Văn bản hợp nhất 12/VBHN-BNNPTNT

DECREE

PROVIDING GUIDANCE ON THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE ORDINANCE ON VETERINARY MEDICINE

The Decree No. 33/2005/NĐ-CP dated March 15^th, 2005 by the Government detailing the implementation of a number of articles of the Ordinance on Veterinary Medicine, effective from April 05^th, 2005, is amended by:

1. The Decree No. 119/2008/NĐ-CP dated November 28^th, 2008 by the Government providing amendments to a number of articles of the Decree No. 33/2005/NĐ-CP dated March 15^th, 2005 by the Government, effective from December 23^rd, 2008.

2. The Decree No. 98/2011/NĐ-CP dated October 26^th, 2011 by the Government providing amendments to a number of articles of the decrees on agriculture, effective from December 15^th, 2011.

Pursuant to the Law on Government organization dated December 25^th, 2001;

Pursuant to the Ordinance on Veterinary Medicine dated April 29^th, 2004;

At the request of the Minister of Agriculture and Rural Development; the Minister of Fisheries 1

DECREES:

Chapter I

GENERAL PROVISIONS

Article 1. Regulated scope and entities

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.

If International Treaties which the Socialist Republic of Vietnam has signed or acceded contains provisions different from those of this Decree, such International Treaties shall prevail.

Article 2. Interpretation of terms

In this Decree, these following terms can be 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 areas 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 that are 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 supervision 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 reduce the spread of epidemics, the number of epidemic hotspots and the number of newly infected animals in epidemic hotspot.

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

12. Animal raising carried 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 obtain the business registration certificates for slaughtering animals and/or preliminarily processing animals and/or animal products from competent agencies.

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 carry out the raising, slaughter, preliminary processing and preservation of animals and 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, and quality inspection by establishments and satisfy the 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 when 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 physical, 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 according 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) Not containing or containing insufficient types of active ingredients as registered;

b) Containing drug substances 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 affiliated to the Agriculture and Rural Development Ministry; the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals affiliated to the Ministry of Fisheries.

b) The Ministry of Agriculture and Rural Development Ministry define the functions, tasks, powers and organizational structure of the Animal Health Department; the Ministry of Fisheries 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 and central-affiliated cities (hereinafter referred 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 referred to as districts or district-level) where there are district-level state management agencies in charge of animal health;

c) The Ministry of Agriculture and Rural Development and the Ministry of Fisheries shall cooperate with the Ministry of Home Affairs in providing guidance on functions, tasks powers and organizational structures of state management agencies in charge of animal health at all levels.

The People’s Committees of provinces 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 prescribed by People’s Committees of provinces 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 carried by households and individuals

1. Households and individuals that raise terrestrial animals shall fully satisfy the veterinary hygiene conditions prescribed in Clause 1, Article 12 of the Ordinance on Veterinary Medicine and the following conditions on stables:

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 and animals suspected of being infected;

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

dd) There are measures to kill harmful rodents and insects.

2. Households and individuals that raise aquatic or amphibian animals shall satisfy the veterinary hygiene conditions specified in Points a, b, c, d and dd 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 shall ensure the conditions specified at Points d and g, Clause 2, Article 7 of this Decree;

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

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

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

1. Concentrated terrestrial animal-raising establishments shall 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 shall be situated in line with the plannings approved by competent authorities;

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

c) Establishments shall have separate administrative quarters;

d) Establishments shall have personal hygiene and clothes-changing places for officials, workers and visitors;

dd) Establishments shall have sterilization pits for people and means of transport before entering the establishments and animal-raising places;

e) Stables shall be suitable to raised animals, airy in summer, warm in winter and easy to cleanse and disinfect;

f) The distance between stables shall be long enough to ensure airiness;

g) The environment of animal-raising places shall satisfy the prescribed veterinary hygiene standards;

h) Establishments shall have separate storehouses for preserving feeds, materials for production of feeds; raising tools; and toxic chemicals for disinfection;

i) Cleansing and disinfection upon outbreaks of epidemics and after each animal-raising cycle or sale of animals shall be conducted periodically;

k) The empty period of stables after each animal-raising cycle or each sale of animals shall be ensured;

l) There shall be measures to kill harmful rodents and insects.

2. Establishments for concentrated raising of aquatic or amphibian animals in ponds or marshes shall 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 shall be situated in line with the plannings approved by competent authorities;

b) Establishments shall have separate canals for supplying water for raising animals and for draining wastewater;

c) Establishments shall have ponds for treating water before it is channeled into animal-raising ponds or marshes;

d) Wastewater or solid waste shall be treated according to hygiene standards before it is discharged from the establishments;

dd) Establishments shall have places of personal hygiene for officials, workers and visitors separated from animal-raising ponds or marshes;

e) Establishments shall have 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;

f) Cleansing and disinfection upon outbreaks of epidemics and after each animal-raising cycle or sale of animals shall be conducted periodically;

g) Duration of interruption after each animal-raising cycle shall be ensured;

h) Measures to prevent people and animals from penetrating into the establishments shall be applied.

3. Establishments for concentrated raising of aquatic or amphibian animals in floating cages or weirs shall 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 shall be situated in line with the plannings approved by competent authorities;

b) Solid waste shall be treated before being discharged;

c) Houses for personal hygiene at animal-raising places shall be designed preventing discharge into the raising environment;

d) Establishments shall have 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;

dd) Cleansing and disinfection upon outbreaks of epidemics and after each animal-raising cycle or sale of animals shall be conducted periodically;

e) Duration of interruption after each animal-raising cycle shall be ensured.

4. Animal-raising establishments, animal-raising places; equipment, tools, means of transport and water used in animal raising and treated animal wastes shall satisfy the veterinary hygiene standards specified in 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 animal raising, of pastures and animal wastes

1. Feeds shall fully satisfy veterinary hygiene standards, not causing harms to animals and users of animal products. Feeds used for animals in concentrated animal-raising establishments shall be inspected and assessed according to veterinary hygiene standards.

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

3. Homemade or recycled feeds shall be treated to ensure veterinary hygiene before being given to animals.

4. Water used in animal raising and animal feed processing shall ensure veterinary hygiene. Untreated industrial wastewater shall not be used for raising animals.

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

6. Regarding pastures sprayed with pesticides or disinfectants, a sufficient time shall 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 shall be raised in isolation. The time of isolated raising shall depend on each disease and each animal species as follows:

a) From 15 to 30 days for terrestrial animals;

b) From 3 to 30 days for imported aquatic or amphibian animals.

2. During the time of isolated raising, separate supervising and raising people and tools shall 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 shall be technically treated according to regulations on specific diseases.

Article 10. Compulsory prevention of animal diseases

1. Owners of terrestrial animals shall comply with the following provisions on compulsory prevention of animal diseases:

a) Use veterinary drugs, bio-preparations for preventing the diseases included in the List of diseases subject to application of compulsory preventive measures;

b) Comply with vaccination instructions of People’s Committees of provinces, vaccination plans of state management agencies of in charge of animal health of provinces 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) Administer drugs to animals on a periodical basis to prevent blood-borne parasitic diseases and eradicate parasitical worms;

d) Apply compulsory veterinary hygiene measures in animal raising; kill rats, flies, mosquitoes and other vectors in animal-raising places.

2. Animal owners shall perform the prevention of aquatic and amphibian animal diseases as follows:

a) Comply with the regulations of the Ministry of Fisheries 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) Comply with regulations on cleansing and disinfection of equipment and tools in the raising and harvesting processes;

c) Apply veterinary hygiene measures to wastewater and animal wastes before discharging them into the environment;

d) 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 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. Comply with 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 prescribed in Articles 6, 7, 8 and 9 of this Decree and apply compulsory measures to prevent diseases for animals specified in Clauses 1 and 2, Article 10 of this Decree.

2. Make declaration of herds of raised animals as follows:

a) Owners of concentrated animal-raising establishments shall 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 Department of Animal Health or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals when epidemics occur;

b) Animal-raising households and individuals shall have a logbook for the delivery and receipt of animals, prevention and treatment of animal diseases; report to commune-level veterinarians or state management agencies of districts in charge of animal health on their animal herds when epidemics occur.

3. Comply with 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. Construction and management of animal epidemic-free areas and establishments

1. The construction of animal epidemic-free areas and establishments shall comply with the provisions of Article 14 of the Ordinance on Veterinary Medicine.

