Decree No. 35/2016/NĐ-CP detailing certain provisions of the Law on Animal Health

DECREE

DETAILING CERTAIN PROVISIONS OF THE ANIMAL HEALTH LAW

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

Based on the Law on Veterinary Medicine dated June 19, 2015;

Pursuant to the Investment Law dated November 26, 2014;

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

The Government promulgates this Decree detailing certain provisions of the Animal Health Law.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree details and guides the implementation of certain provisions of the Animal Health Law, specifically as follows:

1. The system of specialized animal health management agencies and the regime, policies for village, ward, town animal health staff.

2. Budget for preventing and controlling animal diseases.

3. Suspension of export and import; prohibition of export and import of animals and animal products.

4. Conditions for producing, trading, importing, testing, and trial of veterinary drugs; regulations on good manufacturing practice (GMP) for veterinary drug production.

5. Conditions for practicing veterinary medicine.

Article 2. Applicability

This Decree applies to agencies, organizations, and individuals within the country and foreign organizations and individuals related to animal health activities in Vietnam.

Article 3. Explanation of Terms

In this Decree, the following terms are understood as follows;

1. Good Manufacturing Practice (GMP) for drug production refers to principles, regulations, and guidelines regarding drug production conditions to ensure that drug products meet quality standards.

2. GMP-WHO is Good Manufacturing Practice for drug production issued by the World Health Organization (WHO), including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Storage Practice (GSP) for drug production.

3. GMP-ASEAN is Good Manufacturing Practice for drug production issued by the Association of Southeast Asian Nations (ASEAN).

Chapter II
SPECIFIC PROVISIONS

Section 1
SYSTEM OF SPECIALIZED ANIMAL HEALTH MANAGEMENT AGENCIES AND REGIME, POLICIES FOR VILLAGE, WARD, TOWN ANIMAL HEALTH STAFF

Article 4. System of specialized animal health management agencies

1. At the Central Level:

The Department of Animal Health under the Ministry of Agriculture and Rural Development has the function of advising and assisting the Minister of Agriculture and Rural Development in state management and enforcing laws in the field of animal disease prevention, treatment, and control; animal quarantine, animal product quarantine; animal slaughter control, initial processing, and animal product processing; veterinary hygiene inspection; veterinary drug management; veterinary practice nationwide.

2. At the Local Level:

a) The provincial-level specialized animal health management agency (hereinafter referred to as the provincial specialized animal health management agency) under the Provincial Department of Agriculture and Rural Development (hereinafter referred to as the provincial department) assists the Director of the provincial department in advising the People's Committee of the province to implement state management functions and enforce laws in the fields of animal disease prevention, treatment, and control; animal quarantine, animal product quarantine; animal slaughter control, initial processing, and animal product processing; veterinary hygiene inspection; veterinary drug management; veterinary practice in the province and directly under the central city, and is subject to professional guidance from the Department of Animal Health.

b) The station under the specialized animal health management agency located at the district, urban district, town, and equivalent administrative unit (hereinafter referred to as the district specialized animal health management agency) performs assigned tasks in the district area and cooperates with the District Department of Agriculture and Rural Development or economic department to assist the People's Committee of the district in state management in the fields of animal disease prevention, treatment, and control; animal quarantine, animal product quarantine; animal slaughter control, initial processing, and animal product processing; veterinary hygiene inspection; veterinary drug management; veterinary practice in the district area.

Article 5. Regulations and policies for veterinary staff at communes, wards, and towns

1. Based on the requirements of veterinary activities in the locality and the ability to balance local resources, the People's Committee of the province or centrally governed city proposes to the People's Council at the same level to consider and decide on the allocation of veterinary staff at communes, wards, and towns (hereinafter referred to as commune veterinary staff) in accordance with Clause 2, Article 6 of the Law on Veterinary.

2. Commune veterinary staff shall enjoy allowances and health insurance benefits as stipulated in Clause 3, Article 1 of Decree No. 29/2013/ND-CP dated April 8, 2013 of the Government amending and supplementing some articles of Decree No. 92/2009/ND-CP dated October 22, 2009 of the Government on job titles, number of personnel, and certain regulations and policies for cadres and civil servants at communes, wards, and towns and persons working non-professionally at the commune level, and shall implement social insurance benefits as prescribed in the Social Insurance Law 2014.

