Decree No. 35/2016/ND-CP dated May 15, 2016 of the Government detailing a number of articles of the Law on Animal Health

DECREE

Detailing a number of articles of
the Law on Animal Health[1]

Pursuant to the June 19, 2015 Law on Organization of the Government;

Pursuant to the June 19, 2015 Law on Animal Health;

Pursuant to the November 26, 2014 Investment Law;

At the proposal of the Minister of Agriculture and Rural Development;

The Government promulgates the Decree detailing a number of articles of the Law on Animal Health.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Decree details and guides the implementation of a number of articles of the Law on Animal Health regarding:

1. The system of specialized management agencies in charge of animal health and entitlements and policies for veterinarians in communes, wards or townships.

2. Funds for animal epidemic prevention and control.

3. Suspension of or ban on export or import of animals and animal products.

4. Conditions for manufacture, trading, import, testing and trial of veterinary drugs; and veterinary drug good manufacturing practices.

5. Conditions for veterinary practice.

Article 2. Subjects of application

This Decree applies to domestic agencies, organizations and individuals and foreign organizations and individuals that are involved in veterinary activities in Vietnam.

Article 3. Interpretation of terms

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

1. Drug Good Manufacturing Practice (GMP) means rules, regulations and guidelines on drug manufacture in order to ensure that manufactured drugs are up to quality standards.

2. GMP-WHO means Good Manufacturing Practices regulated by the World Health Organization (WHO), including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Store Practice (GSP).

3. GMP-ASEAN means Good Manufacturing Practices regulated by the Association of Southeast Asian Nations (ASEAN).

Chapter II

SPECIFIC PROVISIONS

Section 1

SYSTEM OF SPECIALIZED MANAGEMENT AGENCIES IN CHARGE OF ANIMAL HEALTH AND ENTITLEMENTS AND POLICIES FOR VETERINARIANS IN COMMUNES, WARDS OR TOWNSHIPS

Article 4. System of specialized management agencies in charge of animal health

1. At the central level:

The Animal Health Department of the Ministry of Agriculture and Rural Development shall function to advise and assist the Minister of Agriculture and Rural Development in performing the state management and organizing the law enforcement in the fields of animal disease prevention and treatment and animal epidemic control; quarantine of animals and animal products; control of animal slaughter and preliminary processing and processing of animals and animal products; vetarinary sanitation inspection; management of veterinary drugs; and veterinary practice nationwide.

2. At local levels:

a/ Sub-departments performing specialized management of animal health, which are attached to provincial-level Agriculture and Rural Development Departments (below referred to as provincial-level specialized management agencies in charge of animal health), shall assist directors of provincial-level Agriculture and Rural Development Departments in advising provincial-level People’s Committees on performing the state management and organizing the law enforcement in the fields of animal disease prevention and treatment and animal epidemic control; quarantine of animals and animal products; control of animal slaughter and preliminary processing and processing of animals and animal products; vetarinary sanitation inspection; management of veterinary drugs; and veterinary practice in their provinces or centrally run cities, and receive professional instructions from the Animal Health Department;

b/ Stations of sub-departments performing specialized management of animal health, which are located in rural districts, urban districts, towns, provincial cities and the equivalent (below referred to as district-level specialized management agencies in charge of animal health), shall perform their assigned tasks in district-level localities and coordinate with district-level Agriculture and Rural Development Divisions or Economic Divisions in assisting district-level People’s Committees in performing the state management in the fields of animal disease prevention and treatment and animal epidemic control; quarantine of animals and animal products; control of animal slaughter and preliminary processing and processing of animals and animal products; vetarinary sanitation inspection; management of veterinary drugs; and veterinary practice in their district-level localities.

Article 5. Entitlements and policies for veterinarians in communes, wards or townships   

1. Based on requirements of veterinary activities in their localities and local resources, provincial-level People’s Committees shall propose their People’s Councils to consider and decide on arrangement of veterinarians in communes, wards or townships (below referred to as commune veterinarians) under Clause 2, Article 6 of the Law on Animal Health.

