Nghị định 33/2005/ND-CP

Decree No. 33/2005/ND-CP of March, 15, 2005, detailing the implementation of a number of articles of the Ordinance on veterinary medicine

Decree No. 33/2005/ND-CP of March, 15, 2005, detailing the implementation of a number of articles of the Ordinance on veterinary medicine đã được thay thế bởi Decree 35/2016/ND-CP guidelines law veterinary medicine và được áp dụng kể từ ngày 01/07/2016.

Nội dung toàn văn Decree No. 33/2005/ND-CP of March, 15, 2005, detailing the implementation of a number of articles of the Ordinance on veterinary medicine


THE GOVERNMENT
-------

SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom – Happiness
----------

No. 33/2005/ND-CP

Hanoi, March 15, 2005

 

DECREE

DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE ORDINANCE ON VETERINARY MEDICINE

THE GOVERNMENT

Pursuant to the December 25, 2001 Law on Organization of the Government;
Pursuant to the April 29, 2004 Ordinance on Veterinary Medicine;
At the proposals of the Agriculture and Rural Development Minister and the Fisheries Minister,

DECREES:

Chapter I

GENERAL PROVISIONS

Article 1.- Scope and subjects of application

1. This Decree details the implementation of a number of articles of the Ordinance on Veterinary Medicine regarding:

a/ Prevention and treatment of animal diseases, prevention and control of animal epidemics;

b/ Quarantine of animals and animal products; control of slaughter and inspection of veterinary hygiene;

c/ Management of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use;

d/ Practice of veterinary medicine.

2. This Decree applies to Vietnamese organizations and individuals as well as foreign organizations and individuals engaged in veterinary activities in the Vietnamese territory.

Where international treaties which the Socialist Republic of Vietnam has signed or acceded to contain provisions different from those of this Decree, such international treaties shall apply.

Article 2.- Interpretation of terms

In this Decree, the following terms are construed as follows:

1. Animals infected with disease mean animals that are infected with disease and show typical symptoms and signs of disease or have the identified pathogens of disease.

2. Animals suspected of being infected with disease mean animals that show unclear symptoms and signs or have the unidentified pathogens of disease or animals that live in the epidemic-hit zones and show abnormal signs or give up eating and get a fever.

3. Animals affected by disease mean animals that show abnormal signs but not pathological symptoms.

4. Animals suspected of being affected by disease mean animals susceptible to disease and have come into contact with or have been close to animals infected or animals suspected of being infected with disease.

5. Animal epidemic means an infectious animal disease which can spread into an epidemic.

6. Pathological material means a sample taken from alive or dead animals, containing or suspected of containing causative pathological or parasitic agents, to be sent to laboratories for diagnosis.

7. Diagnosis of an animal disease means the use of techniques to identify the disease.

8. Animal isolation means raising animals in complete isolation from, with no direct or indirect contact with, other animals in establishments for a given period of time in order to monitor the health of animals and, when necessary, to conduct tests to identify diseases.

9. Epidemic surveillance means the monitoring, examination and evaluation of the nature and causes of a disease, and the mode of its transmission throughout the process of raising, transportation, slaughtering, preliminarily processing and trading of animals or animal products.

10. Epidemic control means the application of various measures to check the spread of epidemics, the number of epidemic focuses and the number of newly infected animals in epidemic focuses.

11. Eradication of an animal disease means the application of technical veterinary measures and other measures to eradicate an animal disease within a certain zone.

12. Animal raising by households or individuals means animal raising within a scope not yet reaching the criteria of farm economy according to regulations of competent state agencies.

13. Concentrated animal-raising establishments mean animal-raising establishments of enterprises or animal-raising establishments of farm or larger scope.

14. Animal quarantine cadres mean cadres performing the task of quarantining animals, animal products, controlling slaughtering and inspecting veterinary hygiene, and having quarantine cadre’s cards granted by competent animal health agencies.

15. Establishments that slaughter animals, preliminarily process animals, animal products mean fixed places which are granted by competent agencies the business registration certificates for slaughtering animals and/or preliminarily processing animals and/or animal products.

16. Goods owners mean owners of animals and/or animal products or managers, representatives, escorts, transporters or attendants of animals and/or animal products on behalf of goods owners.

17. Establishment owners mean owners of establishments that raise, slaughter animals, preliminarily process, preserve animals, animal products.

18. Veterinary drug materials mean substances included in the composition of veterinary drugs.

19. Finished veterinary drugs mean drugs which have undergone all stages of the manufacturing process, including final packaging, labeling, quality inspection by establishments, and meet quality norms stated in registration dossiers.

20. New drugs mean drugs with a pharmaceutical formula containing new active ingredients, drugs with a new combination of active ingredients, drugs with a new pharmaceutical form, drugs with new indications or drugs with a new usage route.

21. Vaccines mean products containing antigens which, after being introduced into the animals, will enable the animals to be immune to an epidemic, and are used for preventive purposes.

22. Veterinary drug residue means the volume of active ingredients or their transformed products left in the tissues of animals or animal products after drugs are no longer used, possibly causing harms to consumers’ health.

23. Withdrawal time means the duration of time from the time the last dose of drug is administered to an animal to the time the animal can be slaughtered or its products can be used to ensure that drug residues in animal products do not exceed the permitted limit.

24. Drug stability means the capability of maintaining intrinsic physic, chemical, biological, pharmaceutical or toxic characteristics of drugs within the prescribed limits under given preservation conditions.

25. Good drug-manufacturing practice (GMP) means the application of manufacturing principles and standards to secure the quality of drugs up to the announced quality standards.

26. Drug quality standards mean technical criteria, testing methods, packaging, labeling, transportation, preservation and other requirements related to the quality of drugs.

27. Poor quality drugs mean drugs failing to meet quality standards announced by establishments and accepted by competent agencies.

28. Fake veterinary drugs mean veterinary drug products without manufacturing registration certificates granted by competent agencies or products manufactured in the form of drug in one of the following cases:

a/ Containing no or insufficient active ingredients as registered;

b/ Containing pharmaceutical materials different from those indicated on labels;

c/ Illegally bearing the names, designs and codes registered for circulation of products of other establishments;

d/ Illegally bearing the names or industrial designs of products of other establishments for which industrial property protection has been registered.

Article 3.- System of state management agencies in charge of animal health

1. At the central level:

a/ The Animal Health Department under the Agriculture and Rural Development Ministry; the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals under the Fisheries Ministry.

b/ The Agriculture and Rural Development Ministry shall define the functions, tasks, powers and organizational structure of the Animal Health Department; the Fisheries Ministry shall define the functions, tasks, powers and organizational structure of the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals.

2. At the local level:

a/ Provinces, centrally-run cities (hereinafter referred collectively to as provinces or provincial-level) where there are provincial-level state management agencies in charge of animal health;

b/ Urban districts, rural districts, towns, provincial cities (hereinafter collectively referred to as districts or district-level) where there are district-level state management agencies in charge of animal health;

c/ The Agriculture and Rural Development Ministry and the Fisheries Ministry shall coordinate with the Home Affairs Ministry in guiding the functions, tasks powers and organizational structures of state management agencies in charge of animal health at all levels.

The People’s Committees of provinces and centrally-run cities shall specify the tasks, powers and organizational structures of state management agencies in charge of animal health at all levels.

Article 4.- Animal health networks in communes, wards and townships

1. In communes, wards and townships (hereinafter collectively referred to as communes or commune level) there shall be veterinarians. Veterinarians shall receive allowances as provided for by the provincial-level People’s Committees and these allowances shall be paid from local budgets.

2. Organizations and individuals practicing veterinary medicine in villages or hamlets shall be encouraged and supported by the State in professional training and enjoy remuneration when they perform tasks at the requests of state management agencies in charge of animal health.

Article 5.- Animal health in establishments

Concentrated animal-raising establishments must have staffs specialized in animal health to perform veterinary work in the establishments under the professional guidance of competent state management agencies in charge of animal health.

Chapter II

PREVENTION AND TREATMENT OF ANIMAL DISEASES, CONTROL OF ANIMAL EPIDEMICS

Article 6.- Veterinary hygiene conditions for animal raising by households and individuals

1. Households and individuals that raise terrestrial animals must fully meet the veterinary hygiene conditions provided for in Clause 1, Article 12 of the Ordinance on Veterinary Medicine and the following conditions on breeding facilities:

a/ Being suitable to raised animals, easy to cleanse and disinfect;

b/ Being hygienic, ventilating in summer and warm in winter;

c/ There are stables for isolation of infected animals, animals suspected of being infected, affected animals or animals suspected of being affected;

d/ There are places for treatment of animal wastes, which ensure veterinary hygiene and environmental sanitation;

e/ There are measures to kill harmful rodents and insects.

2. Households and individuals that raise aquatic or amphibian animals must satisfy all veterinary hygiene conditions specified at Points a, b, c, d and e, Clause 1, Article 12 of the Ordinance on Veterinary Medicine and the following conditions on raising places:

a/ Ponds or marshes for raising aquatic animals must ensure the conditions specified at Points d and h, Clause 2, Article 7 of this Decree;

b/ Floating cages and weirs for raising aquatic or amphibian animals must ensure the conditions specified at Point b and f, Clause 3, Article 7 of this Decree.

3. Periodically, before and after each raising cycle, all stables, raising grounds, means and tools used in raising animals must be disinfected.

Article 7.- Veterinary hygiene conditions on concentrated animal-raising establishments

1. Concentrated terrestrial animal-raising establishments must satisfy all veterinary hygiene conditions specified in Clause 2, Article 12 of the Ordinance on Veterinary Medicine and the following conditions on location, environment and raising facilities:

a/ Establishments must be situated in line with the plannings approved by competent authorities;

b/ Establishments must have fences or walls to prevent people or animals from penetrating into the establishments;

c/ Having separate administrative quarters;

d/ Having personal hygiene and clothes-changing places for officials, workers and visitors;

e/ Having sterilization pits for people and means of transport before entering the establishments and animal-raising places;

f/ Stables must be suitable to raised animals, airy in summer, warm in winter, and easy to cleanse and disinfect;

g/ The distance between stables must be long enough to ensure airiness;

h/ The environment of animal-raising places must satisfy the prescribed veterinary hygiene standards;

i/ Having separate storehouses for preserving feeds, materials for production of feeds; raising tools; and toxic chemicals for disinfection;

j/ Conducting cleansing and disinfection on a periodical basis, upon outbreaks of epidemics and after each animal-raising cycle or sale of animals;

k/ Ensuring the duration of keeping stables empty after each animal-raising cycle or each sale of animals;

l/ Applying measures to kill harmful rodents and insects.

2. Establishments for concentrated raising of aquatic or amphibian animals in ponds or marshes must satisfy all veterinary hygiene conditions specified in Clause 2, Article 12 of the Ordinance on Veterinary Medicine and the following conditions on location, environment and raising facilities:

a/ Establishments must be situated in line with the plannings approved by competent authorities;

b/ Having separate canals for supplying water for raising animals and for draining wastewater;

c/ Having ponds for treating water before it is channeled into animal-raising ponds or marshes;

d/ Treating wastewater or solid waste up to veterinary hygiene standards before it is discharged from the establishments;

e/ Having places of personal hygiene for officials, workers and visitors separated from animal-raising ponds or marshes;

f/ Having separate storehouses for preserving feeds, materials used for the production of feeds; tools for raising animals; drugs, chemicals, bio-preparations used in the animal-raising process;

g/ Conducting cleansing and disinfection on a periodical basis, upon outbreaks of epidemics and after each animal-raising cycle, each time of sale of animals;

h/ Ensuring the duration of interruption after each animal-raising cycle;

i/ Applying measures to prevent people and animals from penetrating into the establishments.