3. Commune veterinary staff shall be trained and further educated in accordance with Clause 1, Article 15 of Decree No. 92/2009/ND-CP dated October 22, 2009 of the Government on job titles, number of personnel, and certain regulations and policies for cadres and civil servants at communes, wards, and towns and persons working non-professionally at the commune level.

Section 2

EXPENSES FOR PREVENTION AND CONTROL OF ANIMAL DISEASES

Section 3
SUSPENSION OF EXPORT AND IMPORT; PROHIBITION OF EXPORT AND IMPORT OF ANIMALS AND ANIMAL PRODUCTS

Article 6. Expenses for prevention and control of animal diseases

1. The sources of expenses for prevention and control of animal diseases shall be implemented in accordance with Clause 2, Article 23 of the Law on Veterinary.

2. Utilization of expenses for prevention and control of animal diseases:

a) State budget:

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

The local budget allocates funds for prevention and control of animal diseases in the locality. In cases where the expenses for prevention and control of animal diseases exceed the local budget's balancing capacity, the provincial People's Committee reports in writing to the Ministry of Agriculture and Rural Development and the Ministry of Finance to submit to the Prime Minister for consideration and decision in accordance with Point d, Clause 3, Article 27 of the Law on Veterinary.

b) Expenses of animal owners, livestock farm owners, and aquaculture operators

Costs for prevention and control of disease outside the funding support from the state budget, and financial assistance from organizations and individuals both within and outside the country.

c) Contributions and financial assistance from organizations and individuals both within and outside the country shall be carried out in accordance with the State Budget Law, guiding documents of the State Budget Law, and other relevant laws.

3. Contents of expenditure from the state budget:

a) Propaganda, dissemination, training, organization of prevention and control of animal diseases;

b) Purchase of equipment, devices, veterinary drugs (vaccines, disinfectants), and costs for personnel participating in the prevention and control of animal diseases;

c) Surveillance, sampling, testing; environmental monitoring and warning for animal husbandry; assessment of animal disease risk;

d) Forecasting and warning of animal diseases; investigation and research on animal diseases;

đ) Support for building disease-free zones for animals;

e) Support for losses caused by animal diseases or compulsory measures applied according to the requirements of competent authorities and costs for handling;

g) Support for restoring the breeding environment and aquaculture environment;

4. Level of support from the state budget:

a) Level of support for losses caused by animal diseases, and support for losses due to compulsory measures applied to animals according to the requirements of competent authorities shall be implemented in accordance with current regulations.

For contents without specified levels of support, the Ministry of Finance shall take the lead, coordinate with the Ministry of Agriculture and Rural Development to submit to the Prime Minister for decision in accordance with Point b, Clause 2, Article 27 and Clause 3, Article 30 of the Law on Veterinary; the provincial People's Committee shall submit to the People's Council at the same level for decision on appropriate levels of support based on the local budget capacity.

b) Level of support for restoring the breeding and aquaculture environment

Based on the budget balancing capacity, guidelines of the Ministry of Agriculture and Rural Development, and actual needs in the locality, the provincial People's Committee shall submit to the People's Council at the same level for decision on appropriate levels of support based on the local budget capacity.

Article 7. Suspension of Export and Import of Animals and Animal Products

1. Suspension of export of animals and animal products in the following cases:

a) Animals and animal products that pose a risk of carrying quarantine objects for animals and animal products or veterinary hygiene inspection objects as prescribed by the importing country and have not been thoroughly treated with veterinary hygiene measures;

b) Animals and animal products exported in violation of the regulations of the importing country, warned by the importing country but have not taken thorough measures to eliminate the causes of the violations and pose a risk of losing Vietnam's export market.

2. Suspension of import of animals and animal products in the following cases:

a) Animals and animal products originating from a country or territory currently experiencing animal diseases listed in the List of Diseases Requiring Disease Notification in Vietnam or the List of Zoonotic Diseases or new infectious disease agents;

b) Animals and animal products originating from a country or territory found to be infected with quarantine objects for animals and animal products or veterinary hygiene inspection objects of Vietnam, which have been warned by the Department of Animal Health but do not comply with Vietnam’s regulations;

c) Animals and animal products originating from a country or territory that pose a high risk of carrying quarantine objects for animals and animal products or veterinary hygiene inspection objects of Vietnam and have not been thoroughly treated.