2. Commune veterinarians are entitled to allowances and health insurance under Clause 3, Article 1 of the Government’s Decree No. 29/2013/ND-CP of April 8, 2013, amending and supplementing a number of articles of the Government’s Decree No. 92/2009/ND-CP of October 22, 2009, on titles of, and a number of entitlements and policies for, cadres and civil servants in communes, wards or townships and part-time commune officers, and to insurance in accordance with the 2014 Law on Social Insurance.

3. Commune veterinarians shall be professionally trained under Clause 1, Article 15 of the Government’s Decree No. 92/2009/ND-CP of October 22, 2009, on titles of, and a number of entitlements and policies for, cadres and civil servants in communes, wards or townships and part-time commune officers.

Section 2

FUNDS FOR ANIMAL DISEASE AND EPIDEMIC PREVENTION AND CONTROL

Article 6. Funds for animal disease and epidemic prevention and control

1. Funds for animal disease and epidemic prenvetion and control come from the sources specified in Clause 2, Article 23 of the Law on Animal Health.

2. Use of funds for animal disease and epidemic prenvetion and control:

a/ The state budget:

The central budget shall allocate funds to the ministries and central agencies in accordance with the Law on the State Budget.

Local budgets shall allocate funds for animal disease and epidemic prevention and control in their localities. In case funds for animal disease and epidemic prevention and control exceed the capacity of their local budgets, provincial-level People’s Committees shall send reports thereon to the Ministry of Agriculture and Rural Development and the Ministry of Finance for submission to the Prime Minister for consideration and decision under Point d, Clause 3, Article 27 of the Law on Animal Health.

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

These funds shall cover expenses for epidemic prevention and control not covered by the state budget’s support funds or by financial assistance of domestic and foreign organizations and individuals.

c/ Contributions and financial assistance of domestic and foreign organizations and individuals must comply with the Law on the State Budget, legal documents guiding the Law on the State Budget and other relevant regulations.

3. The state budget shall cover expenses for:

a/ The dissemination of information on, training in, and organization of, animal health disease and epidemic prevention and control;

b/ Purchase of vehicles, equipment, tools and veterinary drugs (vaccines and disinfectants) and payment of remuneration for people participating in animal disease and epidemic prevention and control;

c/ Surveillance, sampling and testing; monitoring and warning of farming environment; assessment of animal disease and epidemic risks;

d/ Forecast or warning of animal diseases and epidemics; investigation and research into animal diseases;

dd/ Support for establishment of animal epidemic-free zones;

e/ Support for compensation for damage caused by animal diseases or epidemics or by the application of compulsory animal disposal measures at the request of competent state agencies, and for payment of animal disposal expenses;

g/ Support for restoration of the farming and aquaculture environment.

4. Level of support from the state budget:

a/ The level of support for compensation for damage caused by animal diseases or epidemics or by the application of measures to dispose of animals at the request of competent state agencies must comply with current regulations.

For activities for which support levels are not yet prescribed, the Ministry of Finance shall assume the prime responsibility for, and coordinate with the Ministry of Agriculture and Rural Development in, submitting support levels to the Prime Minister for decision under Point b, Clause 2, Article 27 and Clause 3, Article 30 of the Law on Animal Health; or provincial-level People’s Committees shall submit to their People’s Councils for decision support levels suitable to their local budget capability.

b/ Levels of support for restoration of the farming and aquaculture environment

Based on the capacity of their budgets, the instructions of the Ministry of Agriculture and Rural Development and practical requirements of their localities, provincial-level People’s Committees shall submit suitable support levels to their People’s Councils for decision.

Section 3

SUSPENSION OF OR BAN ON EXPORT OR IMPORT OF ANIMALS AND ANIMAL PRODUCTS

Article 7. Suspension of export or import of animals and animal products

1. The export of the following animals and animal products shall be suspended:

a/ Animals and animal products that are at risk of carrying objects of animal and animal product quanrantine or veterinary sanitation inspection under regulations of the importing country and have not yet undergone thorough veterinary sanitation measures;

b/ Exported animals and animal products that violate regulations of the importing country and are subject to warnings by this country and likely to cause loss of Vietnam’s export markets because there are no measures taken to thoroughly address the causes of these violations.  

