Ordinance No. 18/2004/PL-UBTVQH11 on Veterinary Medicine

ORDINANCE

Veterinary

____

Based on the Constitution of the Socialist Republic of Vietnam in 1992, amended and supplemented by Resolution No. 51/2001/QH10 dated December 25, 2001 of the Tenth National Assembly, tenth session;

Based on Resolution No. 21/2003/QH11 dated November 26, 2003 of the National Assembly, Session 4, regarding the legislative program for 2004;

This Ordinance stipulates veterinary matters,

PART I

GENERAL PROVISIONS

Article 1. Scope of application

This Ordinance stipulates disease prevention and treatment for animals, control of animal epidemics; quarantine of animals and animal products; slaughterhouse supervision, veterinary hygiene inspection; management of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary practices; veterinary practice.

Article 2. Applicability

This Ordinance applies to Vietnamese organizations and individuals, foreign organizations and individuals engaged in activities related to veterinary matters within the territory of Vietnam.

In cases where international treaties to which the Socialist Republic of Vietnam is a party provide different provisions from those set forth in this Ordinance, such treaties shall be applied.

Article 3. Definitions

In this Ordinance, the following terms shall be understood as follows:

1. Animals include mammals, birds, reptiles, bees, silkworms, and other insects; amphibians; fish, crustaceans, mollusks, aquatic mammals, and other aquatic animals.

2. Animal Products include meat, eggs, milk, honey, beeswax, royal jelly, animal semen, embryos, blood, organs, skin, hair, bones, horns, tusks, nails, and other products derived from animals.

3Processing of Animals and Animal Products refers to post-harvesting, slaughtering work including washing, filleting, drying, freezing, packaging of animals and animal products.

4. Veterinary Activities refer to state management of veterinary matters and activities for disease prevention and treatment of animals, control of animal epidemics; quarantine of animals and animal products; slaughterhouse supervision; veterinary hygiene inspection; management of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary practices; veterinary practice.

5. Disease-Free Zones and Facilities refer to zones and facilities determined as areas where dangerous infectious diseases listed in the List of Notifiable Diseases have not occurred during a specified period for each disease, each animal species, and veterinary activities in those zones and facilities ensure disease control.

6Animal Epidemic refers to an infectious disease listed in the List of Notifiable Diseases or the List of Dangerous Diseases of Animals causing many animals to fall ill or die or spread in one or more regions.

7. Animal Disease Focus refers to a place where dangerous infectious diseases of animals listed in the List of Notifiable Diseases or the List of Dangerous Diseases of Animals are present.

8. Infected Zone refers to a region with multiple disease foci identified by authorized veterinary agencies.

9. Threatened Zone refers to the peripheral area surrounding the infected zone or adjacent to the infected zone at the border of neighboring countries, identified by authorized veterinary agencies within a certain range depending on the disease.

10. Buffer Zone refers to the peripheral area surrounding the threatened zone, identified by authorized veterinary agencies within a certain range depending on the disease.

11. List of Notifiable Diseases (List A) refers to the list of dangerous infectious diseases of animals causing significant economic losses or having the potential to infect humans, which must be declared when an epidemic occurs.

12. List of Dangerous Diseases of Animals (List B) refers to the list of diseases caused by microorganisms and parasites affecting animals that can spread widely and may infect humans.

13. Veterinary Hygiene Standards refer to technical indicators for veterinary hygiene meeting requirements for protecting and developing animals, not harming human health, and not polluting the environment.

14. Quarantine of Animals and Animal Products refers to the implementation of diagnostic and testing measures to detect quarantine targets of animals and animal products.

15. Quarantine Targets of Animals and Animal Products refer to factors causing disease and harm to human and animal health, including microorganisms, parasites, eggs and larvae of parasites; hormones, toxins, residues; harmful animal species to humans, animals, the environment, and ecosystems.

16. Slaughterhouse Supervision refers to the inspection and testing to detect slaughter supervision targets before, during, and after slaughtering.

17. Slaughter Supervision Targets refer to factors causing disease in animals and harm to human health, including microorganisms, parasites, eggs and larvae of parasites.

18. Veterinary Hygiene Inspection refers to the implementation of technical measures to detect veterinary hygiene inspection targets.

19Veterinary Hygiene Inspection Targets refer to factors causing disease and harm to humans and animals, including microorganisms, parasites, eggs and larvae of parasites, humidity, dust, light, noise, toxic gases, toxins, and other environmental factors affecting human and animal health and environmental hygiene.

20. Animal Waste refers to substances generated during animal breeding, slaughtering, processing, transportation of animals and animal products.

21. Quarantine Isolation Area refers to a place for keeping animals and preserving animal products isolated completely from other animals and products for a specific period for quarantine purposes.

22. Disinfection and Sterilization refers to the elimination of pathogens in animal disease foci, infected zones, threatened zones; quarantine isolation areas, breeding facilities, production facilities for animal breeds; slaughterhouses, processing facilities for animals and animal products; feed production facilities, veterinary drug production facilities, biological preparation production facilities, microorganism production facilities used in veterinary practices; transportation means, containers, enclosures for animals and animal products, transportation vehicles for animal waste; animal waste capable of transmitting disease to animals or contaminating animal products.

23. Veterinary drugs refers to substances or compounds of animal, plant, microbial, mineral, or chemical origin used for disease prevention, diagnosis, treatment, or to restore, adjust, and improve animal body functions, including pharmaceuticals, chemicals, vaccines, hormones, some biological preparations, and some microorganisms used in veterinary practices.

24Biological Preparations Used in Veterinary Practices refer to products of biological origin used for diagnosis, disease prevention, treatment, regulation of growth and reproduction processes of animals, and environmental treatment for animal breeding.

25. Microorganisms Used in Veterinary Practices refer to bacterial, viral, single-cell parasitic, mold, yeast, and other microorganism species used for animal diagnosis, disease prevention, treatment; research, production, testing, and verification of veterinary drugs.

26. Veterinary drug testing, biological products, microorganisms, chemicals used in veterinary medicine is the examination and determination of technical standards for veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine.

27. Veterinary drug trials, biological products, microorganisms, chemicals used in veterinary medicine is the trial use of new veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine that are not included in the list of permitted veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine circulating in Vietnam to determine their characteristics, efficacy, and safety on certain animals at the trial facility.

28. Veterinary drug evaluation, biological products, microorganisms, chemicals used in veterinary medicine is the examination and determination of characteristics, efficacy, and safety of samples of foreign-produced veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine when registering for importation into Vietnam for the first time on certain animals at the evaluation facility.

29. Veterinary drug certification, biological products, microorganisms, chemicals used in veterinary medicine is the re-examination and assessment of the quality of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine that have been tested, trialed, evaluated, or are currently circulating when there is a dispute, complaint, or request for appraisal from authorized state agencies.

30. Compulsory disease prevention measures is the mandatory use of vaccines, veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine to prevent diseases in animals; the mandatory application of veterinary hygiene measures in animal husbandry.

Article 4Principles of veterinary activities

1. Developing strategies, planning, and plans for veterinary activities that are consistent with economic and social development requirements, expanding international cooperation, promoting socialization of veterinary activities; combining short-term and long-term interests to ensure the common benefits of society.

2. Prioritizing disease prevention, timely treatment of diseases, and prompt control of epidemics to effectively prevent and control diseases; thoroughly preventing the invasion and development of harmful animal species that affect humans, animals, the environment, and ecosystems.

3. Applying scientific and technological progress, combining modern science and technology with the experience of the people in disease prevention and control, quickly detecting diseases, accurately diagnosing diseases, effectively treating animals, ensuring food safety for consumers of animal products, and preventing the spread of diseases to humans and animals.

4. Strictly managing the production and business of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine.

5. Promoting autonomy and responsibility, ensuring equality and legitimate interests of organizations and individuals in veterinary activities.

Article 5State policy on veterinary activities

1. The State invests in the following veterinary activities:

a) Scientific research, technological development, and human resource training in the field of veterinary activities;

b) Strengthening material and technical infrastructure for veterinary research institutions, animal quarantine agencies; diagnostic, testing facilities for animal diseases, veterinary hygiene inspection facilities; testing, trial, and evaluation facilities for veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine;

c) Developing disease surveillance information systems;

d) Establishing quarantine zones for animals at some border gates or suitable locations for aquatic animals;

đ) Developing and implementing programs to control and eradicate certain dangerous infectious diseases in animals and zoonotic diseases;

2. The State supports funding for research and production of vaccines, disease prevention and control, and mitigation of the consequences of animal disease outbreaks.