Article 8. Conditions for Continuing Export and Import of Animals and Animal Products

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

a) Animals and animal products that do not pose a risk of carrying quarantine objects for animals and animal products or veterinary hygiene inspection objects and have applied measures to ensure compliance with veterinary hygiene requirements as requested by the importing country;

b) Animals and animal products that have been inspected, monitored, and confirmed to effectively implement measures to eliminate the causes of violations as required by the importing country.

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

a) Animals and animal products suspended from import as stipulated in point a, Clause 2, Article 7 of this Decree may be imported into Vietnam when the competent authority of the exporting country confirms that it has controlled the disease or new infectious disease agent and has implemented measures to ensure there is no longer a risk of spreading the disease according to Vietnam’s requirements;

b) Animals and animal products as stipulated in point b, Clause 2, Article 7 of this Decree may be imported into Vietnam when the competent authority of the exporting country reports on identifying the cause of infection with quarantine objects for animals and animal products or veterinary hygiene inspection objects and has implemented thorough measures to eliminate them;

c) Animals and animal products as stipulated in point c, Clause 2, Article 7 of this Decree may be imported into Vietnam when the competent authority of the exporting country inspects, monitors, confirms the elimination, and ensures there is no longer a high risk.

Article 9. Prohibition of Export and Import of Animals and Animal Products

1. Prohibition of export of animals and animal products infected with quarantine objects for animals and animal products or veterinary hygiene inspection objects without treatment measures or with treatment measures that do not meet the requirements of the importing country.

2. Prohibition of import of animals and animal products in the following cases:

a) Animals and animal products originating from a country or territory carrying pathogens of diseases listed in the List of Diseases Requiring Disease Notification in Vietnam or the List of Zoonotic Diseases or new infectious disease agents; posing a risk of spreading the disease to domestic animals and affecting human health;

b) Animals and animal products that have been temporarily suspended from import but still have not applied corrective measures or have applied corrective measures but still do not meet Vietnam’s requirements.

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

1. Based on the provisions of Articles 7 and 9 of this Decree, the Department of Animal Health shall specifically determine the types of animals and animal products that must be suspended from or prohibited from export and import; the reasons for suspending or prohibiting export and import for a specific country or territory, and report to the Minister of Agriculture and Rural Development.

2. The Minister of Agriculture and Rural Development shall consider the report of the Department of Animal Health before deciding on the suspension or prohibition of export and import of animals and animal products.

3. The decision on the suspension or prohibition of export and import of animals and animal products must specify the following contents:

a) Name of the animal or animal product (including scientific name);

b) Name of the country or territory from which the animal or animal product is exported to Vietnam or imported from Vietnam;

c) Reasons for suspending or prohibiting export and import (including legal basis and scientific basis).

4. The suspension or prohibition of export and import of animals and animal products shall take effect from the date the decision becomes effective; it shall be immediately published on mass media and notified to relevant agencies in Vietnam and competent authorities of the exporting country or territory.

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

1. Based on the provisions of Article 8 of this Decree, the Department of Animal Health shall inspect, supervise, confirm the effective implementation of corrective measures, and report to the Minister of Agriculture and Rural Development.

2. The Minister of Agriculture and Rural Development shall consider the report of the Department of Animal Health and decide to allow the resumption of export and import of animals and animal products; the decision shall be immediately published on mass media and notified to relevant agencies in Vietnam and competent authorities of the exporting and importing countries or territories.

Section 4
PRODUCTION, SALE, IMPORTATION,

TESTING AND RESEARCH OF VETERINARY DRUGS

Article 12. General Conditions for the Production of Veterinary Drugs

Organizations and individuals producing veterinary drugs must comply with the provisions of Article 90 of the Law on Animal Health; fire prevention and control laws; environmental protection laws; labor safety and hygiene laws, and meet the following conditions:

1. Location:

a) Must be isolated from residential areas, public buildings, hospitals, veterinary clinics, diagnostic facilities for animals, and other sources of pollution;

b) Not contaminated by external environment;

c) Not affect the surrounding environment.

2. Factory:

a) Must have a design suitable for the scale and type of drug produced, preventing flooding, moisture penetration, and intrusion by insects and other animals; with positions to isolate sources of infection from outside;

b) Using sturdy materials appropriate for ensuring safe labor and production;

c) The floor must be dry, smooth, without cracks, slippery, water-permeable, or water accumulation, easy to clean, disinfect, and sterilize;

d) Walls and ceilings must be made of durable, easy-to-clean materials;

đ) Must have an appropriate lighting system;

e) Must have a clean water supply and treatment system for production; a drainage and wastewater treatment system meeting veterinary hygiene requirements and environmental protection laws;

g) Must have a fire alarm and extinguishing system; escape routes for people according to regulations.