2. Animal epidemic-free areas 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. The management of areas and establishments already recognized to be animal epidemic-free includes the following activities:

a) Epidemic supervision: periodic reports on the animal raising, epidemics and slaughtering; periodical tests of serums and pathological materials for prompt detection of diseases;

b) Close control of transport of animals and animal products into epidemic-free areas and establishments;

c) Any organization and individual detecting dangerous infectious diseases in animals in epidemic-free areas or establishments shall immediately report them to veterinarians of communes or the nearest state management agencies in charge of animal health for diagnosis and identification of such diseases and 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 shall be formulated into national programs and submitted to the Prime Minister for approval. The formulation of such programs shall ensure the principles prescribed 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) shall comply with the following provisions:

a) Infected animals shall be treated promptly;

b) Owners of animals, veterinarians of communes, organizations and individuals practicing veterinary medicine that treating diseases for animals in epidemic-hit areas shall 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 shall ensure the quality and shall be included in 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;

dd) When drugs are administered to animals, a withdrawal period of time shall be ensured before animals are harvested or slaughtered under the guidance of drug manufacturers or veterinary medicine practitioners;

e) Veterinarians of communes, organizations and individuals practicing veterinary medicine shall wear protective uniforms under the guidance of state management agencies in charge of animal health when treating animal diseases in epidemic-hit areas.

2. Owners of animals that detect infected animals shall provide treatment specified in Clause 1 of this Article and immediately inform such cases to veterinarians of communes or local state management agencies in charge of animal health.

Article 15. Testing and diagnosis of animal diseases

1. Owners of animals, organizations and individuals doubting that animals are infected with dangerous infectious diseases or seeing that animals die in large numbers for unidentified causes shall immediately inform such cases to veterinarians of communes or the nearest state management agencies in charge of animal health. In case of necessity, such animals shall be taken 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. If a local state management agency in charge of animal health or a commune-level veterinarian detect or receive information on animals suspected of being infected with dangerous infectious disease or on animals dying in large numbers for unidentified causes, then such agency/veterinarian shall conduct diagnosis to identify the disease and immediately notify the superior state management agencies in charge of animal health of such case. In case of necessity, samples of such animal shall be taken for test and diagnosis.

3. Samples of animals in breeding establishments shall be taken biannually by state management agencies in charge of animal health for testing according to regulations.

4. Samples of animals in areas and establishments already recognized to be animal epidemic-free shall be annually taken by state management agencies in charge of animal health for testing for diseases registered to be free of. The collection of samples for testing 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 shall satisfy the following veterinary hygiene conditions:

a) Their locations shall be distant from residential areas and public works;

b) Having adequate area, technical and material foundations, equipment, tools, chemicals, materials and raw materials to meet the requirements for 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 satisfying veterinary hygiene standards.

2. Animal surgery establishments shall satisfy the following conditions:

a) Having adequate area, technical and material foundations, equipment, tools, chemicals, materials and raw materials to satisfy the requirements for 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 satisfying veterinary hygiene standards.

Article 17. Animal health measures for areas with old epidemic hotspots and epidemic-threatened areas

1. Healthcare measures for terrestrial animals:

a) Regarding old epidemic hotspots, animal epidemics shall be supervised regularly; pathological materials shall be periodically taken for tests in order to early detect diseases; compulsory vaccinations shall be provided for 100% of animals subject to vaccination; other compulsory preventive measures shall be applied to animals;

b) Regarding epidemic-threatened areas, on the basis of specific areas, nature of specific diseases and specific animal species, compulsory vaccination shall be provided for animals within the regulated time limit.

2. Healthcare measures for aquatic and amphibian animals:

a) Regarding old epidemic hotspots, disinfection and environmental rehabilitation measures shall be applied when the epidemic has been stamped out; previously occurred animal epidemics shall be supervised often; pathological materials shall be periodically taken for tests in order to early detect diseases; other compulsory preventive measures shall be also applied;

b) Regarding epidemic-threatened areas, on the basis of specific areas, nature of specific diseases and specific animal species, compulsory preventive measures shall be applied according to the regulations.

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

1. The presidents of People’s Committees of provinces shall be in charge of the declaration of animal epidemics in their local areas when all conditions specified in Clause 1, Article 17 of the Ordinance on Veterinary Medicine are met and shall:

a) Issue decision to set up Steering Committees for Prevention and Control of Animal Epidemics of provinces in which a leading official of the People’s Committee of province is head, leading officials of the Services of Agriculture and Rural Development and Services of Fisheries are deputy heads and the heads of the relevant departments are members;

b) The Steering Committees for Prevention and Control of Animal Epidemics shall assist the Presidents of the People’s Committees of provinces in directing the agricultural and fisheries services to cooperate with the relevant branches, levels, organizations and individuals in local areas; mobilize human and material powers in accordance with the provisions of law to apply anti-epidemic measures specified in Articles 19, 20, 21, 22 and 23 of this Decree.

2. The Minister of Agriculture and Rural Development and the Fisheries Minister shall be in charge of the declaration of animal epidemics in multiple provinces when all the conditions specified in Clause 2, Article 17 of the Ordinance on Veterinary Medicine are met and shall:

a) Set up ministerial Steering Committees for Prevention and Control of Animal Epidemics in which a leading official of the ministry is head, leading officials of the Department of Animal Health and the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals are deputy heads and leading officials of the relevant departments and institutes are members;

b) The Steering Committees for Prevention and Control of Animal Epidemics shall assist the Minister of Agriculture and Rural development and the Minister of Fisheries in directing the agricultural and fisheries services to cooperate with the relevant branches, levels, organizations and individuals in local areas; mobilize human and material powers in accordance with the provisions of law to apply anti-epidemic measures specified in Articles 19, 20, 21, 22 and 23 of this Decree.

3. The Prime Minister shall be in charge of the declaration of epidemics upon occurrence of dangerous infectious epidemics of animals that are possible to transmit to humans at the request of the Minister of Agriculture and Rural Development or the Minister of Fisheries and according to the regulations in Clause 3, Article 18 of the Ordinance on Veterinary Medicine.

4. The Ministries, ministerial-level agencies, Governmental agencies, within their tasks and power, shall cooperate with the Ministry of Agriculture and Rural Development and the Ministry of Fisheries in the prevention and control of animal epidemics.

Article 19. Management of epidemic-hit areas

1. Services of Agriculture and Rural development, Services of Fisheries shall cooperate with the Department of Animal Health and the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals in steering local state management agencies in charge of animal health at all levels to identify epidemic-hit areas, epidemic-threatened areas and buffer zone; 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. People’s Committees of provinces shall steer the 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, inspect and monitor 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 areas.

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

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

Article 20. Isolation of animals in epidemic-hit areas

1. Infected animals, animals suspected of being infected shall be raised in isolation throughout the duration of occurrence of epidemics for monitoring and treating or handling appropriately for each disease; shall 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 shall be treated and disinfected till epidemic is erased.

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

1. Any kinds of animal products susceptible to the declared epidemics is forbidden to take into or out of epidemic-hit areas. Any feeds, animal-raising tools and animal wastes capable of transmitting epidemics is forbidden to take out of epidemic-hit areas. The transport of animals to places of slaughtering or preliminary processing shall comply with 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 an epidemic-hit area, the transport shall be allowed by the People’s Committee of province and shall follow the route determined by the Steering Committee for Prevention and Control of Animal Epidemics of provinces without stop. Transport vehicle shall be disinfected immediately when it has been out of the epidemic-hit area.

3. The slaughter, circulation, trade and exchange terrestrial animals and their products susceptible to the declared epidemics are forbidden.

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

1. State management agencies of in charge of animal health of provinces shall designate animal species subject to compulsory vaccination and expeditiously organize and direct state management agencies of districts in charge of animal health, veterinarian officials of communes and veterinary medicine-practicing organizations and individuals to provide compulsory vaccinations and apply other compulsory preventive measures to animals susceptible to the declared epidemics in epidemic-hit areas and supervise the cleansing and disinfection work.

2. Owners of animals shall follow all guidance of local state management agencies in charge of animal health on compulsory vaccination or application of other compulsory preventive measures to animals; perform the cleansing and disinfection of epidemic-hit areas with appropriate disinfectants of sufficient content according to the regulations for:

a) Places of raising, pastures, culling and slaughtering of animals;

b) Raising and slaughtering tools, transport vehicles for 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 areas and buffer zones

1. State management agencies of in charge of animal health of provinces shall cooperate with local administrations and concerned agencies in taking the following measures for epidemic-threatened areas:

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

b) Identifying animal species susceptible to epidemics;

c) Closely controlling the transport into and out of epidemic-threatened areas of animals susceptible to the declared epidemics and their products;

d) Providing vaccinations or applying other compulsory preventive measures according to regulations for specific disease;

dd) Intensifying epidemic supervision, regularly conduct screening to identify new epidemic hotspots for prompt handling.

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

a) Intensify epidemic supervision and regularly monitor animals that are infected and dead from unidentified causes;

b) Increase the 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) Conduct testing of serums and pathological materials to detect the circulation of diseases.