3. The State creates conditions for domestic organizations and individuals, as well as foreign organizations and individuals, to invest in, research, and apply scientific and technological achievements in the production of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine; building centralized animal slaughterhouses; establishing disease-free zones and facilities for animals.

4. The State has policies for personnel engaged in grassroots veterinary work; encouraging pet insurance activities and veterinary practice.

Article 6. State management responsibilities for veterinary activities

1. The Government uniformly manages state affairs related to veterinary activities.

2. The Ministry of Agriculture and Rural Development is responsible before the Government for managing state affairs related to terrestrial animals nationwide.

3. The Ministry of Fisheries is responsible before the Government for managing state affairs related to aquatic animals and amphibians nationwide.

4. Ministries, agencies equivalent to ministries, and government-affiliated agencies within their respective duties and authorities shall cooperate with the Ministry of Agriculture and Rural Development and the Ministry of Fisheries to manage state affairs related to veterinary activities according to the division of labor by the Government.

5. People's Committees at all levels shall manage state affairs related to veterinary activities within their localities according to the delegation by the Government.

6. Specialized agencies for veterinary activities are organized from central to county, district, town, city under province levels (hereinafter referred to as county level).

The Government shall specify in detail the organization, tasks, and powers of state management agencies for veterinary activities and the network of veterinary stations at commune, ward, town levels (hereinafter referred to as commune level).

, Clause 1, Clause 2 Article 7a of this Regulation.System of veterinary hygiene standards; system of veterinary drug standards, biological products, microorganisms, chemicals used in veterinary medicine

1. The system of veterinary hygiene standards; the system of veterinary drug standards, biological products, microorganisms, and chemicals used in veterinary medicine includes:

a) Vietnamese Standards;

b) Industry Standards;

c) Enterprise Standards;

d) International Standards, regional standards, and foreign standards permitted for application in Vietnam.

2. The Ministry of Science and Technology promulgates Vietnamese Standards, including:

a) Veterinary hygiene standards for breeding, collection, trading facilities for animals; breeding stock production and trading facilities;

b) Veterinary hygiene standards for equipment, tools, transportation means used in animal husbandry.

c) Veterinary hygiene standards for livestock feed, water used for animals at concentrated livestock farms, animal-derived raw materials used to produce livestock feed;

d) Veterinary hygiene standards for animal waste, other objects required to be inspected under veterinary hygiene laws;

đ) Veterinary hygiene standards for disease-free zones and facilities for animals;

e) Veterinary hygiene standards for animals and animal products listed in the quarantine list;

g) Veterinary hygiene standards for animal quarantine and disinfection zones;

h) Veterinary hygiene standards for animals intended for slaughter;

i) Veterinary hygiene standards for slaughterhouses, initial processing, and preservation facilities for animals and animal products;

k) Veterinary hygiene standards for animals and animal products circulating, consumed domestically, exported, or imported;

l) Veterinary hygiene standards for facilities producing, trading in veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices;

m) Standards for veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices;

3. The Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall issue industry standards, including:

a) Veterinary hygiene standards for breeding, collection, trading facilities for animals; breeding stock production and trading facilities;

b) Veterinary hygiene standards for equipment, tools, transportation means used in animal husbandry.

c) Veterinary hygiene standards for livestock feed, water used for animals at concentrated livestock farms, animal-derived raw materials used to produce livestock feed;

d) Veterinary hygiene standards for animal waste, other objects required to be inspected under veterinary hygiene laws;

đ) Veterinary hygiene standards for disease-free zones and facilities for animals;

e) Veterinary hygiene standards for animals and animal products listed in the quarantine list;

g) Veterinary hygiene standards for animal quarantine and disinfection zones;

h) Veterinary hygiene standards for animals intended for slaughter;

i) Veterinary hygiene standards for slaughterhouses, initial processing, and preservation facilities for animals and animal products;

k) Veterinary hygiene standards for animals and animal products circulating, consumed domestically, exported, or imported;

l) Veterinary hygiene standards for facilities producing, trading in veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices;

m) Standards for veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices;

4. Basic standards are self-established and published by the facility but must not be lower than the standards specified in points a, b, c, g, i, l, and m of Clause 2, and points a, b, c, g, i, l, and m of Clause 3 of this Article, and must be accepted by the competent state management authority on veterinary matters.

Article 8. Prohibited acts

1. Violating regulations on veterinary hygiene for livestock farms, slaughterhouses, initial processing, and trading in animals and animal products; facilities producing veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices; facilities producing livestock feed.

2. Producing, trading, and importing animals, animal products, animal-derived raw materials used to produce livestock feed, animal-derived livestock feed; counterfeit veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices that do not meet veterinary hygiene standards, have expired, have unclear origins, are prohibited from use, or are not permitted to circulate in Vietnam.

3. Failing to implement mandatory disease prevention measures for animals.

4. Disposing of diseased animal carcasses causing the spread of diseases among animals and humans.

5. Illegally transporting sick animals and animal products carrying dangerous infectious pathogens from one locality to another.

6. Transporting animals and animal products from epidemic areas or threatened areas to other regions.

7. Importing animal carcasses, microorganisms, and parasites without permission from the Ministry of Agriculture and Rural Development and the Ministry of Fisheries.

8. Importing and exporting animals and animal products listed in the prohibited import/export list of animals and animal products.

9. Importing animals and animal products from countries or territories currently experiencing dangerous epidemics affecting those animals.

10. Evading domestic quarantine inspections, export, import, temporary import for re-export, temporary export for re-import, transfer between ports, and transit through Vietnamese territory for animals and animal products.

11. Swapping quarantined animals and animal products with unquarantined ones.

12. Slaughtering animals for trade at slaughterhouses that do not meet veterinary hygiene standards.

13. Slaughtering diseased animals; endangered animals listed in the rare animal list that are diseased.

14. Trading in animals and animal products that do not meet veterinary hygiene standards.

15. Using chemicals harmful to human health when treating animal products; using unauthorized coloring agents; soaking animals and animal products in chemicals, injecting water or other liquids into them.

16. Circulating veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices contrary to the approved labeling by the competent state authority on veterinary matters.

17. Counterfeiting registered veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices circulating in the market.

18. Advertising and marketing veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices contrary to their registered functions and uses.

19. Counterfeiting veterinary inspection officer cards, animal quarantine officer cards, permits, certificates, and veterinary practice licenses.

20. Using unprocessed raw materials and medicinal herbs harmful to animals for disease prevention and treatment.

21. Other violations as prescribed by law.

PART II
DISEASE PREVENTION, TREATMENT, AND CONTROL
FOR ANIMALS

Article 9. Contents of disease prevention, treatment, and control for animals

1. Implementing preventive measures, diagnosing and treating diseases; controlling and eradicating epidemics; monitoring and containing animal epidemics.

2. Caring for animal health.

3. Conducting animal and animal product quarantine inspections; inspecting veterinary hygiene for animal products and other objects required to be inspected under veterinary hygiene laws.

4. Establishing disease-free zones and facilities, programs to contain and eradicate certain dangerous infectious diseases of animals and zoonotic diseases.

5. Ensuring veterinary hygiene standards for facilities producing, trading in animals and breeding stock; facilities producing, trading in livestock feed, veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices; facilities slaughtering animals, initially processing animals and animal products.

Article 10. Responsibilities of state agencies in disease prevention, treatment, and control for animals

1. The Prime Minister shall establish a National Steering Committee for Animal Disease Prevention and Control upon the request of the Ministry of Agriculture and Rural Development and the Ministry of Fisheries when dangerous animal infectious diseases capable of infecting humans occur, to control and extinguish epidemics in emergency situations; deciding to use financial resources from the Animal Disease Prevention and Control Fund to implement disease prevention and control measures, extinguish animal epidemics, and mitigate the consequences of animal epidemics.