3. Storage Areas for Raw Materials, Auxiliary Materials, Finished Drugs:

a) Must have separate storage areas for raw materials, auxiliary materials, and finished drugs;

b) Must have an external storage area for flammable and explosive solvents and raw materials;

c) Must prevent flooding, moisture penetration, and intrusion by insects and other animals;

d) The floor must be dry, without water permeation or accumulation;

đ) Must have an appropriate lighting system;

e) Must have a fire alarm and extinguishing system; escape routes for people according to fire prevention and control laws;

g) Must have shelves and equipment for storing raw materials, auxiliary materials, packaging, and finished drugs; equipment and means to ensure storage conditions.

4. Equipment and Tools:

a) Must be arranged and installed appropriately according to the scale and type of drug produced; have operating instructions; maintenance plans; cleaning procedures to meet hygiene requirements, preventing contamination or cross-contamination between products.

5. Quality Control of Veterinary Drugs:

a) The quality control area must be separated from the production area; properly arranged to avoid cross-contamination; areas for conducting biological and microbiological tests;

b) Samples and standards must be stored in a separate area, ensuring storage conditions;

Article 13. Conditions for veterinary pharmaceutical production facilities in the form of drugs and vaccines

In addition to the conditions stipulated in Article 12 of this Decree, veterinary pharmaceutical production facilities in the form of drugs and vaccines must apply Good Manufacturing Practices (GMP) of the Association of Southeast Asian Nations (ASEAN-GMP) or World Health Organization (WHO-GMP) or equivalent GMP but not lower than ASEAN-GMP.

Article 14. Procedures and formalities for issuing the GMP Good Manufacturing Practice Certificate for veterinary pharmaceuticals

1. The application dossier for issuing the GMP Good Manufacturing Practice Certificate (hereinafter referred to as the GMP Certificate) includes:

h) Environmental impact assessment report approved by the competent state environmental management agency;

The GMP inspection application dossier must have a cover page and table of contents, arranged according to the table of contents, with clear separation between sections.

2. Time limit for processing:

b) Within thirty days from the date of receiving a complete and valid dossier, the Department of Animal Health issues a decision to establish a GMP inspection team, simultaneously notifying the schedule to the facility and conducting the inspection;

c) Within ten days from the end of the inspection, if the facility meets the requirements, the Department of Animal Health will issue the GMP Certificate; if the facility does not meet the requirements, it must respond in writing and specify the reasons for non-compliance.

3. Inspection process:

a) Facilities undergoing GMP inspections must report on their operational status and implementation of GMP through diagrams, charts, and concise data;

b) During GMP inspections, ongoing activities must be conducted;

c) All activities of the veterinary pharmaceutical production facility under GMP, the application dossier of the facility, and current professional regulations shall be inspected comprehensively.

4. Handling of inspection results:

a) Based on the inspection record, the Head of the Inspection Team proposes to the Director of the Department of Animal Health to issue the GMP Certificate to facilities that meet GMP conditions;

b) For facilities that meet GMP conditions but have some remaining issues that can be resolved within a short period, the inspection team requires the facility to rectify and repair these issues. Within two months from the date of inspection, the facility must rectify and repair the issues and submit a written report of the results to the Department of Animal Health. The Head of the Inspection Team reviews and proposes to the Director of the Department of Animal Health to issue the GMP Certificate to the facility that meets the requirements;

c) For facilities that do not meet GMP conditions, they must address and correct the remaining issues. After self-inspection and evaluation, if the conditions of GMP are met, the facility must resubmit the application dossier according to the regulations.

5. The validity period of the GMP Certificate is five years. Three months before the expiration date of the GMP Certificate, organizations and individuals wishing to continue producing veterinary pharmaceuticals must submit an application for extending the GMP Certificate. Facilities already holding a GMP Certificate do not need to go through the procedure for obtaining a Certificate of Compliance for Veterinary Pharmaceutical Production Conditions.