Article 24. Responsibilities of state management agencies in charge of animal health for the prevention and control of animal epidemics

1. Upon the outbreaks of animal epidemics, the central state management agencies in charge of animal health shall promptly provide local state management agencies in charge of animal health with guidance on technical measures to quickly stamp out epidemics, Intensify the control and expedite the application of animal health measures specified 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, take the responsibilities for:

a) Organizing and directing the state management agencies of districts in charge of animal health and veterinarians of communes to provide animal-raising organizations and individuals guidance on the implementation of regulations on compulsory prevention of animal diseases, isolation of animals, purchase and sale of animals and animal products, cleansing and disinfection;

b) Inspecting and supervising the places of isolation of infected animals;

c) Guiding the medical treatment for infected animals;

d) Notifying state management agencies of in charge of animal health of the province that received animals susceptible to the current epidemics and originating from epidemic-hit areas so as to monitor animals for a period of time at least equal to the incubation period;

e) Guiding animal owners to apply the prescribed measures for incurable infected animals or dead animals according to the regulations.

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 as follows:

a) The state management agencies of in charge of animal health of province shall report the cases to Services of Agriculture and Rural development to request the President of the People’s Committee of the provinces to issue decision 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 state management agencies in charge of animal health of provinces and all animal health measures must be applied in these houses in accordance with regulations;

c) Vehicles for transport of animals for compulsory slaughter must have close floors so that waste matters are not dropped on road and shall 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;

dd) Meat of animals subjected to compulsory slaughter must not be used fresh but must be treated to ensure veterinary hygiene according to the regulation. 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 according to 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 satisfy veterinary hygiene standards regulated 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 included in 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 according to the guidance of state management agencies in charge of animal health and the technical processes developed by the natural resource and environment agencies.

2. Bodies of animals which died of anthrax and 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 according to the guidance of the People’s Committees at all levels.

In case there is no choice but to build a work above the animal burial pit, the owner of such work shall comply with all guidance of state management agencies in charge of animal health of provinces on the excavation and destruction of all substances in burial pits and cleansing and disinfection of these places. The owner of work shall fully pay for such activities.

Article 27. Conditions and competence in declaration of the end of epidemics

1. The declaration of the end of an epidemic is issue if:

a) All of animals susceptible to the declared epidemic in epidemic-hit areas and epidemic-threatened areas have been vaccinated or applied with other compulsory preventive measures. Regarding terrestrial animals, a sufficient duration is required for immunity to the disease concerned;

b) Within 30 days, depending on specific disease, from the day on which last infected animal or aquatic flock die or are slaughtered, preliminarily treated or culled or fully recover, not any other animal or aquatic flock infected or die of the declared epidemic;

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

2. Competence in declaration of the end of an epidemic:

a) Heads of the state management agency in charge of animal health of provinces shall conduct an inspection of conditions for declaration of the end of the epidemic then send a written report on the satisfactory cases to Heads of the central state management agency, the Service of Agriculture and Rural development and the Service of Fisheries. When the approval for declaration of the end of epidemic from the Head of the central state management agency is received, Heads of the state management agency in charge of animal health of provinces shall request the President of the People’s Committee of provinces to issue a declaration of the epidemic in local area.

b) After checking to ensure that all conditions for declaration of the end of epidemics are satisfied, the head of the central state management agency in charge of animal health shall request the Minister of Agriculture and Rural development and the Minister of Fisheries to declare the end of epidemics (applicable to epidemics occurred in multiple provinces); report to the Ministry of Agriculture and Rural development and the Ministry of Fisheries to request the Prime Minister to declare the end of the epidemic (applicable to 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 according to the regulations in Article 22 of the Ordinance on Veterinary Medicine.

2. The Ministry of Finance shall preside over and cooperate with the Ministry of Agriculture and Rural Development, the Ministry of Fisheries and relevant Ministries, regulatory bodies in requesting the Prime Minister to issue the decision on the establishment, management and use of the Funds for prevention and control of animal epidemics at central and provincial levels.

Chapter III

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

Section 1. QUARANTINE OF ANIMALS, ANIMAL PRODUCTS

Article 29. Principle of quarantine animals, animal products

1. The quarantine of animals and animal products shall comply with the principles specified in Article 23 of the Ordinance on Veterinary Medicine.

2. Terrestrial animals and product thereof included in the List of animals and animal products subject to quarantine that are transported in large amount out of a district shall undergo quarantine once in the departure place.

3. Aquatic and amphibian animals and products thereof included in the List of animals and animal products subject to quarantine that are circulated within the country shall undergo quarantine once in the 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 thereof2

1. When transporting or circulating within the country terrestrial animals and/or animal products included in the List of animals and animal products subject to quarantine, a declaration shall be made and one (01) application for quarantine shall be sent to the state management agencies in charge of animal health of provinces or districts or cities affiliated to provinces. The quarantine declaration is stipulated as follows:

a) The declaration shall be made at least two (02) working days before the transport if animals have been applied with compulsory preventive measures according to the regulations and still stay immune, otherwise, the declaration shall be made at least fifteen (15) to thirty (30) working days before the transport;

b) The declaration shall be made at least two (02) working days before the transport if animal products have undergone testing for veterinary hygiene criteria or are sent by post, otherwise, the declaration shall be made at least seven (07) working days before the transport.

Within one (01) working day from the day on which the satisfactory application is received, the receiving agency shall certify the quarantine declaration and make a notification of the location and time of quarantine.

Within one (01) working day from the day on which animals and/or animal products are gathered at the arranged location, the application receiving agency shall conduct the quarantine.

2. Any wishing to export, import, temporarily import for re-export, temporarily export for re-import, transit through Vietnam territory animals and/or animal products included in the List of animals and animal products subject to quarantine or alien animals and/or animal products to Vietnam shall apply for quarantine and shall send one (01) quarantine application according to the regulations to a competent authorized animal quarantine agency according to the regulation of the Ministry of Agriculture and Rural Development.

Within five (05) working days from the day on which the satisfactory application is received, the authorized animal quarantine agency shall send a reply and provide the guidance on requirements of quarantine for the applicant and relevant authorized animal quarantine agencies for cooperation in quarantine activities.

Before goods are at the border, goods owner shall make a declaration to the authorized animal quarantine agency, specifically as follows:

a) The declaration before shipment shall comply with the regulations in points a and b clause 1 of this Article;

b) The declaration of import shall be made at least eight (08) days before goods come to the border; two (02) days before goods come to the post office;

c) The declaration of temporary importing for re-export, temporary exporting for re-import, transit through Vietnam territory shall be made at least four (04) days before goods come to the border gate.

Within one (01) working day from the day on which the declaration from the goods owner is received, the competent Authorized animal quarantine agency shall notify the goods owner of the location and time of quarantine, the importing checkpoint, exporting checkpoint and other relevant regulations (applicable to the transiting through Vietnam territory of animals or animal products).

3. The Ministry of Agriculture and Rural Development is responsible for:

a) Arranging Authorized animal quarantine agencies competent in receiving the applications and conduct quarantine of animals/animal products for export, import, temporarily importing for re-export, temporarily exporting for re-import, transit through Vietnam territory;

b) Announcing the List of countries and regions allowed to export animals/animal products into Vietnam or List of countries and regions not allowed to export animals/animal products into Vietnam before January 01^st , 2012. These lists will be modified often in case of change.

c) Regulating that from January 01^st , 2015, any organizations/individuals importing animals/animal products into Vietnam will perform the procedures for application and quarantine at one authorized animal quarantine agency.”

Article 31. Declaration of quarantine of aquatic and amphibian animals and products thereof3

1. When transporting or circulating within the country the animals and/or animal products included in the List of animals and animal products subject to quarantine, a declaration shall be made according to the form and sent to the state management agencies in charge of animal health of provinces. The quarantine declaration is stipulated as follows:

a) Regarding parental aquatic animals and seed animals, declaration shall be made at least 3 days before the transport or before the shipment;

b) Regarding commercial animals/animal products, declaration shall be made at least 2 days before the transport or before the shipment.

Within one (01) working day from the day on which the satisfactory documents are received, the receiving agency shall certify the quarantine application and make a notification of the location and time of quarantine.

Within one (01) working day from the day on which animals and/or animal products are gathered at the arranged location, the quarantining agency shall conduct the quarantine.

2. Any entities wishing to export, import, temporarily import for re-export, temporarily export for re-import, transit through Vietnam territory animals and/or animal products included in the List of animals and animal products subject to quarantine or alien animals and/or animal products to Vietnam shall send a quarantine application according to the regulations to Department of Animal Health or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals,

Within five (05) working days from the day on which satisfactory application is received, the Department of Animal Health or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall send a response to the applicant containing the name of animal quarantine agency that will conduct the quarantine for such animal and shall send a notification to the relevant animal quarantine agencies for cooperation in quarantine activities.

