in animals;

e/ Expanding and maintaining animal epidemic-free zones and establishments.

3. The containment and elimination of zoonotic diseases cover the following activities:

a/ Conducting research and investigation to discover pathogens of these diseases;

b/ Controlling and containing infectious sources, preventing the transmission of these diseases;

c/ Taking compulsory measures to prevent diseases for animals, including vaccination, sanitization, disinfection and decontamination of farming or rearing areas, compulsory destruction or slaughter of diseased animals and other compulsory technical measures as requested by the animal health management agency;

d/ Conducting surveillance of these diseases; establishing a system of information and warning about the risk of infection of zoonotic diseases;

dd/ Observing the regime of information and reporting on animal disease situations between the animal health management agency and health agency in the response to and treatment of diseases and epidemics;

e/ Mobilizing, training and guiding organizations and individuals to actively prevent and combat zoonotic diseases under the guidance of the animal health management agency.

4. The Minister of Agriculture and Rural Development shall:

a/ Formulate programs and plans on containment and elimination of a number of dangerous infectious diseases in animals and zoonotic diseases, then submit them to the Prime Minister for approval;

b/ Direct the implementation of compulsory measures to contain and eliminate dangerous infectious diseases in animals and zoonotic diseases;

c/ Annually assess the situation, containment and elimination of animal diseases and epidemics and report it to the Prime Minister.

5. The Minister of Health shall assume the prime responsibility for, and coordinate with the Minister of Agriculture and Rural Development in, processing information relating to zoonotic diseases; organizing timely treatment of diseased persons; and announcing epidemics in accordance with the law on prevention and combat of infectious diseases.

6. The Minister of Finance shall ensure funds for implementation of programs and plans prescribed at Point a, Clause 4 of this Article.

7. Chairpersons of People’s Committees at all levels shall organize the implementation of programs and plans on containment and elimination of a number of dangerous infectious diseases in animals and zoonotic diseases.

Article 19.Animal disease and epidemic declaration, diagnosis and investigation

1. When discovering diseased or dead animals or animals showing signs of contracting an infectious disease, owners of domestic animals and owners of animal farming or aquaculture establishments and veterinarians shall immediately report such to commune-level animal health officers or People’s Committees or the nearest animal health management agency.

2. When discovering or receiving reports on diseased or dead animals or animals showing signs of contracting an infectious disease, commune-level animal health officers shall:

a/ Verify the information, conducting clinical diagnosis and assist the animal health management agency in collecting specimens for testing;

b/ Guide owners of domestic animals or owners of animal farming or aquaculture establishments in taking the measures prescribed in Clause 1, Article 25 and Clause 1, Article 33 of this Law;

c/ Report to the commune-level People’s Committee and district-level animal health management agency.

3. When receiving reports on diseased or dead animals or animals showing signs of contracting an infectious disease, a district-level animal health management agency shall:

a/ Verify the information, conducting clinical diagnosis and investigating animal disease foci;

b/ Collect specimens for testing and identification of pathogens;

c/ Guide measures to prevent and combat animal diseases and epidemics;

d/ Report to the district-level People’s Committee and provincial-level animal health management agency.

4. The Minister of Agriculture and Rural Development shall specify this Article.

Article 20.Treatment of animal diseases

1. Animals showing signs of contracting a disease shall be promptly diagnosed, isolated, cared for and treated, except where disease treatment is banned or slaughter or destruction is compulsory under regulations of the Ministry of Agriculture and Rural Development.

2. When treating animal diseases in an animal epidemic focus or zone, owners  of domestic animals and owners of animal farming or aquaculture establishments, commune-level animal health officers and veterinarians shall comply with the guidance of the animal health management agency; conduct sanitization, disinfection and decontamination and comply with regulations on animal disease and epidemic prevention and combat.

3. The use of veterinary drugs to treat diseased animals must comply with Clause 1, Article 104 of this Law.

Article 21.Treatment of animals

1. Organizations and individuals that farm animals, rear aquatic animals or use animals shall:

a/ Manage, care for, rear and transport animals in a manner suitable to each animal species;

b/ Minimize pain and fear for animals and treat them humanely in farming or aquaculture, transportation, slaughter, destruction, disease prevention and combat, and scientific research.

2. Organizations and individuals that keep animals as pets or rear animals for the purpose of biodiversity conservation shall care for, nurture, prevent and combat diseases for these animals in a satisfactory and timely manner in accordance with this Law.

Article 22.Reservation and use of veterinary drugs on the list of national reserve goods

1. Reservation of veterinary drugs on the list of national reserve goods is as follows:

a/ The Minister of Agriculture and Rural Development shall submit to the Prime Minister for decision quantities and categories of veterinary drugs as national reserve goods;

b/ Veterinary drugs on the list of national reserve goods shall be managed and used in accordance with the law on national reserves.

2. The use of veterinary drugs on the list of national reserve goods is as follows:

a/ In case of emergency upon the occurrence of a natural disaster or an animal epidemic, and at the request of a provincial-level People’s Committee chairperson, the Minister of Agriculture and Rural Development shall decide on ex-warehousing and allocation of veterinary drugs on the list of national reserve goods for animal disease and epidemic prevention and combat. Such a decision is as valid as a decision on budget allocation of the Minister of Finance prescribed in the Law on the State Budget, shall be reported to the Prime Minister and the ex-warehousing and allocation of veterinary drugs as national reserve goods shall be notified to the Ministry of Finance. In case the decision goes beyond the his/her competence, the Minister of Agriculture and Rural Development shall submit to the Prime Minister for consideration and decision;

b/ Provincial-level People’s Committee chairpersons shall direct the receipt, preservation and use of vetarinary drugs on the list of national reserve goods allocated as support for animal disease and epidemic prevention and combat in a timely and effective manner and for proper purpose and report to the Minister of Agriculture and Rural Development on results of use of veterinary drugs allocated to localities.

3. Provincial-level People’s Committees shall allocate reserved veterinary drugs funded with their local budgets for implementation of animal disease and epidemic prevention and combat measures.

Article 23.Funds for animal disease and epidemic prenvetion and combat

1. Funds for animal disease and epidemic prenvetion and combat shall be used for the following activities:

a/ Preventing and combating animal diseases and epidemics;

b/ Overcoming consequences of animal diseases and epidemics;

c/ Restoring the animal farming or aquaculture environment.

2. Funds for animal disease and epidemic prenvetion and combat come from the following sources:

a/ The state budget;

b/ Funds of owners of domestic animals and owners of animal farming or aquaculture establishments;

c/ Contributions and financial assistance of domestic and foreign organizations and individuals, international organizations and other lawful sources prescribed by law.

3. The Government shall stipulate the mobilization, management and use of funds for animal disease and epidemic prenvetion and combat.

Article 24.Steering Committees for animal disease and epidemic prenvetion and combat

1. Steering Committees for animal disease and epidemic prenvetion and combat at all levels shall be established when animal diseases or epidemics are announced.

2. The Prime Minister shall prescribe the establishment, organization and operation of steering committees for animal disease and epidemic prenvetion and combat.

Section 2

TERRESTRIAL ANIMAL DISEASE AND EPIDEMIC PREVENTION AND COMBAT

Article 25.Treatment of terrestrial animal disease foci

1. Owners of domestic animals and animal farming establishments shall:

a/ Isolate diseased animals or animals showing signs of contracting disease;

b/ Refrain from slaughter, trading or disposal of diseased animals, animals showing signs of contracting disease, dead animals or animal products carrying pathogens into the environment;

c/ Conduct sanitization, disinfection, decontamination, compulsory destruction or slaughter of diseased animals, animals showing signs of contracting disease or dead animals under the guidance of the animal health management agency and the law on environmental protection;

d/ Provide accurate information about animal diseases or epidemics at the request of the animal health management agency and commune-level animal health officers;

dd/ Obey inspection and examination requests of competent state agencies.

2. Commune-level animal health officers shall:

a/ Guide owners of domestic animals and animal farming establishments in complying with the provisions of Clause 1 of this Article;

b/ Prevent animal diseases, combat animal diseases and epidemics, diagnose and treat animal diseases, and take clinical specimens under the guidance of the animal health management agency;

c/ Report on animal diseases or epidemics to commune-level People’s Committee chairpersons.

3. Commune-level People’s Committees shall:

a/ Disseminate information about animal disease and epidemic prevention and combat in their localities;

b/ Direct commune-level animal health officers, organizations and individuals to inspect and supervise owners of domestic animals and animal farming establishments in isolating diseased animals, making statistics on diseased animals and animals susceptible to animal diseases and epidemics; coordinating with district-level animal health management agencies in taking clinical specimens;

c/ Organize vaccination for disease prevention, combat animal diseases and epidemics and treat animal diseases under the guidance of the animal health management agency;

d/ Decide on and direct the destruction of animals in animal disease foci; sanitize and disinfect areas for farming, slaughter and trading in animals and animal products;

dd/ Organize the control of transportation of animals and animal products out of or into animal disease foci.

4. District-level People’s Committees shall:

a/ Allocate funds for treatment of animal disease foci;

b/ Request district-level animal health management agencies and direct related sections, departments and sectors in identifying animal disease foci, announcing them in the local mass media and guiding the implementation of veterinary sanitization measures in farming, slaughter, transportation and trading of animals and animal products;

c/ Direct commune-level People’s Committees in implementing the provisions of Clause 3 of this Article.

5. Provincial-level People’s Committees shall direct lower-level People’s Committees and related provincial-level departments, sections and sectors in treating animal disease foci, allocate funds and support owners of domestic animals and animal farming establishments having animals destroyed.

Article 26.Announcement of terrestrial animal diseases or epidemics

1. Principles of announcement of a terrestrial animal disease or epidemic:

a/ The announcement of animal disease or epidemic must ensure sufficient conditions and be conducted by competent persons in a public, accurate and timely manner;

b/ Within 24 hours after receiving a request for animal disease or epidemic announcement, a competent person defined in Clauses 4 and 5 of this Article shall decide to make animal disease or epidemic announcement.

2. The announcement of a terrestrial animal disease or epidemic shall be conducted when there are sufficient conditions as follows:

a/ There is a focus of an animal disease on the list of animal diseases subject to epidemic announcement which tends to quickly spread on a wide area, or a new infectious disease pathogen is discovered;

b/ An agency competent to diagnose or test animal disease makes a diagnosis conclusion that there exists a disease on the list of animal diseases subject to epidemic announcement or a new infectious disease pathogen.

3. A terrestrial animal disease or epidemic announcement must include:

a/ Name of the animal disease or epidemic or new infectious disease pathogen; name of the diseased animal species;

b/ Time of occurrence of the animal disease or epidemic or time of discovery of the new infectious disease pathogen;

c/ Epidemic, epidemic-threatened and buffer zones;

d/ Measures to prevent and combat the animal disease or epidemic.

4. Competence to announce terrestrial animal diseases and epidemics is prescribed as follows:

a/ District-level People’s Committee chairpersons shall base themselves on requests of district-level animal health management agencies to decide on animal disease or epidemic announcement when there are sufficient conditions prescribed in Clause 2 of this Article and for diseases or epidemics occurring within their districts;

b/ Provincial-level People’s Committee chairpersons shall base themselves on requests of provincial-level animal health management agencies to decide on animal disease or epidemic announcement when there are sufficient conditions prescribed in Clause 2 of this Article and for diseases or epidemics occurring in two or more districts of their provinces.

5. The Minister of Agriculture and Rural Development shall base himself/herself on the request of the Department of Animal Health to decide on animal disease or epidemic announcement when there are sufficient conditions prescribed in Clause 2 of this Article and for diseases or epidemics occurring in two or more provinces; inspect, urge and supervise the epidemic announcement by provincial-level and district-level People’s Committee chairpersons.

6. For an animal disease or epidemic which quickly and widely spreads, seriously threatening human life and health or causing serious socio-economic consequences, the Minister of Agriculture and Rural Development shall report it to the Prime Minister for requesting a competent state agency to declare a state of emergency in accordance with the law on states of emergency.

Article 27.Organization of terrestrial animal disease and epidemic combat in epidemic zones

1. After announcing an animal disease or epidemic, a person competent to announce epidemics shall direct related organizations and individuals in taking the following measures:

a/ Determining the boundaries of the epidemic, epidemic-threatened and buffer zones; putting up signs, checkpoints and instructions for travel and transportation of animals and animal products through the epidemic zone;

b/ Banning unauthorized persons from entering places where there are diseased or dead animals; restricting entry in or exit from the epidemic zone; taking animal disease prevention measures under regulations;

c/ Prohibiting slaughter, bringing into or out of, or circulation in the epidemic zone of animals susceptible to the announced animal disease or epidemic and their products, unless the transportation of animals and animal products is permitted under regulations of the Minister of Agriculture and Rural Development;

d/ Urgently organizing the vaccination for disease prevention or applying other compulsory measures to prevent diseases for animals susceptible to the announced animal disease or epidemic in the epidemic zone; treating the disease or compulsorily slaughtering animals or destroying diseased animals or animal products carrying pathogens under the guidance of the animal health management agency;

dd/ Sanitizing and disinfecting stables, cages and areas where diseased animals are gazed, tools and eqipment used in animal husbandry, and wastes under the guidance of the animal health management agency.

2. The Minister of Agriculture and Rural Development shall:

a/ Direct provincial-level People’s Committees of localities where an epidemic exists to mobilize local resources for quickly taking measures to zone off, contain and eliminate the epidemic and prevent its transmission; inspect, supervise and urge the animal epidemic combat by provincial-level People’s Committees of localities where an epidemic exists;

b/ Submit to the Prime Minister for decision on assistance for animal disease and epidemic prevention and combat and organize the provision of assistance;

c/ Report to the Prime Minister on results of animal disease and epidemic prevention and combat and implementation of the policies on assistance for animal disease and epidemic prevention and combat, overcoming of consequences of diseases or epidemics and restoration of animal husbandry after the epidemic.