3. Establishments for concentrated raising of aquatic or amphibian animals in floating cages or weirs must satisfy all veterinary hygiene conditions specified in Clause 2, Article 12 of the Ordinance on Veterinary Medicine and the following conditions on location, environment and raising facilities:

a/ Establishments must be situated in line with the plannings approved by competent authorities;

b/ Solid waste must be treated before being discharged into the environment;

c/ Houses for personal hygiene at animal-raising places must be designed to prevent discharge into the raising environment;

d/ Having separate storehouses for preserving feeds, materials used for the production of feeds; tools for raising animals; drugs, chemicals, bio-preparations used in the animal-raising process;

e/ Conducting cleansing and disinfection on a periodical basis, upon occurrence of epidemics and after each animal-raising cycle or sale of animals;

f/ Ensuring the duration of interruption after each animal-raising cycle.

4. Animal-raising establishments, animal-raising places, equipment, tools, means of transport and water used in raising animals, and treated animal wastes must meet the veterinary hygiene standards specified at Points a, b, c and d, Clause 3, Article 7 of the Ordinance on Veterinary Medicine.

Article 8.- Veterinary hygiene of feeds and water used in raising animals, of pastures and animal wastes

1. Feeds must fully meet veterinary hygiene standards, not cause harms to animals and users of animal products. Feeds used for animals in concentrated animal-raising establishments must be checked and appraised according to veterinary hygiene standards.

2. Animals and animal products failing to satisfy food standards, and dead animals, if being used as feeds, must be treated to ensure veterinary hygiene before use. After being treated, if they still fail to satisfy veterinary hygiene standards for use as feeds, they must be destroyed.

3. Self-made or recycled feeds must be treated to ensure veterinary hygiene before being given to animals.

4. Water used in raising animals and processing feeds must ensure veterinary hygiene. Untreated industrial wastewater must not be used for raising animals.

5. Carcasses, animal wastes must be treated up to veterinary hygiene standards before they can be used as plant fertilizers.

6. For pastures sprayed with pesticides or disinfectants, a sufficient time must be ensured according to regulations for such pesticides or disinfectants to fully disintegrate before animals are pastured.

Article 9.- Isolation of animals before being put into establishments for raising

1. Before being put into animal-raising establishments for raising, animals must be raised in isolation. The time of isolated raising shall depend on each disease and each animal species as follows:

a/ Between 15 and 30 days for terrestrial animals;

b/ Between 3 and 30 days for imported aquatic or amphibian animals.

2. During the time of isolated raising, separate supervising and raising people and tools must be arranged for animals raised in isolation.

3. After the time of isolated raising, healthy terrestrial animals shall be herded; healthy aquatic or amphibian animals shall be raised in ponds, marshes, floating cases or weirs.

4. Animals infected with a contagious disease must be technically treated according to regulations on the disease concerned.

Article 10.- Compulsory prevention of animal diseases

1. Owners of terrestrial animals must abide by the following provisions on compulsory prevention of animal diseases:

a/ To use veterinary drugs, bio-preparations for preventing diseases on the list of diseases subject to application of compulsory preventive measures;

b/ To implement vaccination instructions of provincial-level People’s Committees, vaccination plans of provincial-level state management agencies in charge of animal health, and pay vaccination expenses.

Owners of animals already provided with compulsory vaccinations shall be granted vaccination certificates as a basis for competent state management agencies in charge of animal health to grant quarantine certificates when such owners need to transport their animals;

c/ To administer drugs to animals on a periodical basis in order to prevent blood-borne parasitic diseases and eradicate parasitical worms;

d/ To apply compulsory veterinary hygiene measures to animal raising; kill rats, flies, mosquitoes, and other vectors in animal-raising places.

2. Animal owners must prevent aquatic and amphibian animal diseases as follows:

a/ To observe the Fisheries Ministry’s regulations on compulsory prevention of diseases by vaccines, veterinary drugs, bio-preparations or chemicals to treat disease pathogens in animal-raising areas (ponds, floating cages);

b/ To implement regulations on cleansing and disinfection of equipment and tools in the raising and harvesting processes;

c/ To apply veterinary hygiene measures to wastewater and animal wastes before discharging them into the environment;

d/ To apply measures to enhance the raised animals’ resistance against diseases through bathing, injection, feeding and preventive measures recommended by animal health agencies.

3. People’s Committees at all levels shall have to direct the compulsory prevention of animal diseases in their respective localities. State management agencies in charge of animal health at all levels shall, within the scope of their functions and tasks, organize and direct commune-level veterinarians, organizations and individuals practicing veterinary medicine to provide compulsory vaccinations for animals, and guide animal owners to apply other compulsory preventive measures.

Article 11.- Responsibilities of animal owners in preventing animal diseases

1. To implement provisions on veterinary hygiene conditions in raising animals, on feeds and water used for animals, pastures, animal-raising places, and on raising animals in isolation in Articles 6, 7, 8 and 9 of this Decree, and to apply compulsory measures to prevent diseases for animals specified in Clauses 1 and 2, Article 10 of this Decree.

2. To make declaration of herds of raised animals as follows:

a/ Owners of concentrated animal-raising establishments must declare to competent state management agencies in charge of animal health on the species, quantities, structures and origin of herds of raised animals; sale of animals or receipt of new herds; the situation of epidemics, prevention and treatment of diseases for their establishments’ animals according to regulations of the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals upon occurrence of epidemics;

b/ Animal-raising households and individuals must keep books to monitor the delivery and receipt of animals, prevention and treatment of animal diseases; report to commune-level veterinarians or district-level state management agencies in charge of animal health on their animal herds upon occurrence of epidemics.

3. To implement regulations on:

a/ Raising animals in isolation before herding them together with other animals;

b/ Veterinary hygiene of feeds and water used for animals;

c/ Raising animals of different species in the same breeding establishment.

Article 12.- Building and management of animal epidemic-free zones and establishments

1. The building of animal epidemic-free zones and establishments must comply with the provisions of Article 14 of the Ordinance on Veterinary Medicine.

2. Animal epidemic-free zones and establishments shall be built for animals of one or more than one species to be free from one or more than one disease.

3. Management of zones and establishments already recognized to be animal epidemic-free includes the following activities:

a/ Conducting epidemic surveillance: Making periodical reports on the animal raising, epidemics and slaughtering; conducting periodical tests of serums and pathological materials in order to detect diseases in time;

b/ Closely controlling the transport of animals and animal products into epidemic-free zones and establishments;

c/ When detecting dangerous infectious diseases in animals in epidemic-free zones or establishments, organizations and individuals must immediately report them to commune-level veterinarians or state management agencies in charge of animal health in the nearest places for diagnosis and identification of such diseases; application of measures to stamp out epidemics.

Article 13.- Animal epidemic control and eradication programs

The control and eradication of a number of dangerous infectious animal diseases must be formulated into national programs for submission to the Prime Minister for approval. The formulation of such programs must ensure the principles laid down in Clause 1, Article 15 of the Ordinance on Veterinary Medicine.

Article 14.- Treatment of animal diseases

1. The treatment of animal diseases (excluding diseases banned from treatment according to regulations) must comply with the following provisions:

a/ Infected animals must be treated in time;

b/ Owners of raised animals, commune-level veterinarians, organizations and individuals practicing veterinary medicine must, when treating diseases for animals in epidemic-hit zones, follow the guidance of state management agencies in charge of animal health and ensure that epidemics will not spread and the environment will not be polluted;

c/ Drugs used for disease treatment must be of quality and on the list of veterinary drugs permitted for circulation in Vietnam;

d/ Only prescribed veterinary drug materials can be used for prevention and treatment of animal diseases;

e/ When drugs are administered to animals, a withdrawal time must be ensured before animals can be harvested or slaughtered under the guidance of drug manufacturers or veterinary medicine practitioners;

f/ Commune-level veterinarians, veterinary medicine-practicing organizations and individuals must wear protective uniforms under the guidance of state management agencies in charge of animal health when treating animal diseases in epidemic-hit zones.

2. Owners of raised animals must, when detecting infected animals, provide treatment as provided for in Clause 1 of this Article, and immediately inform such to commune-level veterinarians or local state management agencies in charge of animal health.

Article 15.- Testing and diagnosis of animal diseases

1. Owners of raised animals, organizations and individuals must, when doubting that animals are infected with dangerous infectious diseases or seeing that animals die in large numbers for unidentified causes, immediately inform such to commune-level veterinarians or local state management agencies in charge of animal health in the nearest places. In case of necessity, they shall take samples for tests and disease diagnosis at animal disease testing and diagnosis establishments within the system of state management agencies in charge of animal health or establishments permitted to test and diagnose animal diseases.

2. Local state management agencies in charge of animal health or commune-level veterinarians must, when detecting or receiving information on animals suspected of being infected with dangerous infectious disease or on animals dying in large numbers for unidentified causes, conduct diagnosis to identify diseases and immediately notify such to their superior state management agencies in charge of animal health. In case of necessity, they must take samples and send them for test and diagnosis.

3. For animals in breeding establishments, once every six months, samples must be taken by state management agencies in charge of animal health for disease tests according to regulations.

4. For zones and establishments already recognized to be animal epidemic-free, annually, samples must be taken by state management agencies in charge of animal health for tests for diseases registered to be free of. The taking of samples for tests for other diseases shall comply with the provisions of Clause 3 of this Article.

Article 16.- Veterinary hygiene conditions on animal disease testing establishments, animal disease testing and diagnosis establishments, animal surgery establishments

1. Animal disease testing establishments and animal disease testing and diagnosis establishments must ensure the following veterinary hygiene conditions:

a/ Their locations must be distant from population quarters and public works;

b/ Having adequate area, technical and material foundations, equipment, tools, chemicals, materials and raw materials to meet the requirements of animal disease testing and diagnosis;

c/ Having separate places for raising animals for experiments, a system for treating waste matters, carcasses and pathological materials to ensure veterinary hygiene and environmental sanitation;

d/ Having sufficient water up to veterinary hygiene standards.

2. Animal surgery establishments must ensure the following conditions:

a/ Having adequate area, technical and material foundations, equipment, tools, chemicals, materials and raw materials to meet the requirements of animal surgery;

b/ Having stables for raising and taking care of animals before and after surgery;

c/ Having places for treating waste matters to ensure veterinary hygiene and environmental sanitation;

d/ Having sufficient water up to veterinary hygiene standards.

Article 17.- Animal health measures for zones with old epidemic focuses and epidemic-threatened zones

1. Terrestrial-animal health measures:

a/ For old epidemic focuses, to regularly conduct surveillance of animal epidemics, periodically take pathological materials for tests in order to early detect diseases; to provide compulsory vaccinations for 100% of animals subject to vaccination; to apply other compulsory preventive measures to animals;

b/ For epidemic-threatened zones, depending on each zone and the nature of each disease and each animal species, to provide compulsory vaccination within the prescribed time limit.

2. Aquatic and amphibian animal health measures:

a/ For old epidemic focuses, to apply disinfection and environmental rehabilitation measures after epidemics are stamped out; to regularly conduct surveillance of previously occurred animal epidemics; to periodically take pathological materials for tests in order to early detect diseases; to apply other compulsory preventive measures;

b/ For epidemic-threatened zones, depending on each zone, each disease and each animal species, to apply compulsory preventive measures according to regulations.

Article 18.- Competence and responsibilities of state agencies when animal epidemics are declared

1. The presidents of provincial-level People’s Committees shall declare animal epidemics in their respective localities when there exist all conditions provided for in Clause 1, Article 17 of the Ordinance on Veterinary Medicine and have the responsibility:

a/ To decide to set up provincial-level Steering Committees for Prevention and Control of Animal Epidemics, which shall each have a leading official of the provincial-level People’s Committee as head, leading officials of the provincial-level Agriculture and Rural Development Service and Fisheries Service as deputy heads, and the heads of the concerned departments and branches as members;

b/ The Steering Committees for Prevention and Control of Animal Epidemics shall have to assist the presidents of the provincial-level People’s Committees in directing the agricultural and fisheries services to coordinate with the concerned branches, levels, organizations and individuals in localities and mobilize human and material powers in accordance with the provisions of law to apply anti-epidemic measures provided for in Articles 19, 20, 21, 22 and 23 of this Decree.