Article 15. Procedure for Extending the Good Manufacturing Practice (GMP) Certificate

a) Application form for re-inspection of GMP;

b) Report on activities and changes at the facility over the past five years of implementing GMP;

c) Report on rectifying deficiencies from the previous inspection;

d) Report on training and education at the facility;

đ) List of existing equipment at the facility;

e) List of products currently being manufactured;

g) List of standard operating procedures;

h) Environmental impact assessment report approved by the competent state environmental management agency;

i) Minutes of the most recent self-inspection and evaluation conducted by the facility within the last three months regarding the implementation of GMP.

2. Time limit for processing, inspection process, handling of inspection results, and validity of the GMP Certificate shall be carried out in accordance with Clause 2, Clause 3, Clause 4, and Clause 5 of Article 14 of this Decree.

Article 16. Procedure for Reissuing and Revoking the GMP Certificate

a) The dossier for reissuing the GMP Certificate includes: application form for reissuance; documents proving the changed content in cases of information change related to the registering entity; previously issued GMP Certificate, except in cases of loss;

b) Organizations and individuals submit the reissuance dossier for the GMP Certificate to the Department of Animal Health; within five working days from the date of receiving a complete and valid dossier, the Department of Animal Health will reissue the GMP Certificate; if not issued, a written response must be provided with clear reasons.

2. The Department of Animal Health will revoke the GMP Certificate of organizations and individuals producing veterinary drugs in the following cases:

a) The GMP Certificate has been erased or altered;

b) Violation of laws resulting in administrative penalties three times or more in a year or three consecutive times for the same violation in the field of veterinary drug production;

c) Ceased operations in veterinary drug production;

d) Other violations prescribed by law that require revocation of the GMP Certificate.

The Minister of Agriculture and Rural Development shall guide the dossiers for extending, revoking, changing, and supplementing the GMP Certificate.

Article 17. Conditions for Trading in Veterinary Drugs

Organizations and individuals trading in veterinary drugs must comply with Article 92 of the Law on Animal Health and meet the following conditions:

1. Having a fixed business location and signboard.

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

3. Having equipment ensuring storage conditions for drugs as prescribed.

4. Maintaining ledgers and invoices to track purchases and sales.

5. For facilities trading in vaccines and biological products, they must have refrigerators, coolers, or cold storage rooms to store according to the preservation conditions indicated on the label; having thermometers to check preservation conditions. They must also have backup generators, transportation equipment, and means to distribute vaccines under the preservation conditions specified on the product label during transportation and distribution.

Article 18. Conditions for importing veterinary drugs

Article 18. Conditions for Importing Veterinary Drugs

Organizations and individuals importing veterinary drugs must comply with Article 94 of the Law on Animal Health, Article 17 of this Decree, and meet the following conditions:

1. Having a warehouse meeting the requirements stipulated in Clause 3 of Article 12 of this Decree.

2. Having appropriate equipment such as fans, air conditioning systems, thermometers, hygrometers to ensure storage conditions.

3. Must have a system of ledgers and standard operating procedures to ensure storage, control, and tracking of imports and exports of veterinary drugs.

Article 19. Conditions for veterinary drug testing facilities

Veterinary drug testing facilities must comply with the provisions of Clause 3, Article 101 of the Law on Animal Health and meet the following conditions:

1. The location must be isolated from residential areas and public buildings.

2. Infrastructure must ensure biosafety and be suitable for testing microbiological indicators; there must be clean rooms for analyzing physical and chemical indicators.

3. It must be equipped with machinery and tools to ensure accurate sampling, analysis, calibration, and data processing. Analytical equipment must comply with testing methods and current standards and technical regulations.

4. There must be a place to keep experimental animals; there must be a separate area for toxicity testing of vaccines and microorganisms; for testing high-pathogenicity vaccines, there must be a safe biological laboratory for animal housing.

5. There must be a system for treating waste and wastewater to ensure veterinary hygiene and environmental sanitation; there must be a separate area for disposing of experimental animals used in vaccine and microorganism testing.

6. There must be specialized equipment for preserving microbial strains to serve testing purposes.

Article 20. Conditions for veterinary drug trial facilities

Veterinary drug trial facilities must comply with the provisions of Article 88 of the Law on Animal Health and meet the following conditions:

1. Livestock breeding and aquaculture sites must meet the following conditions:

a) The location must be appropriate according to local land use planning or approved by the competent authority;

b) There must be a fence or wall surrounding the facility to prevent people and animals from entering;

c) There must be a clean water source;

d) There must be sufficient space in pens, ponds, and tanks to arrange animals for trial results;

đ) There must be enough types and quantities of animals to meet trial requirements; there must be a separate area for experimental animal housing, and a system for treating waste, wastewater, animal carcasses, and diseased samples to ensure veterinary hygiene and environmental sanitation;

e) Production, processing, and storage areas for livestock feed must be separated from hazardous chemicals and have measures to prevent pests and harmful animals;

g) Feeding areas within pens, ponds, and tanks must be separate and designed to meet storage requirements.