2. The Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall be responsible for:

a) Developing and directing the implementation of strategies, plans, and programs for disease prevention and epidemic control for animals;

b) Prescribe conditions and procedures for recognizing disease-free zones and facilities for animal diseases;

c) Direct the implementation of disease prevention, treatment, and control measures for animal diseases throughout the country;

d) Issue the List of Diseases to be Declared as Epidemics, the List of Dangerous Animal Diseases, and the List of Diseases Requiring Compulsory Prevention Measures;

đ) Decide on declaring epidemics, epidemic areas, threatened areas, buffer zones according to the authority stipulated in Clause 2, Article 17 of this Ordinance;

e) Prescribe compulsory preventive measures for animals in epidemic areas, threatened areas, buffer zones, previously affected areas, and previously threatened areas;

g) Prescribe the handling of diseased animals and animal products, as well as disinfection measures;

3. Provincial People's Committees (hereinafter referred to as provincial-level People's Committees) shall have the responsibility:

a) To organize the implementation of disease prevention, treatment, and control measures for animal diseases within their localities;

b) To decide on declaring epidemics, epidemic areas, threatened areas, and buffer zones within their localities;

c) To establish provincial-level Animal Disease Control Steering Committees according to the directives of the Government;

4. State management agencies in charge of veterinary affairs shall have the responsibility to guide and inspect the implementation of the provisions set out in Points a, b, c, đ, e, and g of Clause 2 of this Article;

5. People's Committees at all levels shall have the responsibility to organize and direct disease prevention and control for animals, report animal diseases, inspect epidemic areas, and build disease-free zones and facilities for animal diseases;

Article 11. Responsibilities of organizations and individuals in disease prevention, treatment, and control for animals

1. Pet owners must comply with the regulations on veterinary hygiene conditions in breeding as prescribed in this Ordinance and implement compulsory preventive measures, treatment, and disease control for animals;

2. Organizations and individuals when using veterinary drugs, biological preparations, microorganisms, chemicals for veterinary purposes to prevent and treat diseases in animals shall have the responsibility:

a) To use veterinary drugs, biological preparations, microorganisms, and chemicals for veterinary purposes listed in the Veterinary Drug Catalogue permitted for circulation in Vietnam, and the Biological Preparation, Microorganism, and Chemical Catalogue for Veterinary Purposes permitted for circulation in Vietnam;

b) To strictly follow usage instructions or directions provided by veterinarians or authorized veterinary practitioners;

Article 12. Veterinary Hygiene Conditions in Breeding

1. Veterinary hygiene conditions for household and individual breeding:

a) Livestock housing and other breeding places must be cleaned, disinfected, and decontaminated regularly and after each breeding cycle;

b) Breeding equipment must be cleaned before use;

c) Breeding stock must meet the quality standards for livestock breeds as prescribed by laws on livestock breeds and must not carry infectious diseases, having been quarantined and subjected to compulsory preventive measures;, d) Livestock feed must meet veterinary hygiene standards, not harmful to animals and consumers of animal products;

e) Water used for breeding must be clean and not cause disease in animals;

đ) Animals taken to communal grazing areas must be healthy and free from infectious diseases and dangerous parasites;

2. Veterinary hygiene conditions for centralized breeding facilities:

a) The location of the breeding facility must comply with planning requirements, located far from residential areas, public works, main roads, and pollution sources;

b) Must meet the veterinary hygiene standards specified in Points a, b, c, and d of Clause 2, and Points a, b, c, and d of Clause 3 of Article 7 of this Ordinance;

c) The breeding area must have waste disposal sites, isolation areas for animals, cleaning and disinfection areas for breeding equipment, and slaughter and examination areas;

d) Entry and exit points to the breeding area must apply hygiene and disinfection measures for people and transport vehicles passing through;

đ) Areas for producing, processing, and storing livestock feed must be isolated from areas containing hazardous chemicals;

Care for Animal Health

Article 13. 1. Land-based pets must be ensured the following conditions:

a) Adequate water and suitable food for each species must be provided;

b) Livestock housing and breeding equipment must meet veterinary hygiene standards and be appropriate for each type of pet;

c) Timely disease prevention and treatment must be provided;

2. Aquatic and amphibious animals must be ensured the following conditions:

a) They must live in suitable aquatic environments for each species. The water supply to aquaculture facilities must meet environmental standards, be treated to remove pathogens and intermediate hosts of diseases. Effluent from these facilities must be treated to meet prescribed standards;

b) Adequate and suitable food for each species must be provided according to established technical procedures. Proper waste management and cleaning and disinfection of breeding equipment must be implemented to prevent disease transmission between facilities and from outside sources;

c) Environmental standards must be monitored, and disease symptoms observed according to prescribed frequency and methods to detect and promptly address newly emerging diseases;

d) Timely disease prevention and treatment must be provided;

Building Disease-Free Zones and Facilities for Animal Diseases

Article 14. 1. Zones and facilities meeting the following conditions may be recognized as disease-free zones and facilities for animal diseases:

a) Ensuring veterinary hygiene conditions for disease-free zones and facilities as specified in Point đ of Clause 2 and Point đ of Clause 3 of Article 7 of this Ordinance;

b) Implementing compulsory preventive measures, quarantine of animals, and veterinary hygiene inspections for breeding facilities, production of breeding stock, slaughtering, initial processing of animals and animal products;

c) Having registered and been assessed as meeting the veterinary hygiene standards for disease-free zones and facilities for animal diseases;

2. Responsibilities of state agencies in building disease-free zones and facilities for animal diseases are as follows:

a) The Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall direct the construction of disease-free zones and facilities for animal diseases nationwide;

a) The Ministry of Agriculture and Rural Development, the Fisheries Ministry direct the construction of animal disease safety zones and facilities throughout the country;

b) The state management agency for veterinary affairs under the Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall guide local state management agencies on veterinary affairs in planning the construction of animal disease-safe zones and facilities; appraising and recognizing animal disease-safe zones and facilities; managing veterinary activities related to such zones and facilities according to the分级制度; supervising and inspecting veterinary activities related to such zones and facilities according to the分级制度;

c) People's Committees at all levels shall organize the construction of animal disease-safe zones and facilities within their respective jurisdictions; invest in veterinary activities within such zones and facilities;

d) Provincial-level state management agencies on veterinary affairs shall assist the same-level People's Committees in constructing, managing animal disease-safe zones and facilities within their respective jurisdictions.

3. Responsibilities of organizations and individuals in the construction of animal disease-safe zones and facilities are stipulated as follows:

a) Organizations and individuals engaged in animal husbandry must register to construct animal disease-safe zones and facilities and comply with legal provisions on veterinary affairs concerning such zones and facilities;

b) Organizations and individuals involved in activities related to animal disease-safe zones and facilities must comply with legal provisions on veterinary affairs concerning such zones and facilities.

Article 15. Developing a program to control and eradicate animal diseases

1. Principles for developing a program to control and eradicate animal diseases include:

a) Ensuring the effectiveness of controlling and eradicating dangerous animal diseases and zoonoses; meeting export requirements for animals and animal products;

b) Implementing measures to gradually reduce the number of outbreaks, sick animals, and ultimately eradicate animal diseases;

c) Leveraging contributions from domestic organizations and individuals, as well as foreign organizations and individuals, in controlling and eradicating animal diseases.

2. Responsibilities of state agencies in developing a program to control and eradicate animal diseases are stipulated as follows:

a) The Government shall have a national program to control and eradicate certain dangerous infectious diseases of animals; direct relevant ministries and sectors to cooperate with the Ministry of Agriculture and Rural Development and the Ministry of Fisheries in developing and implementing the national program to control and eradicate animal diseases;

b) The Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall develop the national program to control and eradicate animal diseases, submit it to the Government for approval, and direct its implementation;

c) State management agencies on veterinary affairs under the Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall guide the implementation of measures to control and eradicate animal diseases; supervise, inspect, and evaluate the implementation of such measures; cooperate with other countries and international organizations to implement the program to control and eradicate animal diseases;

d) People's Committees at all levels shall organize the implementation of the program to control and eradicate animal diseases; disseminate and popularize laws on veterinary affairs, and educate the local population about compliance with such laws;

đ) Provincial-level state management agencies on veterinary affairs shall disseminate and guide measures to control and eradicate animal diseases; supervise and inspect the implementation of such measures by organizations and individuals engaged in animal husbandry and veterinary activities in the locality.

Organizations and individuals engaged in animal husbandry are responsible for strictly complying with legal provisions on veterinary affairs and following the guidance of veterinary agencies to implement the program to control and eradicate animal diseases.