2. The Agriculture and Rural Development Minister or the Fisheries Minister shall declare animal epidemics in two or more provinces when there exist all conditions provided for in Clause 2, Article 17 of the Ordinance on Veterinary Medicine and have the responsibility:

a/ To set up ministerial Steering Committees for Prevention and Control of Animal Epidemics, which shall each have a leading official of the ministry as head, leading officials of the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals as deputy heads, and leading officials of the concerned departments and institutes as members;

b/ The Steering Committees for Prevention and Control of Animal Epidemics shall have to assist the Agriculture and Rural Development Minister and the Fisheries Minister in directing the agricultural and fisheries services to coordinate with the concerned branches, services, organizations and individuals in epidemic-hit localities to apply epidemic prevention and control measures provided for in Articles 19, 20, 21, 22 and 23 of this Decree.

3. The Prime Minister shall declare epidemics upon occurrence of dangerous infectious epidemics of animals that are possible to transmit to humans at the proposal of the Agriculture and Rural Development Minister or the Fisheries Minister and in accordance with the provisions of Clause 3, Article 18 of the Ordinance on Veterinary Medicine.

4. The ministries, ministerial-level agencies and Government-attached agencies shall, within the scope of their tasks and powers, have to coordinate with the Agriculture and Rural Development Ministry and the Fisheries Ministry in preventing and controlling animal epidemics.

Article 19.- Management of epidemic-hit zones

1. Provincial-level Agriculture and Rural Development Services and the Fisheries Services shall coordinate with the Animal Health Department and the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall direct local state management agencies in charge of animal health at all levels to identify epidemic-hit zones, epidemic-threatened zones and buffer zones; collect statistics and mark infected animals and animals susceptible to the declared epidemic in order to organize the isolation of such animals and the application of other animal health measures.

2. Provincial-level People’s Committees shall direct their subordinate People’s Committees and local state management agencies in charge of animal health at all levels to establish quarantine checkpoints with the participation of veterinary, police and market control forces to guide, check and oversee the transportation of animals and animal products; to place signboards in epidemic-hit places; to restrict circulation of animals and animal products; to guide travel and transportation of animals and animal products away from epidemic-hit zones.

3. People not on duty are prohibited from entering zones where there are diseased animals or dead animals; and travel out of and into epidemic-hit zones is restricted.

4. Organizations and individuals are not allowed to organize sightseeing tours and exhibitions in epidemic-hit zones.

Article 20.- Isolation of animals in epidemic-hit zones

1. Infected animals, animals suspected of being infected, affected animals, animals suspected of being affected must be raised in isolation throughout the duration of occurrence of epidemics for monitoring and treatment or handling as appropriate to each disease; must not be grazed on common pastures or in raising places.

2. Attendants and raising tools must be arranged separately for animals raised in isolation. Tools and materials used for animals raised in isolation, left-over feeds and animal wastes must be treated and disinfected till the end of epidemics.

Article 21.- Circulation of animals, animal products in epidemic-hit zones

1. It is forbidden to take into or out of epidemic-hit zones animal species and kinds of animal products susceptible to the declared epidemics. It is forbidden to take out of epidemic-hit zones feeds, animal-raising tools and animal wastes capable of transmitting epidemics. When transporting animals to slaughterhouses, compulsory preliminary processing shall be required under the guidance of state management agencies in charge of animal health.

2. In cases where there is no choice but to transport animals susceptible to epidemics, animal products, feeds or animal wastes across epidemic-hit zones, the permission of the provincial-level People’s Committee concerned is required and the route determined by the provincial-level Steering Committee for Prevention and Control of Animal Epidemics must be followed without stop. Immediately after passing epidemic-hit zones, means of transport must be disinfected.

3. It is forbidden to slaughter, circulate, trade in, or exchange terrestrial animals and their products susceptible to the declared epidemics.

Article 22.- Compulsory prevention of diseases for animals in epidemic-hit zones

1. Provincial-level state management agencies in charge of animal health shall designate animal species subject to compulsory vaccination and expeditiously organize and direct district-level state management agencies in charge of animal health, commune-level veterinarians, veterinary medicine-practicing organizations and individuals to provide compulsory vaccinations for, and apply other compulsory preventive measures to, animals susceptible to the declared epidemics in epidemic-hit zones; supervise the cleansing and disinfection work.

2. Owners of raised animals shall have to follow all guidance of local state management agencies in charge of animal health on compulsory vaccination for, and application of other compulsory preventive measures, to animals; cleanse and disinfect epidemic-hit zones with appropriate disinfectants of sufficient content according to the right techniques for:

a/ Raising places, pastures, culling and slaughtering places;

b/ Raising and slaughtering tools, means of transport of animals and animal products;

c/ Animal wastes.

3. The disinfection must not cause harms to humans, animals and environment.

Article 23.- Measures for epidemic-threatened zones, buffer zones

1. Provincial-level state management agencies in charge of animal health shall coordinate with local administrations and concerned agencies in taking the following measures for epidemic-threatened zones:

a/ Establishing temporary quarantine checkpoints along main roads to control animals and animal products transported into and out of epidemic-threatened zones;

b/ Identifying animal species susceptible to epidemics;

c/ Closely controlling the taking into and out of epidemic-threatened zones animals susceptible to the declared epidemics and their products;

d/ Providing vaccinations or applying other compulsory preventive measures as required for each disease;

e/ Intensifying epidemic surveillance, regularly checking and detecting new epidemic focuses for timely handling.

2. For quickly transmitted epidemics, the Animal Health Department and the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall guide provincial-level state management agencies in charge of animal health to identify buffer zones and apply the following animal health measures for these zones:

a/ To intensify epidemic surveillance and regularly monitor animals that are diseased and dead for unidentified causes;

b/ To increase control of animals, animal products, breeding aquatic animals originating from buffer zones, ensuring that animals or animal products taken out of buffer zones must be quarantined and not infected with pathogens of the occurring epidemics;

c/ To test serums and pathological materials to detect the circulation of diseases.

Article 24.- Responsibilities of state management agencies in charge of animal health to prevent and control animal epidemics

1. Upon the outbreaks of animal epidemics, the central state management agency in charge of animal health must give timely guidance to local state management agencies in charge of animal health on technical measures to quickly stamp out epidemics, step up control and urge the application of animal health measures provided for in Articles 19, 20, 21, 22 and 23 of this Decree.

2. Provincial-level state management agencies in charge of animal health shall, within the scope of their tasks and powers, have the responsibilities:

a/ To organize and direct district-level state management agencies in charge of animal health and commune-level veterinarians to guide animal-raising organizations and individuals to implement regulations on compulsory prevention of animal diseases, isolation of animals, purchase and sale of animals and animal products, cleansing and disinfection;

b/ To supervise and monitor the places of isolation of infected animals;

c/ To guide the medical treatment of infected animals;

d/ To inform provincial-level state management agencies in charge of animal health of the places of receipt of animals susceptible to the current epidemics and originating from epidemic-hit zones so as to monitor animals for a duration at least equal to the incubation period;

e/ To guide animal owners to apply the required measures to dispose of animals infected with incurable diseases or dead animals.

Article 25.- Handling of animals infected or suspected of being infected with dangerous infectious disease

1. Animals infected or suspected of being infected with dangerous infectious disease shall be handled according to the following provisions:

a/ Provincial-level state management agencies in charge of animal health shall report to the provincial/municipal Agriculture and Rural Development Services so that the Services can propose the provincial-level People’s Committees to issue decisions to cull or slaughter animals that are infected or suspected of being infected and subject to compulsory cull or slaughter according to regulations. The cull of animals shall comply with the provisions of Article 26 of this Decree;

b/ The compulsory slaughter of animals must be carried out at slaughterhouses designated by provincial-level state management agencies in charge of animal health and all animal health measures must be applied in these houses in accordance with regulations;

c/ Means of transport of animals for compulsory slaughter must have tight floors so that waste matters are not dropped on road and must be disinfected immediately after transportation;

d/ Slaughtering places, slaughtering tools, wastes of animals subjected to compulsory slaughter must be treated and disinfected immediately after slaughter;

e/ Meat of animals subjected to compulsory slaughter must not be used fresh but must be treated to ensure veterinary hygiene as required. Sub-products and other products of animals subjected to compulsory slaughter which cannot be used as food, feeds or for industrial processing must be destroyed under the provisions of Article 26 of this Decree.

2. The handling of aquatic and amphibian animals infected or suspected of being infected with dangerous infectious disease must ensure veterinary hygiene standards provided for by the Fisheries Ministry.

Article 26.- Cull of animals infected or suspected of being infected with dangerous infectious disease

1. Animals infected, carcasses infected or suspected of being infected with diseases on the list of diseases subject to epidemic declaration and must be culled according to regulations; products of animals subjected to compulsory cull which cannot be used, and bedding and waste matters of these animals must be burned or buried deep under the ground under the guidance of state management agencies in charge of animal health and ensure the technical processes developed by the natural resource and environment agencies.

2. Bodies of animals which died of anthrax, bedding and wastes of these animals must be burned and buried, and burial pits must be filled with concrete under the supervision and certification of competent state agencies in charge of animal health under the guidance of the People’s Committees at all levels.

Where it is compulsory to build projects on animal burial pits, project owners must observe all guidance of provincial-level state management agencies in charge of animal health on the excavation and destruction of all substances in burial pits, cleansing and disinfection of these places. Project owners shall pay for this work.

Article 27.- Conditions for declaration of, and competence to declare, the end of epidemics

1. Conditions for declaration of the end of an epidemic

a/ Animals susceptible to the declared epidemic in epidemic-hit zones and epidemic-threatened zones have been all vaccinated or applied with other compulsory preventive measures. For terrestrial animals, a sufficient duration is required for immunity to the disease concerned;

b/ Within 30 days, depending on each disease, from the date the animal or aquatic flock which is the last that has contracted the disease dies or die, is or are slaughtered, preliminarily processed, culled or fully recovered while not any other animal or aquatic flock contract(s) or die(s) of the declared epidemic;

c/ Cleansing and disinfection measures have been applied in epidemic-hit and epidemic-threatened zones to ensure the requirements of veterinary hygiene.

2. Competence to declare the end of an epidemic:

a/ The heads of provincial-level state management agencies in charge of animal health, after checking to ensure that there are all conditions for declaration of the end of epidemics, shall send reports thereon to the head of the central-level state management agency in charge of animal health, the provincial-level Agriculture and Rural Development Services or Fisheries Services. After obtaining the approval of the central-level state management agency in charge of animal health, they shall propose the presidents of the provincial-level People’s Committees to declare the end of epidemics in the localities;

b/ The head of the central-level state management agency in charge of animal health, after checking to ensure that there are all conditions for declaration of the end of epidemics, shall propose the Agriculture and Rural Development Minister or Fisheries Minister to declare the end of epidemics in two or more provinces; shall report to the Agriculture and Rural Development Ministry or Fisheries Ministry to propose the Prime Minister to declare the end of animals’ dangerous infectious epidemics capable of transmitting to humans.

Article 28.- Funds for prevention and control of animal epidemics

1. The Funds for Prevention and Control of Animal Epidemics shall be set up in accordance with the provisions of Article 22 of the Ordinance on Veterinary Medicine.

2. The Finance Ministry shall assume the prime responsibility for, and coordinate with the Agriculture and Rural Development Ministry, the Fisheries Ministry, and the concerned ministries and branches in, submitting to the Prime Minister for decision the setting up, regulations on management and use of the Funds for Prevention and Control of Animal Epidemics at the central and provincial levels.