2. There must be a veterinary drug testing facility or a contract for renting such a facility; the testing facility must meet the conditions stipulated in Article 19 of this Decree.

Section 5
PROFESSIONAL CONDITIONS FOR VETERINARY PRACTICE

Article 21. Professional conditions for veterinary practice

Organizations and individuals practicing veterinary activities must meet the conditions stipulated in Article 108 of the Law on Animal Health and must satisfy the following professional requirements:

1. Individuals diagnosing, treating, performing surgery on animals, and advising on activities related to veterinary fields must have at least a secondary vocational degree in veterinary science, animal husbandry, or secondary vocational degree in aquaculture, aquatic pathology for aquatic veterinary practice. Individuals administering vaccines to animals must hold a certificate of completion of a training course in injection techniques issued by the provincial competent state management agency.

2. Technical supervisors of animal surgical facilities, examination, diagnosis, and disease testing facilities must have a bachelor's degree or higher in veterinary science, animal husbandry, or aquaculture, aquatic pathology for aquatic veterinary practice.

3. Individuals selling veterinary drugs must have a secondary vocational degree or higher in veterinary science, animal husbandry, or secondary vocational degree in aquaculture, aquatic pathology for aquatic veterinary practice.

4. Technical supervisors of veterinary drug trial, export, and import facilities are specified as follows:

a) For facilities conducting trials, exporting, and importing drugs for terrestrial animals, they must have a bachelor's degree or higher in veterinary science, animal husbandry, pharmacy, pharmaceutical chemistry, chemistry, or biology;

b) For facilities conducting trials, exporting, and importing drugs for aquatic animals, they must have a bachelor's degree or higher in aquaculture, aquatic pathology, pharmacy, pharmaceutical chemistry, chemistry, or biology.

5. Technical supervisors of veterinary drug production and testing facilities are specified as follows:

a) For facilities producing and testing veterinary drugs that are pharmaceuticals for terrestrial animals, they must have a bachelor's degree or higher in veterinary science, pharmacy, or pharmaceutical chemistry; for aquatic animals, they must have a bachelor's degree or higher in aquaculture, aquatic pathology, pharmacy, or pharmaceutical chemistry;

b) For facilities producing and testing veterinary drugs that are vaccines, biological products, microorganisms, and chemicals for terrestrial animals, they must have a bachelor's degree or higher in veterinary science, animal husbandry, pharmacy, pharmaceutical chemistry, chemistry, or biology; for aquatic animals, they must have a bachelor's degree or higher in aquaculture, aquatic pathology, biology, pharmacy, or pharmaceutical chemistry.

Article 22. Veterinary Practice Certificate

1. The Veterinary Practice Certificate shall be issued to organizations and individuals who meet the conditions for practice as stipulated in Article 108 of the Law on Animal Health, Clause 21 of this Decree, and the dossier as prescribed in Clause 2 and Clause 5 of Article 109 of the Law on Animal Health.

2. The contents of the Veterinary Practice Certificate include:

a) Full name and date of birth;

b) Place of residence;

c) Professional qualifications;

d) Type of practice;

đ) Location.

Attached herewith with this Decree is the Appendix on the model of the Veterinary Practice Certificate and the Application for Issuance of the Veterinary Practice Certificate.

3. The use of the Veterinary Practice Certificate is regulated as follows:

a) The Veterinary Practice Certificate for vaccination, diagnosis, treatment, surgery, and consultation related to animal health can be used throughout the country. The issuing authority does not record the place of practice in the certificate;

b) The Veterinary Practice Certificate for technical personnel at animal surgical facilities, veterinary clinics, diagnostic laboratories, and veterinary drug sales outlets can be used within the province or centrally-administered city;

c) The Veterinary Practice Certificate for technical personnel at facilities producing, testing, evaluating, exporting, and importing veterinary drugs can be used throughout the country.