Article 16. Responsibilities for handling animal diseases

1. Animal owners and animal product producers are responsible for:

a) When animal owners discover diseased animals, dead animals due to disease, or animals showing signs of disease listed in the Catalogue of Dangerous Diseases of Animals, they must not sell, slaughter, or discard them but must isolate them immediately and report to the nearest veterinary staff or veterinary agency;

During transportation, at slaughterhouses or processing facilities, if animal product producers discover spoiled animal products, products that do not meet hygiene standards, or products showing signs of carrying dangerous pathogens, they must immediately report to the nearest veterinary staff or veterinary agency;

b) Upon determining that animals are diseased or animal products carry dangerous infectious pathogens listed in the Catalogue of Diseases Requiring Disease Outbreak Declarations, animal owners and animal product producers must isolate diseased animals, separately store contaminated animal products, arrange personnel to care for the animals, use separate feeding equipment and feed for the animals; limit the circulation of animals, animal products, and people entering animal husbandry facilities; implement mandatory measures for contaminated feed, diseased animals, contaminated animal products, and animal waste according to regulations specific to each disease; clean and disinfect animal husbandry, slaughter, processing facilities, animal husbandry equipment, slaughter equipment, veterinary equipment, and transport vehicles.

2. Veterinary staff and veterinary agencies are responsible for:

a) Upon receiving notifications as stipulated in point a, Clause 1 of this Article, veterinary staff and veterinary agencies must promptly diagnose and determine the disease;

b) Upon determining that animals are diseased or animal products carry dangerous infectious pathogens listed in the Catalogue of Diseases Requiring Disease Outbreak Declarations, veterinary staff and veterinary agencies must promptly guide animal owners and animal product producers to immediately implement the measures stipulated in point b, Clause 1 of this Article;

c) Depending on the nature and severity of the disease outbreak, veterinary agencies shall report to the same-level People's Committee to implement preventive and control measures for the affected area, while reporting to higher-level veterinary agencies.

Article 17Authority and conditions for declaring animal disease outbreaks

1. The Chairman of the Provincial People's Committee shall decide to declare an animal disease outbreak when the following conditions are met:

a) A disease listed in the Catalogue of Diseases Requiring Disease Outbreak Declarations occurs in the province with the potential to spread widely;

b) There is a written report from the Chairman of the District People's Committee on the development of the disease situation.

c) Having a diagnostic conclusion definitively identifying a dangerous animal infectious disease listed in the Catalogue of Diseases to be Declared and having a document requesting the declaration of a disease from the provincial state management agency for veterinary affairs or the state management agency for veterinary affairs under the Ministry of Agriculture and Rural Development, the Ministry of Fisheries.

2. The Minister of Agriculture and Rural Development, the Minister of Fisheries shall declare a disease based on the level, scale, and dangerous nature of the disease listed in the Catalogue of Diseases to be Declared occurring in two provinces or more.

3. The Prime Minister shall declare a disease when there is a dangerous animal infectious disease with the potential to infect humans, upon the proposal of the Minister of Agriculture and Rural Development, the Minister of Fisheries.

Article 18. Disease control organization in the affected area

1. When declaring a disease, the Chairman of the People's Committee of the province shall be responsible for organizing and directing the agriculture sector, the fisheries sector, organizations, and individuals related to implement the following measures:

a) Determining the boundaries of the affected area, the threatened area, and the buffer zone; placing warning signs, checkpoints, and guiding movement and transportation of animals and animal products to avoid the affected area;

b) Prohibiting people without duties from entering places where diseased animals or dead animals are present; limiting entry and exit in the affected area;

c) Prohibiting slaughtering, bringing in, taking out, or circulating within the affected area animals and animal products susceptible to the declared disease;

d) Urgently organizing vaccination or applying other mandatory preventive measures for animals susceptible to the declared disease in the affected area and the threatened area; treating or destroying diseased animals and animal products carrying pathogens according to the guidance of the competent veterinary authority; strengthening monitoring of animals in the buffer zone;

đ) Disinfecting and decontaminating animal shelters, ponds, lakes, places where diseased animals are raised, tools and equipment used in animal husbandry, waste, and contaminated environments according to the guidance of the veterinary authority and implementing other necessary veterinary hygiene measures in the affected area.

2. When declaring a disease, the Minister of Agriculture and Rural Development, the Minister of Fisheries shall be responsible for organizing and directing the agriculture sector, the fisheries sector, organizations, and individuals related to implement the measures prescribed in Clause 1 of this Article.

3. When declaring a disease, the Prime Minister decides:

a) Establishing the National Steering Committee for Prevention and Control of Animal Diseases;

b) Entrusting the Chairman of the People's Committee of the province to establish the Steering Committee for Prevention and Control of Animal Diseases at localities affected by the disease.

4. The Steering Committee for Prevention and Control of Animal Diseases has the right to mobilize personnel, means, and funds in accordance with the provisions of the law to organize the implementation of measures to extinguish the disease.

Article 19. Prevention and control of disease in the threatened area

1. When declaring a disease, the person authorized to declare animal diseases as stipulated in Article 17 of this Ordinance shall simultaneously declare the threatened area.

2. In case the disease occurs within a province, the provincial state management agency for veterinary affairs must strictly monitor and control activities related to animals and animal products in the threatened area and implement the following measures:

a) Controlling the introduction into and removal from the threatened area of animals and animal products susceptible to the declared disease;

b) Strictly controlling the slaughtering and circulation of animals and animal products within the area;

c) Applying mandatory preventive measures for animals.

3. In case the threatened area borders the affected area at the border of a neighboring country, the Chairman of the People's Committee of the province shall be responsible for:

a) Declaring the threatened area within a radius of 5 kilometers from the border and implementing the measures prescribed in Clause 2 of this Article;

b) Deciding on the border gate and species of animals not permitted to pass through the border gate;

c) Deciding to prohibit the introduction into Vietnam of species of animals and animal products susceptible to the pathogen of the disease currently occurring in the neighboring country;

d) Directing relevant agencies to strictly monitor and control activities related to animals and animal products in the area; implementing hygiene, disinfection, and decontamination measures for people and transport vehicles passing through the border gate.

Article 20. Prevention and control of disease in the buffer zone

1. When declaring a disease, the person authorized to declare animal diseases as stipulated in Article 17 of this Ordinance shall simultaneously declare the buffer zone.

2. When declaring a disease, the local state management agency for veterinary affairs must implement the following measures:

a) Monitoring and controlling activities related to animals and animal products in the buffer zone;

b) Strictly controlling the circulation of animals and animal products susceptible to the disease in the buffer zone;

c) Regularly monitoring and supervising animals susceptible to the disease.

Article 21. Conditions and Authority for Announcing the End of an Epidemic

1. The conditions for announcing the end of an epidemic include:

a) Having vaccinated or applied other mandatory preventive measures for animals susceptible to the epidemic disease in the affected area and areas at risk of the epidemic;

b) Within the specified period for each disease, from the date of death, slaughter, destruction, compulsory treatment, or recovery without recurrence of any animal or farmed aquatic animal being infected with or dying from the announced epidemic disease;

c) Having implemented hygiene, disinfection, and decontamination measures ensuring veterinary hygiene requirements for the affected area and areas at risk of the epidemic.

2. The person responsible for declaring an epidemic under Article 17 of this Ordinance has the authority to announce the end of an epidemic, revoke the declaration of the affected area, areas at risk of the epidemic, and buffer zones.

Article 22. Animal Disease Prevention and Control Fund

1. The animal disease prevention and control fund consists of physical assets and money used for the following purposes:

a) Preventing and controlling animal diseases;

b) Eradicating animal epidemics;

c) Mitigating the consequences of animal epidemics.

2. The animal disease prevention and control fund is formed from:

a) State budget;

b) Contributions from organizations and individuals involved in breeding, slaughtering, processing, trading, exporting, importing animals and animal products; producing, trading veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine, practicing veterinary medicine; contributions and sponsorships from domestic and foreign organizations and individuals, international organizations, and other sources as prescribed by law.

3. The animal disease prevention and control fund is established at the central level and provincial level. The establishment, management, and use of the animal disease prevention and control fund are regulated by the Government.