Chapter III

QUARANTINE OF ANIMALS, ANIMAL PRODUCTS; CONTROL OF SLAUGHTER; VETERINARY HYGIENE INSPECTION

Section 1. QUARANTINE OF ANIMALS, ANIMAL PRODUCTS

Article 29.- Principles for quarantine of animals, animal products

1. The quarantine of animals and animal products must abide by the principles provided for in Article 23 of the Ordinance on Veterinary Medicine.

2. Terrestrial animals and products thereof on the list of animals and animal products subject to quarantine, when being transported in large numbers or volumes out of the territory of a district, must be quarantined once in departure places.

3. Aquatic and amphibian animals and products thereof on the list of animals and animal products subject to quarantine, when being circulated within the country, must be quarantined once in departure places in the following cases:

a/ Commercial animals and animal products before being taken out of the territory of a district being hit by an epidemic;

b/ Breeding animals before taken out of breeding establishments.

Article 30.- Declaration of quarantine of terrestrial animals and products thereof

1. When transporting or circulating within the country animals and/or animal products on the list of animals and animal products subject to quarantine, declaration must be made and quarantine dossiers, made according to a set form, must be sent to competent state management agencies in charge of animal health. The quarantine declaration is stipulated as follows:

a/ Making declaration at least 5 (five) days in advance if animals have been applied with compulsory preventive measures according to regulations and still stay immune; between 15 (fifteen) and 30 (thirty) days in advance if animals have not been applied with compulsory preventive measures according to regulations or are not immune;

b/ Making declaration at least 3 (three) days in advance if animal products have been tested for veterinary hygiene criteria or are sent by post; 10 (ten) days in advance if animal products have not been tested for veterinary hygiene criteria.

Within 2 (two) days as from the date of receipt of valid quarantine dossiers, the dossier-receiving agencies shall have to give quarantine registration certification and notify the places and time of quarantine.

2. When importing, temporarily importing for re-export, temporarily exporting for re-import, border gate-to-border gate transferring or transiting through Vietnamese territory animals and/or animal products on the list of animals and animals products subject to quarantine, or alien animals and/or animal products to existing in Vietnam, quarantine must be registered with the Animal Health Department. Within 7 (seven) days, the Animal Health Department shall have to reply. After getting the approval of the Animal Health Department, organizations or individuals shall make quarantine declaration to competent agencies in charge of quarantining exported and imported animals.

3. When exporting, importing, temporarily importing for re-export, temporarily exporting for re-import, border gate-to-border gate transferring or transiting through Vietnamese territory animals and/or animal products, declaration thereof must be made and quarantine dossiers, made according to a set form, must be sent to competent agencies in charge of quarantining exported and imported animals. The quarantine declaration is stipulated as follows:

a/ Export declaration before goods are delivered: between at least 15 (fifteen) days and 30 (thirty) days for animals; 10 (ten) days for animal products; 5 (five) days before sending goods by post;

b/ Import declaration: At least 15 (fifteen) days before goods arrive at border gate; 5 (five) days before goods arrive at post office;

c/ Declaration of temporary import for re-export, temporary export for re-import, border gate-to-border gate transfer, transit through Vietnamese territory: at least 7 (seven) days before goods arrive at border gate;

Within 5 (five) days for cases of temporary import for re-export, temporary export for re-import, border gate-to-border gate transfer, transit through Vietnamese territory of animals and/or animal products; 10 (ten) days for cases of import of animals and animal products as from the date of receipt of valid quarantine dossiers, the dossier-receiving agencies shall have to inform the goods owners of the places and time of quarantine and the import border gate, export border gate, itinerary, mode of transportation, and other relevant regulations for cases of transit through Vietnamese territory of animals and animal products.

Article 31.- Declaration of quarantine of aquatic and amphibian animals and products thereof

1. When transporting or circulating within the country animals and/or animal products on the list of animals and animal products subject to quarantine, declaration must be made and quarantine dossiers, made according to a set form, must be sent to competent state management agencies in charge of animal health. The quarantine declaration is stipulated as follows:

a/ For parental aquatic animals and seed animals, declaration must be made at least 3 (three) days before transportation;

b/ For commercial animals, animal products, declaration must be made at least 2 (two) days before transportation.

Within 2 (two) days as from the date of receipt of valid quarantine dossiers, the dossier-receiving agencies shall have to give quarantine registration certification and notify the places and time for quarantine.

2. When importing, temporarily importing for re-export, temporarily exporting for re-import, border gate-to-border gate transferring or transiting through Vietnamese territory animals and/or animal products on the list of animals and animals products subject to quarantine, or alien animals and/or animal products to existing in Vietnam, quarantine must be registered with the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals. Within 7 (seven) days, the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall have to reply. After getting the approval, organizations or individuals shall make quarantine declaration to competent agencies in charge of quarantine and health of aquatic animals.

3. When exporting, importing, temporarily importing for re-export, temporarily exporting for re-import, border gate-to-border gate transferring or transiting through Vietnamese territory aquatic and amphibian animals and/or products thereof on the list of animals and animal products subject to quarantine, declaration thereof must be made and quarantine dossiers, made according to a set form, must be sent to competent agencies in charge of quarantine and health of aquatic animals. The quarantine declaration is stipulated as follows:

a/ Export declaration before goods are delivered: at least 15 (fifteen) days for animals; 10 (ten) days for animal products;

b/ Import declaration before goods arrive at border gates: at least 10 (ten) days for animals; 7 (seven) days for animal products;

c/ Declaration of temporary import for re-export, temporary export for re-import, border gate-to-border gate transfer, transit through Vietnamese territory: at least 7 (seven) days before goods arrive at border gate;

Within 5 (five) days as from the date of receipt of valid quarantine dossiers, the dossier-receiving agencies shall have to inform the goods owners of the places and time of quarantine.

Article 32.- Quarantine of animals and animal products circulated within the country in departure places

1. The order of quarantine of terrestrial animals and products thereof is stipulated as follows:

a/ Checking the implementation of provisions on veterinary hygiene conditions of places of collection, means of transport, containers, packages, and other related objects in Articles 44 and 45 of this Decree;

b/ Quarantining according to the process and veterinary hygiene standards provided for domestically circulated animals and animal products;

c/ Marking animals; affixing veterinary hygiene stamps on animal products up to veterinary hygiene standards;

d/ Guiding goods owners to cleanse and disinfect places of collection, loading animals, animal products, means of transport, and other related objects in the course of transportation;

e/ Granting quarantine certificates for animals and animal products up to veterinary hygiene standards; sealing up means of transport, containers of animals or animal products;

f/ Requesting goods owners to apply the required technical measures to animals and animal products failing to meet all veterinary hygiene standards. After the technical measures are applied, if animals and animal products meet all veterinary hygiene standards, they shall be granted quarantine certificates; if they fail to satisfy all veterinary hygiene standards, depending on the extent of satisfaction, permitting the use of such animals and animal products for other purposes or forcing the destruction of such animals and animal products.

2. The order of quarantine of aquatic or amphibian animals and products thereof is stipulated as follows:

a/ Checking the implementation of provisions on veterinary hygiene conditions of places of collection, means of transport, containers, packages, and other related objects in Articles 44 and 45 of this Decree;

b/ Quarantining according to the process and veterinary hygiene standards provided for domestically circulated animals and animal products;

c/ Guiding goods owners to cleanse and disinfect places of collection, means of transport, and other related objects in the course of transportation;

d/ Affixing veterinary hygiene stamps on lots of animals and animal products up to veterinary hygiene standards;

e/ Granting quarantine certificates for animals and animal products up to veterinary hygiene standards; sealing up means of transport, containers of animals or animal products;

f/ Requesting goods owners to apply the required technical measures to animals and animal products failing to meet all veterinary hygiene standards. After the technical measures are applied, if animals and animal products meet all veterinary hygiene standards, they shall be granted quarantine certificates; if they fail to satisfy all veterinary hygiene standards, depending on the extent of satisfaction, permitting the use of such animals and animal products for other purposes or forcing the destruction of such animals and animal products.

Article 33.- Quarantine of animals, animal products at animal quarantine stations located in main roads

1. Checking quarantine dossiers, quantities and species of animals, categories of animal products according to the accompanied quarantine certificates; veterinary hygiene codes, marks or stamps; seals of transport means.

2. Checking the health of animals, actual veterinary hygiene conditions of animal products.

3. Checking actual veterinary hygiene conditions of means of transport and related objects in the course of transportation.

4. Giving certification if animals or animal products are accompanied by valid quarantine certificates or means of transport and other related objects ensure veterinary hygiene.

If detecting that there are no quarantine certificates or quarantine certificates are invalid, means of transport and other related objects fail to meet all veterinary hygiene standards or come from localities where the delivery of animals or animal products is suspended because of epidemic, animal quarantine cadres must suspend the transportation and handle the cases according to regulations, and must take responsibility before law for their handling.

Article 34.- Quarantine of exported animals, animal products

1. Exported animals, animal products must be quarantined in the following cases:

a/ Quarantine is provided for in sale and purchase contracts or in international agreements;

b/ Quarantine of animals or animal products is requested by goods owners.

The declaration of quarantine of animals or animal products shall comply with the provisions of Point a, Clause 3, Article 30 or Point a, Clause 3, Article 31 of this Decree.

2. Competent agencies in charge of quarantining exported and imported animals shall quarantine animals or animal products at departure places or in quarantine areas at border gates according to the process and veterinary hygiene standards provided for exported animals and animal products.

3. Animals and animal products on the list of those subject to quarantine, means of transport and other related objects which meet all veterinary hygiene standards shall be granted export quarantine certificates by agencies in charge of quarantining exported and imported animals within 24 hours before they are loaded.

4. At export border gates, border-gate animal quarantine agencies shall:

a/ Check quarantine dossiers;

b/ Re-check quantities and species of animals or kinds of animal products, packages of animal products according to the accompanied quarantine certificates only in case of doubt of fraudulent swap, increase or reduction of animals, animal products or changed packages of animal products. If detecting violations, depending on their seriousness, re-quarantine or return animals or animal products to their departure places;

c/ Exchange quarantine certificates if requested by goods owners or importing countries; re-grant quarantine certificates in case of re-quarantine;

d/ Guide goods owners to cleanse and disinfect means of transport, bedding, animal wastes and related objects after transportation.

5. Organizations and individuals exporting by post animals and/or animal products on the list of those subject to quarantine must make quarantine declaration to competent quarantine agencies provided for at Point a, Clause 3, Article 30 or at Point a, Clause 3, Article 31 of this Decree.

Animal quarantine agencies shall check animals and/ or animal products and grant quarantine certificates to goods meeting all veterinary hygiene standards.

Article 35.- Quarantine of imported animals, animal products

1. The quarantine of imported animals and animal products is stipulated as follows:

a/ Organizations and individuals, when importing animals and/or animal products on the list of those subject to quarantine must register and make declaration for import quarantine according to the provisions of Clause 2, Point b, Clause 3, Article 30 or Clause 2, Point b, Clause 3, Article 31 of this Decree;

b/ In case of importation of animals by sea or by air, animal quarantine cadres shall check quarantine dossiers, the health of animals at buoy zero or in the airports’ landing yards;

c/ If quarantine dossiers are valid, animals are healthy, animal products show no sign of degeneration or carry no disease pathogen, animal quarantine cadres shall give certification for goods owners to carry out customs procedures and take animals and/or animal products to isolated quarantine areas or establishments;

d/ If quarantine dossiers are invalid, animal quarantine agencies shall inform competent authorities of exporting countries thereof for re-checking, amending and completing such dossiers;

e/ If determining that animals are infected with disease, animal products carry pathogens of dangerous infectious disease, they shall be slaughtered, culled, destroyed or returned to exporting countries if this measure does not involve transit through a third country;

f/ The duration of quarantine isolation of animals shall depend on each disease and each animal species but shall not exceed 45 (forty five) days; the duration of quarantine isolation of animal products shall not exceed 10 (ten) days. If the duration of quarantine isolation is longer than the above-said time limit, animal quarantine agencies must inform goods owners of the reasons therefor;

g/ After the duration of quarantine isolation, if animals or animal products meet all the required veterinary hygiene standards, they shall be granted quarantine certificates;

h/ Animal quarantine agencies shall have to guide goods owners to apply veterinary hygiene measures to persons coming into contact with animals; cleanse and disinfect raising tools, loading/unloading tools, containers, means of transport, places of collection, quarantine isolation of animals or animal products, bedding, animal wastes and other related objects after transportation and after supervision and quarantine isolation.