2. The import of the following animals and animal products shall be suspended:

a/ Animals and animal products that originate from a country or territory where breaks out an animal disease on Vietnam’s list of animal diseases subject to epidemic announcement or the list of zoonotic diseases or new infectious pathogens;

b/ Animals and animals products that originate from a certain country or territory and are identified as carrying objects of Vietnam’s animal and animal product quarantine or veterinary sanitation inspection as warned by the Animal Health Department and fail to comply with regulations of Vietnam;

c/ Animals and animal products that originate from a country or territory with a high risk of carrying objects of Vietnam’s animal and animal product quarantine or veterinary sanitation inspection and have not yet undergone thorough handling measures.

Article 8. Conditions for resumption of export or import of animals and animal products

1. Conditions for resumption of export of animals and animal products:

a/ These animals and animal products are no longer at risk of carrying objects of animal and animal product quarantine or objects of veterinary sanitation inspection and have undergone handling measures to satisfy veterinary sanitation requirements of the importing country;

b/ These animals and animal products have undergone inspection, supervision and certification of effective application of measures to address causes of violations as requested by the importing country.

2. Conditions for resumption of import of animals and animal products:

a/ Animals and animal products suspended from import under Point a, Clause 2, Article 7 of this Decree are allowed to be imported into Vietnam when competent agencies of the exporting country confirm that they have controlled diseases or new infectious pathogens and applied measures to ensure that the risk of disease transmission no longer exists as requested by Vietnam;

b/ Animals and animal products specified at Point b, Clause 2, Article 7 of this Decree are allowed to be imported into Vietnam when competent agencies of the exporting country make reports identifying reasons for these animals and animal products carrying objects of animal and animal product quarantine or objects of veterinary sanitation inspection and have applied thorough handling measures;

c/ Animals and animal products specified at Point c, Clause 2, Article 7 of this Decree are allowed to be imported into Vietnam when competent agencies of the exporting country inspect, supervise and certify that the high risk no longer exists after its causes are addressed.

Article 9. Ban on export or import of animals and animal products

1. Ban shall be imposed on the export of animals and animal products carrying objects of animal and animal product quanrantine or objects of veterinary sanitation inspection which have not yet undergone any handling measures or have undergone handling measures but still fail to satisfy requirements of the importing country.

2. The import of the following animals and animal products shall be banned:  

a/ Animals and animal products that originate from a country or territory with a risk of carrying pathogens of a disease on Vietnam’s list of diseases subject to epidemic announcement, the list of zoonotic diseases or new infectious pathogens; or with a risk of spreading a disease to domestic animals in the country or causing adverse impacts on human health;

b/ Animals and animal products that have been suspended from import but not yet undergone handling measures or that have undergone handling measures but still fail to satisfy requirements of Vietnam.

Article 10. Provisions on suspension of, or ban on, export or import of animals and animal products subject to quarantine

1. In pursuance to Articles 7 and 9 of this Decree, the Animal Health Department shall specify animals and animal products to be suspended or banned from export or import; reasons for export or import suspension or ban with regard to a certain country or territory, and report them to the Minister of Agriculture and Rural Development.

2. Based on reports of the Animal Health Department, the Minister of Agriculture and Rural Development shall consider and decide on suspension of, or ban on, the export or import of animals and animal products.

3. A decision to suspend or ban the export or import of animals and animal products must have the following details:

a/ Names of animals and animal products (including scientific names);

b/ Name of the country or territory from which these animals and animal products are exported to Vietnam or into which these animals and animal products are imported from Vietnam;

c/ Reason(s) for the export or import suspension or ban (including also legal bases and scientific grounds).

4. The suspension of, or ban on, the export or import of animals and animal products starts from the date the suspension or ban decision takes effect and shall be immediately announced in the mass media and notified to related Vietnamese agencies and competent agencies of the exporting country or territory.

Article 11. Provisions on resumption of export or import of animals and animal products

1. In pursuance to Article 8 of this Decree, the Animal Health Department shall inspect, supervise and certify the effective application of handling measures and report it to the Minister of Agriculture and Rural Development.