CHAPTER III
ANIMAL DISEASE INSPECTION; ANIMAL PRODUCTS DISEASE INSPECTION;
SLAUGHTER CONTROL; VETERINARY HYGIENE INSPECTION

PART I
ANIMAL DISEASE INSPECTION; ANIMAL PRODUCTS DISEASE INSPECTION

Article 23. Principles of animal and animal product inspection

1. Animals and animal products transported in large quantities out of a district must be inspected once at the place of origin.

2. Animals and animal products listed in the list of objects subject to animal and animal product inspection issued by the Ministry of Agriculture and Rural Development and the Ministry of Fisheries when imported, temporarily imported for re-export, temporarily exported for re-import, transferred between ports, or transiting must be inspected according to Articles 28 and 29 of this Ordinance.

For exported animals and animal products, the inspection shall be carried out according to the requirements of the importing country and in accordance with Article 27 of this Ordinance.

3. Animal and animal product inspection shall be conducted according to veterinary hygiene standards, inspection procedures, and processes issued by the Ministry of Agriculture and Rural Development and the Ministry of Fisheries.

4. Inspected animals and animal products must be quickly and accurately checked and identified.

5. Animals and animal products transported within the country that cannot be traced back to their owners may be allowed to be used or destroyed according to regulations depending on the condition of the animals and animal products.

Imported animals and animal products that cannot be traced back to their owners must be destroyed.

"d) Within no more than one working day from the date of receiving the dossier submitted for administrative procedures by the specialized agency assigned by the Provincial People's Committee, the Chairman of the Provincial People's Committee shall issue a notification of the result of the inspection of plant-based food exports or a certificate at the request of the importing country."Contents of animal and animal product inspection

1. Checking the inspection dossier.

2. Concentrating animals and animal products at designated locations or bringing them into quarantine inspection zones; conducting clinical examinations, diagnoses, and tests on animals and animal products to identify the inspected objects.

3. Concluding the inspection results to issue or not issue a health certificate for inspection, certify or not certify the inspection.

4. Requiring the owner of animals and animal products to handle according to point d, Clause 1, Article 25 of this Ordinance.

Article 25. Responsibilities of agencies, organizations, and individuals in animal and animal product inspection

1. The Ministry of Agriculture and Rural Development, the Ministry of Fisheries shall be responsible for:

a) Issuing the list of objects subject to animal and animal product inspection; the list of animals and animal products subject to inspection;

b) Issuing the list of prohibited imports of animals, animal products, livestock feed, raw materials of animal origin used to produce livestock feed;

c) Issuing inspection procedures and processes for animals and animal products transported domestically, exported, imported, temporarily imported for re-export, temporarily exported for re-import, transferred between ports, and transiting through Vietnam's territory according to points e and g, Clause 2, points e and g, Clause 3, Article 7 of this Ordinance;

d) Specifying measures to deal with animals, animal products, transportation vehicles, and containers that do not meet veterinary hygiene standards;

đ) Specifying uniforms, insignia, badges, signs, inspection certificates, and sample inspection dossiers for animals and animal products.

2. Customs, Trade, Transportation, and Police agencies have the responsibility to cooperate with the competent state agency on veterinary matters to carry out animal and animal product inspections within their respective localities.

3. Provincial People's Committees are responsible for planning the construction sites for quarantine zones for animals and animal products and directing the agencies mentioned in Clause 2 of this Article to conduct animal and animal product inspections.

4. The competent state agency on veterinary matters is responsible for carrying out animal and animal product inspections at road, railway, inland waterway, sea, air transport hubs, border gates, and post offices according to Articles 26, 27, 28, and 29 of this Ordinance.

The competent state agency on veterinary matters has the responsibility to assist the People's Committee at the same level in determining locations and guiding, inspecting the implementation of veterinary hygiene during the concentration of animals and animal products for participation in animal and animal product fairs and exhibitions according to Article 30 of this Ordinance.

5. The competent state agency on veterinary matters under the Ministry of Agriculture and Rural Development and the Ministry of Fisheries is responsible for inspecting and issuing health certificates or inspection certificates for exported, imported, temporarily imported for re-export, temporarily exported for re-import, transferred between ports, and transiting animals and animal products through Vietnam's territory.

6. The provincial state management agency for veterinary affairs is responsible for inspecting and issuing certificates of inspection for animals and animal products transported within the country.

7. People's Committees at all levels shall direct relevant sectors in their localities to carry out inspections of animals and animal products transported within the country.

8. Organizations and individuals transporting animals and animal products must comply with regulations on animal inspection and pay fees and charges as prescribed by laws on fees and charges.

Article 26. Inspection of Animals and Animal Products Transported Within the Country

1. The owner of animals and animal products must declare to the competent veterinary authority before transporting such animals and products.

The veterinary authority is responsible for conducting inspections according to regulations and issuing certificates of inspection; allowing the continued circulation of animals and animal products being transported if they have valid certificates of inspection.

In cases where the certificate of inspection is invalid or not available, the veterinary authority shall handle the matter in accordance with the provisions of the law.

2. Animals and animal products meeting the following conditions shall be issued certificates of inspection:

a) Animals meeting the hygiene standards set forth in point e, Clause 2, point e, Clause 3, Article 7 of this Ordinance, sourced from areas or facilities free from animal disease outbreaks, having been subject to mandatory preventive measures and still immune.

b) Animal products sourced from animals specified in point a of this clause and meeting hygiene standards, properly packaged and stored in accordance with the law;

c) Animal waste sourced from animals specified in point a of this clause and meeting hygiene standards as stipulated in point d, Clause 2, point d, Clause 3, Article 7 of this Ordinance.

3. Livestock equipment, transportation vehicles, containers for animals, animal products, and animal waste must be cleaned, disinfected, and sterilized before and after transportation; transportation vehicles for animal products must be specialized vehicles that meet the hygiene standards set forth in point b, Clause 2, and point b, Clause 3, Article 7 of this Ordinance and must be sealed before transporting inspected animal products.

4. The owners of animals, animal products, transportation vehicles, and containers for animals and animal products subject to hygiene inspection must be responsible for their goods, transportation vehicles, and declarations; ensuring hygiene and environmental sanitation during the concentration and transportation of animals and animal products in accordance with the law on veterinary affairs and the law on environmental protection.

Article 27. Inspection of Exported Animals and Animal Products

1. Exported animals and animal products must undergo inspection and hygiene examination at the place of origin in accordance with the requirements of the importing country or the owner of the animals and animal products.

2. Organizations and individuals exporting animals and animal products requiring inspection must declare in advance to the competent animal inspection authority. Based on the nature, quantity, type of animals and animal products, the animal inspection authority will notify the owner of the goods about the location and time of inspection.

3. The animal inspection authority issues certificates of inspection at the place of origin for animals, animal products, and transportation vehicles for animals and animal products that meet the hygiene standards.

In cases where it is determined that animals, animal products, and transportation vehicles for animals and animal products subject to hygiene inspection do not meet the hygiene standards required by the importing country, the animal inspection authority will require the owner of the goods to implement handling measures as prescribed in point d, Clause 1, Article 25 of this Ordinance.

Article 28. Inspection of Imported Animals and Animal Products

1. Organizations and individuals importing animals and animal products must declare in advance to the competent animal inspection authority of Vietnam.

Based on the nature, quantity, type of animals and animal products, the animal inspection authority will notify organizations and individuals importing animals and animal products about the location and time of inspection and quarantine observation.

2. The inspection must be carried out after the animals and animal products are brought to the location designated by the animal inspection authority. The inspection period for animal products shall not exceed ten days.

3. The inspection of imported animals is regulated as follows:

a) When animals arrive at the border gate, the inspection authority will check the documents and health status of the animals. If the documents are valid and the animals show no signs of dangerous diseases, the authority will confirm so that the owner can proceed with customs procedures and move the animals to the quarantine area for observation, with the quarantine period varying depending on the disease and species but not exceeding forty-five days; guiding the owner to implement hygiene measures for people in contact with the animals, environmental sanitation, livestock equipment, loading and unloading equipment, transportation vehicles, animal compartments, and other objects subject to hygiene inspection.

b) During transportation, loading, care, and quarantine observation of animals in the quarantine area, the owner or representative must follow the guidance of the veterinary authority.