2. The quarantine of hand-carried imported animals and animal products is stipulated as follows:

a/ Goods owners must make declaration in exit/entry declaration forms, produce quarantine certificates of national animal health agencies of exporting countries for checking by border-gate animal quarantine agencies;

b/ Goods owners shall not have to make declaration and produce quarantine certificates in cases of carrying along cooked food of animal origin for non-business purposes; industrially processed products of animal origin for non-food purposes;

c/ Border-gate animal quarantine agencies shall check quarantine dossiers, if finding that such dossiers are valid and animals or animal products meet all veterinary hygiene standards, they shall grant import quarantine certificates.

3. The quarantine of imported animals and animal products sent by post is stipulated as follows:

a/ Organizations and individuals, when importing by post animals and/or animal products on the list of those subject to quarantine must register and make declaration for import quarantine according to the provisions of Clause 2, Point b, Clause 3, Article 30 or Clause 2, Point b, Clause 3, Article 31 of this Decree;

b/ Animal quarantine agencies shall check animals or animal products and grant quarantine certificates for animals or animals products meeting all veterinary hygiene standards.

Article 36.- Quarantine of animals and animal products which are temporarily imported for re-export, temporarily exported for re-import, transferred from border gate to border gate or transited through Vietnamese territory

1. Organizations and individuals, when temporarily importing for re-export, temporarily exporting for re-import, transferring from border gate to border gate or transiting through Vietnamese territory animals and/or animal products on the list of those subject to quarantine must register and make declaration for quarantine according to the provisions of Clause 2, Point c, Clause 3, Article 30 or Clause 2, Point c, Clause 3, Article 31 of this Decree.

2. The quarantine of animals and animal products which are temporarily imported for re-export, temporarily exported for re-import, transferred from border gate to border gate is stipulated as follows:

a/ Border-gate animal quarantine agencies shall quarantine according to the required process and veterinary hygiene standards animals or animal products which are temporarily imported for re-export, temporarily exported for re-import, transferred from border gate to border gate and grant quarantine certificates for, or certify quarantine of, animals and/or animal products meeting all veterinary hygiene standards for goods owners to carry out customs procedures;

b/ If quarantine certificates are invalid, animal quarantine agencies shall inform competent authorities of exporting countries thereof for re-checking and amending quarantine certificates;

c/ If determining that animals are infected with dangerous infectious disease, animal products carry pathogens of dangerous infectious disease, they shall be slaughtered, culled, destroyed or returned to exporting countries, if this measure does not involve transit though a third country.

3. The quarantine of animals and animal products transiting through Vietnamese territory is stipulated as follows:

a/ When goods arrive at border gates, goods owners must produce quarantine certificates granted by national animal health agencies of exporting countries and other related papers to border-gate animal quarantine agencies;

b/ Border-gate animal quarantine agencies shall check quarantine certificates, the actual veterinary hygiene conditions of goods and means of transport, and the implementation of regulations as already notified beforehand to goods owners. If all conditions are met, they shall give quarantine certification for goods owners to carry out customs procedures;

c/ Goods owners must not unload goods or dismount means of transport without permission; must not change itinerary without permission or stop at places not pre-determined; means of transport in transit must be technically safe, not let waste matters drop on road;

d/ Goods owners must obey instructions of animal quarantine agencies and not let animals in transit come into contact with domestic animals in cases where they must stop to care for and nurture animals in transit;

e/ Dead animals, animal wastes, bedding, left-over food and feeds, packages of animal products and other waste matters in the course of transportation must be treated according to regulations of animal quarantine agencies;

f/ Where animals or animal products are transited through Vietnamese territory in containers or in other tightly-closed means, border-gate animal quarantine agencies shall check quarantine certificates of national animal health agencies of exporting countries as well as means of transport; if all requirements are met, they shall give certification to permit the transit; if detecting that animals or animal products show abnormal signs, they may request goods owners to open containers or means of transport for re-inspection of veterinary hygiene;

g/ If animals, animal products, means of transport, containers and packages fail to meet all veterinary hygiene standards or quarantine certificates are invalid or animals show pathological symptoms, animal products carry pathogens of dangerous infectious disease, border-gate animal quarantine agencies shall not permit the transit;

h/ If quarantine certificates are invalid, border-gate animal quarantine agencies shall inform competent authorities of exporting countries thereof for re-checking and amending quarantine certificates. After being amended, if quarantine certificates are valid, border-gate animal quarantine agencies shall permit the transit;

i/ If determining that animals are infected with, or animal products carry pathogens of, dangerous infectious disease, border-gate animal quarantine agencies shall not permit the transit, order such animals or animals products to be slaughtered, culled, destroyed, or returned to exporting countries, if this measure dose not involve transit through a third country.

4. Goods owners must incur all expenses during the time when animals and/or animal products are kept for checking and amendment of animal quarantine certificates.

Article 37.- Receipt and sending of pathological materials

1. Pathological materials may be imported into Vietnam or sent abroad only if it is agreed in writing by the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals.

2. Pathological materials must be preserved and packed according to regulations to ensure veterinary hygiene and environmental sanitation.

3. Pathological materials brought into Vietnam without permission shall be destroyed.

Section 2. CONTROL OF SLAUGHTER, PRELIMINARY PROCESSING OF ANIMALS, ANIMAL PRODUCTS

Article 38.- General provisions on slaughter, preliminary processing of animals, animal products

1. The slaughter and preliminary processing of terrestrial animals and products thereof is stipulated as follows:

a/ Animals to be slaughtered or preliminarily processed must meet all veterinary hygiene standards, be quarantined by competent state management agencies in charge of animal health in departure places and granted quarantine certificates in accordance with the provisions of Article 32 of this Decree;

b/ Animals to be slaughtered or preliminarily processed must not fall into cases where slaughter or preliminary processing is banned in Article 39 of this Decree;

c/ The slaughter or preliminary processing of animals or animal products for business purposes must be carried out at slaughterhouses or preliminary processing establishments meeting veterinary hygiene standards and subject to control by competent state management agencies in charge of animal health before, throughout and after the slaughter or preliminary processing;

d/ In the process of controlling the slaughter or preliminary processing of animals, animal products, if detecting animals infected or suspected of being infected with diseases, affected or suspected of being affected by diseases on the list of diseases subject to epidemic declaration, animal quarantine cadres shall request to stop the slaughter or preliminary processing; guide establishment owners to cleanse and disinfect their premises and slaughtering or preliminary processing places, and immediately report such to competent animal health agencies.

2. The preliminary processing of aquatic and amphibian animals must ensure veterinary hygiene standards according to regulations of the Fisheries Ministry.

Article 39.- Cases where slaughter or preliminary processing of animals, animal products is banned

1. Animals infected or suspected of being infected with diseases, affected or suspected of being affected by diseases the slaughter or preliminary processing of which is banned according to regulations.

2. Animals which have received vaccinations for less than 15 days.

3. Animals which have been given drugs but the withdrawal time is not long enough as guided by manufacturers.

4. Products of animals mentioned in Clauses 1, 2 and 3 of this Article.

Article 40.- Control before slaughter, preliminary processing of terrestrial animals and products thereof

1. Checking animal quarantine certificates or vaccination certificates granted by state management agencies in charge of animal health in departure places.

2. Clinically checking and classifying animals. Healthy animals shall be taken to slaughter-awaiting places; weak, skinny animals must be separated for later slaughter; animals infected or suspected of being infected with disease, affected or suspected of being affected by disease must be taken to separate slaughtering places for handling according to regulations. Animals must be cleansed before slaughter. Animals not yet slaughtered shall be re-checked from 12 to 24 hours later, depending on each animal species.

3. Checking the implementation of regulations on veterinary hygiene conditions of establishments, equipment, tools, people involved in slaughter, preliminary processing of animals and/or animal products.

4. Checking the cleansing and disinfection of slaughtering places, preliminary processing places, animal-keeping places, and means of transport; the handling of bedding and wastes in the course of transportation and after receipt of animals for slaughter or preliminary processing.

Article 41.- Control in the process of slaughtering, preliminarily processing animals, animal products

1. Checking the observance of the procedures for slaughtering or preliminary processing; the implementation of regulations on veterinary hygiene in the process of slaughtering or preliminarily processing animals or animal products.

2. Checking veterinary hygiene of meat, innards, and other products in order to detect those subject to slaughtering control.

3. Affixing marks or veterinary hygiene stamps on meat and other products that meet all veterinary hygiene standards.

Meat, innards and other animal products failing to meet all veterinary hygiene standards must be separated, marked for distinction, and handled according to regulations.

Article 42.- Preservation, transportation of animal products after slaughter, preliminary processing

1. Places for preservation of meat, innards and other animal products must ensure the required veterinary hygiene standards so as not to affect product quality. Meat must not be mixed with innards and other animal products.

2. Means of transport, containers, packages of animal products in slaughterhouses or preliminary processing establishments must ensure veterinary hygiene standards, must not affect the quality of products and must be cleansed and disinfected before and after use.

Means of transport of animal products must be those exclusively used for this purpose, ensure veterinary hygiene conditions provided for in Article 45 of this Decree and must be cleansed and disinfected before and after use.

Section 3. VETERINARY HYGIENE INSPECTION

Article 43.- Competence to inspect veterinary hygiene

1. The veterinary hygiene inspection must ensure the principles provided for in Article 35 of the Ordinance on Veterinary Medicine.

2. The Animal Health Department and the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall be responsible for inspecting veterinary hygiene and granting certificates of satisfaction of veterinary hygiene standards with regard to:

a/ Centrally-run concentrated animal-raising establishments and national breeding establishments;

b/ Feeds, water used for animals, materials of animal origin used for the production of feeds; equipment, tools and means of transport exclusively used in animal raising; animal wastes in raising establishments mentioned at Point a, Clause 2 of this Article;

c/ Animal epidemic-free zones and establishments as assigned by the Agriculture and Rural Development Ministry or the Fisheries Ministry;

d/ Quarantine places for exported and imported animals and animal products;

e/ Establishments that slaughter, preliminarily process and/or preserve terrestrial animals and products thereof and carry out export activities; establishments that preliminarily process and/or preserve aquatic and amphibian animals and products thereof as assigned by the Fisheries Ministry;

f/ Establishments that manufacture veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use;

g/ Establishments that trade in microorganisms for veterinary use.

3. Provincial-level state management agencies in charge of animal health shall be responsible for inspecting veterinary hygiene and granting certificates of satisfaction of veterinary hygiene standards with regard to:

a/ Concentrated animal-raising establishments and breeding establishments within provinces;

b/ Feeds, water used for animals, materials of animal origin used for the production of feeds; equipment, tools and means of transport exclusively used in animal raising; animal wastes in raising establishments mentioned at Point a, Clause 3 of this Article;

c/ Epidemic-free zones and establishments as assigned by the Agriculture and Rural Development Ministry or the Fisheries Ministry;

d/ Establishments that slaughter, preliminarily process and/or preserve terrestrial animals and products thereof for domestic consumption; establishments that preliminarily process and/or preserve aquatic and amphibian animals and products thereof as assigned by the Fisheries Ministry;

e/ Establishments and shops that trade in veterinary drugs, bio-preparations and/or chemicals for veterinary use within provinces.