3. Provincial-level People’s Committee chairpersons shall:

a/ Direct district-level People’s Committees, provincial-level animal health management agencies, and related agencies, organizations and individuals in taking animal disease and epidemic prevention and combat measures; mobilize local resources to prevent and combat animal diseases and epidemics; inspect and examine animal disease and epidemic prevention and combat activities;

b/ Popularize measures to prevent and combat animal diseases and epidemics in their localities;

c/ Direct the implementation of the policies on assistance for animal disease and epidemic prevention and combat, overcoming of consequences of diseases or epidemics, stabilization of farmers’ livelihood and restoration of animal husbandry in their localities;

d/ Propose the Minister of Agriculture and Rural Development to submit to the Prime Minister for decision allocation of support funds, materials and resources when requests for animal disease and epidemic prevention and combat are beyond local capability;

dd/ Report to the Minister of Agriculture and Rural Development on results of animal disease and epidemic prevention and combat and implementation of policies on assistance for epidemic prevention and combat, overcoming of consequences of diseases and epidemics and restoration of animal husbandry in their localities.

4. District-level People’s Committee chairpersons shall:

a/ Direct and organize the application of animal disease and epidemic prevention and combat measures under the direction of provincial-level People’s Committee chairpersons;

b/ Organize the popularization of animal disease and epidemic prevention and combat measures in their localities;

c/ Implement policies on assistance for disease and epidemic prevention and combat, overcoming of consequences of diseases and epidemics, stabilization of farmers’ livelihood and restoration of animal husbandry in their localities;

d/ Submit to provincial-level People’s Committee chairpersons for decision allocation of support funds, materials and resources when requests for animal disease and epidemic prevention and combat are beyond local capability;

dd/ Report to provincial-level People’s Committee chairpersons on results of animal disease and epidemic prevention and combat and implementation of policies on assistance for epidemic prevention and combat, overcoming of consequences of diseases and epidemics and restoration of animal husbandry in their localities.

5. Commune-level People’s Committee chairpersons shall:

a/ Organize the application of animal disease and epidemic prevention and combat measures under the direction of higher-level People’s Committee chairpersons;

b/ Organize the destruction of dead and diseased animals; compulsory slaughter of diseased animals; sanitization, disinfection and decontamination;

c/ Organize popularization of animal disease and epidemic prevention and combat measures in their localities;

d/ Implement policies on assistance for disease and epidemic prevention and combat, overcoming of consequences of diseases and epidemics, stabilization of farmers’ livelihood and restoration of animal husbandry in their localities;

dd/ Submit to district-level People’s Committee chairpersons for decision allocation of support funds, materials and resources when requests for animal disease and epidemic prevention and combat are beyond local capability;

e/ Report to district-level People’s Committee chairpersons on results of animal disease and epidemic prevention and combat and implementation of policies on assistance for epidemic prevention and combat, overcoming of consequences of diseases and epidemics and restoration of animal husbandry in their localities.

6. The Department of Animal Health shall:

a/ Provide local animal health management agencies with guidance on animal disease and epidemic prevention and combat measures; assist localities in preventing and combating animal diseases and epidemics, investigating diseases and epidemics and assessing animal disease foci;

b/ Identify infectious pathogens of new diseases or diseases with unidentified causes.

7. Local animal health management agencies shall advise People’s Committees at the same level, guide the application of animal disease and epidemic prevention and combat measures and determination of damage caused by diseases or epidemics; monitor, summarize and appraise the effectivenes of animal disease and epidemic prevention and combat, and make reports under regulations.

8. Commune-level animal health officers shall:

a/ Obey directions of commune-level People’s Committees and animal health management agencies in aminal disease and epidemic prevention and combat;

b/ Treating animal disease foci under Clause 2, Article 25 of this Law;

c/ Guide and take part in the application of sanitization, disinfection and decontamination measures to prevent transmission of animal diseases and epidemics;

d/ Make statistics on domestic animals, diseased animals, dead animals and animals to be destroyed under the guidance of animal health management agencies.

9. Owners of domestic animals and animal farming establishments shall:

a/ Treat animal disease foci under Clause 1, Article 25 of this Law;

b/ Apply animal disease and epidemic prevention and combat measures at the request of People’s Committees at all levels, animal health management agencies and commune-level animal health officers;

c/ Pay expenses for overcoming violation consequences; pay compensations for damage caused by their violations of the law on animal disease and epidemic prevention and combat in accordance with law.

Article 28.Terrestrial animal disease and epidemic prevention and combat in epidemic-threatened zones

1. People’s Committees at all levels shall direct the application of the following measures:

a/ Controlling the bringing into or out of epidemic-threatened zones of animals susceptible to announced animal diseases and epidemics and their products;

b/ Strictly controlling the slaughter and transportation of animals and animal products in epidemic-threatened zones;

c/ Organizing vaccination for disease prevention and applying compulsory measures for disease prevention for animals susceptible to announced animal diseases and epidemics;

d/ Popularizing animal disease and epidemic prevention and combat measures in their localities.

2. In case an animal epidemic occurs in a border area of a neighboring country, the provincial-level People’s Committee chairperson shall apply the following measures and promptly report to the Minister of Agriculture and Rural Development:

a/ Announcing the epidemic-threatened zone within a radius of 5 km from the border and applying the measures specified in Clause 1 of this Article;

b/ Identifying border gates and animals and animal products not allowed to be transported through such border gates;

c/ Deciding on a temporary ban during the period of an animal epidemic on bringing into the Vietnamese territory of animals susceptible to the epidemic occuring in the neighboring country and their products;

d/ Directing related agencies in strictly inspecting and controlling activities related to animals and animal products in epidemic-threatened zones; applying sanitization and disinfection measures to humans and vehicles or vessels traveling through border gates.

3. Owners of domestic animals and animal farming establishments shall:

a/ Conduct vaccination for disease prevention and apply other animal disease prevention measures under the guidance of animal health management agencies;

b/ Sanitize, disinfect and decontaminate animal farming areas, tools and environment;

c/ Implement animal disease and epidemic prevention and combat measures at the request of competent state agencies.

Article 29.Terrestrial animal disease and epidemic prevention and combat in buffer zones

1. People’s Committees at all levels shall direct related agencies in applying the following measures:

a/ Inspecting and controlling the transportation, slaughter and trading of animals and animal products;

b/ Regularly monitoring and supervising animals susceptible to animal disease or epidemic.

2. Owners of domestic animal and animal farming establishments shall apply the measures specified in Clause 3, Article 28 of this Law.

Article 30.Compulsory disposal of diseased animals, animals showing signs of contracting disease and animal products carrying pathogens on the list of animal diseases subject to epidemic announcement, the list of zoonotic diseases or carrying newly discovered infectious disease pathogens

1. Compulsory measures of disposing of diseased animals, animals showing signs of contracting diseases and animal products carrying pathogens on the list of animal diseases subject to epidemic announcement, the list of zoonotic diseases or carrying newly discovered infectious disease pathogens include:

a/ Compulsory destruction;

b/ Compulsory slaughter.

2. The Minister of Agriculture and Rural Development and chairpersons of People’s Committees at all levels shall, within the ambit of their tasks and powers, decide on handling measures specified in Clause 1 of this Article.

3. The State supports the compulsory destruction and slaughter of diseased animals, animals showing signs of contracting diseases and animal products carrying pathogens on the list of animal diseases subject to epidemic announcement or the list of zoonotic diseases or carrying newly discovered infectious disease pathogens. In each period, the Prime Minister shall decide on specific subjects eligible for support and levels of support for the compulsory destruction and slaughter of diseased animals, animals showing signs of contracting diseases and animal products carrying pathogens on the list of animal diseases subject to epidemic announcement or the list of zoonotic diseases.

4. The compulsory slaughter of anumals shall be conducted as follows:

a/ It shall be conducted at slaughter houses designated by local animal health management agencies and apply all prescribed veterinary sanitization measures;

b/ Vehicles or vessels for transportation of compulsorily slaughtered animals must have tight trunk floors to prevent waste from dropping en route and be sanitized, disinfected and decontaminated right after transportation;

c/ Slaughterhouses and tools and wastes of slaughtered animals shall be treated, sanitized, disinfected or decontaminated after slaughter;

d/ Bodies and meat of compulsorily slaughtered animals may be used after being treated up to veterinary sanitization requirements;

dd/ Byproducts and other products of compulsorily slaughtered animals, stable stuffing materials and wastes of animals shall be burned or buried.

5. The compulsory destruction and slaughter of diseased animals, animals showing signs of contracting diseases and animal products carrying pathogens on the list of animal diseases subject to epidemic announcement or the list of zoonotic diseases or carrying newly discovered infectious disease pathogens must comply with the laws on animal health, infectious disease prevention and combat and environmental protection.

6. Owners of domestic animals and animal farming establishments having animals subject to compulsory destruction or slaughter shall:

a/ Obey the compulsory destruction or slaughter, and sell products of compulsorily slaughtered animals under the guidance of animal health management agencies;

b/ Comply with the provisions of Clause 1, Article 25 of this Law.

7. Annually, provincial-level People’s Committees shall allocate reserve funds for the destruction of animals and provide support for owners of domestic animals and animal farming establishments having animals destroyed to ensure quick and effective containment and prevention of animal diseases and epidemics and environmental sanitation.

8. The Minister of Agriculture and Rural Development shall specify Clauses 1, 4 and 5 of this Article.

Article 31.Announcement of termination of terrestrial animal epidemics

1. Conditions for announcing termination of a terrestrial animal epidemic include:

a/ Within the time limit prescribed for each disease, counting from the date the last diseased animal dies, is slaughtered or compulsorily destroyed or recovers from ailment, no other animal is infected with or dies of the announced epidemic;

b/ Vaccination or other compulsory measures to prevent diseases for animals susceptible to the animal epidemic in the epidemic zone or epidemic-threatened zone have been applied;

c/ Measures of sanitization, disinfection and decontamination have been applied to meet the veterinary sanitation requirements for the epidemic zone or epidemic-threatened zone;

d/ An animal health management agency requests announcement of animal epidemic termination which has been verified and recognized by the superior animal health agency.

The Minister of Agriculture and Rural Development shall specify this Clause.

2. Persons competent to announce animal epidemics defined in Article 26 of this Law are competent to announce the termination of animal epidemics when there are sufficient conditions prescribed in Clause 1 of this Article.

Section 3

AQUATIC ANIMAL DISEASE AND EPIDEMIC PREVENTION AND COMBAT

Article 32.Aquaculture environment monitoring and warning

1. Aquaculture establishment owners shall:

a/ Monitor, supervise and inspect environmental indicators in aquaculture areas and fully record collected information and data;

b/ Provide information and data on environmental monitoring and aquatic animal disease and epidemic prevention at requests of competent state agencies.

2. Fisheries management agencies shall assume the prime responsibility for, and coordinate with aquatic animal management agencies:

a/ Formulating and submitting to competent authorities for approval programs on aquaculture environment monitoring and warning;

b/ Implementing or coordinating with aquaculture environment observers in implementing programs on aquaculture environment monitoring and warning in order to early discover unfavorable signs of the environment and recommend aquaculture establishment owners to make timely adjustments.

3. Provincial-level People’s Committees shall approve and allocate funds for and direct the implementation of programs on aquaculture environment monitoring and warning.

4. The Minister of Agriculture and Rural Development shall:

a/ Guide and organize the aquaculture environment monitoring, forecasting and warning; handle and address environmental changes in aquaculture areas;

b/ Designate organizations and individuals qualified for participating in aquaculture environment monitoring and warning, and send monitoring and warning results to animal health management agencies and fisheries management agencies.

Article 33.Treatment of aquatic animal disease foci

1. Aquaculture establishment owners have the following obligations:

a/ Not to discharge untreated or improperly treated wastewater and wastes into the environment;

b/ Not to dump diseased or dead aquatic animals or aquatic animals showing signs of contracting an infectious disease into the environment;

c/ To treat, harvest or dispose of diseased or dead aquatic animals or aquatic animals showing signs of contracting infectious diseases, and apply other measures under the guidance of animal health management agencies;

d/ To declare aquatic animal diseases and epidemics under Clause 1, Article 19 of this Law; to provide information about aquatic animal diseases and epidemics at the request of animal health management agencies and commune-level animal health officers;

dd/ To sanitize and disinfect the aquaculture environment and tools under the guidance of animal health management agencies;

e/ To dispose of and destroy aquatic animals to prevent the transmission of diseases and epidemics;

g/ To obey inspection and examination requests of competent state agencies.

2. Commune-level animal health officers have the following responsibilities:

a/ To comply with the provisions of Points a and c, Clause 8, Article 27 of this Law; guide and supervise aquaculture establishment owners in applying the measures specified in Clause 1 of this Article;

b/ To make statistics and reports on aquaculture areas and quantities of reared aquatic animals; number of diseased aquatic animals and aquaculture areas infected with aquatic animal diseases.

3. Animal health management agencies shall investigate and report on aquatic animal disease foci and propose measures to treat these places as prescribed in Clauses 6 and 7, Article 27 of this Law.

4. Commune-level People’s Committees have the following responsibilities:

a/ To promptly and accurately notify the situation of animal diseases and epidemics occuring in their communes based on conclusions of agencies competent to diagnose and test animal diseases for diseases on the list of animal diseases which are subject to epidemic announcement and at the request of commune-level animal health officers;

b/ To supervise and warn about animal epidemic zones;

c/ To disseminate information about animal disease and epidemic prevention and combat in their localities; to implement policies on assistance for animal disease and epidemic prevention and combat, overcoming of consequences of diseases and epidemics, and restoration of aquaculture in their localities;

d/ To direct the treatment, harvest, disposal of, or supervise the disposal of diseased aquatic animals; to make statistics on aquaculture areas, number of diseased aquatic animals and aquaculture areas infected with aquatic animal diseases; to sanitize and disinfect the environment in epidemic zones;

dd/ To organize the application of animal disease and epidemic prevention and combat measures under the direction of district-level People’s Committees;

e/ To submit to district-level People’s Committee chairpersons for decision support funds, materials and resources when animal disease and epidemic prevention and combat requests are beyond local capability;

g/ To report to district-level People’s Committee chairpersons on results of animal disease and epidemic prevention and combat and implementation of policies on assistance for animal disease and epidemic prevention and combat.

5. District-level People’s Committees have the following responsibilities:

a/ To promptly and accurately notify the situation of animal diseases and epidemics occuring in their districts based on conclusions of agencies competent to diagnose and test animal diseases for diseases on the list of animal diseases which are subject to epidemic announcement and at the request of district-level animal health management agencies;

b/ To organize aquatic animal disease prevention and treat diseased aquatic animals; to sanitize and disinfect the aquaculture environment as required for each disease;

c/ To guide aquaculture establishment owners, aquatic animal traders and transporters to apply veterinary sanitation measures to prevent transmission of animal diseases;

d/ To implement policies on assistance for animal disease and epidemic prevention and combat, overcoming of consequences of diseases and epidemics, and restoration of aquaculture in their localities;

dd/ To organize the application of animal disease and epidemic prevention and combat measures under the direction of provincial-level People’s Committees;

e/ To popularize animal disease and epidemic prevention and combat measures in their localities;

g/ To submit to provincial-level People’s Committee chairpersons for decision support funds, materials and resources when animal disease and epidemic prevention and combat requests are beyond local capability;

h/ To report to provincial-level People’s Committee chairpersons on results of animal disease and epidemic prevention and combat and implementation of policies on assistance for animal disease and epidemic prevention and combat.

6. Provincial-level People’s Committees have the following responsibilities:

a/ To direct People’s Committees at all levels, related provincial-level departments, divisions and sectors in treating animal disease foci;

b/ To allocate funds for treating animal disease foci and supporting owners of aquaculture establishments having diseased or dead aquatic animals or aquatic animals subject to compulsory destruction.

Article 34.Announcement of aquatic animal diseases or epidemics

1. Principles and contents of announcement of an aquatic animal disease or epidemic must comply with Clauses 1 and 3, Article 26 of this Law.

2. An aquatic animal disease or epidemic shall be announced when there are sufficient conditions as follows:

a/ There is an focus of an animal disease on the list of animal diseases subject to epidemic announcement which tends to quickly spread on a wide area or a new infectious disease pathogen is discovered;

b/ An agency competent to diagnose or test animal diseases makes a diagnotic conclusion that there exists a disease on the list of animal diseases subject to epidemic announcement or a new infectious disease pathogen.

c/ The provincial-level animal health management agency makes a written request for epidemic announcement.

3. Provincial-level People’s Committee chairpersons shall decide on announcement of aquatic animal diseases and epidemics when there are sufficient conditions prescribed in Clause 2 of this Article.

Article 35.Organization of aquatic animal disease and epidemic combat in epidemic zones

1. When announcing an animal disease or epidemic, a person competent to announce epidemics shall direct related agencies, departments, sectors, organizations and individuals in applying the following measures:

a/ Determining the boundary of the epidemic zone; putting up signs and instructions for travel and transportation of animals and animal products through the epidemic zone;

b/ Restricting unauthorized persons from entering places where there are diseased aquatic animals or aquatic animals dying of the disease;

c/ Controlling the transportation of aquatic animals and aquatic animal products into or out of the epidemic zone; preventing and treating the disease;

d/ Sanitizing, disinfecting and decontaminating aquaculture areas, tools, vehicles or vessels, wastewater and wastes under the guidance of the animal health management agency.

2. The Minister of Agriculture and Rural Development shall organize the epidemic prevention and combat under Clause 2, Article 27 of this Law.

3. Provincial-level People’s Committee chairpersons shall:

a/ Direct provincial-level animal health management agencies, and related agencies, organizations and individuals in applying animal disease and epidemic prevention and combat measures; mobilize local resources to prevent and combat animal diseases and epidemics;

b/ Popularize measures to prevent and combat animal diseases and epidemics in their localities;

c/ Direct the implementation of policies on assistance for animal disease and epidemic prevention and combat, overcoming of consequences of diseases or epidemics, and restoration of aquaculture in their localities;

d/ Inspect and examine the animal disease and epidemic prevention and combat;

dd/ Propose the Minister of Agriculture and Rural Development to submit to the Prime Minister for decision allocation of support funds, materials and resources when requests for animal disease and epidemic prevention and combat are beyond local capability;

e/ Report to the Minister of Agriculture and Rural Development on results of animal disease and epidemic prevention and combat and implementation of policies on assistance for epidemic prevention and combat, overcoming of consequences of diseases and epidemics, and restoration of aquaculture in their localities.

4. District-level People’s Committee chairpersons shall:

a/ Direct and organize the application of animal disease and epidemic prevention and combat measures under regulations;

b/ Organize the popularization of animal disease and epidemic prevention and combat measures in their localities;

c/ Implement policies on assistance for disease and epidemic prevention and combat, overcoming of consequences of diseases and epidemics, and restoration of aquaculture in their localities;

d/ Submit to provincial-level People’s Committee chairpersons for decision allocation of support funds, materials and resources when requests for animal disease and epidemic prevention and combat are beyond local capability;

dd/ Report to provincial-level People’s Committee chairpersons on results of animal disease and epidemic prevention and combat and implementation of policies on assistance for epidemic prevention and combat, overcoming of consequences of diseases and epidemics and restoration of aquaculture in their localities.

5. Commune-level People’s Committee chairpersons shall:

a/ Organize the application of animal disease and epidemic prevention and combat measures under regulations;

b/ Supervise the disposal of diseased aquatic animals under regulations;

c/ Organize the popularization of animal disease and epidemic prevention and combat measures in their localities;

d/ Implement policies on assistance for disease and epidemic prevention and combat, overcoming of consequences of diseases and epidemics, and restoration of aquaculture in their localities;

dd/ Submit to district-level People’s Committee chairpersons for decision allocation of support funds, materials and resources when requests for animal disease and epidemic prevention and combat are beyond local capability;

e/ Report to district-level People’s Committee chairpersons and animal health management agencies on results of animal disease and epidemic prevention and combat and implementation of policies on assistance for epidemic prevention and combat, overcoming of consequences of diseases and epidemics and restoration of aquaculture in their localities.

6. Animal health management agencies shall comply with Clauses 6 and 7, Article 27 of this Law.

7. Commune-level animal health officers shall:

a/ Obey instructions of People’s Committees and animal health management agencies in aminal disease and epidemic prevention and combat;

b/ Treating animal disease foci under Clause 2, Article 33 of this Law;

c/ Guide and take part in the application of sanitization, disinfection and decontamination measures to prevent transmission of animal diseases and epidemics;

d/ Take clinical specimens under the guidance of district-level animal health management agencies.

8. Aquaculture establishment owners shall comply with Clause 1, Article 33 of this Law.

9. Owners of aquaculture establishments that have no diseased animals but are located in an epidemic zone shall apply measures to prevent entry of pathogens into their establishments; intensify environmental monitoring and warning, caring for, nurturing and raising disease resistance of aquatic animals; and supervise diseases and epidemics in order to early discover diseased aquatic animals.

Article 36.Announcement of termination of aquatic animal epidemics

1. Conditions for announcing termination of an aquatic animal epidemic include:

a/ There is no new animal disease focus after the last focus has been treated under regulations for each disease;

b/ Compulsory measures to prevent diseases for animals susceptible to the animal epidemic in the epidemic zone have been applied;

c/ Sanitization, disinfection and decontamination measures have been applied to meet the veterinary sanitation requirements for the epidemic zone;

d/ There is a written request of the provincial-level animal health management agency for announcement of animal epidemic termination which is verified and recognized by the Department of Animal Health.

2. Provincial-level People’s Committee chairpersons shall announce the termination of animal epidemics when there are sufficient conditions prescribed in Clause 1 of this Article.

Chapter III

QUARANTINE OF ANIMALS AND ANIMAL PRODUCTS

Section 1

QUARANTINE OF TERRESTRIAL ANIMALS AND ANIMAL PRODUCTS

Article 37.General provisions on quarantine of terrestrial animals and animal products

1. Animals and animal products on the list of terrestrial animals and animal products subject to quarantine before being transported out of provinces shall be quarantined for once at places of departure if they are:

a/ Animals and animal products from collecting and trading establishments;

b/ Animals and animal products from farming establishments that have not yet undergone animal disease and epidemic surveillance;

c/ Animals not yet vaccinated under Clause 4, Article 15 of this Law or already vaccinated but no longer having protective immunity;

d/ Animals and animal products from establishments not yet recognized as free from animal disease and epidemic;

dd/ Animal products from preliminary processing or processing establishments that have not yet undergone regular veterinary sanitation inspection;

e/ Animals and animal products other than those specified at Points b, c, d and dd of this Clause, when their owners so request.

2. Animals and animal products on the list of terrestrial animals and animal products subject to quarantine before export at the request of importing countries or owners and before import, temporary import for re-export, temporary export for re-import, border-gate or bonded warehouse transfer, or transit through the Vietnamese territory shall be quarantined.

3. The Minister of Agriculture and Rural Development shall promulgate:

a/ The list of terrestrial animals and animal products subject to quarantine;

b/ The list of terrestrial animals and animal products exempted from quarantine;

c/ The list of terrestrial animals and animal products subject to risk analysis before import into Vietnam;

d/ The list of objects subject to terrestrial animal and animal product quarantine;

dd/ Specific provisions on dossiers of quarantine for animals and animal products to be transported out of provinces; export, import, temporary import for re-export, temporary export for re-import, border-gate and bonded warehouse transfer, transit through the Vietnamese territory, and animals and animal products carried along by persons; marking, grant of animal identification numbers, sealing of vehicles or vessels and containers of animals and animal products subject to quarantine.

Article 38.Requirements on terrestrial animals and animal products transported out of provinces

1. When transported out of a province, animals and animal products on the list of terrestrial animals and animal products subject to quarantine must meet the following requirements:

a/ Having an animal and animal product quarantine certificate granted by the animal health management agency at the place of departure;

b/ Being healthy, for aquatic animals, or satisfying veterinary sanitation requirements, for aquatic animal products;

c/ Being unlikely to spread an animal disease or epidemic and cause harm to human health.

2. Animals and animal products shall be transported by vehicles or vessels and in containers satisfying the veterinary sanitation requirements prescribed in Article 70 of this Law.

Article 39.Procedures for quarantine of terrestrial animals and animal products transported out of provinces

1. Animals and animal products specified in Clause 1, Article 37 of this Law shall be quarantined as follows:

a/ When transporting these animals and animal products, a transporter shall register for quarantine with the local animal health management agency;

b/ Within 1 working day after receiving a quanrantine registration, the local animal health management agency shall decide on quarantine place and time and notify them to quarantine registrant;

c/ Quarantine includes clinical check, diagnosis and testing of animals and animal products to detect quarantine objects and veterinary sanitation inspection objects;

d/ Within 5 working days after the quarantine begins, if quarantine requirements are satisfied, the local animal health management agency shall grant a quarantine certificate. In case the quarantine lasts more than 5 working days or the local animal health management agency refuses to grant a quarantine certificate, it shall notify such and reply in writing to the registrant, clearly stating the reason.

2. Animals and animal products coming from establishments recognized as free from disease and epidemic or participating in a disease and epidemic surveillance program or having been vaccinated and still having protective immunity, or animal products coming from preliminary processing or processing establishments having undergone regular veterinary sanitation inspection shall be quarantined as follows:

a/ When transporting these animals and animal products, a transporter shall register for quarantine with the local animal health management agency;

b/ Within 1 working day after receiving a quanrantine registration, the local animal health management agency shall grant a quarantine certificate.

Article 40.Animal quarantine stations at traffic hubs

1. The quarantine of animals and animal products transported through traffic hubs shall be conducted by animal quarantine stations. Animal quarantine stations at traffic hubs must have representatives of public security, market management and animal health agencies.

2. Contents of animal and animal product quanratine at a traffic hub include:

a/ Checking quantities and categories of animals and animal products stated in quarantine certificates; veterinary sanitation identification numbers, seals and stamps; sealing marks and lead seals of vehicles or vessels;

b/ Checking health conditions of animals; actual state of veterinary sanitation of animal products and vehicles or vessels; sanitizing, disinfecting and decontaminating vehicles or vessels;

c/ Giving certification of animal and animal production inspection in satisfactory cases. In unsatisfactory cases, suspending the transportation of animals and animal products and disposing of them in accordance with law.

3. The Minister of Agriculture and Rural Development shall make and approve the planning of animal quarantine stations at traffic hubs nationwide.

4. Provincial-level People’s Committees shall base themselves on the planning prescribed in Clause 3 of this Article to decide on establishment of animal quarantine stations at traffic hubs in their localities and organize the quanrantine of animals and animal products at these stations.

Article 41.Quarantine of exported terrestrial animals and animal products

1. Before being exported, animals and animal products on the list of terrestrial animals and animal products subject to quarantine shall be quarantined and obtain quarantine certificates as required by importing countries or their owners. In case importing countries or owners do not require quarantine, regulations on quarantine of terrestrial animals and animal products to be transported out of provinces shall be complied with.

2. The Department of Animal Health shall conduct quarantine and grant quarantine certificates in accordance with Vietnamese law and requirements of importing countries or animal and animal product owners.

3. The quarantine of animals and animal products shall be conducted either at places of departure or places of quarantine isolation at border gates according to the veterinary sanitation procedures and requirements applicable to exported animals and animal products.

Article 42.Procedures for quarantine of exported terrestrial animals and animal products

1. A dossier for quarantine of exported terrestrial animals and animal products must comprise:

a/ An application for quarantine registration;

b/ Veterinary sanitation requirements of the importing country or owner (if any);

c/ Model quarantine certificate of the competent authority of the importing country (if any).

2. The quarantine of exported animals and animal products shall be conducted as follows:

a/ When exporting animals and animal products on the list of terrestrial animals and animal products subject to quarantine, the exporter shall submit a dossier for quarantine registration prescribed in Clause 1 of this Article to the Department of Animal Health;

b/ Within 1 working day after receiving a valid dosier, the Department of Animal Health shall decide on quarantine place and time and notify them to the quarantine registrant;

c/ Within 5 working days after the quarantine begins, if quarantine requirements are satisfied, the Department of Animal Health shall grant a quarantine certificate. If the quarantine lasts more than 5 working days or the Department of Animal Health refuses to grant a quarantine certificate, it shall notify such and reply in writing to the registrant, clearly stating the reason.

3. In case the importing country does not require quarantine, Article 39 of this Law shall be complied with.

Article 43.Risk analysis of imported terrestrial animals and animal products

1. Animals and animal products on the list of terrestrial animals and animal products subject to risk analysis before import into Vietnam must undergo risk analysis.

2. The Department of Animal Health shall conduct risk analysis based on information provided by animal health authorities of exporting countries and other relevant information sources.

3. Based on risk analysis results, the Department of Animal Health shall decide on import of animals and animal products.

Article 44.Requirements on imported terrestrial animal and animal products

1. For animals:

a/ Being healthy; coming from zones or establishments recognized as free from disease and epidemic or having no dangerous disease under regulations of the World Organization for Animal Health and Vietnam;

b/ Having quarantine certificates granted by competent authorities of exporting countries satisfying veterinary sanitation requirements of Vietnam.

2. For animal products used as food:

a/ Being of animal origin satisfying the provisions of Point a, Clause 1 of this Article;

b/ Having quarantine certificates granted by competent authorities of exporting countries satisfying veterinary sanitation requirements of Vietnam;

c/ Being from animals slaughtered, preliminarily processed or processed at production establishments that have registered for export to Vietnam.

3. For animal products not used as food:

a/ Being taken from animals specified at Point a, Clause 1 of this Article;

b/ Having quarantine certificates granted by competent authorities of exporting countries satisfying veterinary sanitation requirements of Vietnam;

c/ In case they are used for breeding, they must come from disease- and epidemic-free zones or establishments or have no dangerous infectious disease under regulations of the World Organization for Animal Health and Vietnam.

4. In case of necessity, the Department of Animal Health shall supervise the process of quarantine isolation; inspect and assess systems of animal disease and epidemic and veterinary sanitation management and surveillance in exporting countries.

Article 45.Dossiers for imported terrestrial animal and animal product quarantine registration and declaration

1. A dossier for imported terrestrial animal and animal product quarantine registration must comprise:

a/ A written request for instructions on quarantine of imported animals and animal products;

b/ For animals and animal products under the management by other related competent state agencies, documents or permits shall be submitted as required.

2. A dossier for imported terrestrial animal and animal product quarantine declaration must comprise:

a/ An application for quarantine declaration;

b/ A quarantine certificate of the exporting country.

Article 46.Procedures for quarantine of imported terrestrial animals and animal products

1. When importing animals and animal products on the list of terrestrial animals and animal products subject to quarantine, the importer shall submit a dossier for quarantine registration prescribed in Clause 1, Article 45 of this Law to the Department of Animal Health.

2. Within 5 working days after receiving a valid dossier prescribed in Clause 1, Article 45 of this Law, based on the situation of diseases and epidemics and the disease and epidemic and veterinary sanitation management and surveilance system of the exporting country, the Department of Animal Health shall give writen consent to quarantine of imported animals and animal products and guide related organizations and individuals in conducting the quarantine of imported animals and animal products. In case of refusal to give such consent, it shall notify such in writing, clearly stating the reason.

Animals and animal products from countries or territories that have registered for the first-time import into Vietnam or from countries or territories with high risk of animal disease and epidemic must undergo risk analysis conducted by the Department of Animal Health under Article 43 of this Law.

3. Within 1 working day after receiving a valid dossier for animal and animal product quarantine declaration prescribed in Clause 2, Article 45 of this Law, the Department of Animal Health shall decide on quarantine place and time and notify them to the quarantine registrant under Article 47 of this Law.

Article 47.Contents of quarantine of imported terrestrial animals and animal products

1. For imported animals, the Department of Animal Health shall conduct quarantine as follows:

a/ Examining the dossier for quarantine declaration, health conditions of animals; if the quarantine dossier is valid and animals show no sign of contracting a dangerous disease, giving certification for carrying procedures and transferring animals to a quarantine isolation zone or an inspection place with sufficient conditions for quarantine isolation;

b/ Supervising animals at the quarantine isolation zone or place with sufficient conditions for quarantine isolation. The period of monitoring quarantine isolation must be suitable to each animal species and each disease subject to quarantine but must not exceed 45 days after the quarantine isolation begins;

c/ Collecting specimens for inspecting animal diseases, and applying compulsory animal disease prevention measures as prescribed;

d/ Granting an import quarantine certificate for animals satisfying veterinary sanitation requirements and notifying such to the animal health management agency in the place of destination;

dd/ Guiding the animal and animal product owner in applying sanitization, disinfection and decontamination measures.

2. For imported animal products, the Department of Animal Health shall conduct quarantine as follows:

a/ Examining the dossier for quarantine declaration and actual state of products; if requirements are satisfied, taking samples for checking veterinary sanitation indicators under regulations;

b/ Granting an import quarantine certificate for animal products satisfying veterinary sanitation requirements and notifying such to the animal health management agency in the place of destination;

c/ Guiding the animal and animal product owner in applying sanitization, disinfection and decontamination measures.

3. In case animals and animal products fail to satisfy requirements, the Department of Animal Health shall make a written record of violation and handle the violation in accordance with law.

Article 48.Dossiers for quarantine of terrestrial animals and animal products temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory

1. A dossier for quarantine registration must comprise:

a/ A written request of the registrant for instructions for quarantine of terrestrial animals and animal products temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory;

b/ A commercial contract;

c/ For animals and animal products subject to management by another related competent state agency, documents or permits as required shall be submitted.

2. A dossier for quarantine declaration must comprise:

a/ An application for quarantine declaration;

b/ A quarantine certificate of the exporting country.

Article 49.Procedures for quarantine of terrestrial animals and animal products temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory

1. When temporarily importing for re-export, temporarily exporting for re-import, transferring from border gate to border gate or from bonded warehouse to bonded warehouse or transiting through the Vietnamese territory terrestrial animals and animal products on the list of terrestrial animals and animal products subject to quarantine, an organization or individual shall submit a dossier prescribed in Clause 1, Article 48 of this Law to the Department of Animal Health.

2. Within 5 working days after receiving a valid dossier, based on the situation of diseases and epidemics and the disease and epidemic and veterinary sanitation management and surveillance system of the exporting country, the Department of Animal Health shall issue a document to guide the quarantine of animals and animal products temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory.

3. At the border gate, within 1 working day after receiving a valid dossier prescribed in Clause 2, Article 48 of this Law, the Department of Animal Health shall decide on quarantine place and time and notify them to the quarantine registrant under Article 50 of this Law.

Article 50.Quarantine of terrestrial animals and animal products temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory

1. At the border gate of importation, the Department of Animal Health shall:

a/ Examine the quarantine dossier and actual state of the goods lot;

b/ Grant a quarantine certificate, except the cases specified in Clause 4 of this Article;

c/ Affix sealing marks or lead seals on vehicles or vessels carrying animals and animal products;

d/ Guide the goods owner in complying with regulations on veterinary sanitation during the storage and transportation of animals and animal products in the Vietnamese territory; sanitize and disinfect vehicles or vessels and places where goods are loaded and unloaded;

dd/ In case animals and animal products are carried in containers or other closed devices, if detecting abnormal signs of vehicles or vessels, sealing marks or lead seals, the Department of Animal Health shall request the goods owner to open the containers and vehicles or vessels for veterinary sanitation inspection to the witness of a customs office and the goods owner.

2. When transporting animals and animal products temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory, goods owners shall:

a/ Obey instructions of the Department of Animal Health during the storage and transportation of animals and animal products in the Vietnamese territory. In case of necessity to change the transport itinerary or border gate, a written approval of the Department of Animal Health is required;

b/ Refrain from unloading goods or breaking sealing marks or lead seals without permission, unless it is necessary to do so in the presence of the animal health management agency. In case of necessity to change vehicles or vessels, a written approval of the Department of Animal Health is required;

c/ Let no animal contact other animals in water; only set animals free to feed and drink water or in other special cases with permission of and under supervision by the animal health management agency;

d/ Ensure that vehicles or vessels carrying animals and animal products are closed, letting no waste drop en route. Animal carcasses, wastes, stuffing materials, leftover feed and unused containing devices during the transportation shall be collected and disposed of at places designated by the Department of Animal Health.

3. At the border gate of exportation, the Department of Animal Health shall:

a/ Check quarantine certificates;

b/ Check sealing marks or lead seals of vehicles or vessels carrying animals and animal products;

c/ If goods are consistent with those stated in quarantine certificates granted at the border gate of importation, give certification for the goods owner to carry out procedures for exporting goods out of the Vietnamese territory.

4. No quarantine certificate shall be granted for animals and animal products temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory in the following cases:

a/ Animals and animal products have gone through a country or territory where exist an animal epidemic to which these animals are susceptible;

b/ The quarantine certificate of the exporting country is invalid;

c/ Animals are sick or show signs of contracting a disease or animal products carry dangerous pathogens prescribed by Vietnamese law.

Article 51.Requirements on terretrial animals participating in trade fairs, exhibitions, sport competitions or art performances; terrestrial animal products participating in trade fairs or exhibitions

1. Terretrial animals participating in trade fairs, exhibitions, sport competitions or art performances; terrestrial animal products participating in trade fairs or exhibitions must:

a/ Be of clear origin and carry no pathogen;

b/ Having been quarantined at places of departure and destination under regulations.

2. While participating in trade fairs, exhibitions, sport competitions or art performances, animal and animal product owners shall comply with regulations on veterinary sanitation requirements under supervision by a local animal health management agency.

3. At the end of trade fairs, exhibitions, sport competitions or art performances, local animal health management agencies shall guide sanitization, disinfection and decontamination in areas where animals and animal products are gathered in large numbers; inspect and grant quarantine certificates for animals and animal products satisfying veterinary sanitation requirements for transportation and use in the country. In case they need to export animals and animal products out of Vietnam, owners shall carry out procedures under regulations on export quarantine.

Article 52.Transportation of clinical specimens

1. Organizations and individuals that wish to bring into Vietnam or send abroad clinical specimens shall register with and send dossiers to the Department of Animal Health for transportation permission.

2. Clinical specimens to be sent to a testing establishment shall be properly packaged, preserved and transported up to veterinary sanitation requirements, thus preventing spread of pathogens and environmental pollution.

3. Clinical specimens that are neither permitted to be brought into Vietnam nor properly packaged, preserved and transported up to veterinary sanitation requirements, thus being likely to spread pathogens and cause environmental pollution, shall be destroyed in accordance with the laws on animal health, prevention and combat of infectious diseases, and environmental protection.

Section 2

QUARANTINE OF AQUATIC ANIMALS AND ANIMAL PRODUCTS

Article 53.General provisions on quarantine of aquatic animals and animal products

1. Aquatic animals and animal products on the list of aquatic animals and animal products subject to quarantine before being transported out of provinces shall be quarantined for once at places of departure if they are:

a/ Aquatic animals and animal products from an epidemic zone announced by a competent state agency;

b/ Aquatic animals used as breeds from collecting and trading establishments;

c/ Aquatic animals used as breeds from aquaculture establishments that have not yet been recognized as free from animal disease and epidemic or have not yet undergone animal disease and epidemic surveillance under regulations;

d/ Animals and animal products other than those specified at Points a, b and c of this Clause, when their owners so request.

2. Aquatic animals and animal products on the list of aquatic animals and animal products subject to quarantine before export at the request of importing countries or owners and before import, temporary import for re-export, temporary export for re-import, border-gate or bonded warehouse transfer, or transit through the Vietnamese territory shall be quarantined.

3. The Minister of Agriculture and Rural Development shall promulgate:

a/ The lists of aquatic animals and animal products subject to quarantine and exempted from quarantine;

b/ The list of aquatic animals and animal products subject to risk analysis before import into Vietnam;

c/ The list of objects subject to aquatic animal and animal product quarantine;

d/ Specific provisions on contents and dossiers of quarantine of aquatic animals and animal products to be transported out of provinces, exported, imported, temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded warehouse transfer or in transit through the Vietnamese territory.

Article 54.Requirements on aquatic animals and animal products transported out of provinces

1. When transported out of a province, aquatic animals and animal products on the list of aquatic animals and animal products subject to quarantine must satisfy the following requirements:

a/ Having an aquatic animal and animal product quarantine certificate granted by the animal health management agency at the place of departure;

b/ Being healthy, for aquatic animals, or satisfying veterinary sanitation requirements, for aquatic animal products;

c/ Being unlikely to spread animal disease or epidemic and cause harm to human health.

2. Aquatic animals and animal products shall be carried by vehicles or vessels and in containers satisfying the veterinary sanitation requirements prescribed in Article 70 of this Law.

Article 55.Procedures for quarantine of aquatic animals and animal products transported out of provinces

1. Aquatic animals and animal products specified in Clause 1, Article 53 of this Law shall be quarantined as follows:

a/ When transporting these aquatic animals and animal products, a transporter shall register for quarantine with the local animal health management agency;

b/ Within 1 working day after receiving a quanrantine registration, the local animal health management agency shall decide on quarantine place and time and notify them to the quarantine registrant;

c/ Quarantine includes clinical check, diagnosis and testing of aquatic animals and animal products to detect quarantine objects and veterinary sanitation inspection objects;

d/ Within 3 working days after the quarantine begins, if quarantine requirements are satisfied, the local animal health management agency shall grant a quarantine certificate. In case the quarantine lasts more than 3 working days or the local animal health management agency refuses to grant a quarantine certificate, it shall notify such and reply in writing to the registrant, clearly stating the reason.

2. Aquatic animals used as breeds coming from establishments recognized as free from disease and epidemic or participating in the disease and epidemic surveillance program shall be quarantined as follows:

a/ When transporting aquatic animals used as breeds, a transporter shall register for quarantine with the local animal health management agency;

b/ Within 1 working day after receiving a quanrantine registration, the local animal health management agency shall grant a quarantine certificate.

Article 56.Procedures for, and contents of, quarantine of exported aquatic animals and animal products not for use as food

Procedures for, and contents of, quarantine of aquatic animals and animal products on the list of aquatic animals and animal products subject to export quarantine and not for use as food must comply with Articles 41 and 42 of this Law.

Article 57.Procedures for quarantine of exported aquatic animals and animal products for use as food

1. Before exporting aquatic animals and animal products on the list of aquatic animals and animal products subject to quarantine for use as food, an exporter shall register for quarantine with a competent agency. A dossier for quarantine registration must comprise:

a/ An application for quarantine registration;

b/ Quarantine requirements of the importing country (if any);

c/ For aquatic animals and animal products subject to management by a related competent state agency, a document or permit as required by such agency;

d/ The disease and epidemic safety certificate of the aquaculture establishment of origin of aquatic animals and products used for production of the goods batch (if any).

2. Upon receiving the quarantine registration of the exporter, the competent agency shall conduct the quarantine of animals and animal products as follows:

a/ Checking quantities, categories and packages of aquatic animals and animal products;

b/ Checking signs of contracting animal disease;

c/ Collecting specimens for disease testing at the request of the importing country (if any), except diseases from which the aquaculture establishment of origin of aquatic animals is recognized as free;

d/ In case of collecting specimens for disease testing, the agency competent to conduct quarantine shall send these specimens to a designated laboratory within 1 working day after these specimens are collected;

dd/ Within 3 working days after receiving specimens for disease testing, the laboratory shall notify disease testing results to the agency competent to conduct quarantine.

3. The grant of quarantine certificates is as follows:

a/ In case collection of specimens for disease testing is not required, the agency competent to conduct quarantine shall grant an export quarantine certificate within 1 working day after receiving satisfactory checking results;

b/ In case collection of specimens for disease testing is required, the agency competent to conduct quarantine shall grant an export quarantine certificate within 1 working day after receiving satisfactory testing results;

c/ In case the animal and animal product owner requests renewal of the quarantine certificate for a goods batch, the agency competent to conduct quarantine shall check the batch and renew the quarantine certificate.

Article 58.Procedures for, and contents of, quarantine of aquatic animals and animal products imported, temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory; aquatic animals participating in trade fairs, exhibitions, sport competitions or art performances; aquatic animal products participating in trade fairs or exhibitions; transportation of aquatic animal clinical specimens

The procedures for, and contents of, quarantine of aquatic animals and animal products imported, temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory; aquatic animals participating in trade fairs, exhibitions, sport competitions or art performances; and aquatic animal products participating in trade fairs or exhibitions; and transportation of aquatic animal clinical specimens must comply with Articles 44, 45, 46, 47, 48, 49, 50, 51 and 52 of this Law.

Section 3

RESPONSIBILITIES AND POWERS OF ORGANIZATIONS AND INDIVIDUALS IN QUARANTINE OF ANIMALS AND ANIMAL PRODUCTS

Article 59.Responsibilities and powers of the Department of Animal Health

1. The Department of Animal Health has the following responsibilities:

a/ To coordinate with competent animal health offices of countries exporting animals and animal products in conducting checks in these countries or request quarantine under regulations of importing countries;

b/ To decide on disposing measures; to supervise the disposal of animals and animal products subject to import or export quarantine but failing to satisfy veterinary sanitation requirements;

c/ To coordinate with related agencies in disposing of animals and animal products subject to quarantine but left unclaimed or of unclear origin imported from abroad into Vietnam;

d/ To provide information on animal and animal product quarantine to concerned countries when so requested.

2. The Department of Animal Health has the following powers:

a/ To request competent animal health offices of countries exporting animals and animal products to provide relevant information and coordinate with them in conducting checks in these countries;

b/ To refuse to import animals and animal products that fail to satisfy the prescribed veterinary sanitation requirements;

c/ To request owners of imported animals and animal products to dispose of animals and animal products that fail to satisfy the prescribed veterinary sanitation requirements;

d/ In case of necessity, to authorize provincial-level animal health management agencies to conduct quarantine and grant quarantine certificates for import, export, temporary import for re-export, temporary export for re-import, border-gate or bonded-warehouse transfer or transit through the Vietnamese territory of animals and animal products through a number of border gates.

Article 60.Responsibilities and powers of local animal health management agencies

1. To quarantine animals and animal products imported, exported, temporarily imported for re-export, temporarily exported for re-import, in border-gate or bonded-warehouse transfer or transit through the Vietnamese territory when authorized by the Department of Animal Health.

2. To decide on disposing measures; to supervise the disposal of animals and animal products; request disposal of animals and animal products that fail to satisfy veterinary sanitation requirements; to request animal and animal product owners to conduct the disposal and pay expenses for the disposal.

Article 61.Suspension from import or export; ban on import or export of animals and animal products

1. The Minister of Agriculture and Rural Development shall decide on suspension from, or ban on, import or export of animals and animal products in the following cases:

a/ Imported animals and animal products are identified as carrying dangerous infectious disease pathogens or being at risk of spreading diseases to domestic animals in the country or causing bad effects on human health; are subject to warnings or fail to satisfy requirements of Vietnam; or cause serious impacts on Vietnamese exports;

b/ Exported animals and animal products fail to satisfy veterinary sanitation requirements, are subject to warnings by importing countries or likely to cause loss of export markets of Vietnam.

2. Once the risks specified in Clause 1 of this Article are averted, animals and animal products may continue to be imported or exported.

3. The Government shall detail this Article.

Article 62.Responsibilities and powers of animal quarantine officers

1. To conduct quanrantine of animals and animal products in accordance with this Law; to observe the professional process of quarantine and bear responsibility for the performance of their responsibilities and exercise of their powers; to wear animal quarantine uniform, office insignia, rank badge and officer card.

2. To request animal and animal product owners to provide relevant files and documents necessary for quarantine.

3. To guide and supervise animal and animal product owners to carry their animals and animal products to places and zones of quarantine isolation; to sanitize and disinfect vehicles or vessels carrying and devices containing animals and animal products.

4. To check and take samples in the course of quarantine under regulations.

Article 63.Rights and obligations of animal and animal product owners

1. An animal and animal product owner has the following rights:

a/ To be provided with information about animal and animal product quarantine;

b/ To be guided by animal health management agencies to identify and discover elements harmful to animals and animal products and sanitization, disinfection and decontamination measures;

c/ To request animal health management agencies to conduct quarantine of animals and animal products specified at Point e, Clause 1, Article 37, and Point d, Clause 1, Article 53, of this Law, except such quarantine is beyond the capacity of these agencies;

d/ To complain about quarantine results and decisions of animal health management agencies.

2. An animal and animal product owner has the following obligations:

a/ To comply with this Law and relevant laws in the quarantine of animals and animal products;

b/ To create favorable conditions for animal health management agencies to conduct quarantine of animals and animal products;

c/ To provide necessary information to serve the quarantine as requested by animal health management agencies;

d/ To keep, raise and care for animals, preserve animal products and transporting vehicles or vessels, and take responsibility for quarantine declaration contents; to satisfy veterinary and environmental sanitation requirements in the course of gathering and transportation of animals and animal products under regulations;

dd/ To report to the nearest animal health management agency upon dicovering strange diseases or animals showing signs of contracting disease or animal products carrying pathogens of a disease on the list of animal diseases subject to epidemic announcement;

e/ Not to fraudulently exchange or change numbers of animals or volumes of animal products that have been quarantined; not to add, erase or tamper with animal and animal product quarantine certificates;

g/ Not to break sealing marks or lead seals or change transporting vehicles or vessels and places from and to which animals and animal products are transported or change without permission identification numbers marked on animals in the course of transportation;

h/ To pay expenses for handling and compensations for damage caused by violations of the law on animal and animal product quarantine;

i/ To pay charges, fees and expenses for animal and animal product quarantine in accordance with law.

Chapter IV

CONTROL OF SLAUGHTER OF TERRESTRIAL ANIMALS; PRELIMINARY PROCESSING AND PROCESSING OF TERRESTRIAL ANIMALS AND ANIMAL PRODUCTS; VETERINARY SANITATION INSPECTION

Section 1

CONTROL OF SLAUGHTER OF TERRESTRIAL ANIMALS

Article 64.Requirements on slaughter of terrestrial animals for trading

1. The slaughter of animals on the list of animals subject to slaughter control shall be controlled by animal health management agencies according to the prescribed process.

2. The slaughter of animals shall be carried out at concentrated slaughtering facilities that satisfy the veterinary sanitation requirements prescribed in Clause 1, Article 69 of this Law.

In rural and mountainous areas, islands, ethnic minotiry areas and areas meeting difficult socio-economic conditions where no concentrated slaughtering facilities are available, the slaughter of animals may be carried out at small slaughterhouses that satisfy the veterinary sanitation requirements prescribed in Clause 2, Article 69 of this Law.

3. When brought to slaughter, animals on the list of animals subject to slaughter control must be healthy up to veterinary sanitation requirements and be treated under Point b, Clause 1, Article 21 of this Law.

Article 65.Contents of terrestrial animal slaughter control

1. Checking the satisfaction of veterinary sanitation requirements by animals to be slaughtered.

2. Checking the satisfaction of veterinary sanitation requirements by slaughtering facilities under Clauses 1 and 2, Article 69 of this Law.

3. Checking the observance of regulations applicable to persons directly engaged in animal slaughter.

4. Conducting inspections before and after animal slaughter to discover elements causing disease or harm to animals, human health and the environment.

5. Disposing of animals and animal products that fail to meet veterinary sanitation requirements.

6. Appending slaugher control seals or marks on the bodies of animals or sticking veterinary sanitation stamps; granting quarantine certificates for animal products to be transported out of provinces.

Section 2

CONTROL OF PRELIMINARY PROCESSING AND PROCESSING OF ANIMALS AND ANIMAL PRODUCTS

Article 66.Veterinary sanitation requirements on preliminary processing and processing of animals and animal products

1. Veterinary sanitation inspection shall be conducted by animal health management agencies in the course of preliminary processing and processing of animals and animal products.

2. Establishments preliminarily processing and processing animals and animal products must satisfy veterinary sanitation requirements prescribed in Clauses 3 and 4, Article 69 of this Law and the law on food safety.

Article 67.Contents of control of preliminary processing and processing of animals and animal products

1. Checking the satisfaction of veterinary sanitation requirements on establishments preliminarily processing and processing animals and animal products prescribed in Clauses 3 and 4, Article 69 of this Law.

2. Checking the observance of the regulations applicable to persons directly engaged in prelimitary processing and processing of animals and animal products.

3. Disposing of animals and animal products that fail to satisfy veterinary sanitation and food safety requirements.

Section 3

VETERINARY SANITATION INSPECTION

Article 68.General provisions on veterinary sanitation inspection

1. Veterinary sanitation inspection shall be conducted in the course of animal farming, aquaculture, transportation and slaughter of terrestrial animals, and preliminary processing, processing, preservation and trading of animals and animal products.

2. Animal health management agencies shall inspect and supervise the satisfaction of veterinary sanitation requirements by objects on the list of objects subject to veterinary saniation inspection; analyze risks and trace origin of animals and animal products.

3. Contents of veterinary sanitation inspection:

a/ Inspecting and assessing the satisfaction of veterinary sanitation requirements by objects subject to veterinary sanitation inspection;

b/ Applying technical measures to detect veterinary sanitation inspection objects;

c/ Making conclusions and handling violations in accordance with law.

Article 69.Veterinary sanitation requirements on establishments slaughtering terrestrial animals and establishments preliminarily processing or processing animal products

1. For concentrated slaughtering facilities:

a/ Their locations comply with the planning by local administrations;

b/ They have separate sections designed to prevent cross-contamination;

c/ Their equiment, tools and water for animal slaughter satisfy veterinary sanitation requirements;

d/ They have wastewater and waste treatment systems to ensure the state of being free from disease and epidemic and comply with the law on environmental protection;

dd/ Persons directly engaged in animal slaughter shall observe regulations on health and observe sanitation processes in the course of slaughter.

2. For small slaughterhouses:

a/ Their locations are far from hazardous and polluting sources;

b/ They have appropriate slaughtering equipment and tools which are not hazardous to, or cause no contamination of, animal products;

c/ They have sufficient water to satisfy veterinary sanitation requirements of animal slaughter;

d/ They apply measures to collect and treat wastewater and wastes to be free from disease and epidemic and comply with the law on environmental protection;

dd/ Persons directly engaged in animal slaughter shall comply with regulations on health and observe sanitation processes in the course of slaughering.

3. For establishments preliminarily processing or processing animals and animal products for trading:

a/ They have appropriate locations and areas at a safe distance from hazardous and polluting sources and other harmful elements;

b/ They have separate sections designed to prevent cross-contamination;

c/ Their equipment and tools satisfy veterinary sanitation requirements;

d/ They have sufficient water of quality up to technical regulations to serve the preliminary processing or processing of animal products;

dd/ They have systems to treat wastewater and waste to be free from disease and epidemic and comply with the law on environmental protection;

e/ They have preliminary processing or processing processes to ensure that products are not cross-contaminated or in contact with polluting or hazardous elements;

g/ Persons directly engaged in the preliminary processing or processing of animal products shall comply with regulations on health and observe sanitation processes in the course of preliminary processing or processing.

4. For small-sized establishments preliminarily processing or processing animals and animal products:

a/ They are located at a safe distance to ensure they are not contaminated by harmful agents;

b/ Their equipment and tools satisfy veterinary sanitation requirements;

c/ They have sufficient water of quality up to technical regulations to serve the preliminary processing or processing of animal products;

d/ They apply measures to collect and treat wastewater and wastes to be free from disease and epidemic and comply with the law on environmental protection.

dd/ Persons directly engaged in preliminary processing or processing of animals and animal products shall comply with regulations on health and observe sanitation processes in the course of preliminary processing or processing.

Article 70.Veterinary sanitation requirements on transportation of animals and animal products

1. For vehicles or vessels carrying animals:

a/ They satisfy technical safety requirements for protection of animals in the course of transportation;

b/ They can prevent leakage of wastewater and wastes into the environment in the course of transportation;

c/ They are easy to cleanse and disinfect;

d/ Closed vehicles or vessels must have an appropriate air supply or vetilation system.

2. For vehicles or vessels carrying and devices containing animal products:

a/ They satisfy technical safety requirements to ensure that the quality of animal products is not badly affected in the course of transportation;

b/ The inner side of devices containing animal products shall be made of stainless material which is easy to cleanse and disinfect;

c/ Devices containing animal products must be airtight to protect these products from being contaminated from the outside environment or vice versa;

d/ They satisfy the requirement of preservation temperature for each type of animal product throughout the course of transportation.

3. Wastewater and wastes in the course of transportation shall be collected and treated to be free from disease and epidemic and comply with the law on environmental protection.

Article 71.Veterinary sanitation requirements on animal trading markets and collecting establishments

1. For animal trading markets:

a/ Their locations comply with the planning of local administrations;

b/ They have separate sections for different animal species;

c/ Their equipment, tools and water satisfy veterinary sanitation requirements;

d/ They apply measures to collect and treat wastewater and wastes to be free from disease and epidemic and comply with the law on environmental protection;

dd/ They conduct sanitization, disinfection and decontamination under regulations.

2. For small-sized animal markets:

a/ Their locations are distant from markets for other goods;

b/ They are convenient for sanitization, disinfection, decontamination, and collection and treatment of wastewater and wastes.

3. For animal-collecting establishments:

a/ Their locations are distant from residential areas, animal farming or aquaculture areas and public works;

b/ They have separate sections for different animal species;

c/ Their equipment, tools and water satisfy veterinary sanitation requirements;

d/ They apply measures to collect and treat wastewater and wastes to be free from disease and epidemic and comply with the law on environmental protection.

Article 72.Veterinary sanitation requirements on animal product trading establishments

1. For animal product trading establishments:

a/ Their instruments for display of animal products for sale and devices containing animal products are made of stainless material which is not likely to badly affect product quality and is easy to cleanse and disinfect;

b/ They apply appropriate preservation methods to ensure animal products always satisfy food safety requirements and do not degenerate;

c/ Places and tools used in animal product trading shall be cleansed before, during and after the sale and frequently disinfected and decontaminated;

d/ Warehouses and equipment for preservation of animal products must comply with corresponding technical regulations;

dd/ Wastewater and wastes in the course of animal product trading shall be treated to be free from disease and epidemic and comply with the law on environmental protection.

2. Establishments trading in animal products for use as food must satisfy the veterinary sanitation requirements prescribed in Clause 1 of this Article and comply with the law on food safety.

Article 73.Veterinary sanitation requirements on animal testing, diagnosis and surgery establishments

1. For animal disease testing and diagnosis establishments:

a/ Their locations are distant from residential areas and public works;

b/ They have appropriate physical foundations, equipment, tools and chemicals;

c/ They have separate places for keeping and rearing animals;

d/ They apply measures to collect and treat wastewater and wastes to be free from disease and epidemic and comply with the law on environmental protection.

2. For animal surgery establishments:

a/ They have adequate areas, physical and technical foundations, equipment, tools and chemicals;

b/ They have places for keeping and rearing animals before and after surgery;

c/ They apply measures to collect and treat wastewater and wastes to be free from disease and epidemic and comply with the law on environmental protection.

Section 4

RESPONSIBILITIES FOR MANAGEMENT OF SLAUGHTER OF TERRESTRIAL ANIMALS; PRELIMINARY PROCESSING AND PROCESSING OF ANIMALS AND ANIMAL PRODUCTS; VETERINARY SANITATION INSPECTION

Article 74.Responsibilities of the Minister of Agriculture and Rural Development

The Minister of Agriculture and Rural Development shall promulgate:

1. National technical regulations on veterinary sanitation requirements on objects subject to veterinary sanitation inspection; animal testing, diagnosis and surgery establishments; and establishmens slaughtering, preliminarily processing and processing animals and animal products;

2. The list of animals subject to slaughter control; the list of objects subject to veterinary sanitation inspection; and the list of entities subject to veterinary sanitation inspection;

3. The process of animal slaughter control; process and dossiers of veterinary sanitation inspection; slaughter control seal and veterinary sanitation stamp designs; and regulations on disposal of animals and animal products failing to satisfy veterinary sanitation requirements.

Article 75.Responsibilities of animal health management agencies

1. To guide, inspect and supervise the observance of regulations on veterinary sanitation requirements by objects subject to inspection of veterinary sanitation requirements and entities subject to veterinary sanitation inspection.

2. To guide measures of disposing of objects subject to veterinary sanitation inspection but failing to satisfy veterinary sanitation requirements.

3. To provide training in slaughering control and veterinary sanitation inspection.

4. The Department of Animal Health shall control the slaughter of terrestrial animals for export.

5. Local animal health management agencies shall control the slaughter of terrestrial animals for domestic consumption.

Article 76.Responsibilities of People’s Committees at all levels

1. Provincial-level People’s Committees have the following responsibilities:

a/ To promulgate regulations, policies and guidance on slaughter and control of slaughter of terrestrial animals; preliminary processing, processing, transportation and trading of animals and animal products; and veterinary sanitation inspection;

b/ To direct the planning of concentrated animal slaughtering facilities and make plans on concentrated animal slaughter;

c/ To direct related provincial-level departments, offices and sectors to coordinate with one another in managing the slaughter and control of slaughter of terrestrial animals; preliminary processing, processing, transportation and trading of animals and animal products and veterinary sanitation in their localities; to organize dissemination of the law on animal health;

d/ To direct the inspection, examination, and handling of violations in slaughter and control of slaughter of animals; preliminary processing, processing, transportation and trading of animals and animal products and veterinary sanitation in their localities.

2. District-level People’s Committees have the following responsibilities:

a/ To coordinate with related sections, divisions and sectors in organizing the implementation of the master plan on concentrated animal slaughtering facilities;

b/ To manage operation of concentrated animal slaughtering facilities; preliminary processing, processing, transportation and trading of animals and animal products and veterinary sanitation in their localities;

c/ To organize the implementation of the provisions of Points a and d, Clause 2, Article 9 of this Law.

3. Commune-level People’s Committees have the following responsibilities:

a/ To coordinate with competent agencies in managing the concentrated animal slaughter, preliminary processing, processing, transportation and trading of animals and animal products and veterinary sanitation in their localities;

b/ To manage operation of small-sized slaughter houses.

Article 77.Responsibilities of organizations and individuals

1. To comply with regulations on veterinary sanitation requirements on slaughter, preliminary processing and processing of animals and animal products.

2. To keep dossiers and necessary information for tracing origin of animals and animal products.

Chapter V

MANAGEMENT OF VETERINARY DRUGS

Section 1

MANAGEMENT AND REGISTRATION OF VETERINARY DRUGS

Article 78.General provisions on management of veterinary drugs

1. Veterinary drugs are subject to quality control under technical regulations.

2. Veterinary drugs must be of quality under technical regulations to be eligible for grant of certificates of circulation in Vietnam.

3. Organizations and individuals that import veterinary drugs under Clauses 1, 2 and 3, Article 100 of this Law must have import permits and use these drugs for proper purposes stated in import permits.

4. The Minister of Agriculture and Rural Development shall promulgate:

a/ Technical regulations on veterinary drugs;

b/ List of veterinary drugs permitted for circulation in Vietnam;

c/ List of veterinary drugs banned from use in Vietnam;

d/ Regulations on labeling contents, trial dossiers, manufacture, trading, import and circulation of veterinary drugs.

5. The Government shall specify conditions for manufacture, trading, import, testing and trial of veterinary drugs.

Article 79.Veterinary drugs ineligible for circulation registration

1. Veterinary drugs on the list of veterinary drugs banned from use in Vietnam.

2. Veterinary drugs with high risk of badly impacting human and animal health and the environment.

3. Veterinary drugs concluded by competent state agencies to have infringed upon intellectual property rights.

4. Veterinary drugs registered for circulation by organizations and individuals that have tampered with registration contents or used forged documents and papers in their registration dossiers.

5. Veterinary drugs registered for circulation by organizations and individuals that have used counterfeit seals, fake signatures or seals of related organizations and individuals in their registration dossiers.

Article 80.Registration for veterinary drug circulation

1. Organizations and individuals that manufacture or import veterinary drugs shall register for circulation of these veterinary drugs with the Department of Animal Health in the following cases:

a/ These veterinary drugs are newly manufactured in the country;

b/ These veterinary drugs are imported for the first time into Vietnam for trading or manufacture.

2. A registration dossier for grant of a certificate of veterinary drug circulation must comprise:

a/ A registration application;

b/ Technical documents and label of the veterinary drug;

c/ Results of product quality analysis by the manufacturer; results of veterinary drug quality inspection by the designated laboratory in Vietnam; and results of trial of efficacy and safety of the veterinary drug, for drugs subject to trial;

d/ A certificate of veterinary drug good manufacturing practices or certificate of eligibility for manufacture or certificate of eligibility for import of veterinary drugs; and certificate of free sale of the veterinary drug granted by the authorities of the country of manufacture, for imported veterinary drugs.

3. Order and procedures for grant of a certificate of veterinary drug circulation:

a/ An organization or individual submits a registration dossier to the Department of Animal Health;

b/ Within 6 months after receiving a valid dossier, the Department of Animal Health shall examine the dossier and grant a certificate of veterinary drug circulation if the dossier satisfies the requirements. In case of refusal to grant a certificate, it shall notify such in writing, clearly stating the reason.

4. A certificate of veterinary drug circulation is valid for 5 years.

Article 81.Extension of certificates of veterinary drug circulation

1. Three months before the expiration of a certificate of veterinary drug circulation, the certificate holder that wishes to have the certificate extended shall submit a registration dossier for extension.

2. A registration dossier for extension of a certificate of veterinary drug circulation must comprise:

a/ A registration application for extension;

b/ A copy of the granted certificate of veterinary drug circulation;

c/ Results of product quality analysis by the manufacturer; and results of veterinary drug quality inspection by the designated laboratory in Vietnam;

d/ A certificate of veterinary drug good manufacturing practices or certificate of eligibility for manufacture of veterinary drugs; and certificate of free sale of the veterinary drug granted by the authorities of the country of manufacture, for imported veterinary drugs.

3. Within 20 days after receiving a valid dossier, the Department of Animal Health shall examine the dossier and extend the certificate of veterinary drug circulation if the dossier satisfies the requirements. In case of refusal to extend the certificate, it shall notify such in writing, clearly stating the reason.

4. An extended certificate of veterinary drug circulation is valid for 5 years.

Article 82.Re-grant of certificates of veterinary drug circulation

1. A certificate of veterinary drug circulation shall be re-granted in the following cases:

a/ There is a change in the composition, ingredients, formulation type, usage, dosage and treatment prescription of the veterinary drug; the manufacturing method or process changes without affecting the product quality; the quality, efficacy and safety of the veterinary drug is reassessed under regulations. The dossier, order and procedures for registration for re-grant of a certificate of veterinary drug circulation must comply with Clauses 2 and 3, Article 80 of this Law;

b/ It is lost, erroneous or damaged; there is a change in the product name or information relating to the registrant for veterinary drug circulation.

2. A registration dossier for a re-grant of certificate of veterinary drug circulation in the case specified at Point b, Clause 1 of this Article must comprise:

a/ A registration application for re-grant of the certificate;

b/ Documents proving the changed content;

c/ The granted certificate of veterinary drug circulation, unless it is lost.

3. The order and procedures for re-grant of a certificate of veterinary drug circulation in the case specified at Point b, Clause 1 of this Article:

a/ The certificate holder shall submit a registration dossier for re-grant of the certificate to the Department of Animal Health;

b/ Within 15 days after receiving a valid dossier, the Department of Animal Health shall examine the dossier and re-grant the certificate if the dossier satisfies the requirements. In case of refusal to re-grant the certificate, it shall notify such in writing, clearly stating the reason.

Article 83.Revocation of certificates of veterinary drug circulation

1. A certificate of veterinary drug circulation shall be revoked in the following cases:

a/ The certificate is erased or tampered with;

b/ A forged document or paper or untruthful information is detected in the approved circulation registration dossier;

c/ The veterinary drug is banned from circulation in Vietnam;

d/ There is scientific proof that the veterinary drug causes a bad effect on human or animal health and the environment;

dd/ Two consecutive manufacture lots of the veterinary drug fail to conform to the quality standards or the veterinary drug seriously violates the quality standards for once as concluded by the state management agency in charge of veterinary drugs;

e/ The certificate holder requests the registration revocation;

g/ The veterinary drug’s free sale certificate is revoked in the country of manufacture or exportation;

h/ The veterinary drug is concluded by a competent state agency to have infringed upon intellectual property rights;

i/ The certificate holder commits another violation subject to certificate revocation as prescribed by law.

2. The Department of Animal Health shall revoke certificates of veterinary drug circulation.

Section 2

TRIAL OF VETERINARY DRUGS

Article 84.Trial of veterinary drugs

1. Trial shall be conducted for all veterinary drugs before they are registered for circulation in Vietnam, except those exempted from trial under regulations of the Minister of Agriculture and Rural Development.

2. The trial of veterinary drugs shall be conducted by organizations satisfying the requirements on veterinary drug trial prescribed in Article 88 of this Law after obtaining a veterinary drug trial permit granted by the Department of Animal Health.

Article 85.Grant of veterinary drug trial permits

1. A registration dossier for grant of a veterinary drug trial permit must comprise:

a/ A registration application;

b/ Documents proving the satisfaction of the requirements prescribed in Article 88 of this Law;

c/ Technical documents of veterinary drugs.

2. Order and procedures for grant of a veterinary drug trial permit:

a/ An organization or individual submits a registration dossier for grant of a veterinary drug trial permit to the Department of Animal Health;

b/ Within 25 days after receiving a valid dossier, the Department of Animal Health shall examine the dossier and grant a veterinary drug trial permit if the dossier satisfies the requirements. In case of refusal to grant a permit, it shall notify such in writing, clearly stating the reason.

3. A veterinary drug trial permit is valid for 5 years.

Article 86.Re-grant of veterinary drug trial permits

1. A veterinary drug trial permit shall be re-granted in case it is lost, erroneous or damaged or there is a change in the veterinary drug name or information on the registrant for veterinary drug trial.

2. A registration dossier for re-grant of a permit must comprise:

a/ A registration application for re-grant;

b/ The granted veterinary drug trial permit, unless it is lost.

3. Order and procedures for re-grant of a veterinary drug trial permit:

a/ The permit holder submits a registration dossier for re-grant of the veterinary drug trial permit to the Department of Animal Health;

b/ Within 5 days after receiving a valid dossier, the Department of Animal Health shall examine the dossier and re-grant the veterinary drug trial permit if the dossier satisfies the requirements. In case of refusal to re-grant the permit, it shall notify such in writing, clearly stating the reason.

Article 87.Revocation of veterinary drug trial permits

1. A veterinary drug trial permit shall be revoked in the following cases:

a/ The certificate contents are erased or tampered with;

b/ A forged document or paper or untruthful information is detected in the registration dossier for grant of the veterinary drug trial permit;

c/ The veterinary drug is likely to cause a bad effect on human or animal health and the environment under regulations of the Minister of Agriculture and Rural Development.

2. The Department of Animal Health shall revoke veterinary drug trial permits.

Article 88.Requirements on veterinary drug trial organizations

1. Their technical officers possess veterinary practice certificates.

2. Their employees have appropriate professional qualifications and have been trained in veterinary drug trial.

3. They neither directly register veterinary drugs in Vietnam under their names nor are authorized to do so.

4. They have physical and technical foundations to serve the veterinary drug trial.

Article 89.Rights and obligations of veterinary drug trial organizations

1. A veterinary drug trial organization has the following rights:

a/ To be provided with information on issues related to veterinary drug trial;

b/ To collect veterinary drug trial charges under regulations;

c/ To complain about decisions of competent state agencies.

2. A veterinary drug trial organization has the following obligations:

a/ To ensure objectivity, accuracy and truthfulness of trial;

b/ To strictly comply with technical regulations, standards and processes and satisfy requirements of trial;

c/ To be held responsible before law for trial results;

d/ To keep documents related to trial for at least 5 years after the trial is completed;

dd/ To obey requests of competent state agencies for inspection, examination or supervision of trial;

e/ To pay compensations for damage as prescribed by law.

Section 3

MANUFACTURE, TRADING, IMPORT AND EXPORT OF VETERINARY DRUGS

Article 90.Conditions for manufacture of veterinary drugs

An organization or individual wishing to manufacture veterinary drugs must satisfy the following conditions:

1. Having an enterprise registration certificate;

2. Having a location, workshops and drug warehouses which are large enough and safely distant from humans, domestic animals and the environment;

3. Having equipment and facilities suitable to the manufacture scale and quality control for each type of veterinary drug;

4. Having a wastewater and waste treatment system up to veterinary sanitation requirements and in accordance with the law on environmental protection;

5. Persons directly managing the manufacture and quality inspection of veterinary drugs must possess a veterinary practice certificate for manufacture and quality inspection of veterinary drugs;

6. Persons directly engaged in the manufacture of veterinary drugs shall be trained in relevant disciplines;

7. Having a certificate of eligibility for manufacture of veterinary drugs.

Article 91.Rights and obligations of veterinary drug manufacturers

1. A veterinary drug manufacturer has the following rights:

a/ To manufacture veterinary drugs that have certificates of veterinary drug circulation in Vietnam;

b/ To import veterinary drugs and veterinary drug materials for manufacture and re-export under contracts with foreign parties; to franchise under contracts;

c/ To advertise veterinary drugs in accordance with the advertising law;

d/ Other rights provided by the relevant laws.

2. A veterinary drug manufacturer has the following obligations:

a/ To manufacture veterinary drugs up to their announced standards;

b/ To comply with regulations on inspection, preservation and distribution of veterinary drugs and good manufacturing practices;

c/ To be held responsible before law for the quality of their veterinary drugs and market only quality veterinary drugs;

d/ To keep veterinary drug samples for each manufacture lot for at least 6 months after veterinary drugs expire;

dd/ To monitor veterinary drugs that they manufacture and, upon detecting marketed veterinary drugs not up to the prescribed requirements, notify and recall all of such veterinary drugs;

e/ To pay compensations for damage caused by its establishments in accordance with law;

g/ To provide documents necessary for inspection, examination and assessment of all veterinary drug manufacturing activities in accordance with law;

h/ To provide training and instructions for use and prevention of undesirable effects of veterinary drugs; to provide professional training for persons directly engaged in manufacturing veterinary drugs;

i/ To observe and implement other regulations on fire and explosion prevention and fighting, chemical and labor safety, and environmental protection.

Article 92.Conditions for trading of veterinary drugs

An organization or individual wishing to trade in veterinary drugs must satisfy the following conditions:

1. Having a business registration certificate or an enterprise registration certificate;

2. Having a suitable location and physical and technical foundations;

3. Veterinary drug sale managers and salespersons possess veterinary practice certificates;

4. Having a certificate of eligible for trading of veterinary drugs.

Article 93.Rights and obligations of veterinary drug traders

1. A veterinary drug trader has the following rights:

a/ To trade in veterinary drugs that have certificate of veterinary drug circulation in Vietnam;

b/ To provide information and instructions related to veterinary drugs;

c/ To participate in training in safe use, preservation and transportation of veterinary drugs and prevention of undesirable effects of veterinary drugs.

2. A veterinary drug trader has the following obligations:

a/ To sell veterinary drugs according to prescriptions, for veterinary drugs requiring prescriptions, or at the request of purchasers, for those requiring no prescription;

b/ To display sale prices, sell veterinary drugs at displayed prices, and keep records to monitor the sale and purchase of veterinary drugs;

c/ To follow the veterinary drug preservation conditions stated in veterinary drug labels and provide veterinary drug use instructions to purchasers according to their labels;

d/ To pay compensations for damage caused by its establishments in accordance with law;

dd/ Upon detecting veterinary drugs traded by its establishments not up to prescribed requirements, to notify such to its direct agents or manufacturers that have supplied such veterinary drugs for recall of all marketed veterinary drugs; to participate in the recall of sold veterinary drugs.

Article 94.Conditions for import of veterinary drugs

A veterinary drug importer must satisfy the following conditions:

1. All the conditions for trading of veterinary drugs prescribed in Clauses 1, 2 and 3, Article 92 of this Law;

2. Having warehouses satisfying the veterinary drug preservation conditions;

3. Possessing a certificate of veterinary drug circulation in Vietnam or a veterinary drug import permit;

4. Having a dossier for quality control and monitoring of warehousing and ex-warehousing for each kind of drug;

5. Having a certificate of eligibility for import of veterinary drugs.

Article 95.Rights and obligations of veterinary drug importers

1. A veterinary drug importer has the following rights:

a/ To have trademarks of its veterinary drugs protected by law;

b/ To lodge complaints and denunciations in accordance with law;

c/ To claim compensations for damage in accordance with law;

d/ Other rights provided by law.

2. A veterinary drug importer has the following obligations:

a/ To provide import dossiers consistent with registered contents;

b/ To comply with regulations on drug preservation conditions;

c/ To provide veterinary drugs of registered quality;

d/ To keep documents relating to each veterinary drug lot for at least 6 months after veterinary drugs expire;

dd/ To submit to management and supervision by competent state agencies; to provide adequate documents relevant to the sampling, inspection and examination when so requested;

e/ To incur expenses for handling of their violations of regulations on import of veterinary drugs and pay compensations for damage caused by these violations in accordance with law.

Article 96.Order and procedures for grant, re-grant and revocation of certificates of eligibility for manufacture of veterinary drugs

1. A registration dossier for grant of a certificate of eligibility for manufacture of veterinary drugs must comprise:

a/ A registration application;

b/ A detailed description of physical and technical foundations prescribed in Article 90 of this Law; and a list of veterinary drugs to be manufactured;

c/ An enterprise registration certificate;

d/ A veterinary practice certificate;

dd/ A copy of the written approval of the environmental impact assessment report of the competent state agency.

2. Order and procedures for grant of a certificate of eligibility for manufacture of veterinary drugs:

a/ A veterinary drug manufacturer submits a registration dossier for grant of a certificate of eligibility for manufacture of veterinary drugs to the Department of Animal Health;

b/ Within 15 days after receiving a valid dossier, the Department of Animal Health shall examine the conditions of the manufacturer. If the conditions are fully satisfied, it shall grant a certificate of eligibility for manufacture of veterinary drugs within 5 working days after the examination is completed. In case of refusal to grant a certificate, it shall notify such in writing, clearly stating the reason.

3. Dossier, order and procedures for re-grant of a certificate of eligibility for manufacture of veterinary drugs in case it is lost, erroneous or damaged or there is a change in information relating to the registrant:

a/ A registration dossier for re-grant of the certificate of eligibility for manufacture of veterinary drugs must comprise a registration application for re-grant; documents proving the change in information relating to the registrant; and the granted certificate of eligibility for manufacture of veterinary drugs, unless it is lost;

b/ The registrant shall submit the registration dossier for re-grant of the certificate to the Department of Animal Health. Within 5 working days after receiving the valid dossier, the Department of Animal Health shall re-grant the certificate. In case of refusal to re-grant the certificate, it shall notify such in writing, clearly stating the reason.

4. The Department of Animal Health shall revoke the certificate of eligibility for manufacture of veterinary drugs of a veterinary drug manufacturer in the following cases:

a/ The certificate is erased or tampered with;

b/ The certificate holder commits violations for which he/she/it is administratively sanctioned for at least three times a year or is administratively sanctioned for three consecutive times for the same violation in the manufacture of veterinary drugs;

c/ The certificate holder no longer manufactures veterinary drugs;

d/ The certificate holder commits another violation which is subject to revocation of certificate of eligibility for manufacture of veterinary drugs as prescribed by law.

Article 97.Order and procedures for grant, re-grant and revocation of certificates of eligibility for trading of veterinary drugs

1. A registration dossier for grant of a certificate of eligibility for trading of veterinary drugs must comprise:

a/ A registration application;

b/ A detailed description of physical and technical foundations;

c/ An enterprise registration certificate or a business registration certificate;

d/ A veterinary practice certificate.

2. Order and procedures for grant of a certificate of eligibility for trading of veterinary drugs:

a/ A veterinary drug trader submits a registration dossier for grant of a certificate of eligibility for trading of veterinary drugs to the provincial-level animal health management agency ;

b/ Within 5 days after receiving a valid dossier, the provincial-level animal health management agency shall examine the conditions of the veterinary drug trader. If the conditions are fully satisfied, it shall grant a certificate of eligibility for trading of veterinary drugs within 3 working days after the examination is completed. In case of refusal to grant a certificate, it shall notify such in writing, clearly stating the reason.

3. Dossier, order and procedures for re-grant of a certificate of eligibility for trading of veterinary drugs in case it is lost, erroneous or damaged or there is a change in information relating to the registrant:

a/ A registration dossier for re-grant of the certificate of eligibility for trading of veterinary drugs must comprise a registration application for re-grant; documents proving the change in information about the registrant; and the granted certificate of eligibility for trading of veterinary drugs, unless it is lost;

b/ The registrant shall submit the registration dossier for re-grant of the certificate to the provincial-level animal health management agency. Within 5 working days after receiving the valid dossier, the Department of Animal Health shall re-grant the certificate. In case of refusal to re-grant the certificate, it shall notify such in writing, clearly stating the reason.

4. The provincial-level management animal health agency shall revoke a certificate of eligibility for trading of veterinary drugs of a veterinary drug trader in the following cases:

a/ The certificate is erased or tampered with;

b/ The certificate holder commits violations for which he/she/it is administratively sanctioned for at least three times a year or is administratively sanctioned for three consecutive times for the same violation in the trading in veterinary drugs;

c/ The certificate holder no longer trades in veterinary drugs;

d/ The certificate holder commits another violation which is subject to revocation of certificate of eligibility for trading of veterinary drugs as prescribed by law.

Article 98.Order and procedures for grant, re-grant and revocation of certificates of eligibility for import of veterinary drugs

1. A registration dossier for grant of a certificate of eligibility for import of veterinary drugs must comprise:

a/ A registration application;

b/ A detailed description of physical and technical foundations;

c/ An enterprise registration certificate or a business registration certificate;

d/ A veterinary practice certificate.

2. Order and procedures for grant of a certificate of eligibility for import of veterinary drugs:

a/ A veterinary drug importer submits a registration dossier for grant of a certificate of eligibility for import of veterinary drugs to the Department of Animal Health;

b/ Within 10 days after receiving a valid dossier, the Department of Animal Health shall examine the conditions of the importer. If the conditions are fully satisfied, it shall grant a certificate of eligibility for manufacture of veterinary drugs within 3 working days after the examination is completed. In case of refusal to grant a certificate, it shall notify such in writing, clearly stating the reason.

3. Dossier, order and procedures for re-grant of a certificate of eligibility for import of veterinary drugs in case it is lost, erroneous or damaged or there is a change in information relating to the registrant:

a/ A registration dossier for re-grant of the certificate of eligibility for import of veterinary drugs must comprise a registration application for re-grant; documents proving the change in information relating to the registrant; and the granted certificate of eligibility for import of veterinary drugs, unless it is lost;

b/ The registrant shall submit the registration dossier for re-grant of the certificate to the Department of Animal Health. Within 5 working days after receiving the valid dossier, the Department of Animal Health shall re-grant the certificate. In case of refusal to re-grant the certificate, it shall notify such in writing, clearly stating the reason.

4. The Department of Animal Health shall revoke the certificate of eligibility for import of veterinary drugs of a veterinary drug importer in the following cases:

a/ The certificate is erased or tampered with;

b/ The certificate holder commits violations for which he/she/it is administratively sanctioned for at least three times a year or is administratively sanctioned for three consecutive times for the same violation in the import of veterinary drugs;

c/ The certificate holder no longer imports veterinary drugs;

d/ The certificate holder commits another violation which is subject to the revocation of certificate of eligibility for import of veterinary drugs as prescribed by law.

Article 99.Validity duration of certificates of eligibility for manufacture, trading or import of veterinary drugs

1. A certificate of eligibility for manufacture, trading or import of veterinary drugs is valid for 5 years.

2. Three months before the date of expiration of a certificate of eligibility for manufacture, trading or import of veterinary drugs, the certificate holder that wishes to continue manufacturing, trading in or importing veterinary drugs shall submit a registration application for extension of the certificate. The order and procedures for extension of certificates must comply with Clause 2, Article 96; Clause 2, Article 97, and Clause 2, Article 98 of this Law.

Article 100.Import and export of veterinary drugs and veterinary drug materials

1. Veterinary drugs having certificates of veterinary drug circulation in Vietnam may be imported, except vaccines and microorganisms for veterinary use the import of which requires import permits of the Department of Animal Health.

2. A veterinary drug having no certificate of veterinary drug circulation in Vietnam may be imported in the following cases:

a/ It is imported for urgent animal disease and epidemic prevention and combat or overcoming of natural disaster consequences;

b/ It is imported as a sample for inspection, trial, circulation registration, display at a trade fair or an exhibition, or scientific research;

c/ It is imported for treatment of a disease of animals temporarily imported for re-export or in transit through the Vietnamese territory;

d/ It is temporarily imported for re-export or for export processing under a contract signed with a foreign party;

dd/ It is used for veterinary diagnosis, testing or inspection;

e/ It is imported as international aid or in other forms of non-commercial import.

3. A veterinary drug material may be imported in the following cases:

a/ It is used for manufacture of a veterinary drug having a certificate of veterinary drug circulation in Vietnam;

b/ It is used for veterinary diagnosis, testing or inspection under regulations of the Minister of Agriculture and Rural Development.

4. An importer of vaccines and microorganisms specified in Clause 1 of this Article or veterinary drugs and veterinary drug materials specified in Clauses 2 and 3 of this Article shall submit a registration dossier for import of veterinary drugs and veterinary drug materials to the Department of Animal Health. Within 5 working days after receiving a valid dossier, the Department of Animal Health shall consider and grant an import permit. In case of refusal to grant a permit, it shall notify such in writing, clearly stating the reason.

The Minister of Agriculture and Rural Development shall prescribe registration dossiers for import of veterinary drugs and veterinary drug materials.

5. Imported veterinary drugs and veterinary drug materials mentioned in Clause 1; Point a, Clause 2, and Point a, Clause 3 of this Article must undergo quality check upon importation and may only be imported when their quality is satisfactory.

6. The Department of Animal Health shall check the quality of imported veterinary drugs at border gates in accordance with law.

7. Veterinary drug manufacturers and traders may export veterinary drugs in accordance with law.

Article 101.Testing of veterinary drugs

1. Veterinary drugs shall be quality-tested by a designated veterinary drug testing establishment before being registered for circulation in Vietnam.

2. Testing of veterinary drugs shall be conducted according to quality standards of registering manufacturers.

3. Conditions on a veterinary drug testing establishment:

a/ Having an appropriate location, physical foundations and equipment;

b/ Its manager or person directly engaged in testing possess a veterinary practice certificate.

4. Rights and obligations of a veterinary drug testing establishment:

a/ To refuse to receive veterinary drug samples if they fail to satisfy the requirements of quantity, preservation and accompanying dossier;

b/ To be provided with information about testing samples;

c/ To be held responsible for testing results of tested veterinary drug samples;

d/ To provide information on testing results and dossiers only when requested by competent state agencies;

dd/ To pay compensations for damage caused by inaccurate testing results in accordance with law.

5. The Minister of Agriculture and Rural Development shall specify this Article.

Article 102.Quality inspection of veterinary drugs

1. Quality inspection of veterinary drugs shall be conducted to reassess the quality of such veterinary drugs.

2. A veterinary drug shall be inspected in the following cases:

a/ There is a complaint or denunciation about its quality;

b/ A competent state agency requests expert assessment.

3. Competent state agencies shall designate veterinary drug testing establishments to inspect veterinary drugs in the cases specified in Clause 2 of this Article.

Article 103.Labels of veterinary drugs

A marketed veterinary drug must have a label that:

1. Contains use instructions in Vietnamese;

2. Contains sufficient information about the use of the veterinary drug;

3. Bears the phrase “For veterinary use only”;

4. Complies with the law on goods labeling;

5. Contains contents consistent with label contents registered with the Department of Animal Health.

Article 104.Use of veterinary drugs

1. Veterinary drugs shall be used according to instructions of manufacturers and prescriptions of individual veterinarians or animal health management agencies.

2. A veterinary drug user has the following rights:

a/ To be provided with information and instructions for use of veterinary drugs;

b/ To request veterinary drug stores to provide instructions for use of veterinary drugs under Clause 1 of this Article;

c/ To receive compensations for damage caused by veterinary drug traders in accordance with law.

3. A veterinary drug user has the following obligations:

a/ To use veterinary drugs under Clause 1 of this Article;

b/ Upon detecting a veterinary drug harmful to animals, the environment and human health, to stop using such drug and promptly report it to the commune-level People’s Committee or local animal health management agency.

Section 4

RECALL AND DESTRUCTION OF VETERINARY DRUGS

Article 105.Recall of veterinary drugs on the market and disposal of recalled veterinary drugs

1. A veterinary drug shall be recalled in the following cases:

a/ It has no certificate of veterinary drug circulation in Vietnam, except the cases specified in Clauses 2 and 3, Article 100 of this Law;

b/ It has expired;

c/ Its quality is inferior;

d/ Its label fails to comply with Article 103 of this Law.

2. Upon detecting a veterinary drug that shall be recalled under Clause 1 of this Article, a manufacturer or an importer shall announce the concerned veterinary drug lot in the mass media and recall the whole lot. In case the manufacturer or importer fails to voluntarily recall the veterinary drug, a competent agency shall issue a decision on compulsory recall.

3. Measures to dispose of a recalled veterinary drug include:

a/ Re-export;

b/ Recycling;

c/ Destruction;

d/ Correction of labeling error.

4. Competence to dispose of recalled veterinary drugs is provided as follows:

a/ The Department of Animal Health may decide on measures and time limits for disposing of recalled veterinary drugs nationwide;

b/ Provincial-level animal health management agencies may decide on measures and time limits for disposing of recalled veterinary drugs in their provinces.

5. Manufacturers or importers of veterinary drugs that are recalled shall bear all expenses for the recall and disposal of their drugs.

Article 106.Destruction of veterinary drugs

1. A veterinary drug shall be destroyed in the following cases:

a/ It has no certificate of veterinary drug circulation in Vietnam, except the cases specified in Clauses 2 and 3, Article 100 of this Law;

b/ Its quality is inferior; it expires and cannot be reprocessed or contains an active ingredient banned from use;

c/ It is counterfeited, left unclaimed or of unclear origin.

2. The responsibility to destroy veterinary drugs:

a/ Organizations and individuals that have veterinary drugs subject to destruction shall destroy them in accordance with the law on environmental protection and bear all expenses;

b/ Provincial-level People’s Committees shall direct and allocate funds for the destruction of veterinary drugs left unclaimed;

c/ State agencies competent to decide on destruction of veterinary drugs shall supervise and certify the destruction.

Chapter VI

VETERINARY PRACTICE

Article 107.Types of veterinary practice

1. Vaccination, treatment of animal diseases, animal surgery; counseling on animal health-related activities.

2. Medical examination, diagnosis and testing of animal diseases.

3. Veterinary drug trading.

4. Manufacture, testing, trial, import and export of veterinary drugs.

Article 108.Conditions on veterinary practice

1. For a veterinarian:

a/ Holding a certificate of veterinary practice suitable to each type of veterinary practice;

b/ Possessing professional ethics;

c/ Being physically fit for practice.

2. For a veterinary practice organization:

a/ Having employees who satisfy the conditions prescribed in Clause 1 of this Article;

b/ Having physical and technical foundations suitable to each type of veterinary practice as prescribed by law.

3. The Government shall specify this Article.

Article 109.Grant and extension of certificates of veterinary practice

1. Competence to grant certificates of veterinary practice is as follows:

a/ Provincial-level animal health management agencies may grant certificates of veterinary practice for the activities specified in Clauses 1, 2 and 3, Article 107 of this Law.

b/ The Department of Animal Health may grant certificates of veterinary practice for the activity specified in Clause 4, Article 107 of this Law.

2. A registration dossier for grant of a certificate of veterinary practice must comprise:

a/ A registration application;

b/ Diplomas and professional certificates suitable to each type of veterinary practice;

c/ A health certificate of the applicant;

d/ The citizen identity card of the applicant. For foreigners, in addition to documents specified at Points a, b and c of this Clause, a judicial record certified by a competent agency is required.

3. Order and procedures for grant of a certificate of veterinary practice:

a/ An individual that wishes to be granted a certificate of veterinary practice shall submit a dossier to an animal health management agency defined in Clause 1 of this Article;

b/ Within 5 working days after receiving a valid dossier, the dossier-receiving agency shall decide to grant a certificate of veterinary practice. In case of refusal to grant a certificate of veterinary practice, it shall reply in writing, clearly stating the reason.

4. A certificate of veterinary practice is valid for 5 years.

5. Dossier, order and procedure for extension of a certificate of veterinary practice:

a/ An individual that wishes to have his/her certificate of veterinary practice extended shall send a dossier to an animal health management agency defined in Clause 1 of this Article at least 30 days before the certificate expires. A dossier must comprise a registration application for extension, the granted certificate of veterinary practice and a health certificate;

b/ Within 3 working days after receiving a valid dossier, the dossier-receiving agency shall decide to extend the certificate of veterinary practice. In case of refusal to extend the certificate of veterinary practice, it shall reply in writing, clearly stating the reason.

Article 110.Re-grant of certificates of veterinary practice

1. A certificate of veterinary practice shall be re-granted in the following cases:

a/ It is lost, erroneous or damaged;

b/ There is a change in information about its holder.

2. A dossier for re-grant of a certificate of veterinary practice must comprise:

a/ A registration application for re-grant of the certificate;

b/ The granted certificate of veterinary practice, unless it is lost.

3. Order and procedures for re-grant of a certificate of veterinary practice:

a/ An organization or individual that registers for re-grant of its/his/her certificate of veterinary practice sends a dossier to an animal health management agency defined in Clause 1, Article 109 of this Law;

b/ Within 3 working days after receiving a valid dossier, the dossier-receiving agency shall decide to re-grant the certificate of veterinary practice. In case of refusal to re-grant the certificate, it shall reply in writing, clearly stating the reason.

Article 111.Refusal to grant certificates of veterinary practice

An individual shall not be granted a certificate of veterinary practice in the following cases:

1. He/she has no appropriate diploma or professional certificate;

2. He/she is banned from practice under a court judgment or ruling;

3. He/she is disciplined for a violation related to veterinary practice;

4. He/she is examined for penal liability;

5. He/she is serving a criminal sentence or is subjected to the administrative handling measure of consigning to a compulsory education or compulsory detoxification establishment;

6. His/her civil act capacity is restricted or lost.

Article 112.Revocation of certificates of veterinary practice

1. A certificate of veterinary practice shall be revoked in the following cases:

a/ It is erased or tampered with;

b/ A forged paper or untruthful information in the registration dossier for grant of the certificate of veterinary practice is detected;

c/ Its holder commits a violation of the rules of professional ethics and relevant regulations.

2. The competent agencies defined in Clause 1, Article 109 of this Law shall revoke certificates of veterinary practice.

Article 113.Rights and obligations of veterinarians and veterinary practice organizations

1. Veterinarians and veterinary practice organizations have the following rights:

a/ To practice according to their certificates and veterinary practice;

b/ To be provided with training in veterinary skills;

c/ To be assisted or encouraged by the State when participating in animal disease and epidemic prevention and combat in their localities.

2. Veterinarians and veterinary practice organizations have the following obligations:

a/ To comply with the law on animal health and relevant laws in their practice; to pay compensations for damage caused by their fault in veterinary practice;

b/ To provide relevant information to animal health management agencies; to obey requests of, and participate in health animal activities when requested by, competent agencies.

Article 114.Animal health councils

1. Animal health councils shall be established at central and provincial levels.

2. Animal health councils shall work on a part-time basis to advise the Minister of Agriculture and Rural Development and provincial-level Agriculture and Rural Development Department directors on animal health activities.

3. An animal health council shall be composed of representatives of the animal health management agency, societies, associations, universities, research institutes and specialists in the field of animal health.

4. The Minister of Agriculture and Rural Development shall stipulate in detail the organizational structure, functions, tasks and powers of animal health councils at all levels.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 115.Effect

1. This Law takes effect on July 1, 2016.

2. Ordinance No. 18/2004/PL-UBTVQH10 on Animal Health ceases to be effective on the effective date of this Law.

3. Animal health-related permits, licenses and certificates that are granted before the effective date of this Law and have not yet expired remain valid until they expire.

Article 116.Detailing

The Government and competent agencies shall detail the articles and clauses of this Law as assigned to them.

This Law was passed on June 19, 2015, by the XIII^thNational Assembly of the Socialist Republic of Vietnam at its 9^thsession.-

Chairman of the National Assembly
NGUYEN SINH HUNG