3. When exporting, importing, temporarily importing for re-export, temporarily exporting for re-import or transiting through the Vietnamese territory animals or animal products, goods owners shall make a declaration to the animal quarantine agency assigned by the Department of Animal Health or Department for Management of Agricultural, Forestry and Fishery Product Quality for conducting quarantine. The quarantine declaration is stipulated as follows:

a) The declaration of export shall be made at least ten (10) days (for animals) or five (05) days (for animal products) before the shipment;

b) The declaration of import shall be made at least eight (08) days (for animals) or four (04) days (for animal products) before goods arrive at border gates.

c) The declaration of temporary importing for re-export, temporary exporting for re-import or transit through Vietnam territory shall be made at least four (04) days before goods come to the border gate.

Within one (01) working day from the day on which the declaration from the goods owner is received, the animal quarantine agency assigned by the Department of Animal Health or Department for Management of Agricultural, Forestry and Fishery Product Quality shall notify the goods owner of the location and time of quarantine, the importing checkpoint, exporting checkpoint and other relevant regulations (applicable to the transiting through Vietnam territory of animals or animal products).

Article 32. Quarantine of animals and animal products circulated within Vietnam at departure places

1. The procedures for quarantine of terrestrial animals and products thereof are specified as follows:

a) Check the compliance with regulations on veterinary hygiene conditions of places of gathering, transport vehicles, containers, packages and other related objects specified in Articles 44 and 45 of this Decree;

b) Conduct quarantine according to the procedures and veterinary hygiene standards provided for domestically circulated animals and animal products;

c) Leave marks on animals; affix veterinary hygiene stamps on animal products that satisfy veterinary hygiene standards;

d) Provide goods owners with guidelines for cleansing and disinfecting gathering places, loading animals/animal products, transport vehicles and other objects relating to the transportation;

dd) Grant quarantine certificates for animals and animal products satisfying veterinary hygiene standards; seal off the transport vehicles, containers of animals or animal products;

e) Request the goods owner to apply the technical measures according to the regulations applicable to animals/animal products failing to satisfy veterinary hygiene standards. After the technical measures are applied, if animals and animal products satisfy all veterinary hygiene standards, they shall be granted quarantine certificates; otherwise, such animals/animal products shall have using purpose changed or shall be compelled to destroy, depending on the extent of satisfaction,

2. The procedures for quarantine of aquatic or amphibian animals and products thereof are specified as follows:

a) Check the compliance with regulations on veterinary hygiene conditions of places of gathering, transport vehicles, containers, packages and other related objects specified in Articles 44 and 45 of this Decree;

b) Conduct quarantine according to the procedures and veterinary hygiene standards provided for domestically circulated animals and animal products;

c) Provide goods owners with guidelines for cleansing and disinfecting gathering places, transport vehicles and other objects relating to the transportation;

d) Affix veterinary hygiene stamps on animal products that satisfy veterinary hygiene standards;

dd) Grant quarantine certificates for animals and animal products satisfying veterinary hygiene standards; seal off the transport vehicles, containers of animals or animal products;

e) Request the goods owner to apply the technical measures according to the regulations applicable to animals/animal products failing to satisfy veterinary hygiene standards. After the technical measures are applied, if animals and animal products satisfy all veterinary hygiene standards, they shall be granted quarantine certificates; otherwise, such animals/animal products shall have using purpose changed or shall be compelled to destroy, depending on the extent of satisfaction,

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

1. Examine the quarantine application, quantities and species of animals, categories of animal products according to the quarantine certificates; veterinary hygiene codes, marks or stamps; seals of transport vehicles.

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

3. Examine the actual veterinary hygiene conditions of transport vehicles and objects relating to the transportation.

4. Give certification for animals/animal products that have conformable quarantine certificates and satisfactory transport vehicles and relevant objects.

If there are not conformable quarantine certificates of animals/animal products; transport vehicles and relevant objects are not satisfactory or come from areas where the delivery of animals or animal products is suspended because of epidemic, then animal quarantine cadres shall suspend the transportation and handle the cases according to regulations. Such cadres shall take legal responsibility for their handling.

Article 34. Quarantine of exported animals and products thereof

1. Exported animals/animal products shall undergo quarantine in the following cases:

a) According to the request in the trading contract or the provisions of International Treaties;

b) At the request of the goods owner.

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

2. Competent agencies in charge or quarantining exported and imported animals shall conduct quarantine at the departure places or in quarantine areas at border gates according to the procedures and veterinary hygiene standards applicable to exported animals/animal products.

3. Animals and animal products included in the List of animals and animal products subject to quarantine, transport vehicles and relevant objects that satisfy the 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, the border-gate animal quarantine agencies shall:

a) Examine the quarantine applications;

b) Re-check the quantity and species of animals/animal products, packages of animal products according to the quarantine certificate only in case of doubt of swap, increase or reduction of animals/animal products or change of packages of animal products. If any violation detected, a re-quarantine shall be conducted or animals/animal products shall be returned to their departure places, depending on the seriousness of the violation.

c) Exchange quarantine certificates on request of goods owners or the importing countries; re-grant quarantine certificates for re-quarantine cases;

d) Provide goods owner with guidelines on cleansing and disinfection of transport vehicles, bedding, animal wastes and relevant objects after transportation.

5. Any organizations and individuals exporting by post animals and/or animal products included in List of animals and animal products subject to quarantine shall make a quarantine declaration to competent quarantine agencies according to the regulations in Point a, Clause 3, Article 30 or Point a, Clause 3, Article 31 of this Decree.

Animal quarantine agencies shall examine animals and/ or animal products and grant quarantine certificates to goods satisfying veterinary hygiene standards.

Article 35. Quarantine of imported animals and products thereof

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

a) Any organizations and individuals importing animals and/or animal products included in List of animals and animal products subject to quarantine shall make an import quarantine declaration according to the regulations in Clause 2 and Point b Clause 3 Article 30 or Clause 2 and 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 examine the quarantine documents, the health of animals at buoy zero or in the airports’ landing yards;

c) If quarantine dossiers are conformable, 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 unconformable, animal quarantine agencies shall notify competent authorities of the exporting countries for re-checking and completing such documents;

dd) If an animal is determined infected with disease or an animal product is determined carrying pathogens of dangerous infectious diseases, such animal/product shall be slaughtered, culled, destroyed or returned to the exporting country (in case this measure does not involve transit through a third country);

e) 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 time limit above, animal quarantine agencies shall notify goods owners of the reasons;

f) After the duration of quarantine isolation, if animals or animal products satisfy the required veterinary hygiene standards, they shall be granted quarantine certificates;

g) Animal quarantine agencies shall provide goods owners with guidelines for applying veterinary hygiene measures to people in contact with animals; cleansing and disinfecting raising tools, loading/unloading tools, containers, transport vehicles, places of gathering, quarantine isolation of animals/animal products, bedding, animal wastes and other relevant objects after the transportation and after the supervision and quarantine isolation.

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

a) Goods owners shall fill in the exit/entry declaration forms, present quarantine certificates of national animal health agencies of the exporting country for checking by border-gate animal quarantine agencies;

b) Goods owners are not required to make declaration and present quarantine certificates in cases of carrying along cooked food from animal that is for non-business purposes; industrially processed products from animal that are not used as foods;

c) Border-gate animal quarantine agencies shall examine the quarantine application and grant import quarantine certificates if such documents are conformable and animals/animal products satisfy all veterinary hygiene standards.

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

a) Any organizations and individuals importing by post animals and/or animal products included in List of animals and animal products subject to quarantine shall make an import quarantine declaration according to the regulations in Clause 2 and Point b Clause 3 Article 30 or Clause 2 and Point b Clause 3 Article 31 of this Decree;

b) The animal quarantine agencies shall examine the animals/animal products and grant quarantine certificates for animals/animal products satisfying the veterinary hygiene standards.