2. Based on the report of the Animal Health Department, the Minister of Agriculture and Rural Development shall consider and decide on resumption of the export or import of animals and animal products; immediately announce his/her decision in the mass media and notify it to related Vietnamese agencies and competent agencies of the importing or exporting country or territory.

Section 4

CONDITIONS FOR MANUFACTURE, TRADING, IMPORT, TESTING AND TRIAL OF VETERINARY DRUGS 

Article 12. General conditions for manufacture of veterinary drugs

Manufacturers of veterinary drugs shall comply with Article 90 of the Law on Animal Health; the law on fire prevention and fighting; the law on environmental protection; and the law on occupational safety and health, and must satisfy the following conditions:

1. A manufacturing location must:

a/ Be far from residential areas, public works, hospitals, veterinary infirmaries, establishments for animal disease diagnosis and other polluting sources;

b/ Not be affected by pollution from the surrounding environment;

c/ Cause no impact on the surrounding environment.

2. A workshop must:

a/ Be designed to be suitable to the manufacturing scale and types of drugs to be manufactured; be free from inundation, flood, permeation and infiltration of insects and other pests; be separated from external sources of infection;

b/ Be built of solid and appropriate materials to ensure occupational and production safety;

c/ Have a high foundation and a smooth and crack-free floor which is non-slippery, waterproof, and easy to clean and disinfect;

d/ Have ceilings and walls made of durable and solid materials which are easy to clean;

dd/ Have a proper lighting system;

e/ Have a clean water supply and treatment system for drug manufacture; have a wastewater drainage and treatment system and a waste disposal system meeting the veterinary sanitation requirements and as prescribed by the law on environmental protection;

g/ Have a fire alarm and fighting system and emergency exits for persons as prescribed.

3. A warehouse of materials, auxiliary materials and finished drug products shall be built on an area suitable to the manufacturing scale, and must satisfy the following conditions:

a/ Having a separate storehouse for materials, auxiliary materials and finished drug products;

b/ Having an separate external storehouse for solvents and flammable materials;

c/ Being free from inundation, flood, permeation and infiltration of insects and other pests;

d/ Having a high and waterproof foundation;

dd/ Having a proper lighting system;

e/ Having a fire alarm and fighting system and emergency exits for persons as prescribed by the law on fire prevention and fighting;

g/ Having shelves and racks for storing materials, auxiliary materials and finished drug products; having equipment and tools to ensure preservation conditions.

4. Equipment and tools shall be arranged and installed suitable to the manufacturing scale and types of drugs to be manufactured; must have operation manuals; have warranty and maintenance plans; have cleaning processes and meet sanitation requirements, and cause no contamination or cross-contamination among products.

5. Quality control of veterinary drugs:

a/ The quality control area shall be seprated from the manufacturing area and arranged in a way to prevent cross-contamination; and must have rooms for biological and microbiological tests;

b/ Samples and standard substances shall be preserved in separate areas under strict preservation conditions;

c/ The quality control area must have sufficient equipment and tools.

Article 13. Conditions on establishments manufacturing veterinary drugs in the form of pharmaceuticals or vaccines 

In addition to the conditions prescribed in Article 12 of this Decree, establishments manufacturing veterinary drugs in the form of pharmaceuticals or vaccines shall apply the good manufacturing practices of the ASEAN (GMP-ASEAN) or of the World Health Organization (GMP-WHO) or good manufacturing practices at least equivalent to GMP-ASEAN.

Article 14. Order and procedures for grant of certificates of veterinary drug good manufacturing practices

1. A dossier for grant of a certificate of veterinary drug good manufacturing practices (below referred to as GMP certificate) must comprise:

a/ A registration form for GMP inspection;

b/ An enterprise registration certificate;

c/ An organization and personnel diagram of the establishment;

d/ A GMP training program and documents and assessment of training results at the establishment;

dd/ A list of manufacturing, preservation and quality control equipment;

e/ A list of standard operation processes;

g/ A list of goods items currently manufactured or to be manufactured;

h/ An environmental impact assessment report approved by the state management agency in charge of environment;

i/ A written record of GMP self-inspection;

k/ A newly founded establishment registering for GMP inspection shall additionally submit manufacturing practice certificates of the person in charge of technical operations and of the person in charge of veterinary drug testing laboratory.

