Decree 35/2016/NĐ-CP – guiding the Veterinary Law

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

Pursuant to the Veterinary Law 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 a Decree detailing the implementation of a number of articles of the Veterinary Law.

Chapter I. GENERAL PROVISIONS

Article 1. Scope of regulation

This decree provides details and guidance for the implementation of certain articles of the Veterinary Law, specifically as follows:

1. The system of specialized veterinary management agencies and the regimes and policies for veterinary staff at communes, wards, and towns.

2. Funding for the prevention and control of animal diseases.

3. Temporarily suspending exports and imports; banning the export and import of animals and animal products.

4. Conditions for production, trading, importing, testing, and trial testing of veterinary drugs; regulations on Good Manufacturing Practice (GMP) for veterinary drug production.

5. Conditions for practicing veterinary medicine.

Article 2. Subjects of application

This Decree applies to agencies, organizations, and individuals within the country as well as foreign organizations and individuals related to veterinary activities in Vietnam.

Article 3. Interpretation of terms

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

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

2. GMP-WHO is good manufacturing practice for pharmaceuticals issued by the World Health Organization (WHO), including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Store Practice (GSP).

3. GMP-ASEAN is good manufacturing practice for pharmaceuticals issued by the Association of Southeast Asian Nations (ASEAN).

Chapter II. SPECIFIC REGULATIONS

Section 1. SYSTEM OF VETERINARY MANAGEMENT AGENCIES AND REGIMES, POLICIES FOR VETERINARY STAFF AT COMMUNE, WARD, AND TOWN LEVELS

Article 4. System of veterinary 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 organizing the implementation of laws in the field of animal disease prevention, treatment, and epidemic control; animal and animal product quarantine; control of animal slaughter, primary processing, and processing of animals and animal products; veterinary hygiene inspection; management of veterinary drugs; and veterinary practice nationwide.

2. At the local level:

a) The sub-department has the function of managing veterinary specialties under the Department of Agriculture and Rural Development of the province or centrally-run city (hereinafter referred to as the provincial-level veterinary specialty management agency), assisting the Director of the Department in advising the Provincial People's Committee in implementing state management functions and organizing law enforcement in the fields of disease prevention, treatment, and epidemic control of animals; animal and animal product quarantine; control of animal slaughter, initial processing, and processing of animals and animal products; veterinary hygiene inspection; management of veterinary drugs; veterinary practice within the province or centrally-run city and is subject to professional guidance from the Department of Veterinary Medicine;

b) The station under the Sub-Department with specialized veterinary management functions, located in districts, towns, provincial cities, and equivalent administrative units (hereinafter referred to as the district-level specialized veterinary management agency), performs assigned tasks in the district area and coordinates with the Department of Agriculture and Rural Development or the economic department to assist the District People's Committee in state management in the fields of disease prevention, treatment, and control of animal epidemics; animal and animal product quarantine; control of animal slaughtering, preliminary processing, and processing of animals and animal products; inspection of veterinary hygiene; management of veterinary drugs; and veterinary practice in the district area.

Article 5. Regime and policies for veterinary staff in communes, wards, and towns

1. Based on the requirements of veterinary activities in the area and the ability to balance local resources, the People's Committee of the province or centrally-run city proposes that the People's Council of the same level consider and decide on arranging commune, ward, and township veterinary staff (hereinafter referred to as commune veterinary staff) according to the provisions of Clause 2, Article 6 of the Veterinary Law.

2. Commune veterinary staff are entitled to allowances and health insurance according to the provisions of Clause 3, Article 1 of Decree No. 29/2013/NĐ-CP dated April 8, 2013, of the Government amending and supplementing certain Articles of Decree No. 92/2009/NĐ-CP dated October 22, 2009, of the Government on the titles, quantity, and some regimes and policies for officials and civil servants at the commune, ward, and township levels, as well as for non-specialized activists at the commune level, and are entitled to social insurance in accordance with the provisions of the 2014 Social Insurance Law.

3. Commune veterinary staff are trained and fostered according to the provisions in Clause 1 Article 15 of Decree No. 92/2009/NĐ-CP dated October 22, 2009, of the Government regarding the titles, number, and certain regimes and policies for officials, civil servants in communes, wards, towns, and non-professional individuals at the commune level.