Chapter III
IMPLEMENTING PROVISIONS

Article 23. Effectiveness of Implementation

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

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

Article 24. Responsibility for Implementation

Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairpersons of provincial People's Committees under central cities, and relevant agencies are responsible for implementing this Decree./.

ANNEX I

MODEL OF VETERINARY PRACTICE CERTIFICATE
(Attached to Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government)

ANNEX II

MODEL OF VETERINARY PRACTICE CERTIFICATE
(Attached to Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government)

ANNEX III

MODEL APPLICATION FOR ISSUANCE OF VETERINARY PRACTICE CERTIFICATE
(Attached to Decree No. 35/2016/NĐ-CP dated May 15, 2016 of the Government)

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------

APPLICATION FOR REGISTRATION
ISSUE VETERINARY PRACTICE CERTIFICATE

Dear: Department of Animal Health,

My name is: …

Date of birth: ...

Permanent address: ...

Professional qualifications: ...

Date of Issue: …

We hereby request your agency to issue the Veterinary Practice Certificate:

□ Production of veterinary drugs for terrestrial animals.

□ Production of veterinary drugs for aquatic animals.

□ Export and import of veterinary drugs for terrestrial animals.

□ Export and import of veterinary drugs for aquatic animals.

□ Testing of veterinary drugs for terrestrial animals.

□ Testing of veterinary drugs for aquatic animals.

□ Inspection of veterinary drugs for terrestrial animals.

□ Inspection of veterinary drugs for aquatic animals.

At Enterprise/Company: …

……………………………………………………………………………………………………

Place of practice: …

……………………………………………………………………………………………………

I solemnly undertake to strictly comply with all laws and regulations of the animal health sector.

(Note: If the individual applying for production and export/import certificates should mark both boxes for production and export/import. Submit two 4x6 photos.

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------

APPLICATION FOR REGISTRATION
RENEWAL OF VETERINARY PRACTICE CERTIFICATE

Dear: Department of Animal Health,

My name is: …

Date of birth: ...

Permanent address: ...

Has been issued the Veterinary Practice Certificate by the Department of Animal Health:

□ Production of veterinary drugs for terrestrial animals.

□ Production of veterinary drugs for aquatic animals.

□ Export and import of veterinary drugs for terrestrial animals.

□ Export and import of veterinary drugs for aquatic animals.

□ Testing of veterinary drugs for terrestrial animals.

□ Testing of veterinary drugs for aquatic animals.

□ Inspection of veterinary drugs for terrestrial animals.

□ Inspection of veterinary drugs for aquatic animals.

At Enterprise/Company: …

……………………………………………………………………………………………………

……………………………………………………………………………………………………

Certificate Number: …

Date of Issue: …

We hereby request your department to renew the above-mentioned Veterinary Practice Certificate.

Enclose expired Veterinary Practice Certificate and two 4x6 photos.

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------

APPLICATION FOR REGISTRATION
ISSUE VETERINARY PRACTICE CERTIFICATE

Dear: Provincial Animal Health Service

My name is: …

Date of birth: ...

Permanent address: ...

Professional qualifications: ...

Date of Issue: …

We hereby request your agency to issue the Veterinary Practice Certificate:

□ Vaccination, treatment, minor surgery (castration, tail docking), and consultation related to animal health activities.

□ Diagnosis, surgery, and laboratory testing of animal diseases.

□ Sale of veterinary drugs for terrestrial animals.

□ Sale of veterinary drugs for aquatic animals.

At: ...

……………………………………………………………………………………………………

Place of practice: …

……………………………………………………………………………………………………

I solemnly undertake to strictly comply with all laws and regulations of the animal health sector.

(Remarks: Submit two 4x6 photos)

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------

APPLICATION FOR REGISTRATION
RENEWAL OF VETERINARY PRACTICE CERTIFICATE

Dear: Provincial Animal Health Service

My name is: …

Date of birth: ...

Permanent address: ...

Professional qualifications: ...

Has been issued the Veterinary Practice Certificate by the Provincial Animal Health Service:

□ Vaccination, treatment, minor surgery (castration, tail docking), and consultation related to animal health activities.

□ Diagnosis, surgery, and laboratory testing of animal diseases.

□ Sale of veterinary drugs for terrestrial animals.

□ Sale of veterinary drugs for aquatic animals.

At:...

Certificate Number: …

Date of Issue: …

We hereby request your service to renew the above-mentioned Veterinary Practice Certificate.

Enclose expired Veterinary Practice Certificate and two 4x6 photos.