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

1. Any organizations and individuals temporarily importing for re-export, temporarily exporting for re-import or transiting through Vietnamese territory the animals and/or animal products included in List of animals and animal products subject to quarantine shall make quarantine registration and declaration according to the regulations in Clause 2 and Point c Clause 3 Article 30 or Clause 2 and 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, transited is stipulated as follows:

a)  Border-gate animal quarantine agencies shall conduct quarantine according to the procedures and veterinary hygiene standards of animals/animal products which are temporarily imported for re-export, temporarily exported for re-import or transited and grant quarantine certificates or certify the quarantine of animals and/or animal products satisfying the veterinary hygiene standards for goods owners to carry out customs procedures;

b) If the quarantine certificate is unconformable, the animal quarantine agency shall notify a competent authority of the exporting country for re-checking and completing such documents;

c) If an animal is determined infected with disease or an animal product is determined carrying pathogens of dangerous infectious diseases, such animal/product shall be slaughtered, culled, destroyed or returned to the exporting country (in case this measure does not involve transit through 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 present the quarantine certificate granted by the national animal health agency of the exporting country and other papers relating to border-gate animal quarantine agency;

b) Border-gate animal quarantine agency shall check the quarantine certificate, the actual veterinary hygiene conditions of goods and transport vehicles, and the compliance with regulations already notified beforehand to goods owners.

If the conditions are satisfied, a quarantine certificate shall be granted for goods owner to carry out the custom procedures;

c) Goods owners must not unload goods or dismount transport vehicles without permission; must not change itinerary without permission or stop at unconformable places; transport vehicles in transit shall be technically safe, ensuring not let waste matters drop on road;

d) Goods owners must comply with instructions of animal quarantine agencies and not let animals in transit have contact with domestic animals in cases they must stop for caring during the transit procedures;

dd) Dead animals, animal wastes, bedding, left-over food and feeds, packages of animal products and other waste matters during the transportation shall be treated according to regulations of animal quarantine agencies;

e) If animals/animal products are transited through Vietnamese territory in containers or in other tightly-closed means, border-gate animal quarantine agencies shall examine quarantine certificates from national animal health agencies of exporting countries as well as transport vehicles and shall grant the permit for transit if all requirements are satisfied. If an animal/animal product is detected having abnormal signs, the border-gate animal quarantine agency may request goods owners to open containers or transport vehicles for re-inspection of veterinary hygiene;

f) If animals, animal products, transport vehicles, containers and packages fail to satisfy the veterinary hygiene standards or quarantine certificates are unconformable or animals show pathological symptoms, animal products carry pathogens of dangerous infectious disease, then the border-gate animal quarantine agencies shall not grant the permit for transit;

g) If the quarantine certificate is unconformable, the animal quarantine agency shall notify a competent authority of the exporting country for re-checking and completing such documents. After being modified, if the quarantine certificate is conformable, the border-gate animal quarantine agency shall grant the permit for transit;

h) If an animal is determined infected with disease or an animal product is determined carrying pathogens of dangerous infectious diseases, the border-gate animal quarantine agency shall not grant the permit for transit and such animal/animal product shall be slaughtered, culled, destroyed, or returned to the exporting country (in case this measure does not involve transit through a third country).

4. Goods owners shall bear all expenses during the time when their animals/animal products are kept for inspection and shall pay the expense of amendment of animal quarantine certificates.

Article 37. Receipt and sending of pathological materials

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

2. Pathological materials shall be preserved and packed according to regulations to ensure the conditions of 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 and 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 shall satisfy the veterinary hygiene standards, shall undergo quarantine conducted by a competent state management agency in charge of animal health of the departure places and shall be granted quarantine certificates in accordance with the provisions of Article 32 of this Decree;

b) Animals to be slaughtered or preliminarily processed are not included in cases where slaughter or preliminary processing is banned according to the regulations in Article 39 of this Decree;

c) The slaughter or preliminary processing of animals/animal products for business purposes shall be carried out at slaughterhouses or preliminary processing establishments that satisfy veterinary hygiene standards and shall be under the control of competent state management agencies in charge of animal health before, throughout and after the slaughter or preliminary processing;

d) During the process of controlling the slaughter or preliminary processing of animals, animal products, if any animals is detected infected or suspected of being infected with a disease included in the List of diseases subject to epidemic declaration, animal quarantine cadres shall request for stop of the slaughter or preliminary processing; provide the establishment owner with guidelines for cleansing and disinfecting their premises and slaughtering or preliminary processing places, and immediately report such case to competent animal health agencies.

2. The preliminary processing of aquatic and amphibian animals shall comply with veterinary hygiene standards according to regulations of the Ministry of Fisheries.

Article 39. Cases in which slaughter or preliminary of animals/animal products is banned

1. Animals infected or suspected of being infected with diseases of which slaughter or preliminary processing 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 guidelines of 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. Examine animal quarantine certificates or vaccination certificates granted by state management agencies in charge of animal health in the departure places.

2. Conduct clinic examination and classify animals. Healthy animals shall be taken to slaughter-awaiting places; weak and skinny animals shall be separate for later slaughter; animals infected r suspected of being infected with disease shall be taken to separate slaughtering places for handling according to the regulations. Animals shall be cleansed before slaughter. Animals that have not been slaughtered shall undergo re-examination at 12 to 24 hours after the previous examination depending on specific species of animal.

3. Conduct inspections of the compliance with the regulations on veterinary hygiene conditions of establishments, equipment, tools, people involved in slaughter, preliminary processing of animals and products thereof.

4. Conduct inspections of the cleansing and disinfection of slaughtering places, preliminary processing places, animal keeping places, transport vehicles; the treatment of bedding and wastes during the transportation and after the receipt of animals for slaughter or preliminary processing.

Article 41. Control during the slaughter, preliminary processing of terrestrial animals and products thereof

1. Conduct inspections of the compliance with procedures for slaughtering or preliminary processing; the compliance with the regulations on veterinary hygiene during the process of slaughtering or preliminary processing of animals and products thereof.

2. Conduct inspections of veterinary hygiene of meat, innards and other products so as to determine animals subject to slaughtering control.

3. Affix marks or stick veterinary hygiene stamps on meat and other products that satisfy the veterinary hygiene standards.

Any meat, innards and other animal products that fails to satisfy the veterinary hygiene shall be separated and marked for distinction and handling according to the regulations.

Article 42. Preservation and transport of animal products after slaughter and preliminary processing

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

2. Any transport vehicles, containers, packages of animal products at slaughterhouses or preliminary processing establishments shall ensure the veterinary hygiene standards, must not affect the quality of products and shall be cleansed and disinfected before and after it is used.

Transport vehicles for animal products shall be specialized vehicles that satisfy the veterinary hygiene standards specified in Article 45 of this Decree and shall be cleansed and disinfected before any after they are used.

Section 3. VETERINARY HYGIENE INSPECTION

Article 43. Competence in veterinary hygiene inspection

1. The veterinary hygiene inspection shall ensure the principles specified in Article 35 of the Ordinance on Veterinary Medicine.

2. Department of Animal Health and Department and the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall be responsible for conducting inspection and granting certificates of conformity with veterinary hygiene standards for:

a) Concentrated animal raising establishments under the management of the central authorities, national breeding establishments;

b) Feeds, water for animals, materials from animals used for the production of feeds; equipment, tools, transport vehicles specifically used in animal raising; animal wastes at raising establishments specified in point a clause 2 of this Article;

c) Animal epidemic-free areas and establishments assigned by the Ministry of Agriculture and Rural Development and the Ministry of Fisheries;

d) Quarantine areas for exported and imported animals/animal products;

dd) Establishments that carry out slaughtering, preliminary processing and/or preservation of terrestrial animals and products thereof; establishments that carry out slaughtering, preliminary processing and/or preservation of aquatic and amphibian animals and products thereof according to the assignment of the Ministry of Fisheries;

e) Establishment that manufacture veterinary drugs, bio-preparation, microorganisms and/or chemicals for veterinary use;

f) Establishments that trade in microorganisms for veterinary use.

3. The state management agencies in charge of animal health of provinces shall be responsible for conducting inspection and granting certificates of conformity with veterinary hygiene standards for:

a) Concentrated animal raising establishments and breeding establishments in local areas;

b) Feeds, water for animals, materials from animals used for the production of feeds; equipment, tools, transport vehicles specifically used in animal raising; animal wastes at raising establishments specified in point a clause 3 of this Article;

c) Animal epidemic-free areas and establishments assigned by the Ministry of Agriculture and Rural Development and the Ministry of Fisheries;

d) Establishments that carry out slaughtering, preliminary processing and/or preservation of terrestrial animals and products thereof for domestic consumption; establishments that carry out slaughtering, preliminary processing and/or preservation of aquatic and amphibian animals and products thereof according to the assignment of the Ministry of Fisheries;

dd) Establishments and shops that trade in veterinary drugs, bio-preparation and/or chemicals for veterinary use in local areas.

Article 44. Veterinary hygiene conditions on places of gathering for transport of animals and products thereof

1. Places of gathering of terrestrial animals at airport, railway stations and ports shall satisfy the following veterinary hygiene conditions:

a) Located at convenient place for the examination of animals and products thereof;

b) Having measures to prevent the direct or indirect contract with animals from outside;

c) Having specialized stairs for cattle to get on and off the transport vehicles;

d) Having sufficient water satisfying veterinary hygiene standards;

dd) Being cleansed and disinfected before and after each gathering and loading of animals;

e) Measures of waste water treatment shall be applied, ensuring that waste water satisfies hygiene standards before it is discharged into the environment.