A dossier of registration for GMP inspection must have cover pages and a table of contents and a blank page between two consecutive sections.

2. Time limit for settlement of a registration dossier:

a/ Within 10 days after receiving a registration dossier, the Animal Health Department shall examine it, and may request amendments and supplements to fully meet the requirements;

b/ Within 30 days after receiving a complete and valid dossier, the Animal Health Department shall issue a decision to form a GMP inspection team and concurrently notify the inspection plan to the establishment, then conduct an inspection;

c/ Within 10 days after the inspection is completed, if the establishment satisfies the requirements, the Animal Health Department shall grant a GMP certificate. If the establishment fails, the Department shall reply in writing, clearly stating the reason.

3. Inspection process:

a/ An establishment subject to GMP inspection shall make a report with charts, diagrams and figures on its operation and the application of GMP;

b/ During a GMP inspection, operations must be in progress;

c/ GMP inspection shall be conducted for all operations of the establishment manufacturing veterinary drugs according to GMP, its registration dossier and current professional regulations.

4. Handling of inspection results:

a/ Based on the written record of the inspection, the head of the inspection team shall propose the Director of the Animal Health Department to grant a GMP certificate to the establishment that satisfies the GMP conditions;

b/ If the establishment basically satisfies the GMP conditions and still has some problems which can be early solved, the inspection team shall request the establishment to solve them. Within 2 (two) months from the date of inspection, the establishment shall solve the problems and send a written report thereon to the Animal Health Department. The head of the inspection team shall consider and propose the Director of the Animal Health Department to grant a GMP certificate to the establishment;

c/ If the establishment fails to satisfy the GMP conditions, it shall address existing problems. After conducting a self-inspection and finding itself satisfying the GMP conditions, the establishment may make and submit a registration dossier again.

5. The validity duration of a GMP certificate is 5 years. Three months before the expiration of the GMP certificate, an organization or individual that wishes to continue manufacturing veterinary drugs shall submit an application for extension of its certificate. An establishment already possessing a GMP certificate is not required to carry out the procedures for grant of a certificate of eligibility to manufacture veterinary drugs.

Article 15. Order and procedures for extension of a GMP certificate

1. A dossier for extension of a GMP certificate must comprise:

a/ An application for GMP re-inspection;

b/ A report on operation and changes of the establishment in the past five years’;

c/ A report on solution of problems detected during the previous inspection;

d/ A report on training at the establishment;

dd/ A list of existing equipment of the establishment;

e/ A list of drugs currently manufactured by the establishment;

g/ A list of standard operation processes;

h/ An environmental impact assessment report approved by the state management agency in charge of environment;

i/ A written record of a self-inspection and an assessment by the establishment in the latest inspection of the GMP application (within the past 3 months).

2. The time limit for dossier settlement, inspection process, handling of inspection results and validity of a GMP certificate must comply with Clauses 2, 3, 4 and 5, Article 14 of this Decree.

Article 16. Order and procedures for re-grant or revocation of a GMP certificate

1. The dossier, order and procedures for re-grant of a GMP certificate in case it is lost, erroneous or damaged or there is a change in information about the registering organization:

a/ A dossier for re-grant of a GMP certificate must comprise an application for re-grant; documents proving the changed content in case of a change in information about the registering organization; and the granted GMP certificate, unless it is lost;

b/ The above dossier for re-grant of a GMP certificate shall be submitted to the Animal Health Department. Within 5 working days after receiving a complete and valid dossier, the Animal Health Department shall re-grant the certificate. In case of refusal to re-grant the certificate, the Department shall reply in writing clearly stating the reason.

2. The Animal Health Department shall revoke the GMP certificate of a veterinary drug manufacturer in the following cases:

a/ The GMP certificate is erased or modified;

b/ The manufacturer has committed violations for which it/he/she has been administratively santioned for at least three times within a year or administratively sanctioned for three consecutive times for the same violation in the manufacturing of veterinary drugs;

c/ The manufacturer no longer manufactures veterinary drugs;

d/ The manufacturer commits another violation subject to revocation of GMP certificate as prescribed by law.