4. Animal products and objects subject to hygiene inspection meeting the hygiene standards set forth in point e and point g, Clause 2, point e and point g, Clause 3, Article 7 of this Ordinance will be issued certificates of inspection by the veterinary authority to proceed with customs procedures; in cases where they need to be moved to another location for inspection, they must be issued movement certificates by the veterinary authority to proceed with customs procedures.

5. Organizations and individuals bringing animals and animal products into Vietnam for personal use must declare to the animal inspection authority at the border gate for inspection.

6. Animals and animal products that do not meet hygiene standards or are prohibited from importation shall be handled as follows:

a) Returning the animals to their place of origin or destroying them at the location designated by the veterinary authority and supervising the destruction process.

b) Return animal products to their place of origin or handle them in accordance with the provisions of the law; after handling, if they meet the requirements, they shall be allowed for import.

Article 29. Animal quarantine for temporarily imported and re-exported animals and animal products, temporarily exported and re-imported, transferred between border gates, transiting through the territory of Vietnam

1. Organizations and individuals having animals and animal products temporarily imported and re-exported, temporarily exported and re-imported, transferred between border gates, transiting through the territory of Vietnam must declare to the competent animal quarantine authority of Vietnam at least 7 days before the goods arrive at the border gate.

2. The animal quarantine authority at the border gate checks the export country's health certificate and conducts veterinary hygiene inspections when temporarily imported and re-exported animals and animal products, temporarily exported and re-imported, transferred between border gates, transiting through the territory of Vietnam arrive at the border gate; if they meet the conditions, the animal quarantine authority issues a health certificate or a health inspection certificate.

3. The animal quarantine authority requires organizations and individuals to take the following measures for animals and animal products that do not meet veterinary hygiene standards or are prohibited from importation:

a) Return animals and animal products to their place of origin;

b) Destroy diseased animals and animal products carrying dangerous infectious pathogens.

4. The animal quarantine authority at the border gate checks the export health certificate; only opens containers or seals for veterinary hygiene inspections when necessary according to the law for temporarily imported and re-exported animals and animal products, temporarily exported and re-imported, transferred between border gates, transiting through the territory of Vietnam in containers or other sealed means of transport.

Article 30. Animal quarantine for animals participating in trade fairs, exhibitions, sports competitions, artistic performances; animal products participating in trade fairs, exhibitions

1. Organizations and individuals having animals listed in the Catalogue of animals and animal products requiring quarantine, when gathering to participate in trade fairs, exhibitions, sports competitions, artistic performances; animal products listed in the Catalogue of animals and animal products requiring quarantine when entering trade fairs, exhibitions must comply with the following regulations:

a) Have a health certificate issued by the local state management agency on veterinary affairs for domestic animals and animal products;

b) Have an import health certificate issued by the animal quarantine authority for animals and animal products from abroad;

c) Ensure veterinary hygiene requirements during the time animals are gathered to participate in trade fairs, exhibitions, sports competitions, artistic performances, and animal products are entered into trade fairs, exhibitions, as guided by the local veterinary authority.

2. After the gathering period, trade fairs, exhibitions, the local state management agency on veterinary affairs will conduct a veterinary hygiene inspection for all animals and animal products, guide comprehensive disinfection of the entire area, and issue a health certificate for animals and animal products meeting veterinary hygiene standards for domestic use.

In cases where animals participating in trade fairs, exhibitions, sports competitions, artistic performances, and animal products participating in trade fairs, exhibitions require export from Vietnam, organizations and individuals having animals and animal products must follow the procedures for export quarantine as prescribed by law.

PART 2
CONTROL OF ANIMAL SLAUGHTER

Article 31. Principles of control over animal slaughter

1. Animals slaughtered must be controlled according to the procedures and formalities at the slaughterhouse as stipulated in Clause 1, Article 34 of this Ordinance.

2. Animals slaughtered must meet the veterinary hygiene standards as stipulated in Point h, Clause 2, Point h, Clause 3, Article 7 of this Ordinance, ensuring veterinary hygiene and food safety.

3. Animal products must be inspected and confirmed to meet veterinary hygiene standards before being put into circulation, and marked with a stamp or label for slaughter control or affixed with a veterinary hygiene label.

4. Only those holding an animal health inspector card may perform the task of controlling animal slaughter at animal slaughterhouses.

Article 32. Contents of control over animal slaughter

1. Inspect compliance with veterinary hygiene standards for slaughtered animals as stipulated in Point h, Clause 2, Point h, Clause 3, Article 7 of this Ordinance.

2. Inspect compliance with veterinary hygiene standards for slaughterhouses and initial processing facilities as stipulated in Point i, Clause 2, Point i, Clause 3, Article 7 of this Ordinance.

3. Inspect compliance with regulations for persons directly involved in slaughtering animals as stipulated in Clause 3, Article 33 of this Ordinance.

4. Check the animal health certificate, ensuring that animals are free from dangerous infectious diseases before slaughter.

5. Inspect animals before, during, and after slaughter to identify quarantine objects among animals and animal products.

6. Identify and handle diseased animals and dead animals; animal products that do not meet veterinary hygiene standards.

7. Stamp or mark the carcass or affix a veterinary hygiene label; issue a health certificate for the circulation of animal products.

Article 33. Conditions for veterinary hygiene at animal slaughter and processing facilities

1. The location of animal slaughter and processing facilities must comply with the planning of local People's Committees at all levels, ensuring veterinary hygiene and environmental sanitation.

2. Ensure the veterinary hygiene standards for animal slaughter and processing facilities as stipulated in point i, Clause 2, and point i, Clause 3, Article 7 of this Ordinance.

3. Persons directly involved in slaughtering animals and processing animals must meet health standards, not suffer from infectious or skin diseases, and have regular health check certificates issued by local health authorities.

Article 34. Responsibilities of agencies, organizations, and individuals in animal slaughter

1. The Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall prescribe procedures and formalities for controlling animal slaughter, slaughter control seals, marks, veterinary hygiene labels, and animal quarantine cards.

2. State management agencies under the Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall be responsible for controlling slaughter and inspecting veterinary hygiene at slaughter and processing facilities for export.

3. Provincial People's Committees shall be responsible for planning centralized animal slaughter facility locations within their provinces; directing lower-level People's Committees to plan and construct slaughter facilities at district and commune levels.

4. Local veterinary agencies shall be responsible for controlling slaughter, inspecting veterinary hygiene, and guiding the disposal of animal waste at slaughter and processing facilities serving domestic consumption.

5. Organizations and individuals engaged in animal trade and animal product business must conduct animal slaughter at designated facilities and pay inspection fees and charges as prescribed by law on fees and charges.

PART 3
SLAUGHTER CONTROL,

Article 35Principles of veterinary hygiene inspection

1. Veterinary hygiene inspections must be carried out during animal breeding, transportation, slaughter, processing, storage, circulation, and consumption of live animals and fresh animal products.

2. Veterinary hygiene inspections must be conducted in accordance with the authority, procedures, and formalities prescribed by law.

3. Veterinary hygiene inspections can only be conducted on objects listed in the Catalogue of Objects Subject to Veterinary Hygiene Inspection issued by the Ministry of Agriculture and Rural Development and the Ministry of Fisheries.

4. Only those holding an animal quarantine officer card may perform veterinary hygiene inspection tasks at facilities specified in Clause 1 of this Article.

Article 36Contents of veterinary hygiene inspection

1. Inspect and evaluate the implementation of veterinary hygiene standards as stipulated in points a, b, c, d, đ, g, h, i, k, and l of Clause 2, and points a, b, c, d, đ, g, h, i, k, and l of Clause 3, Article 7 of this Ordinance for:

a) Breeding, collection, and trading facilities for animals; production and trading facilities for animal breeds;

b) Equipment, tools, and means of transport used in animal breeding;

c) Feed and water for animals at concentrated breeding facilities; raw materials of animal origin used for feed production;

d) Animal waste and other objects subject to veterinary hygiene inspection;

đ) Disease-free zones and facilities;

e) Quarantine isolation areas for animals and animal products;

g) Slaughter, processing, and storage facilities for animals and animal products;

h) Production and trading facilities for veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary practices;.

2. Implement technical measures to detect objects subject to veterinary hygiene inspection.

3. Conclude and handle according to the provisions of the law.

Article 37Responsibilities of agencies, organizations, and individuals in veterinary hygiene inspection

1. The Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall be responsible for issuing:

a) Catalogue of objects subject to veterinary hygiene inspection; Catalogue of objects required to undergo veterinary hygiene inspection;

b) Catalogue of objects required to undergo mandatory veterinary hygiene inspection standards;

c) Regulations on the authority, procedures, and formalities for veterinary hygiene inspection.