2. Places of gathering and/or loading of terrestrial animals at raising establishments shall satisfy the following conditions:

a) Convenient and large enough for the examination of animals;

b) Satisfying the regulations specified in points b, c, d and e clause 1 of this Article.

3. Places of gathering of terrestrial animals shall satisfy the following conditions:

a) Their locations shall be distant from residential areas, public works and raising establishments;

b) The regulations specified in points b, c, d and e clause 1 of this Article shall be satisfied.

4. Places of gathering of terrestrial animal products shall satisfy the following conditions:

a) Having preservation warehouses satisfying the veterinary hygiene standards according to the regulations;

b) Such warehouses shall be cleansed and disinfected before and after each gathering of animal products;

c) The regulations specified in points d and e clause 1 of this Article shall be satisfied.

5. Place of gathering of aquatic and amphibian animals/animal products for transport shall satisfy the following veterinary hygiene conditions:

a) Convenient for the examination of animals and products thereof;

b) Having measures to prevent the direct or indirect contract with animals from outside;

c) Having sufficient water satisfying veterinary hygiene standards;

d) Being cleansed and disinfected before and after each gathering and loading of animals/animal products;

dd) Measures for treatment of waste water and waste matters shall be applied, ensuring that waste satisfies hygiene standards before it is discharged into the environment.

Article 45. Veterinary hygiene conditions on transport vehicles for animals and products thereof

1. Transport vehicles for terrestrial animals shall satisfy the following veterinary hygiene standards:

a) Ensuring technically safety to protect animals during the transportation;

b) Containers shall large enough for animals to stand or lie down naturally; vehicles shall contain cages, kennels or boxes to ensure the safety for animals during the transportation; floors shall be flat, unslippery and tight to prevent leakage of water and waste matters during the transportation; vehicles shall be easy to cleanse and disinfect;

c) Closed vehicles shall have appropriate ventilating systems to ensure sufficient ventilation.

2. Vehicles and containers of alive aquatic amphibian animals shall satisfy the following veterinary hygiene conditions:

a) Ensuring technically safety to keep animals alive during the transportation;

b) Animal containers shall be made of appropriate materials, preventing leakage of waste water and matters during the transportation; vehicles and containers shall be easy to cleanse and disinfect;

c) Vehicles and containers shall appropriate oxygen supplying or ventilating systems to ensure sufficient oxygen;

d) Vehicles and containers shall satisfy other technical requirements according to the regulations of the Ministry of Fisheries.

3. Transport vehicles for fresh and raw and preliminarily processed animal products for use as food shall satisfy the following veterinary hygiene conditions:

a) Ensuring safety in preservation technique to ensure that the quality of animal products is not affected during the transportation;

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

c) Animal product containers shall be closed to prevent products from contamination or pollution.

d) Satisfying the requirements of temperature for specific type of animal products during the transportation.

4. Transport vehicles for animal products not for use as food shall have tight floors, easy to cleanse and disinfect.

Article 46. Veterinary hygiene conditions on establishments that carry out slaughtering and preliminary processing of animals and products thereof

1. Any establishment that carry out slaughtering and preliminary processing of animals/animal products shall satisfy the veterinary hygiene conditions according to the regulations specified in Article 33 of the Ordinance on Veterinary Medicine and the conditions of locations, workshops and equipment as follows:

a) Location of the establishment shall be separate from residential areas, public works, main road and polluting sources and shall not be waterlogged. The establishment shall have separate gates for delivery and receipt of animals and products thereof. Road within the precinct of the establishment shall be cemented or concreted;

b) There shall be separate places for keeping animals to be slaughtered; separate places for slaughtering, preliminary processing of animals and products thereof; isolation area for sick animals; places for treating products not satisfying the veterinary hygiene standards;

c) There shall be laboratories;

d) There shall be a system for treatment of waste water and animal waste appropriate with the capacity of slaughtering and preliminary processing. Treated waste water and waste matters shall satisfy hygiene standards before it is discharged into the environment;

dd) Workshops shall be proofed against dust and penetration of harmful animals; ensuring the convenience for cleansing and disinfection; places for storing products for use as food, places for storing products not for use as food, transport vehicles, tools for slaughtering and preliminary processing and people working in such places shall be located at a separate area to prevent pollution and cross-infection;

e) Equipment and tools used in slaughtering and preliminary processing of animals and products thereof shall be made of stainless materials so as not to affect the quality of products and shall be easy to cleanse and disinfect.

2. Water used in slaughtering and preliminary animals and products thereof shall satisfy the required veterinary hygiene standards.

Article 47. Veterinary hygiene conditions on trading of animals and products thereof

1. Organizations and individuals that trade in animals and/or animal products at markets shall be located at places separate from those that trade other types of goods and shall satisfy the following veterinary hygiene conditions:

a) Things used for display, sale and containing of animal products shall be made of stainless materials so as not to affect the quality of products and shall be easy for cleansing and disinfection;

b) Preservation measures shall be taken to prevent animal products from contamination and degeneration;

c) Places and objects for trading of animals and products thereof shall be cleansed after the sale of animals/animal products;

d) Waste water from the trading of animals and products thereof at the markets shall be treated so as to satisfy the veterinary hygiene standards before is discharged into the environment.

2. Places of gathering and trading of terrestrial animals shall be far from residential areas and public works; shall be cleansed and disinfected after each gathering/trading of animals.

3. People are forbidden to perform the trade of:

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 areas where harvest is banned;

c) Animals 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 IN QUARANTINE OF ANIMALS, ANIMAL PRODUCTS; CONTROL OVER SLAUGHTER; VETERINARY HYGIENE INSPECTION

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

1. Perform the quarantine of animals and products thereof; control the slaughtering and preliminary processing of animals/animal products; conduct inspections of veterinary hygiene according to the regulations.

2. Perform the issuance and suspension/withdrawal of animal quarantine certificates, certificates of conformity with veterinary hygiene standards. In case of refusal to grant animal quarantine certificates, the state management agencies shall provide the goods owners with explanation.

3. Provide guidelines, conduct inspection and supervision of goods owners and establishment owners in the implementation of the regulations on veterinary hygiene applicable to animals/animal products subject to quarantine; control the slaughtering, preliminary processing of animals and products thereof; conduct veterinary hygiene inspections.

Article 49. Responsibilities of animal quarantine cadres

1. Perform the quarantine of animals and products thereof; control the slaughtering and preliminary processing of animals/animal products; conduct inspections of veterinary hygiene according to the regulations on animal health.

2. During the performance of their duties, animal quarantine cadres shall wear uniforms, badges, insignias, animal quarantine cadre’s cards and other necessary equipment and devices.

3. Submit proposal to competent authorities to grant or withdraw animal quarantine certificates.

Article 50. Responsibilities of other state agencies

1. People's Committees at all levels shall work out plannings, make announcement about plannings and manage the slaughtering and preliminary  processing of animals and products thereof within local areas; steer the relevant regulatory bodies in local areas to cooperate with state management agencies in charge of animal health in quarantining animals/animal products; controlling slaughtering; conducting inspections of veterinary hygiene and handling violations according to the provisions of law.

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

3. Custom offices shall complete the customs procedures only when goods owner have fulfilled the requirements on quarantine of animals/animal products and veterinary hygiene inspection.

Article 51. Responsibilities of goods owners and establishment owners

1. Comply with the legislations on animal health and other law provisions relating to the quarantine of animals and products thereof; control the slaughtering and preliminary processing of animals/animal products; conduct inspections of veterinary hygiene according to the regulations on animal health.

2. Enable the state management agencies in charge of animal health to perform the quarantine of animals and products thereof; to control the slaughtering and preliminary processing of animals/animal products and to conduct inspections of veterinary hygiene according to the regulations.

3. Take responsibility for keeping and caring animals and preserving animal products; complying with the guidelines of the state management agencies in charge of animal health during the quarantine, control of slaughtering and preliminary processing of animals and products thereof and veterinary hygiene inspection and paying fees and charges according to the regulations.

4. Promptly report to the state management agencies in charge of animal health when an animal is detected or suspected to be infected with disease or when an animal product is suspected to have pathogens of disease.

5. Must not swap or change the quantity of animals that are granted the quarantine certificate during the transportation and shall follow the route regulated by the competent state management agencies in charge of animal health.