Section 2. FUNDING FOR ANIMAL DISEASE PREVENTION AND CONTROL

Section 3. TEMPORARY SUSPENSION OF EXPORTS AND IMPORTS; PROHIBITION OF EXPORT AND IMPORT OF ANIMALS AND ANIMAL PRODUCTS

Article 6. Funding for animal disease prevention and control

1. The funding for animal disease prevention and control is implemented according to the provisions in Clause 2, Article 23 of the Law on Veterinary Medicine.

2. Use of funding for animal disease prevention and control:

a) State budget:

The central budget allocates funds to ministries and central agencies according to the provisions of the Law on State Budget.

Local budgets allocate funds for animal disease prevention and control in the locality. In cases where the funding for animal disease prevention and control exceeds the local budget's balancing capacity, the Provincial People's Committee shall report in writing and send 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 Medicine.

b) Funding from animal owners, livestock farms, and aquaculture facilities

The costs for preventing and controlling epidemics, apart from financial support from the state budget, and funding from organizations and individuals both domestically and internationally.

c) Contributions and sponsorships from organizations and individuals both domestically and internationally shall be implemented in accordance with the provisions of the Law on State Budget, guiding documents of the Law on State Budget, and other relevant legal regulations.

3. Expenditures from the state budget include:

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

b) Procurement of means, equipment, veterinary drugs (vaccines, disinfectants), and expenses for participants in animal disease prevention and control;

c) Surveillance activities, sampling, testing; monitoring, environmental warning in breeding areas; assessing the risk of animal diseases;

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

đ) Support for establishing animal disease-safe zones;

e) Support for damages caused by animal epidemics or due to the need to apply mandatory handling measures as required by competent state authorities and treatment costs;

g) Support to restore livestock and aquaculture environments;

4. Levels of support from the state budget:

a) The level of support for damages caused by animal epidemics, support for damages due to the requirement to apply animal handling measures as requested by the competent state authority shall be implemented in accordance with current regulations.

For content that does not yet have regulations on the level of support, the Ministry of Finance shall take the lead, in coordination with the Ministry of Agriculture and Rural Development, to submit to the Prime Minister for decision in accordance with point b, clause 2 of Article 27 and clause 3 of Article 30 of the Veterinary Law; the provincial People's Committee shall submit to the provincial People's Council to decide on the appropriate level of support in line with the local budget capacity.

b) Level of support for the recovery of livestock and aquaculture environment

Based on the ability to balance the budget, the guidance of the Ministry of Agriculture and Rural Development, and the actual requirements at the local level, the provincial People's Committee shall submit to the provincial People's Council for a decision on the level of support appropriate to the local budget capacity.

Article 7. Temporary suspension of export and import of animals and animal products

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

a) Animals and animal products that are at risk of carrying objects subject to animal quarantine, animal products, or objects subject to veterinary hygiene inspection according to the regulations of the importing country and have not yet undergone thorough veterinary hygienic treatment;

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

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

a) Animals and animal products originating from countries or territories that have animal disease outbreaks listed in Vietnam's List of animal diseases requiring epidemic announcement or the List of zoonotic diseases or newly emerging infectious agents;

b) Animals and animal products originating from countries or territories found to be infected with animal quarantine objects, animal products, or veterinary hygiene inspection objects of Vietnam that have been warned by the Department of Animal Health but do not comply with Vietnam's regulations;

c) Animals and animal products originating from countries or territories with a high risk of carrying animal quarantine subjects, animal products, or objects subject to Vietnam's veterinary inspection that have not yet undergone thorough treatment.

Article 8. Conditions for continuing the export and import of animals and animal products

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

a) Animals and animal products that do not carry animal quarantine subjects, animal products, or objects subject to veterinary inspection and have applied measures to ensure veterinary hygiene requirements according to the requirements of the importing country;

b) Animals and animal products that have been inspected, monitored, and confirmed for effective implementation of remedial measures for causes of violations as required by the importing country.

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

a) Animals and animal products temporarily suspended from import as specified in point a, clause 2, Article 7 of this Decree are allowed to be imported into Vietnam when the competent authority of the exporting country confirms that the epidemic or new infectious disease agents have been controlled and has applied measures to ensure there is no longer a risk of spreading the disease according to Vietnam's requirements;

b) Animals and animal products as specified in point b, clause 2, Article 7 of this Decree are allowed to be imported into Vietnam when the competent authority of the exporting country provides a report determining the cause of infection of the quarantined animal or animal product, or veterinary hygiene inspection object, and has applied thorough remedial measures;

c) Animals and animal products specified in point c, clause 2, Article 7 of this Decree are allowed to be imported into Vietnam when inspected, supervised, confirmed remedied, and ensured no longer posing a high risk by the competent authority of the exporting country.

Article 9. Prohibition of exporting and importing animals and animal products

1. It is prohibited to export animals and animal products infected with animal quarantine objects, animal products, or objects subject to veterinary hygiene inspection without treatment measures, or if treatment measures are applied but do not meet the regulations of the importing country.

2. It is prohibited to import animals and animal products in the following cases:

a) Animals and animal products originating from countries or territories carrying pathogens listed in the Vietnamese list of notifiable animal diseases or the list of zoonotic diseases or newly emerging infectious agents; having the potential to spread disease to domestic animals and affect human health;

b) Imported animals and animal products for which importation has been temporarily suspended but remedial measures have not been applied, or remedial measures have been applied but still fail to meet Vietnamese regulations.

Article 10. Regulations on the temporary 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 identify the types of animals and animal products that must be temporarily suspended or banned from export or import; the reasons for temporarily suspending or banning export or import for a certain country or territory, and report to the Minister of Agriculture and Rural Development.

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

3. The decision to temporarily suspend or ban the export or import of animals and animal products must specifically specify the following contents:

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

b) The name of the country or territory from which the animals or animal products are exported to Vietnam or imported from Vietnam;

c) Reasons for temporarily suspending or prohibiting export and import (including both legal and scientific bases).

4. The temporary suspension or prohibition of the export and import of animals and animal products takes effect from the date of the decision; it must be publicly announced through mass media and notified to the relevant Vietnamese authorities, as well as the competent authorities of the exporting country or territory.

Article 11. Regulations on the continuation of the export and import of animals and animal products

1. Based on the provisions of Article 8 of this Decree, the Department of Animal Health inspects, supervises, and confirms the effective implementation of remedial measures and reports to the Minister of Agriculture and Rural Development.

2. The Minister of Agriculture and Rural Development, based on the report of the Department of Animal Health, shall consider and decide on allowing the continuation of the export and import of animals and animal products; immediately announce the decision through mass media and notify the relevant agencies of Vietnam, as well as the competent authorities of the exporting or importing country or territory.

Section 4. CONDITIONS FOR PRODUCTION, TRADE, AND IMPORT,

TESTING, TRIAL 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 Veterinary Medicine; fire prevention and fighting laws; environmental protection laws; occupational safety and hygiene laws and meet the following conditions:

1. Location:

a) Must be isolated from residential areas, public works, hospitals, veterinary clinics, animal disease diagnostic facilities, and other sources of pollution;

b) Not contaminated from the external environment;

c) Does not affect the surrounding environment.

2. Factory:

a) Must be designed to suit the scale and type of medicine produced, prevent flooding, moisture penetration, and intrusion by insects and other animals; should be located to separate sources of contamination from outside;

b) Use materials with a solid structure, suitable, ensuring labor and production safety;

c) Floors should be elevated, surfaces smooth, without cracks, non-slip, impermeable or without water accumulation, easy to clean, disinfect, and detoxify;

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

e) Have an appropriate lighting system;

f) Have a system for supplying and treating clean water to ensure production; have a drainage system, wastewater treatment, and waste management ensuring veterinary hygiene requirements and compliance with environmental protection laws;

g) Have fire alarm and firefighting systems; ensure emergency exits for people as regulated.

3. Storage areas for raw materials, auxiliary materials, and finished drugs must have an area suitable for the scale of production and ensure the following conditions:

a) There is a separate warehouse to store raw materials, auxiliary materials, and finished drugs;

b) There is a separate external warehouse to store solvents and flammable raw materials;

c) Avoid flooding, moisture penetration, and the intrusion of insects and other animals;

d) Floors are elevated, not absorbing or accumulating water;

e) Have an appropriate lighting system;

e) There is a fire alarm and firefighting system; escape routes for people according to the provisions of the law on fire prevention and fighting;

g) There are racks and shelves for raw materials, auxiliary materials, packaging, and finished medicines; there are equipment and means to ensure storage conditions.

4. Equipment and tools must be arranged and installed appropriately to the scale and type of medicine production; have operating instructions; have maintenance plans; have a sanitation procedure and ensure hygiene requirements are met, preventing contamination or cross-contamination between products.

5. Veterinary Drug Quality Control:

a) The quality control area must be separated from the production area; it should be arranged appropriately to prevent cross-contamination; areas conducting biological or microbiological tests;

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

c) There must be sufficient and appropriate equipment.

Article 13. Conditions for facilities producing veterinary medicinal products and vaccines

In addition to the conditions specified in Article 12 of this Decree, facilities producing veterinary medicinal products and vaccines must apply good manufacturing practices for medicines of the Association of Southeast Asian Nations (GMP - ASEAN) or good manufacturing practices of the World Health Organization (GMP - WHO) or equivalent good manufacturing practices that are not lower than (GMP - ASEAN).

Article 14. Procedures for granting the Certificate of Good Manufacturing Practices for veterinary drugs (GMP)

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

Amended and supplemented provisions:

a) GMP inspection application form;

Provisions repealed

b) Enterprise registration certificate;

Amended and supplemented provisions:

c) Organization chart and personnel of the establishment;

Amended and supplemented provisions:

d) Program, training documents, and assessment of GMP training results at the facility;

Amended and supplemented provisions:

dd) List of production, storage, and quality inspection equipment;

Amended and supplemented provisions:

e) List of standard operating procedures;

Amended and supplemented provisions:

f) List of items currently being produced or planned to be produced;

g) Environmental impact assessment report approved by the state management agency on environment;

Amended and supplemented provisions:

h) GMP self-inspection minutes;

Provisions repealed

k) Newly established facilities registering for GMP inspection must also submit the manufacturing practice certificate of the technical manager and the person in charge of the veterinary drug testing laboratory.

The GMP inspection registration file must have a cover page and a table of contents, arranged according to the order in the table of contents, with separation between sections.

2. Processing time:

Amended and supplemented provisions:

a) Within 10 days from the date of receiving the registration file, the Department of Animal Health shall appraise the file and request amendments or additions if the file does not meet the requirements;

b) Within 30 days from the date of receiving a complete and valid dossier, the Department of Animal Health shall issue a decision to establish a GMP inspection team, simultaneously notifying the inspection schedule to the facility and conducting the inspection;

c) Within 10 days from the end of the inspection, if the facility meets the requirements, the Department of Animal Health shall issue a GMP Certificate; if the facility does not meet the requirements, it must respond in writing and clearly state the reasons for non-compliance.

3. Inspection process:

a) When being inspected for GMP, establishments must report using diagrams, charts, and brief data on operational status and the implementation of GMP application;

b) During GMP inspection, activities must be ongoing;

c) Inspect all activities of the veterinary drug manufacturing establishment according to GMP, the establishment’s registration dossier, and current professional regulations.

4. Handling inspection results:

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

b) For establishments that meet the GMP conditions but still have some deficiencies that can be remedied in a short time, the inspection team requires the establishment to correct and repair them. Within 02 (two) months from the date of inspection, the establishment must remediate and repair the deficiencies and send a written report on the results to the Department of Animal Health. The Head of the Inspection Team will review and recommend that the Director of the Department of Animal Health issue the GMP Certificate to the establishment that meets the requirements;

c) For establishments that do not meet the GMP conditions, they must remedy and repair the existing deficiencies. After self-assessment, if they meet the GMP conditions, the establishment proceeds to redo the registration dossier as prescribed.

5. The validity period of the GMP Certificate is 5 years. Within 3 months prior to the expiration date of the GMP Certificate, organizations or individuals wishing to continue veterinary drug production must submit an application for the renewal of the Certificate. Facilities that have been issued a GMP Certificate are not required to undergo the procedure for obtaining a Certificate of eligibility for veterinary drug production.

Article 15. Procedures for renewing the GMP Certificate

Amended and supplemented provisions:

1. The dossier for applying for the renewal of the GMP Certificate includes:

a) Application for GMP re-inspection;

b) Activity report and changes of the facility over the 5 years of GMP implementation;

c) Report on addressing deficiencies from the previous inspection;

d) Report on the training and education of the facility;

e) Inventory of existing equipment of the facility;

f) List of products currently being manufactured;

g) List of standard operating procedures.

g) Environmental impact assessment report approved by the state management agency on environment;

i) Minutes of self-inspection and evaluation of the facility during the most recent self-inspection (within 03 months) regarding GMP implementation.

2. Time limit for resolution, inspection process, handling of inspection results, validity of the GMP Certificate as prescribed in Clause 2, Clause 3, Clause 4, and Clause 5 of Article 14 of this Decree.

Article 16. Procedures and formalities for re-issuance and revocation of the GMP Certificate

Amended and supplemented provisions:

1. Dossier, order, and procedures for re-issuing the GMP Certificate in cases of loss, errors, damage; changes in information related to the registering organization:

a) The dossier for re-issuing the GMP Certificate includes: an application for re-issuance; documents proving the content of changes in case of changes in information related to the registering organization; the previously issued GMP Certificate, except in cases of loss;

b) Organizations or individuals submit the dossier for re-issuing the GMP Certificate to the Department of Animal Health; within 5 working days from the date of receiving a complete and valid dossier, the Department of Animal Health re-issues the GMP Certificate; in case of refusal, a written response must be provided clearly stating the reason.

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

a) The GMP Certificate is erased or its content is altered;

b) Violation of the law that results in being administratively sanctioned three times or more within one year, or being administratively sanctioned three consecutive times for the same violation in the field of veterinary drug production;

c) No longer engaged in veterinary drug production;

d) Having other violations for which the law requires the revocation of the GMP Certificate.

The Minister of Agriculture and Rural Development shall guide the dossiers for the issuance of extensions, revocation, changes, and supplementation of the GMP Certificate.

Article 17. Conditions for trading veterinary drugs

Organizations and individuals trading veterinary drugs must comply with the provisions of Article 92 of the Law on Veterinary Medicine and meet the following conditions:

1. Have a fixed business location and signage.

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

3. Have equipment ensuring the conditions for drug preservation as prescribed.

4. Have books, invoices, and documents for tracking imports and exports of goods.

5. For businesses trading vaccines and biological products, they must have refrigerators, cool cabinets, or cold storage to preserve according to the storage conditions stated on the label; thermometers must be available to check the storage conditions. There should be a backup generator, equipment, and transportation means for distributing vaccines.

Article 18. Conditions for importing veterinary drugs

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

1. Have a warehouse that ensures the conditions specified in Clause 3, Article 12 of this Decree.

2. Have appropriate equipment such as ventilation fans, air conditioning systems, thermometers, and hygrometers to ensure proper storage conditions.

3. Must have a system of records and standard operating procedures to ensure the preservation, control, and monitoring of veterinary drug import and export.

4. For vaccine and biological product importing establishments, they must have a separate storage, a backup generator, equipment, and means of transportation that ensure the storage conditions indicated on the product label during transportation and distribution.

Article 19. Conditions for veterinary drug testing establishments

Veterinary drug testing establishments must comply with the provisions in Clause 3, Article 101 of the Law on Veterinary Medicine and meet the following conditions:

1. Locations separated from residential areas and public works.

2. Facilities meeting biosafety requirements, ensuring the testing of microbiological indicators; having clean rooms for analyzing physicochemical indicators.

3. Equipped with machinery and tools to ensure accurate sampling, analysis, calibration, and data processing. Analytical equipment must comply with testing methods and meet quality control requirements according to current standards and regulations.

4. Has facilities for housing experimental animals; a separate toxicity testing area for vaccines and microorganisms; for testing vaccines containing highly pathogenic agents, there must be an animal housing room ensuring biosafety.

5. Has a system for treating waste and wastewater, ensuring veterinary hygiene and environmental sanitation; has a separate area to handle experimental animals used for testing vaccines and microorganisms.

6. Has specialized equipment for maintaining microorganism strains to serve testing purposes.

Article 20. Conditions for veterinary drug experimental facilities

Veterinary drug testing facilities must comply with the provisions of Article 88 of the Veterinary Law and meet the following conditions:

1. Livestock and aquaculture facilities meet the following conditions:

a) The location is suitable with the local land use planning or is permitted by the competent authority;

b) There is a fence or surrounding wall to ensure prevention of people and animals from entering the facility;

c) Have a source of clean water;

d) Have sufficient space in barns, ponds, and tanks to accommodate animals and ensure the results of the experiments;

đ) Have sufficient types and numbers of animals to meet the requirements of the experiments; have separate areas for raising experimental animals, with a system for handling waste, wastewater, animal carcasses, and specimens to ensure veterinary hygiene and environmental sanitation;

e) The place for producing, processing, and storing animal feed must be separated from the place for storing hazardous chemicals and have measures to prevent insects and harmful animals;

g) The area for animal pens, ponds, and tanks must have a separate place for storing feed and be designed to meet preservation requirements.

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

Section 5. CONDITIONS FOR PRACTICING VETERINARY MEDICINE

Article 21. Conditions for practicing veterinary medicine

Organizations and individuals practicing veterinary medicine must meet the conditions stipulated in Article 108 of the Veterinary Law and must meet the following professional requirements:

1. Practitioners who diagnose, treat, perform surgery on animals, or provide consultation on activities related to the veterinary field must have at least an intermediate diploma in veterinary medicine, animal husbandry and veterinary medicine, or an intermediate diploma in aquaculture and aquatic animal diseases for practicing aquatic veterinary medicine. Individuals who perform vaccinations on animals must have a graduation certificate from a training course in techniques issued by the provincial-level competent state agency.

2. The technical person in charge of an animal surgery facility, disease diagnosis, veterinary examination, or animal disease testing must have a university degree or higher in veterinary medicine, animal husbandry and veterinary medicine, or aquaculture and aquatic animal diseases for practicing aquatic veterinary medicine.

3. Individuals selling veterinary drugs must have at least an intermediate diploma in veterinary medicine, animal husbandry and veterinary medicine, or an intermediate diploma in aquaculture and aquatic animal diseases for practicing aquatic veterinary medicine.

4. The person in charge of technical matters at the veterinary drug testing, export, and import facility is regulated as follows:

a) Experimental, export, and import facilities for veterinary drugs for terrestrial animals must have a university degree or higher in veterinary medicine, animal husbandry and veterinary, pharmacy, pharmaceutics, chemistry, or biology;

b) Experimental, export, and import facilities for veterinary drugs for aquatic animals must have a university degree or higher in aquaculture, aquatic pathology, pharmacy, pharmaceutics, chemistry, or biology.

5. The technical person in charge of a veterinary drug production and testing facility is regulated as follows:

a) Facilities producing and testing drugs used in veterinary medicine for terrestrial animals must have a university degree or higher in veterinary medicine, pharmacy, or pharmaceutics; for aquatic animals, a university degree or higher in aquaculture, aquatic pathology, pharmacy, or pharmaceutics is required.

b) Production facilities and laboratories for testing drugs such as vaccines, biological products, microorganisms, and chemicals used in veterinary medicine for terrestrial animals must have a university degree or higher in veterinary medicine, animal husbandry and veterinary, pharmacy, bachelor's degree in pharmaceutical chemistry, chemistry, or biology; for veterinary medicine used for aquatic animals, they must have a university degree or higher in aquaculture, aquatic pathology, biology, pharmacy, bachelor's degree in pharmaceutical chemistry, or chemistry.

Article 22. Veterinary Practice Certificate

1. The veterinary practice certificate is granted to organizations and individuals who meet the conditions for practice as prescribed in Article 108 of the Veterinary Law, Article 21 of this Decree, and the dossier as stipulated in Clause 2 and Clause 5 of Article 109 of the Veterinary Law.

2. The contents of the veterinary practice certificate include:

a) Full name, date of birth;

b) Residential address;

c) Professional degree;

d) Type of practice;

e) Location.

Issued together with this Decree is an Appendix on the template for the Veterinary Practice Certificate and the Application Form for Issuance of Veterinary Practice Certificate.

3. The use of the veterinary practice certificate is regulated as follows:

a) Veterinary practice certificates for vaccination, diagnosis, treatment, animal surgery, and consultation on activities related to the veterinary field are used nationwide. The issuing authority does not enter the practice location in the certificate;

b) Veterinary practice certificates of technical managers at establishments performing animal surgery, medical examination, disease diagnosis, animal disease testing, and veterinary drug trading are used within the province or centrally governed city;

c) Veterinary practice certificates of technical managers at establishments producing, testing, trialing, exporting, and importing veterinary drugs are used nationwide.

Chapter III. IMPLEMENTATION PROVISIONS

Article 23. Effective date

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 the implementation of certain articles of the Veterinary Ordinance; 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. Responsibilities for implementation

Ministers, heads of ministerial-level agencies, heads of government agencies, chairpersons of provincial and centrally-run city People's Committees, and relevant agencies are responsible for implementing this Decree./.

APPENDIX I

SAMPLE VETERINARY PRACTICE CERTIFICATE

(Attached with Decree No. 35/2016/NĐ-CP dated May 15, 2016, of the Government)

APPENDIX II

SAMPLE VETERINARY PRACTICE CERTIFICATE

(Attached with Decree No. 35/2016/NĐ-CP dated May 15, 2016, of the Government)

APPENDIX III

APPLICATION FORM FOR VETERINARY PRACTICE CERTIFICATE

(Attached with Decree No. 35/2016/NĐ-CP dated May 15, 2016, of the Government)

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

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REGISTRATION FORM

FOR VETERINARY PRACTICE CERTIFICATE

To: Department of Veterinary Medicine

My name is: ……………………………………………………………………………………….

Date of birth: …………………………………………………………………………

Permanent address: …………………………………………………………………………….

Professional qualification: ………………………………………………………………………..

Date of issue: ……………………………………………………………………………………….

Hereby request Your agency to issue a Practice Certificate for:

□ 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: …………………………………………………………………..

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

Practice address: …………………………………………………………………………….

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

I hereby commit to strictly comply with the laws and regulations of the veterinary sector.

(Note: If the individual requests a veterinary practice certificate for production and export, import, mark both the production and export, import boxes. Submit 02 photographs sized 4x6 cm)

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

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REGISTRATION FORM

EXTENSION OF VETERINARY PRACTICE CERTIFICATE

To: Department of Veterinary Medicine

My name is: ……………………………………………………………………………………….

Date of birth: …………………………………………………………………………

Permanent address: ……………………………………………………………………………

Has been issued a 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: ………………………………………………………………………………………..

Hereby requests your esteemed Department to extend the above veterinary practice certificate.

Attached are the expired veterinary practice certificate and 02 photographs sized 4x6 cm.

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

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REGISTRATION FORM

FOR VETERINARY PRACTICE CERTIFICATE

To: Sub-department……

My name is: ……………………………………………………………………………………….

Date of birth: …………………………………………………………………………

Permanent address: ……………………………………………………………………………..

Professional qualification: ……………………………………………………………………….

Date of issue: ……………………………………………………………………………………….

Hereby request Your agency to issue a Practice Certificate for:

□ Vaccination, disease treatment, minor surgery (castration, tail docking) of animals, consulting on activities related to the veterinary field.

□ Medical examination, disease diagnosis, animal surgery, animal disease testing.

□ Trading veterinary drugs used for terrestrial animals.

□ Trading veterinary drugs used for aquatic animals.

At: …………………………………………………………………………………………………..

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

Practice address: ………………………………………………………………………………..

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

I hereby commit to strictly comply with the laws and regulations of the veterinary sector.

(Note: Submit 02 photos sized 4x6)

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

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REGISTRATION FORM

RENEWAL OF VETERINARY PRACTICE CERTIFICATE

To: Department of Animal Health

My name is: ……………………………………………………………………………………….

Date of birth: …………………………………………………………………………

Permanent address: ……………………………………………………………………………

Professional degree: ………………………………………………………………………

Has been granted a Veterinary Practice Certificate by the Department of …:

□ Vaccination, disease treatment, minor surgery (castration, tail docking) of animals, consulting on activities related to the veterinary field.

□ Medical examination, disease diagnosis, animal surgery, animal disease testing.

□ Trading veterinary drugs used for terrestrial animals.

□ Trading veterinary drugs used for aquatic animals.

At:…………………………………………………………………………………………………..……………………………………………………………………………………………………

Certificate number: ………………………………………………………………………………..

Date of issue: ………………………………………………………………………………………..

Today, we propose that the Department extend the above professional practice certificate.

Attached are the expired veterinary practice certificate and 02 photographs sized 4x6 cm.