2. State management agencies under the Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall be responsible for inspecting veterinary hygiene of objects specified in Clause 1 of Article 36 of this Ordinance at centrally-managed breeding facilities and export-oriented slaughter facilities, and handling violations according to the law.

3. Local People's Committees at all levels shall direct relevant agencies in their locality to coordinate in implementing regulations on veterinary hygiene inspection and handling violations according to the law.

4. Local state management agencies with authority over veterinary matters shall be responsible for inspecting veterinary hygiene of objects specified in Clause 1 of Article 36 of this Ordinance and handling violations according to the law.

5. Organizations and individuals producing and trading in animals and animal products must comply with regulations on veterinary hygiene inspection; pay inspection fees and charges according to the law on fees and charges.

PART IV
MANAGEMENT OF VETERINARY DRUGS, BIOLOGICAL PREPARATIONS, MICROORGANISMS,
CHEMICALS USED IN VETERINARY PRACTICES

Article 38. Conditions for producing, processing, and distributing veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine

Organizations and individuals producing, processing, and distributing veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine must meet the following conditions:

1. Have registration for producing, processing, and distributing veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine;

2. Have premises, factories, equipment, storage facilities, wastewater treatment systems that comply with veterinary hygiene standards as stipulated in point l, clause 2, point l, clause 3, Article 7 of this Ordinance and ensure environmental hygiene;

3. Have sufficient equipment appropriate to the scale of production, processing, distribution, and quality control of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine;

4. Must apply Good Manufacturing Practices (GMP) principles and standards for veterinary drug manufacturing facilities;

5. Have personnel directly managing the production of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine who hold a veterinary practice certificate;

6. Have personnel testing veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine who hold a veterinary practice certificate;

7. Only produce, process, and distribute veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine listed in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam and the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Medicine Permitted for Circulation in Vietnam as specified in point c, clause 1, Article 51 of this Ordinance;

8. Personnel directly producing, processing, and distributing veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine must have a health certificate issued by a Health Center at the district level or higher.

Article 39. Conditions for trading veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine

Organizations and individuals trading veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine must meet the following conditions:

1. Have registration for trading veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine;

2. Have premises, physical and technical facilities for storing and selling goods that comply with veterinary hygiene standards as stipulated in point l, clause 2, point l, clause 3, Article 7 of this Ordinance;

3. Managers and personnel directly selling veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine must hold a veterinary practice certificate;

4. Only trade veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine listed in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam and the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Medicine Permitted for Circulation in Vietnam as specified in point c, clause 1, Article 51 of this Ordinance.

Article 40. Conditions for veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine to be included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam and the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Medicine Permitted for Circulation in Vietnam

1. New veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine produced domestically or imported into Vietnam for the first time shall be recognized when they meet the following conditions:

a) Have test results for new veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine produced domestically; have test results and field trials for new veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine imported into Vietnam for the first time;

b) Have registration files for circulation of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine, including application forms for circulation of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine, summaries of product characteristics; technical information on product quality, technical information on product characteristics, efficacy, and safety, certificates of testing from the manufacturing facility and authorized testing agencies, test results, trials, field trials, and labels of the product;

c) Be evaluated by the specialized scientific council established by the Ministry of Agriculture and Rural Development and the Ministry of Fisheries and recommended for recognition.

2. Based on the recommendation of the specialized scientific council, the Minister of Agriculture and Rural Development and the Minister of Fisheries will consider and decide to recognize new veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine produced domestically or imported into Vietnam for the first time to be included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam and the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Medicine Permitted for Circulation in Vietnam.

Article 41. Veterinary drug testing, biological products, microorganisms, chemicals used in veterinary medicine

1. Veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine not included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam and the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Medicine Permitted for Circulation in Vietnam when registering for circulation or importation must be tested.

2. Testing of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine must be conducted by authorized veterinary drug testing agencies under the Ministry of Agriculture and Rural Development and the Ministry of Fisheries.

Article 42. Testing of new veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine produced domestically

1. New veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine produced domestically when registering for circulation must be tested.

2. The testing facility for veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine must meet the conditions stipulated in point d, clause 1, Article 51 of this Ordinance and be recognized by the competent state management agency for veterinary medicine under the Ministry of Agriculture and Rural Development and the Ministry of Fisheries.

3. The testing and recognition of new veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine produced domestically must be carried out according to procedures and formalities prescribed by the Ministry of Agriculture and Rural Development and the Ministry of Fisheries.

Article 43. Field trials of new veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine imported into Vietnam for the first time

1. Veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine produced abroad and not included in the List of Permitted Veterinary Drugs for Circulation in Vietnam, the List of Permitted Biological Products, Microorganisms, Chemicals Used in Veterinary Medicine for Circulation in Vietnam, when registering for importation into Vietnam for the first time, must be tested.

2. The testing facilities for veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine must meet the conditions stipulated in point d, Clause 1, Article 51 of this Ordinance and must be recognized by the competent state management agency under the Ministry of Agriculture and Rural Development, the Ministry of Fisheries.

3. Testing must be carried out according to the procedures and formalities prescribed by the Ministry of Agriculture and Rural Development, the Ministry of Fisheries.

Article 44. Veterinary drug certification, biological products, microorganisms, chemicals used in veterinary medicine

1. Quality control of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine is conducted to re-evaluate the quality of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine that have been tested, experimented, or examined, or are currently circulating in the market.

2. Veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine must undergo quality control in the following cases:

a) When there are complaints or reports about the quality of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine;

b) Upon request of a competent state authority.

3. Quality control of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine shall be carried out at the testing facility for veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine decided by the Ministry of Agriculture and Rural Development, the Ministry of Fisheries.

Article 45. Costs, fees, and charges for testing, experimenting, examining, and quality control of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine

1. The person requesting testing, experimenting, examining, and quality control of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine must bear the costs according to the contract, fees, and charges as prescribed by the laws on fees and charges.

2. In case the results of quality control of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine determine that the testing, experimenting, or examining results were incorrect, the testing, experimenting, or examining facility must bear the cost of quality control.

Article 46. Announcement of quality standards for veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine

1. Organizations and individuals producing or importing veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine listed in the List of Permitted Veterinary Drugs for Circulation in Vietnam, the List of Permitted Biological Products, Microorganisms, Chemicals Used in Veterinary Medicine for Circulation in Vietnam must announce the quality standards for veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine and be responsible for the announced quality standards in accordance with point m, Clause 2, point m, Clause 3, Article 7 of this Ordinance; the announced quality standards must not be lower than those specified in point a and point b, Clause 1, Article 7 of this Ordinance.

2. The procedures, formalities, and conditions for announcing quality standards for veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine shall be implemented in accordance with the laws on product quality.

Article 47. Announcement of quality of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine meeting standards

1. Organizations and individuals producing or importing veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine must base their announcement of quality meeting standards on:

a) Certificates of test results, quality test results of newly produced domestic veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine from the testing facility, the testing institution;

b) Certificates of test results, examination results of quality of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine imported into Vietnam for the first time from the testing facility, the examination institution;

c) Certificates of conformity to Vietnamese Standards or industry standards as stipulated in Clause 2 and Clause 3 of this Article.

2. The Ministry of Science and Technology shall issue the List of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine that must apply Vietnamese Standards, the List of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine that must be certified as conforming to Vietnamese Standards.

3. The Ministry of Agriculture and Rural Development, the Ministry of Fisheries shall issue the List of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine that must apply industry standards, the List of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine that must be certified as conforming to industry standards.

4. The procedures and formalities for announcing the quality of veterinary drugs, biological products, microorganisms, chemicals used in veterinary medicine meeting standards must be implemented in accordance with the laws on product quality.

Article 48. Conditions for importing and exporting veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices

1. Organizations and individuals are permitted to import various types of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices, raw materials for veterinary drugs, microorganisms, and biological products used in veterinary practices listed in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam, the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices Permitted for Circulation in Vietnam.

Veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices imported for the first time and not included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam, the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices Permitted for Circulation in Vietnam must undergo testing and trial before being included in the Catalogue.

2. Organizations and individuals importing veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices, raw materials for veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices not included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam, the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices Permitted for Circulation in Vietnam must ensure the following conditions:

a) Approval from the competent state management agency for veterinary affairs under the Ministry of Agriculture and Rural Development, the Ministry of Fisheries.

b) Application documents for importation, including an application for importation, Good Manufacturing Practice (GMP) certification of the production facility, a summary of product characteristics, efficacy, and safety, analysis reports, and certificates of permission for production and circulation issued by the competent authority of the producing country.

c) Samples of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices with complete finished product labels, intermediate labels, packaging, and sufficient quantities of drugs for the veterinary drug inspection agency to test quality.

3. In cases of urgent disease outbreaks, the importation of veterinary drugs, vaccines not included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam shall be decided by the Minister of Agriculture and Rural Development, the Minister of Fisheries.

4. The export of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices shall be carried out in accordance with Vietnamese laws and requirements of the importing country.

Article 49. Regulations on labeling of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices

Veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices must have labels when circulating and using. Labeling of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices must comply with legal regulations; the label must include the phrase "For Veterinary Use Only."

Article 50. Handling of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices

1. The handling of veterinary drugs is regulated as follows:

a) Veterinary drugs subject to destruction include those listed in the Catalogue of Veterinary Drugs Prohibited from Circulation in Vietnam, veterinary drugs not included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam; counterfeit veterinary drugs, veterinary drugs of unknown origin, expired veterinary drugs.

The destruction of veterinary drugs must be carried out in accordance with legal provisions and must be supervised and confirmed by the competent state management agency for veterinary affairs, environmental protection agencies, local authorities, and other relevant agencies.

b) Imported veterinary drugs must be returned to their place of origin, including veterinary drugs not included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam, veterinary drugs without labels or with labels that do not comply with Vietnamese legal regulations, substandard veterinary drugs.

c) Veterinary drugs included in the Catalogue of Veterinary Drugs Permitted for Circulation in Vietnam currently circulating in the market but failing to meet registered quality standards shall be suspended from circulation and handled according to legal provisions.

2. The handling of biological products, microorganisms, and chemicals used in veterinary practices is regulated as follows:

a) Biological products, microorganisms, and chemicals used in veterinary practices subject to destruction include those listed in the Catalogue of Prohibited Goods for Use in Vietnam; biological products, microorganisms, and chemicals used in veterinary practices not included in the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices Permitted for Circulation in Vietnam, counterfeit microorganisms, counterfeit biological products, counterfeit chemicals, of unknown origin, expired.

The destruction of biological products, microorganisms, and chemicals used in veterinary practices must be carried out in accordance with legal provisions and must be supervised and confirmed by the competent veterinary agency, environmental protection agencies, local authorities, and other relevant agencies.

b) Imported biological products, microorganisms, and chemicals used in veterinary practices must be returned to their place of origin, including biological products, microorganisms, and chemicals not included in the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices Permitted for Circulation in Vietnam; biological products, microorganisms, and chemicals used in veterinary practices without labels or with labels that do not comply with Vietnamese legal regulations.

c) In cases where biological products, microorganisms, and chemicals used in veterinary practices included in the Catalogue of Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices Permitted for Circulation in Vietnam currently circulating in the market fail to meet prescribed quality standards, they shall be suspended from circulation and handled according to legal provisions.

3. Organizations and individuals possessing veterinary drugs, biological products, microorganisms, and chemicals used in veterinary practices subject to handling must bear the costs of handling in accordance with legal provisions.

Article 51. Responsibilities of State Agencies in Managing Veterinary Drugs, Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices.

1. The Ministry of Agriculture and Rural Development, the Ministry of Fisheries shall be responsible for:

a) Issuing the Catalogue of Veterinary Drugs, Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices Prohibited from Importation.

b) Issuing the Catalogue of Veterinary Drugs, Biological Products, Microorganisms, and Chemicals Used in Veterinary Practices Prohibited and Restricted for Use in Vietnam.

c) Issue the List of Veterinary Drugs Permitted for Circulation in Vietnam, the List of Biological Preparations, Microorganisms, Chemicals Used in Veterinary Medicine Permitted for Circulation in Vietnam;

d) Specify the procedures for research, testing, trial, evaluation, and registration for circulation of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine not included in the List of Veterinary Drugs Permitted for Circulation in Vietnam, the List of Biological Preparations, Microorganisms, Chemicals Used in Veterinary Medicine Permitted for Circulation in Vietnam;

e) Manage, guide, and inspect the implementation of legal provisions on conditions for production, business, importation, and circulation of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine;

2. The State Management Agencies for Veterinary Medicine under the Ministry of Agriculture and Rural Development, the Ministry of Fisheries shall be responsible for:

a) Approving trials and evaluations of new veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine produced domestically or imported into Vietnam for the first time; issuing certificates of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine permitted for circulation in Vietnam;

b) Inspecting and auditing the conditions of establishments producing veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine; guiding the disposal of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine according to technological procedures to ensure environmental hygiene and human health; handling counterfeit, substandard, banned, or unlisted veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine according to Article 50 of this Ordinance and environmental protection laws;

3. People's Committees at all levels shall be responsible for directing relevant agencies at the local level in coordinating the implementation of regulations on managing the production and business of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine; handling violations related to the business of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine according to the law;

4. Provincial State Management Agencies for Veterinary Medicine shall be responsible for:

a) Organizing training and professional development in specialized knowledge, business practices, and laws for individuals engaged in the business of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine; issuing veterinary practice certificates;

b) Inspecting and auditing the conditions of establishments engaged in the business of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine; guiding the disposal of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine according to technological procedures to ensure environmental hygiene and human health; handling counterfeit, banned, or unlisted veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine according to Article 50 of this Ordinance and environmental protection laws;

5. Organizations and individuals producing and trading in veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine must ensure registered quality standards and bear legal responsibility for the quality standards of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine they produce and trade;

CHAPTER V
PRACTICE OF VETERINARY MEDICINE

Article 52Scope of Veterinary Practice

1. Vaccination, testing, diagnosis, prescription writing, treatment, and animal health care.

2. Animal surgery.

3. Production of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine.

4. Business of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine.

5. Testing, evaluation, and trial of veterinary drugs, biological preparations, microorganisms, chemicals used in veterinary medicine.

6. Consulting activities and other services related to veterinary medicine.

Article 53. Conditions for veterinary practitioners

1. Possessing a qualification appropriate to the veterinary specialty.

2. Holding a practice certificate issued by the competent state administrative body for veterinary affairs.

3. Having veterinary equipment, tools, and devices suitable for the registered form of practice.

4. Being in good health to practice.

5. Adhering to professional ethics.

Article 54Competence, procedures for issuing veterinary practice certificates

1. The state administrative body for veterinary affairs under the Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall be responsible for examining conditions and issuing veterinary practice certificates to individual veterinary practitioners as stipulated in Clauses 3, 4, and 5 of Article 52 of this Ordinance.

2. The provincial state administrative body for veterinary affairs shall be responsible for examining conditions and issuing veterinary practice certificates to individual veterinary practitioners as stipulated in Clauses 1, 2, 4, and 6 of Article 52 of this Ordinance.

The person applying for a veterinary practice certificate shall submit an application file to the authorized veterinary authority. The application for a certificate includes:

a) An application for a veterinary practice certificate;

b) A copy of the qualification and certificate of professional level;

c) A curriculum vitae;

d) A health certificate.

Chapter VI
INSPECTION AND DISPUTE RESOLUTION

Article 55. Veterinary inspection

Veterinary inspection is specialized veterinary inspection.

The organization and operation of specialized veterinary inspection shall be carried out in accordance with the laws on inspection.

Article 56. Dispute resolution

Disputes concerning veterinary matters shall be resolved in accordance with the laws.

Chapter VII

IMPLEMENTING PROVISIONS

Article 57. Effectiveness

This Ordinance takes effect from October 1, 2004.

This Ordinance replaces the Veterinary Ordinance dated February 4, 1993.

Article 58. Implementation guidance

The Government shall provide detailed regulations and guidance for the implementation of this Ordinance./.