6. The transport of different animal species and the transport of animals that are used for different purposes on the same vehicles shall comply with the guidelines of Department of Animal Health and the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals. Vehicles that were used for transporting poisonous matters must not be used for transporting animals/animal products.

7. Within 15 days before the establishments that carry out slaughtering/preliminary processing of animals/animal products begin the operation, a report shall be sent to the state management agencies in charge of animal health for veterinary hygiene inspection.

Chapter IV

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

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

1. Any organizations and individuals carrying out the manufacture, processing, portioning of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use shall satisfy the requirements specified in Article 38 of the Ordinance on Veterinary Medicine and the veterinary hygiene conditions specified in clauses 2, 3, 4, 5, 6 and 7 of this Article.

2. The establishment shall be located separately from residential areas, public works, hospitals, veterinary clinics, animal diagnosis establishments and other polluting sources and shall not cause bad effect to the surrounding environment.

3. Establishments that manufacture pharmaceuticals and chemicals for veterinary use shall be designed and built according to GPM principles and standards, and shall contain the following main areas:

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

b) Places for disinfection;

c) Places for weighing and distribution of raw materials;

d) Places for manufacture preparation;

dd) Places for preparation and preservation of semi-finished products;

e) Places for completion of products;

f) Places for checking of products before the shipment;

g) Places for storage of products not satisfying quality standards;

h) Places for personal hygiene and other places serving the manufacture.

4. Apart from the areas specified in clause 3 of this Article, establishment that manufacture vaccines, bio-preparations and microorganisms for veterinary use shall have places for keeping and treating animals used for experiments; places and equipment for keeping breeds of microorganisms for manufacture.

5. Manufacturing workshops shall satisfy 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 shall 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 during the manufacture process.

6. Manufacturing equipment and tools shall satisfy the following veterinary hygiene conditions:

a) Being suitable and convenient for movements, easy for the cleansing, disinfection and maintenance;

b) The surface of equipment and tools that is in contact with raw materials, auxiliary materials, semi-finished and finished products shall be made of inert material, not affecting the purity and activity of raw materials and quality of drugs.

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

8. Manufacturing establishments shall satisfy the veterinary hygiene standards regulated by the Ministry of Agriculture and Rural development, the Ministry of Fisheries and the Ministry of Science and Technology.

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

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

The import of vaccines and microorganisms is only performed if has got a written approval from Department of Animal Health and the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals.

2. If an organization or an individual wished to import veterinary drugs, bio-preparations, microorganisms, chemicals for veterinary use other than those specified in 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, then such organization/individual shall satisfy the conditions specified in Clause 2, Article 48 of the Ordinance on Veterinary Medicine.

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

1. Any organizations and individuals trading veterinary drugs, bio-preparations and chemicals for veterinary use shall satisfy the requirements specified 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;

dd) Business activities must not cause bad effect to the environment.

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

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

1. Establishments that conduct the experiments of veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use shall satisfy the following veterinary hygiene conditions:

a) Having adequate area, material and technical facilities, equipment, tools, chemicals, materials and raw materials that are necessary for the experiment;

b) Having places for keeping and treating experimented animals;

c) Having equipment specialized for keeping microorganisms for experiments;

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

2. Establishments that conduct the tests and assay of veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use shall satisfy the following veterinary hygiene conditions:

a) The locations of establishments, stables, ponds, animal-raising tanks, raising tools, places of treatment of animal wastes, carcasses shall satisfy the conditions specified in Article 7 of this Decree;

b) Having various animal species with sufficient quantity 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 the accuracy of test and assay results;

dd) Having adequate necessary tools and vehicles.

3. Establishments that perform the export/import of veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use shall satisfy 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 subject to performing registration of circulation of veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use

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

2. Veterinary drugs in finished and semi-finished forms, materials, bio-preparations, microorganisms and chemicals for veterinary use which are initially imported into Vietnam 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 specified in Clause 1 Article 58 of this Decree.

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

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

24. Any organizations and individuals wishing to register for circulation of veterinary drugs, bio-preparations, microorganisms and/or chemicals for veterinary use shall submit applications according to the regulations in 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 (applicable to bio-preparations, microorganisms, chemicals and environmental remediation substances used in aquaculture).

If drugs are not subject to tests or assays, an application shall be submitted; otherwise, two (02) applications shall be submitted.

Organizations and individuals wishing to register for circulation of imported veterinary drugs, bio-preparations, microorganisms and/or chemicals shall submit an application in Vietnamese and an import registration applications enclosed with a product circulation permit, the GMP certificate or the ISO certificate, a product quality analysis card granted by a competent authority of the manufacturing countries.

3. Within 15 (fifteen) day from the day on which the application is received, the receiving agency shall make a response. If the application is unsatisfactory, a notification shall be sent to the applicant for completion.

45. Within 40 (forty) days from the day on which the satisfactory application is received, Department of Animal Health/Department of Aquaculture shall carry appraisal of the application and establish a Professional scientific board to carry out the approval for the documents, request the Minister of Agriculture and Rural development to recognize and make additions on quarterly basis to the List of veterinary drugs and the List of bio-preparations, microorganisms and chemicals for veterinary use that are 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 subject to re-registration:

a) Change in composition or formula;

b) Change in pharmaceuticals;

c) Change in the administration of drug;

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

dd) Re-evaluation of the quality, effectiveness and safety of drugs according to regulations.

The formulation of application for re-registration shall comply with the regulations in clause 2 Article 57 of this Decree.

26. Within 40 (forty) days from the day on which the satisfactory application is received, the receiving agency shall carry out the appraisal of the application and make the response.

Article 59. Contents of GMP, procedures for application for GMP certificates

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

a) Concepts;

b) Personnel;

c) Workshops;

d) Equipment, tools;

dd) Hygiene and hygiene measures;

e) Manufacturing;

f) Quality checking;

g) Self-inspection;

h) Handling of product-related complaints, recall of products;

i) Documents.

2. Establishments that manufacture veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use shall apply the good manufacturing practice (GMP) principles and standards and shall receive inspection and evaluation according to the standards and granted certificates of conformity with GPM standards conducted by the Department of Animal Health or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals.

3. An application for GMP inspection shall include:

a) An application form for GMP inspection;

b) Relevant 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 operating procedure (SOP); competent authorities’ written certifications or minutes on the test of fire prevention and fighting; evaluated report on environment; the establishment’s report on GMP self-inspection.

4. Within 60 (sixty) days from the day on which the satisfactory application is received, Department of Animal Health or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals shall conduct inspection, evaluation and grant the certificates of conformity with GMP standards to qualified establishments according to the regulations.

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

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

2. Documents of announcement about quality standards of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use shall be made in 03 (three) sets, each of which shall include:

a) A written announcement about quality standards;

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

3. Documents of announcement about quality standards of veterinary drugs, bio-preparations, microorganisms or chemicals for veterinary use shall be sent to the Department of Animal Health or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals. Within 45 (forty five) days from the day on which the satisfactory document is received, the receiving agency shall examine the conformance of the document and make a response. If the document is reject, there shall be explanation.

4. The Department of Animal Health 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 and chemicals for veterinary use.

5. If there is any change in the quality or labels of veterinary drugs, bio-preparations, microorganisms or chemicals in comparison with the previous publications, establishments shall formulate a document of re-announcement according to the regulations in Clause 2 of this Article.

Article 61. Announcement about 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 obtain certificates of  conformity to Vietnam Standards or standards established by the Ministry of Agriculture and Rural development or the Ministry of Fisheries  and announce the conformity of quality.

2. Documents of announcement about quality standards of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use shall be made in 03 (three) sets, each of which shall include:

a) A written announcement of standards-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. Document of announcement about quality standards of veterinary drugs, bio-preparations, microorganisms or chemicals for veterinary use that are conformable to Vietnam’s Standards shall be sent to the Directorate for Standards, Metrology, and Quality, the Ministry of Science and Technology or the Department for Management of Quality, Safety, Hygiene and Health of Aquatic Animals (applicable to the conformity with the branch standards). Within 45 (forty five) days from the day on which the satisfactory documents are received, the receiving agency shall examine the conformity with the standards and affix stamp on the announcement about standard-conforming quality and return 1 set of document to the establishment.

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

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

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

a) Be safe for human, environment, ecosystem and ensure that the maximum level of residue in land, water and air does not exceed the permissible level;

b) Comply with the technical processes prescribed by the Ministry of Agriculture and Rural Development, the Ministry of Fisheries and the legislations on hazardous waste management;

c) Be under the supervision and have the destruction results certified by the state management in charge of animal health of local areas, agencies in charge of environment, local administration and other relevant agencies;

d) The person who conducts the destruction shall be provided with protective and labor protection equipment.