The Minister of Agriculture and Rural Development shall guide the dossier for extension, revocation or modification and supplemenation of a GMP certificate.

Article 17. Conditions for veterinary drug trading

A veterinary drug trader shall comply with Article 92 of the Law on Animal Health and must satisfy the following conditions:

1. Having a fixed business place and a signboard.

2. Having suitable cabinets, shelves and racks for storing drugs.

3. Having equipment satisfying the prescribed drug preservation conditions.

4. Having books, invoices and documents to monitor the drug delivery and warehousing.       

5. A trader in vaccines and biological preparations must have freezers, coolers or cold storages for preservation thereof under the conditions stated in their labels; thermometers for monitoring the preservation conditions; and an uninterruptible power system, tools and vehicles for transportation and distribution of vaccines.

Article 18. Conditions for veterinary drug import

A veterinary drug importer shall comply with Article 94 of the Law on Animal Health and Article 17 of this Decree, and must satisfy the following conditions:

1. Having a warehouse satisfying the conditions prescribed in Clause 3, Article 12 of this Decree.

2. Having suitable equipment and tools, such as ventilators, air conditioning systems, thermometers and hygrometers to ensure the preservation conditions.

3. Having a system of books and standard operation processes to ensure the preservation, control and monitoring of the import and export of veterinary drugs.

4. An importer of vaccines and biological preparations must have a separate storage for preservation, an uninterruptible power system, equipment, tools and vehicles for transportation ensuring the preservation conditions stated on their labels in the course of transportation and distribution.

Article 19. Conditions on veterinary drug-testing establishments

A veterinary drug-testing establishment shall comply with Clause 3, Article 101 of the Law on Animal Health, and must satisfy the following conditions:

1. Being located far from residential areas and public works.

2. Having physical foundations satisfying bio-safety requirements and capable of testing microorganisms; and having clean rooms for analysis of physico-chemical properties.

3. Being furnished with machines and tools to ensure accurate sampling, analysis, adjustment and processing of data. Analysis equipment must be suitable to testing methods and satisfy quality inspection requirements under current standards and regulations.

4. Having places for keeping experimental animals; having separate wards for testing acute toxicity of vaccines and microorganisms. For the testing of vaccines containing toxic pathogens, there must be animal-keeping wards satisfying bio-safety requirements.

5. Having a waste disposal and wastewater treatment system satisfying vetenirary sanitation and environmental sanitation requirements; having separate wards for disposing of experimental animals used for testing vaccines and microorganisms.

6. Having special-use equipment and tools for keeping microorganism strains for testing.

Article 20. Conditions on establishments conducting trials on veterinary drugs

An establishment conducting trials on veterinary drugs shall comply with Article 88 of the Law on Animal Health, and must satisfy the following conditions:

1. A place for animal farming or aquaculture must satisfy the following conditions:

a/ Having a location in line with the local land use master plan or approved by a competent agency;

b/ Having surrounding fences and walls to prevent people and animals from entering the place;

c/ Having a clean water source;

d/ Having sufficient areas of stables, ponds or rearing tanks for farmed or cultured animals to guarantee trial results;

dd/ Having sufficient animal species in sufficient quantities for trial; having separate wards for keeping experimental animals and a system for treatment of waste and wastewater and disposal of carcasses and medical waste, which ensure veterinary and environmental sanitation;

e/ Having its animal feed production, processing and storage facilities separated from storage places of toxic and hazardous chemicals and applying measures to control harmful insects and pests;

g/ Its stables, ponds and rearing tanks having separate feed intakes and meeting preservation requirements.

2. Having a facility for testing veterinary drugs or having a contract on rent of a testing facility which satisfies the conditions prescribed in Article 19 of this Decree.

Section 5

VETERINARY PRACTICE CONDITIONS

Article 21. Veterinary practice conditions     

An organization or individual that practices veterinary medicine must fully satify the conditions prescribed in Article 108 of the Law on Animal Health and satisfy the following professional requirements:

1. An individual practicing animal disease diagnosis and treatment or animal surgery, or providing counseling on animal health must possess a professional secondary or higher degree in animal health, veterinary husbandry or aquaculture or aquatic pathology for practicing aquatic animal health care. An individual practicing animal vaccination must possess a certificate of completion of a technical training course granted by a provincial-level competent state management agency.