Article 44.- Veterinary hygiene conditions on places of collection for transportation of animals, animal products

1. Places of collection of terrestrial animals in airports, railway stations and ports must ensure the following veterinary hygiene conditions:

a/ Being conveniently situated for the inspection of animals and animal products;

b/ Measures are applied to prevent direct or indirect contract with animals from outside;

c/ There are stairs exclusively used for cattle to get on and get off means of transport;

d/ There is sufficient water up to veterinary hygiene standards;

e/ To be cleansed and disinfected before and after each collection and loading of animals;

f/ Measures are taken to treat waste water and matters up to hygiene standards before being discharged into the environment.

2. Places of collection and loading of terrestrial animals in raising establishments must ensure the following conditions:

a/ Being conveniently situated and large enough for the inspection of animals;

b/ The provisions of Points b, c, d and f, Clause 1 of this Article are ensured.

3. Places of gathering, collection of terrestrial animals must ensure the following conditions:

a/ Being situated separately from population quarters, public facilities, raising establishments;

b/ The provisions of Points b, d and f, Clause 1 of this Article are ensured.

4. Places of collection of terrestrial-animal products must ensure the following conditions:

a/ There are preservation storehouses meeting the required veterinary hygiene standards;

b/ Storehouses must be cleansed and disinfected before and after collection of animal products;

c/ The provisions of Points d and f, Clause 1 of this Article are ensured.

5. Places of collection of aquatic and amphibian animals and products thereof for transportation must ensure the following veterinary hygiene conditions:

a/ Being conveniently situated for the inspection of animals and animal products;

b/ Measures are applied to prevent direct or indirect contract with animals from outside;

c/ There is sufficient water up to veterinary hygiene standards;

d/ To be cleansed and disinfected before and after each collection and loading of animals;

e/ Measures are taken to treat waste water and matters up to hygiene standards before being discharged into the environment.

Article 45.- Veterinary hygiene conditions on means of transport of animals, animal products

1. Means of transport of terrestrial animals must ensure the following veterinary hygiene conditions:

a/ Being technically safe for protection of animals throughout the course of transportation;

b/ There must be enough room and space for animals to stand or lie down in natural position; there must be cages, kennels or boxes to ensure safety for animals in the course of transportation; floors must be flat, not slippery, and tight to prevent leakage of water and waste matters in the course of transportation; easy to cleanse and disinfect;

c/ For closed means of transport, they must have appropriate ventilating systems to ensure ventilation as needed.

2. Means of transport, containers of aquatic and amphibian animals must ensure the following veterinary hygiene conditions:

a/ Being technically safe to ensure that animals are alive throughout the course of transportation;

b/ Animal containers are made of appropriate material, ensuring no leakage of water and waste matters into the environment in the course of transportation, easy to cleanse and disinfect;

c/ There are appropriate oxygen-supplying or -ventilating systems to ensure sufficient oxygen as needed;

d/ Meeting other technical requirements set by the Fisheries Ministry.

3. Means of transport of fresh and raw and preliminarily processed animal products for use as food must ensure the following veterinary hygiene conditions:

a/ Safe preservation techniques are applied to ensure that the quality of animal products is not affected in the course of transportation;

b/ The inside of animal product containers must be made of stainless, flat, anti-leakage, anti-corrosion, non-toxic, odorless materials not affecting the quality of products, easy to cleanse and disinfect;

c/ Animal product containers must be closed to prevent products from contamination and pollution;

d/ Meeting temperature requirements on each kind of animal product throughout the course of transportation.

4. Means of transport of animal products not for use as food must have tight floors, easy to cleanse and disinfect.

Article 46.- Veterinary hygiene conditions on establishments that slaughter, preliminarily process animals, animal products

1. Establishments that slaughter, preliminarily process animals, animal products must meet all veterinary hygiene conditions provided for in Article 33 of the Ordinance on Veterinary Medicine and the following conditions on location, workshop and equipment:

a/ Being situated separately from population quarters, public works, main roads and polluting sources, not being flooded; being wall-fenced; having separate gates for delivery and receipt of animals, animal products; roads within the establishments’ premises must be cemented or concreted;

b/ There are separate places for keeping animals to be slaughtered; separate places for slaughtering, preliminarily processing animals or animal products; places for isolation of sick animals; places for treating products not up to veterinary hygiene standards;

c/ There are testing rooms;

d/ There are systems for treatment of waste water, animal wastes suitable to the slaughtering or preliminary processing capacity. Waste water, wastes, once treated, must satisfy hygiene standards before being discharged into the environment;

e/ Workshops must be proof against dust and penetration of harmful animals; convenient for cleansing and disinfection; have separate places for storing products for use as food, products not for use as food, means of transport, slaughtering and preliminary processing tools and people working in these places in order to prevent pollution and cross-infection;

f/ Equipment and tools used in slaughtering and preliminary processing animals, animal products must be made of stainless material, not affecting the quality of products, easy to cleanse and disinfect.

2. Water used in slaughtering and preliminary processing animals, animal products must meet all veterinary hygiene standards.

Article 47.- Veterinary hygiene conditions on trading of animals, animal products

1. Organizations and individuals that trade in animals and/or animal products in markets must be arranged in places separate from other goods and must ensure the following veterinary hygiene conditions:

a/ Things used for display, sale and containing of animal products must be made of stainless material, not affecting the quality of products, easy to cleanse and disinfect;

b/ Preservation measures are taken to prevent animal products from contamination and degeneration;

c/ Places of, and objects used in, purchase and sale of animals and animal products must be cleansed after sale;

d/ Waste water from the course of trading of animals and animal products in markets must be treated up to veterinary hygiene standards before being discharged into the environment.

2. Places of collection, sale and purchase of terrestrial animals must be far from population quarters and public works; be cleansed and disinfected after each collection, purchase and sale of animals.

3. It is strictly forbidden to buy and sell:

a/ Infected terrestrial animals, animal products carrying pathogens of dangerous infectious disease or animals that are dead for unidentified causes;

b/ Aquatic or amphibian animals originating from zones where harvest is banned;

c/ Animals pumped or injected with water or liquids harmful to users;

d/ Animal products which are degenerated, contain chemicals or colors banned from use.

Section 4. RESPONSIBILITIES OF AGENCIES, ORGANIZATIONS AND INDIVIDUALS FOR QUARANTINE OF ANIMALS, ANIMAL PRODUCTS; CONTROL OF SLAUGHTER; VETERINARY HYGIENE INSPECTION

Article 48.- Responsibilities of state management agencies in charge of animal health

1. To quarantine animals, animal products; control slaughtering and preliminary processing of animals, animal products; inspect veterinary hygiene according to regulations.

2. To grant, withdraw animal quarantine certificates, certificates of satisfaction of veterinary hygiene standards. In case of refusal to grant animal quarantine certificates, to inform owners of the reasons therefor.

3. To guide, check and supervise goods owners, establishment owners to implement regulations on veterinary hygiene on animals and animal products subject to quarantine; control slaughtering and preliminary processing of animals, animal products; inspect veterinary hygiene.

Article 49.- Responsibilities of animal quarantine cadres

1. To quarantine animals, animal products; control slaughtering and preliminary processing of animals, animal products; inspect veterinary hygiene according to the provisions of legislation on veterinary medicine.

2. While performing their duties, to wear uniforms, badges and insignias, animal quarantine cadre’s cards, and other necessary equipment and devices.

3. To propose competent authorities to grant, withdraw animal quarantine certificates.

Article 50.- Responsibilities of other state agencies

1. People’s Committees at all levels shall have to work out plannings on concentrated places for, and organize management of, the slaughtering and preliminary processing of animals, animal products within localities; direct the concerned branches in localities to coordinate with state management agencies in charge of animal health in quarantining animals, animal products, controlling slaughtering; inspecting veterinary hygiene; and handling violations in accordance with the provisions of law.

2. The concerned agencies in charge of health and environmental protection and customs, port management, border guard, police, market control and post shall, within the scope of their respective functions and tasks, have to coordinate with state management agencies in charge of animal health in quarantining animals, animal products, controlling slaughtering; inspecting veterinary hygiene; detecting and preventing the illegal import of animals and animal products.

3. Customs offices shall complete customs procedures only when goods owners have fully complied with requirements of animal and animal product quarantine and veterinary hygiene inspection.

Article 51.- Responsibilities of goods owners and establishment owners

1. To observe the provisions of veterinary medicine legislation and other relevant laws regarding quarantine of animals and animal products; control of slaughtering and preliminary processing of animals and animal products; and inspection of veterinary hygiene.

2. To create favorable conditions for state management agencies in charge of animal health to quarantine animals, animal products, control slaughtering and preliminary processing of animals and animal products; and inspect veterinary hygiene according to regulations.

3. To be responsible for keeping and caring for animals, preserving animal products and follow the guidance of state management agencies in charge of animal health in the process of quarantine; controlling slaughtering and preliminary processing of animals and animal products; and inspecting veterinary hygiene, and paying charges and fees according to the provisions of law.

4. To immediately inform the nearest state management agencies in charge of animal health when detecting strange diseases or suspecting that animals are infected with disease or animal products carry pathogens of disease.

5. Not to swap or change the quantities of animals already granted the quarantine certificates in the course of transportation of animals and to follow the itinerary required by competent state management agencies in charge of animal health.

6. When transporting different animal species or those to be used for different purposes on board the same means of transport, to follow the guidance of the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals. Not to use means of transport already used for transporting hazardous substances to transport animals and animal products.

7. Fifteen days before establishments slaughtering and/or preliminarily processing animals and animal products start operation, report such to competent state management agencies in charge of animal health so that the latter can check veterinary hygiene conditions of these establishments.

Chapter IV

MANAGEMENT OF VETERINARY DRUGS, BIO-PREPARATIONS, MICROORGANISMS AND CHEMICALS FOR VETERINARY USE

Article 52.- Conditions on manufacture, processing, portioning of veterinary drugs, bio-preparations, microorganisms, chemicals for veterinary use

1. Organizations and individuals that manufacture, process, portion veterinary drugs, bio-preparations, microorganisms, chemicals for veterinary use must meet all conditions provided for in Article 38 of the Ordinance on Veterinary Medicine and veterinary hygiene conditions provided for in Clauses 2, 3, 4, 5, 6 and 7 of this Article.

2. Establishments must be situated separately from population quarters, public works, hospitals, veterinary clinics, animal diagnosis establishments, other polluting sources and not badly affect the surrounding environment.

3. Establishments that manufacture pharmaceuticals and chemicals for veterinary use must be designed and built according to GPM principles and standards, and have the following places:

a/ Storehouses of raw materials, auxiliary materials, packages, finished products;

b/ Place for disinfection;

c/ Place for weighing and distribution of raw materials;

d/ Place for manufacture preparation;

e/ Place for preparation and preservation of semi-finished products;

f/ Place for completion of products;

g/ Place for checking of products ex work;

h/ Place for storage of products not up to quality standards;

i/ Place for personal hygiene and other places in service of manufacture.

4. Establishments that manufacture vaccines, bio-preparations and microorganisms for veterinary use must have, apart from the places mentioned in Clause 3 of this Article, places for keeping and treatment of animals used for experiments; place and equipment for keeping of microorganisms in service of manufacture.

5. Manufacturing workshops must ensure the following veterinary hygiene conditions:

a/ Conditions on environmental sanitation; being easy to cleanse and disinfect; proof against dust and the penetration of harmful animals;

b/ Each place must be large enough to meet production requirements, easy for making technical movements, and convenient for checking and supervision;

c/ Having appropriate designs and arrangements to prevent confusion or cross-infection among assorted raw materials and products in the course of manufacture.

6. Manufacturing equipment and tools must ensure the following veterinary hygiene conditions:

a/ Being suitable and convenient for movements, easy to cleanse, disinfect and maintain;

b/ The surface of equipment and tools that comes into contact with raw materials, auxiliary materials, semi-finished and finished products must be made of inert material, not affect the purity and activity of raw materials and quality of drugs.

7. For mechanical equipment, equipment operated by electricity, caloric energy, pressure equipment, there must be written regulations on their adjustment, checking, maintenance and operation so as to ensure labor safety and quality of products.

8. Manufacturing establishments must satisfy veterinary hygiene standards promulgated by the Agriculture and Rural Development Ministry, the Fisheries Ministry or the Science and Technology Ministry.

Article 53.- Conditions on import of veterinary drugs, bio-preparations, microorganisms, chemicals for veterinary use

1. Organizations and individuals that import veterinary drugs, bio-preparations, microorganisms, chemicals for veterinary use on the list of veterinary drugs, the list of bio-preparations, microorganisms and chemicals for veterinary use permitted for circulation in Vietnam shall comply with the provisions of Clause 1, Article 48 of the Ordinance on Veterinary Medicine.

In case of importing vaccines and microorganisms, written approval of the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall be required.

2. Organizations and individuals that import veterinary drugs, bio-preparations, microorganisms, chemicals for veterinary use not on the list of veterinary drugs, the list of bio-preparations, microorganisms and chemicals for veterinary use permitted for circulation in Vietnam for manufacture, scientific and technological research, cooperation or exchange, for participation in fairs or exhibitions or for other purposes must ensure the conditions provided for in Clause 2, Article 48 of the Ordinance on Veterinary Medicine.

Article 54.- Conditions on trading of veterinary drugs, bio-preparations, microorganisms, chemicals for veterinary use

1. Organizations and individuals that trade in veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use must satisfy all conditions provided for in Article 39 of the Ordinance on Veterinary Medicine and the following veterinary hygiene conditions:

a/ Having fixed places of business;

b/ Having shops, display and sale places and storehouses which are large enough and suitably structured so as not to affect the quality of drugs;

c/ Shops must have separate places for sale of different types of goods permitted to be traded in, and have adequate facilities for display, sale and preservation;

d/ Having adequate technical equipment for goods preservation such as ventilating fans, refrigerators or freezing storehouses for preservation of vaccines and bio-preparations; hygrometers, thermometers for checking preservation conditions;

e/ Business activities must not badly affect the environment.

2. Organizations and individuals that trade in vaccines and microorganisms must comply with regulations of the Agriculture and Rural Development Ministry and the Fisheries Ministry.

Article 55.- Veterinary hygiene conditions on establishments that experiment, test, assay, export and/or import veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use

1. Establishments that experiment veterinary drugs, bio-preparations, microorganisms, chemicals for veterinary use must ensure the following veterinary hygiene conditions:

a/ Having adequate area, material and technical foundations, equipment, tools, chemicals, materials and raw materials needed for experiments;

b/ Having places for keeping and treating experimented animals;

c/ Having equipment exclusively used for keeping microorganisms in service of experiments;

d/ Having waste treatment systems to ensure veterinary hygiene and environmental sanitation.

2. Establishments that test and assay veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use must ensure the following veterinary hygiene conditions:

a/ The locations of establishments, stables, ponds, animal-raising tanks, raising tools, places of treatment of animal wastes, carcasses must ensure the conditions provided for in Article 7 of this Decree;

b/ Having all animal species in sufficient quantities needed for tests and assays;

c/ Having places and appropriate equipment for preservation of drugs, bio-preparations, microorganisms and chemicals needed for tests and assays;

d/ Having stables, ponds and animal-raising tanks for animals to ensure accurate test and assay results;

e/ Having adequate necessary tools and facilities.

3. Establishments that export and import veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use must ensure the following veterinary hygiene conditions:

a/ Having storehouses large enough for goods preservation;

b/ Having adequate equipment suitable for preservation and checking of goods preservation conditions;

c/ Having separate storehouses for preservation of veterinary drugs; pharmaceuticals; vaccines, bio-preparations, microorganisms; chemicals for veterinary use.

Article 56.- Cases of registration of circulation of veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use

1. Veterinary drugs, materials for use in veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use which are manufactured in the country for the first time.

2. Veterinary drugs in finished and semi-finished forms, materials, bio-preparations, microorganisms and chemicals for veterinary use which are imported into Vietnam for the first time for business, manufacture, processing or re-packing purposes.

3. Veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use which are recognized and included on the list of veterinary drugs, the list of bio-preparations, microorganisms and chemicals for veterinary use permitted for circulation in Vietnam must be re-registered when there are changes in content provided for in Clause 1, Article 58 of this Decree.

Article 57.- Registration of circulation of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use which are manufactured in the country or imported for the first time

1. Veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use which are manufactured in the country or imported into Vietnam for the first time shall be permitted for circulation in Vietnam if they meet all conditions provided for in Article 40 of the Ordinance on Veterinary Medicine.

2. Organizations and individuals that register for circulation of veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use must submit registration dossiers as provided for at Point b, Clause 1, Article 40 of the Ordinance on Veterinary Medicine to the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals. Registration dossiers shall be made in 3 (three) sets each.

For cases of importation, there must be one set in Vietnamese and import registration applications enclosed with product circulation permits, GMP certificates or ISO certificates, product quality analysis cards granted by competent authorities of manufacturing countries.

3. Within 15 (fifteen) days as from the date of receipt of registration dossiers, the dossier-receiving agencies shall have to reply; ask the registering organizations or individuals to complete their dossiers which are not satisfactory.

4. Within 60 (sixty) days as from the date of receipt of valid dossiers, the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall have to submit the dossier evaluation results to the specialized scientific councils set up by the Agriculture and Rural Development Ministry or the Fisheries Ministry. The specialized scientific councils shall hold regular or extraordinary meetings to consider and approve dossiers, propose the Agriculture and Rural Development Ministry or the Fisheries Ministry to recognize and make additions to the list of veterinary drugs or the list of bio-preparations, microorganisms and chemicals for veterinary use permitted for circulation in Vietnam.

Article 58.- Re-registration of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use which have been granted circulation registration numbers

1. Cases of re-registration:

a/ Change in composition or formula;

b/ Change in pharmaceuticals;

c/ Change in the use route of drug;

d/ Change in the manufacturing method or process resulting in change in product quality;

e/ Re-evaluation of the quality, effectiveness and safety of drugs according to regulations.

The compilation of re-registration dossiers shall comply with the provisions of Clause 2, Article 57 of this Decree.

2. Within 60 (sixty) days for pharmaceuticals and chemicals; 90 (ninety) days for vaccines and bio-preparations as from the date of receipt of valid dossiers, the dossier-receiving agencies shall have to evaluate dossiers and give the results.

Article 59.- Contents of GMP, procedures for registration for grant of GMP certificates

1. Good manufacturing practice (GMP) covers the following contents:

a/ Concepts;

b/ Personnel;

c/ Workshops;

d/ Equipment, tools;

e/ Hygiene and hygiene measures;

f/ Manufacturing;

g/ Quality checking;

h/ Self-inspection;

i/ Handling of product-related complaints, withdrawal of products;

j/ Documents.

2. Establishments that manufacture veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use must apply the good manufacturing practice (GMP) principles and standards and are checked and evaluated according to standards and granted certificates of satisfaction of GPM standards by the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals.

3. Dossiers of registration for GMP checking shall each consist of:

a/ An application for registration of GMP checking;

b/ Related documents, including: the establishment’s GMP training documents; plan on the location and design of manufacturing plants; plan on the production chains; plans on organization of manufacture; list of products permitted to be manufactured or already registered for manufacture; list of manufacturing equipment, equipment for checking product quality; list of standard operation processes (SOP); competent authorities’ written certifications of minutes on the test of fire prevention and fighting; evaluated report on environment; the establishment’s report on GMP self-check.

4. Within 60 (sixty) days as from the date of receipt of valid dossiers, the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall organize examination, evaluation and grant of certificates of satisfaction of GMP standards to the qualified establishments according to regulations.

Article 60.- Publication of quality standards of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use

1. Organizations and individuals that manufacture or import veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use on the list of veterinary drugs and the list of bio-preparations, microorganisms and chemicals for veterinary use permitted for circulation in Vietnam must publish quality standards of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use and take responsibility for the published quality standards. Standards published by establishments must not be contrary to or lower than branch standards or Vietnamese standards.

2. Dossiers of publication of quality standards of veterinary drugs, bio-preparations, microorganisms or chemicals for veterinary use shall be made in 3 (three) sets, each consisting of:

a/ The written publication of quality standards;

b/ A valid copy of the decision recognizing the veterinary drug, bio-preparation, microorganism or chemical for veterinary use permitted for
circulation.

3. Dossiers of publication of quality standards of veterinary drugs, bio-preparations, microorganisms or chemicals for veterinary use shall be addressed to the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals. Within 45 (forty five) days as from the date of receipt of valid dossiers, the dossier-receiving agencies shall have to check the validity of dossiers, accepting such dossiers or giving reasons for non-acceptance.

4. The Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall provide for the recording of numbers of written publications of quality standards of veterinary drugs, bio-preparations, microorganisms or chemicals for veterinary use.

5. If there is any change in the quality or labels of veterinary drugs, bio-preparations, microorganisms or chemicals as compared with the previous publications, establishments must compile dossiers of re-publication as provided for in Clause 2 of this Article.

Article 61.- Publication of quality-conforming standards of veterinary drugs, bio-preparations, microorganisms or chemicals for veterinary use

1. Organizations and individuals that manufacture or import veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use on the list of veterinary drugs and the list of bio-preparations, microorganisms and chemicals for veterinary use must be granted with certificates of satisfaction of Vietnamese standards or branch standards according to regulations of the Agriculture and Rural Development Ministry or the Fisheries Ministry on compulsory publication of standard-conforming quality.

2. Dossiers of publication of the standard-conforming quality of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use in conformity with standards shall be made in 3 (three) sets, each consisting of:

a/ The written publication of standard-conforming quality;

b/ A lawful copy of the certificate of quality in conformity with Vietnamese standards or branch standards, granted by a competent agency.

3. Dossiers of publication of Vietnamese standard-conforming quality of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use shall be addressed to the General Department of Standardization, Metrology and Quality Control under the Science and Technology Ministry; and dossiers of branch standard-conforming quality shall be addressed to the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals. Within 45 (forty five) days as from the date of receipt of valid dossiers, the dossier-receiving agencies shall check the standard conformity, affix stamp on the publications of standard-conforming quality and return one set of the dossiers of publication to the concerned establishments.

Article 62.- Disposal of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use

1. The disposal of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use shall comply with the provisions of Clause 1 and Clause 2 of Article 50 of the Ordinance on Veterinary Medicine.

2. The destruction of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use must ensure:

a/ Safety for human beings, environment, ecology and that the maximum level of residue in land, water and air must not exceed the permitted level;

b/ Compliance with technical processes provided for by the Agriculture and Rural Development Ministry or the Fisheries Ministry and the provisions of legislation on management of hazardous wastes;

c/ That the destruction is conducted under the supervision of local state management agencies in charge of animal health, environment agencies administrations and other relevant agencies and its results are certified by these agencies;

d/ That persons conducting the destruction are fully provided with protective and labor protection equipment.

3. Organizations and individuals that have veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use disposed of shall be responsible for the disposal and bear all expenses therefor according to the provisions of law.

In cases where owners are unidentified, provincial-level People’s Committees shall direct the concerned branches to conduct the destruction according to regulations. Destruction expenses shall be covered by local budgets.

Chapter V

PRACTICE OF VETERINARY MEDICINE

Article 63.- Veterinary medicine practice certificates

1. Individuals that practice veterinary medicine under the provisions of Article 52 of the Ordinance on Veterinary Medicine must have veterinary medicine practice certificates.

2. Veterinary medicine practice certificates shall be granted by state management agencies in charge of animal health in accordance with the provisions of Clause 1 and Clause 2, Article 54 of the Ordinance on Veterinary Medicine.

3. Veterinary medicine practice certificates shall be granted to qualified individuals who personally practice veterinary medicine; owners or technical managers of establishments that test animal diseases or conduct surgery of animals; manufacture, export, import, experiment, test, assay veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use.

Article 64.- Conditions for grant of practice certificates

1. Conditions on professional diplomas

a/ People who provide services of diagnosis, prescription, medical treatment and care for the health of animals must have at least intermediate-level diplomas in animal health or animal raising and animal health or intermediate-level diplomas in aquaculture for practice of veterinary medicine of aquaculture. People who practice animal vaccination or castration must have certificates of technical training granted by provincial-level state management agencies in charge of animal health;

b/ Owners or technical managers of establishments that test animal diseases or conduct surgery of animals must be at least veterinary doctors, animal raising and animal health engineers or bachelors of biology or bio-chemistry or aquaculture engineers who have been trained in testing of aquatic animal diseases for practice of veterinary medicine in aquaculture; and have at least 2 (two) years’ experience in the registered domain of practice;

c/ Owners or technical managers of establishments that manufacture or experiment veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use must be at least veterinary doctors, animal raising and animal health engineers or pharmacists, bachelors of biology or bio-chemistry or aquaculture engineers for practice of veterinary medicine in aquaculture; and have at least 2 (two) years’ experience in the field they register to practice;

d/ Owners of shops dealing in veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use must have at least intermediate-level diplomas in animal health or animal raising and animal health or intermediate-level diplomas in biology or aquaculture for practice of veterinary medicine in aquaculture. Sellers must have at least certificates of training in the registered domain of practice granted by provincial-level state management agencies in charge of animal health;

e/ Owners or technical managers of establishments that experiment and assay veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use must be at least veterinary doctors, animal raising and animal health engineers or bachelors of biology or bio-chemistry or aquaculture engineers who have been trained in animal health for practice of veterinary medicine in aquaculture; and have at least 2 (two) years’ experience in the field they register to practice;

f/ Owners or technical managers of establishments that export and import veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use must be at least veterinary doctors, animal raising and animal health engineers or bachelors of biology or bio-chemistry or aquaculture engineers who have been trained in animal health for practice of veterinary medicine in aquaculture;

g/ People who provide counseling or technical services on animal health must have at least intermediate-level diplomas in animal health, animal raising and animal health or aquaculture and have been trained in animal health for practice of veterinary medicine in aquaculture.

2. Grantees of veterinary medicine practice certificates must have health certificates of their physical fitness to practice veterinary medicine granted by medical establishments of district or higher level.

3. For foreigners, they must, apart from complying with the provisions of Clauses 1 and 2 of this Article, have judicial record cards certified by competent agencies and must be other than those defined in Article 66 of this Decree.

Article 65.- Procedures for grant and validity duration of veterinary medicine practice certificates

1. Applicants for practice certificates for manufacture, export, import, experimentation, test or assay of veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use shall send dossiers to the Animal Health Department or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals.

Applicants for practice certificates for vaccination, test, diagnosis, prescription, medical treatment, care for animal health, animal surgery; trading of drugs, bio-preparations, microorganisms, chemicals used for veterinary use; counseling and other services related to animal health shall send dossiers to provincial-level state management agencies in charge of animal health.

2. Dossiers of application for veterinary medicine practice certificates shall comply with the provisions of Clause 3, Article 54 of the Ordinance on Veterinary Medicine.

Applicants for veterinary medicine practice certificates mentioned at Points b, c and e, Clause 1 of Article 64 of this Decree must have additionally written certifications of establishments that manufacture, experiment, test and/or assay veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use or of establishments that test animal diseases and conduct animal surgery of the time for which they have practiced in such establishments.

In case applicants for veterinary medicine practice certificates are public employees, the written approval of the heads of the agencies where such applicants work shall be required and they must practice within the scope in accordance with the provisions of law on public employees.

3. Within 10 (ten) days as from the date of receipt of valid dossiers, the dossier-receiving agencies shall check dossiers and grant veterinary medicine practice certificates or request completion of dossiers which are invalid or return dossiers and state the reasons for non-grant of veterinary medicine practice certificates.

4. Applicants for veterinary medicine practice certificates must pay charges and fees according to the provisions of law.

5. The validity duration of veterinary medicine practice certificates is 5 (five) years. One month before the expiration of veterinary medicine practice certificates, grantee of veterinary medicine practice certificates, if wishing to continue practicing, must send dossiers to competent state management agencies mentioned in Clause 1 of this Article.

A dossier of registration for extension of veterinary medicine practice certificate shall consist of:

a/ An application for extension of veterinary medicine practice certificate;

b/ A lawful copy of the granted veterinary medicine practice certificate;

c/ The health certificate of physical fitness to practice veterinary medicine, granted by a medical establishment of district or higher level.

Article 66.- People who shall not be granted veterinary medicine practice certificates or shall not have their certificates extended

1. Persons who are banned from practicing under court judgments or decisions.

2. Persons who are subjected to discipline related to the veterinary medicine profession.

3. Persons who are being examined for penal liability.

4. Persons who are serving criminal sentences; subject to administrative measure such as confinement in educational or medical treatment establishments or administrative probation.

5. Persons who have their civil act capacity restricted or have lost their civil act capacity.

Article 67.- Cases of withdrawal of veterinary medicine practice certificates

1. Veterinary medicine practice certificates are granted ultra vires.

2. Conditions provided for in Article 64 of this Decree are no longer fully met.

3. Practice certificates are erased or modified.

4. Grantees of veterinary medicine practice certificates fall into the subjects defined in Article 66 of this Decree.

5. Grantees of veterinary medicine practice certificates commit administrative violations three or more times in the domain of practice during the period they are permitted to practice veterinary medicine.

6. Grantees of veterinary medicine practice certificates commit other acts of violation subjected by law to withdrawal of practice certificates.

Article 68.- Prohibited acts

1. Practicing veterinary medicine without practice certificates or with expired practice certificates.

2. Hiring or borrowing veterinary medicine practice certificates.

3. Forging veterinary medicine practice certificates.

4. Other acts prohibited by law.

Article 69.- Rights and obligations of veterinary medicine practitioners

1. Organizations and individuals that practice veterinary medicine shall have the following rights:

a/ To carry out professional veterinary medicine activities in accordance with the granted veterinary medicine practice certificates;

b/ To join in the Veterinary Medicine Society or other relevant professional associations.

2. Organizations and individuals that practice veterinary medicine shall have the following obligations:

a/ To strictly observe the provisions of law on veterinary medicine and environmental protection in the course of practicing their profession;

b/ To monitor, record, and report in time to local state management agencies in charge of animal health when detecting or doubting the outbreak of, dangerous epidemics of animals or diseases transmitted from animals to humans, and coordinate with state management agencies in charge of animal health in quickly overcoming consequences;

c/ To participate in animal vaccinations organized by local animal health agencies;

d/ To participate in preventing and fighting animal epidemics under the designation of local administrations and state management agencies in charge of animal health;

e/ To supply information on animal health investigations; send statistical reports to local animal health agencies on professional activities on a regular basis and upon outbreak of epidemic;

f/ To take responsibility before law for the results of their practice or of establishments under their management; to compensate according to the provisions of law for damage caused by their practice to other organizations and/or individuals;

g/ To submit to the supervision and inspection of competent functional agencies.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 70.- Implementation effect

This Decree takes effect 15 days after its publication in the Official Gazette and replaces the Regulation on the implementation of the Ordinance on Veterinary Medicine; the Regulation on prevention and control of animal epidemics; the Regulation on quarantine, control of slaughter, and inspection of veterinary hygiene of animals and animal products; the Regulation on management of veterinary drugs, promulgated together with the Government’s Decree No. 93/CP of November 27, 1993 guiding the implementation of the Ordinance on Veterinary Medicine.

Article 71.- Implementation responsibilities

1. The Agriculture and Rural Development Ministry and the Fisheries Ministry shall have the responsibility:

a/ To provide for the duration, types of vaccines, terrestrial animal species subject to compulsory vaccination, compulsory preventive measures for aquatic and amphibian animals in epidemic-threatened zones; the raising of different animal species in the same breeding establishment; animal diseases to be periodically examined in breeding establishments; assorted kinds of veterinary drug materials permitted for use for prevention and treatment of animal diseases.

b/ To provide for diseases banned from treatment; diseases animals infected with which must be culled or slaughtered; measures of veterinary hygiene of places of cull and compulsory slaughter of animals, of meat of compulsorily slaughtered animals; veterinary hygiene standards for the preliminary processing and disposal of aquatic and amphibian animals infected or suspected of being infected with dangerous infectious disease;

c/ To provide for numbers of animals, weights of animal products subject to quarantine if transported out of districts; cases of temporary exemption from quarantine; measures to handle animals, animal products, means of transport and other related objects failing to meet all veterinary hygiene standards; conditions and procedures for receipt and sending of pathological materials;

d/ To provide for the trading of vaccines and microorganisms; procedures for registration of change of ownership; processing, and re-packing of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use; procedures for registration of import of veterinary drugs, bio-preparations, microorganisms not on the list of veterinary drugs, bio-preparations, microorganisms for veterinary use permitted for use in Vietnam in service of manufacture, scientific and technological research, cooperation and exchange, participation in fairs or exhibitions or for other purposes;

e/ To provide for procedures for withdrawal of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use failing to meet all registered quality standards;

f/ To provide for order and procedures for withdrawal and re-grant of veterinary medicine practice certificates.

2. The Agriculture and Rural Development Ministry and the Fisheries Ministry shall have to guide and organize the implementation of this Decree.

3. The ministers, the heads of the ministerial-level agencies, the heads of the Government-attached agencies, and the presidents of the People’s Committees of the provinces and centrally-run cities shall have to implement this Decree.

 

 

ON BEHALF OF THE GOVERNMENT
PRIME MINISTER





Phan Van Khai

 

Đã xem:

Đánh giá:  
 

Thuộc tính Văn bản pháp luật 33/2005/ND-CP

Loại văn bảnNghị định
Số hiệu33/2005/ND-CP
Cơ quan ban hành
Người ký
Ngày ban hành15/03/2005
Ngày hiệu lực05/04/2005
Ngày công báo...
Số công báo
Lĩnh vựcThể thao - Y tế
Tình trạng hiệu lựcHết hiệu lực 01/07/2016
Cập nhật4 năm trước
Yêu cầu cập nhật văn bản này

Download Văn bản pháp luật 33/2005/ND-CP

Lược đồ Decree No. 33/2005/ND-CP of March, 15, 2005, detailing the implementation of a number of articles of the Ordinance on veterinary medicine


Văn bản bị đính chính

    Văn bản đính chính

      Văn bản bị thay thế

        Văn bản hiện thời

        Decree No. 33/2005/ND-CP of March, 15, 2005, detailing the implementation of a number of articles of the Ordinance on veterinary medicine
        Loại văn bảnNghị định
        Số hiệu33/2005/ND-CP
        Cơ quan ban hànhChính phủ
        Người kýPhan Văn Khải
        Ngày ban hành15/03/2005
        Ngày hiệu lực05/04/2005
        Ngày công báo...
        Số công báo
        Lĩnh vựcThể thao - Y tế
        Tình trạng hiệu lựcHết hiệu lực 01/07/2016
        Cập nhật4 năm trước

        Văn bản hợp nhất

          Văn bản gốc Decree No. 33/2005/ND-CP of March, 15, 2005, detailing the implementation of a number of articles of the Ordinance on veterinary medicine

          Lịch sử hiệu lực Decree No. 33/2005/ND-CP of March, 15, 2005, detailing the implementation of a number of articles of the Ordinance on veterinary medicine