3. Organization/individual having veterinary drugs, bio-preparation, microorganisms and chemicals for veterinary use that are required to be handled shall carry out the handling and bear all the expense therfor according to the law provisions.

If the owner is not identified, People’s Committee of provinces shall steer the relevant regulatory bodies to carry out the destruction according to the regulations. The cost of the destruction 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 shall 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 Clauses 1 and 2 Article 54 of the Ordinance on Veterinary Medicine.

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

Article 64. Conditions for grant of practice certificates

1. Conditions for 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 state management agencies in charge of animal health of provinces;

b) Owners or technical managers of establishments that conduct testing for 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 shall 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 shall have at least 2 (two) years’ experience in the field they register to practice;

d) Owners of shops trading 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 the state management agencies in charge of animal health of provinces;

dd) Owners or technical managers of establishments that conduct experiment and assay of 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 shall have at least 2 (two) years’ experience in the field they register to practice;

e) Owners or technical managers of establishments that carry out import or export of 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;

f) 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 districts or higher levels.

3. Apart from complying with the provisions of Clauses 1 and 2 of this Article, grantees who are foreigner shall have judicial record cards certified by competent agencies and must be other than those specified 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 applications to the Department of Animal Health 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 for veterinary use; counseling and other services related to animal health shall send applications to state management agencies in charge of animal health of provinces.

2. The application for veterinary medicine practice certificate shall comply with the regulations in clause 3 Article 54 of the Ordinance on Veterinary Medicine.

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

If the applicants for veterinary medicine practice certificates are officials or civil servants, the written approval of the heads of the agencies where such applicants work shall be required and such officials/civil servants must practice within the scope in accordance with the provisions of law on public employees.

3. Within 10 (ten) days as from the day on which the satisfactory application is received, the receiving agencies shall examine the application and grant veterinary medicine practice certificates or request the completion of the application that is unsatisfactory or return the application and state the reasons for the refusal to grant veterinary medicine practice certificates.

4. Any organization/individual applying for veterinary medicine practice certificates shall pay charges and fees according to the law provisions.

5. The validity duration of veterinary medicine practice certificates is 5 (five) years. One month before the expiration of veterinary medicine practice certificates, any grantee of veterinary medicine practice certificates that wishes to continue practicing shall send an application to competent state management agencies according to the regulations in Clause 1 of this Article.

An application for extension of veterinary medicine practice certificate shall include:

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

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

c) A health certificate of physical fitness to practice veterinary medicine granted by a medical facility of districts or higher levels.

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 the judgments or decisions of the court.

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

3. Persons who are facing criminal prosecution.

4. Persons who are incurring 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 specified in Article 64 of this Decree are no longer satisfied.

3. Contents of practice certificates are erased or modified.

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

5. Grantees of veterinary medicine practice certificates commit administrative violations 03 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 have the following rights:

a) Carry out professional veterinary medicine activities in accordance with the granted veterinary medicine practice certificates;

b) Join in the Veterinary Medicine Society or other relevant professional associations.

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

a) Strictly comply with the legislations on veterinary medicine and environmental protection during the practicing;

b) Monitor, record, and report promptly 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 handling consequences;

c) Participate in animal vaccinations organized by local animal health agencies;

d) Participate in preventing and fighting animal epidemics under the designation of local administration and state management agencies in charge of animal health;

dd) Supply information on animal health investigations; submit to local animal health agencies the reports on professional activities periodically or upon the outbreak of epidemic;

e) Take legal responsibilities for the results of their practice or of the practice of the affiliated establishment; pay compensation according to the law provisions for damage cause by their practice to other organizations/individuals;

f) Beat the supervision and inspection of competent functional agencies.

Chapter VI

IMPLEMENTARY CLAUSE

Article 70. Effect7

This Decree comes into effect after 15 days from the day on which it is posted on “Cong bao” and replaces the Regulations on the implementation of the Ordinance on Veterinary Medicine;

Article 71. Responsibilities for implementation8

1. Responsibilities of the Ministry of Agriculture and Rural Development and the Ministry of Fisheries:

a) Issue regulations on the duration, types of vaccines, terrestrial animal species subject to compulsory vaccination, compulsory preventive measures for aquatic and amphibian animals in epidemic-threatened areas; the raising of different animal species in the same breeding establishment; animal diseases subject to periodic examination in breeding establishments; assorted kinds of veterinary drug materials permitted for use for prevention and treatment of animal diseases.

b) Issue regulations on 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 and of meat of compulsorily slaughtered animals; veterinary hygiene standards for the preliminary processing and handling of aquatic and amphibian animals infected or suspected of being infected with dangerous infectious disease;

c) Issue regulations on 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, vehicles and relevant objects failing to satisfy the veterinary hygiene standards; conditions and procedures for receipt and sending of pathological materials;

d) Issue regulations on the trading of vaccines and microorganisms; procedures for registration of change of ownership, of 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 included in the List of veterinary drugs, bio-preparations, microorganisms for veterinary use permitted for use in Vietnam serving the manufacture, scientific and technological research, cooperation and exchange, participation in fairs or exhibitions or for other purposes;

dd) Issue regulations on procedures for withdrawal of veterinary drugs, bio-preparations, microorganisms and chemicals for veterinary use failing to satisfy the registered quality standards;

e) Issue regulations on procedures for withdrawal and re-grant of veterinary medicine practice certificates.

2. The Ministry of Agriculture and Rural Development and the Ministry of Fisheries are responsible for providing guidelines and organizing the implementation of this Decree.

3. The Ministers, Heads of ministerial-level agencies, Heads of Government agencies and Presidents of People’s Committees of provinces shall be responsible for implementing this Decree.

1 The Decree No. 119/2008/NĐ-CP dated November 28^th, 2008 by the Government providing amendments to a number of articles of the Decree No. 33/2005/NĐ-CP dated March 15th, 2005 by the Government is based on:

The Law on the Government organization dated December 25^th, 2001;

 The Ordinance on Veterinary Medicine dated April 29^th, 2004;

The request of the Minister of Agriculture and Rural Development

The Decree No. 98/2011/NĐ-CP dated October 26^th, 2011 by the Government providing amendments to a number of articles of the decrees on agriculture is based on:

The Law on the Government organization dated December 25^th, 2001;

The request of the Minister of Agriculture and Rural Development

2 This Article is amended according to the provisions of Article 4 of the Decree No. 98/2011/NĐ-CP dated October 26^th, 2011 the Ministry of Health the Government, effective from December 15, 2011.

3 This Article is amended according to the provisions of clause 2 Article 1 of the Decree No. 119/2008/NĐ-CP dated November 28^th, 2008 by the Government, effective from December 23^rd, 2008.

4 This Clause is amended according to the provisions of clause 3 Article 1 of the Decree No. 119/2008/NĐ-CP dated November 28^th, 2008 by the Government, effective from December 23^th, 2008.

5 This Clause is amended according to the provisions of clause 3 Article 1 of the Decree No. 119/2008/NĐ-CP dated November 28^th, 2008 by the Government, effective from December 23^rd, 2008.

6 This Clause is amended according to the provisions of clause 4 Article 1 of the Decree No. 119/2008/NĐ-CP dated November 28^th, 2008 by the Government, effective from December 23^rd, 2008.

7 Clause 2 of the Decree No. 119/2008/NĐ-CP dated November 28^th , 2008 by the Government, effective from December 23^rd , 2008, regulates as follows:

 “Article 2. Effect

This Decree comes into effect after 15 days from the date of its publication in Official Gazette (“CONG BAO”).

Article 7 of the Decree No. 98/2011/NĐ-CP dated October 26^th , 2011 by the Government, effective from December 15^th , 2011, regulates as follows:

 “Article 7. Effect

This Decree comes into effect from December 15^th , 2011”.

8 Clause 3 of the Decree No. 119/2008/NĐ-CP dated November 28^th , 2008 by the Government, effective from December 23^rd , 2008, regulates as follows:

 “Article 3. Implementation

1. The Minister of Agriculture and Rural development is responsible for providing guidelines for the implementation of this Decree.

2. The Ministers, Heads of ministerial-level agencies, Heads of Government agencies, the Presidents of the People’s Committees of provinces and relevant organizations/individuals are responsible for implementing this Decree./.”.

Article 8 of the Decree No. 98/2011/NĐ-CP dated October 26^th , 2011 by the Government, effective from December 15^th , 2011, regulates as follows:

 “Article 8. Implementation

1. The Ministry of Agriculture and Rural Development shall preside over and cooperate with relevant Ministries and regulatory bodies in providing guidelines for the implementation of this Decree.

2. The Ministers, Heads of ministerial-level agencies, Heads of Government agencies, the Presidents of the People’s Committees of provinces are responsible for implementing this Decree./.”.