2. An individual in charge of technical operations of an establishment conducting animal surgery or animal disease examination, diagnosis and testing must possess a university or higher degree in animal health, veterinary husbandry or aquaculture or aquatic pathology for practicing aquatic animal health care.

3. An individual trading in veterinary drugs must possess a professional secondary or higher degree in animal health, veterinary husbandry or aquaculture or aquatic pathology for practicing aquatic animal health care.

4. An individual in charge of technical operations of an establishment conducting trials on or exporting or importing veterinary drugs must satisfy the following conditions:

a/ If such veterinary drugs are used for terrestrial animals, he/she must possess a university or higher degree in animal health or veterinary husbandry, or a pharmacist, chemico-pharmaceutical, chemical or biological bachelor degree;

b/ If such veterinary drugs are used for aquatic animals, he/she must possess a university or higher degree in aquaculture or aquatic pathology, or a pharmacist, chemico-pharmaceutical, chemical or biological bachelor degree.

5. An individual in charge of technical operations of an establishment manufacturing or testing veterinary drugs must satisfy the following condition:

a/ If such veterinary drugs are pharmaceuticals used for terrestrial animals, he/she must possess a university or higher degree in animal health or a pharmacist or chemico-pharmaceutical degree; if such veterinary drugs are used for aquatic animals, he/she must possess a university or higher degree in aquaculture or aquatic pathology, or a pharmacist or chemico-pharmaceutical degree;

b/ If the establishment manufactures or tests vaccines, biological preparations, microorganisms or chemicals used for terrestrial animals, he/she must possess a university or higher degree in animal health or veterinary husbandry, or a pharmacist, chemico-pharmaceutical, chemical or biological bachelor degree; if the establishment manufactures or tests vaccines, biological preparations, microorganisms or chemicals used for aquatic animals, he/she must possess a university or higher degree in aquaculture or aquatic pathology, or a pharmacist, chemico-pharmaceutical or chemical bachelor degree.

Article 22. Veterinary practice certificate

1. A veterinary practice certificate shall be granted to an organization or individual that fully satisfies the practice conditions prescribed in Article 108 of the Law on Animal Health and Article 21 of this Decree and make a dossier as prescribed in Clauses 2 and 5, Article 109 of the Law on Animal Health.

2. A veterinary practice certificate must have the following details:

a/ Full name and date of birth of the certificate holder;

b/ Address of residence;

c/ Professional degrees and diplomas;

d/ Type of practice;

dd/ Practice place.

Attached to this Decree are appendices (not translated) on the veterinary practice certificate form and registration form for application for a veterinary practice certificate.

3. The use of a veterinary practice certificate is prescribed as follows:

a/ A veterinary practice certificate for animal vaccination, animal disease diagnosis and cure, animal surgery and provision of counseling on activities related to animal health may be used nationwide. The agency that grants a veterinary practice certificate should not fill in the detail of practice place in such certificate.

b/ A veterinary practice certificate of a person in charge of technical operations of an establishment conducting animal surgery or animal disease examination, diagnosis and testing or trading in veterinary drugs may be used within a province or centrally run city.

c/ A veterinary practice certificate of a person in charge of technical operations of an establishment manufacturing, testing, conducting trials on, exporting or importing veterinary drugs may be used nationwide.

Chapter III

IMPLEMENTATION PROVISIONS

Article 23. Effect  

1. This Decree takes effect on July 1, 2016.

2. This Decree replaces the Government’s Decree No. 33/2005/ND-CP of March 15, 2005, detailing a number of articles of the Ordinance on Animal Health; and Decree No. 119/2008/ND-CP of November 28, 2008, amending and supplementing a number of articles of Decree No. 33/2005/ND-CP; Article 4 of Decree No. 98/2011/ND-CP of October 26, 2011, amending and supplementing a number of articles of the decrees on agriculture.

Article 24. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People’s Committees, and related agencies shall implement this Decree.-

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC