/ SOCIALIST REPUBLIC OF VIETNAM
Independence-Freedom- Happiness
No: 35/2016/NĐ-CP / Hà Nội, 15 May 2016
DECREE
Stipulating details of some articles of the Animal Health Law
Pursuant to the Law on the Organizationof the Government dated 19 June 2015;
Pursuant to the Animal Health Law dated 19 June 2015;
Pursuant to the Investment Law dated 26 November 2014;
Upon requests by the Minister of Agriculture and Rural Development,
The Government promulgates Decree stipulating details of some articles of the Animal Health Law.
ChapterI
GENERAL REGULATIONS
Article 1. Scope of adjustment
This Decree stipulates details and provide guidance on the implementation of some articles of the Animal Health Law, specifically as follows:
1. The animal health management agencies network and mechanism and policies for animal health workers in communes, wards, towns.
2. Funding for prevention and control of animal diseases.
3. Temporary halt of import and export of and ban of export and import of animals and animal products.
4. Requirements for production, trading, import, testing and experimenting veterinary medicine; regulations on good manufacturing practices in the production of veterinary medicine.
5. Requirements for veterinary practices.
Article 2. Subjects of application
This Decree applies to domestic agencies, organisations and individuals and foreign agencies, organisations and individuals that involve in veterinary activities in Viet Nam.
Article 3. Explanation of terms
In this Decree, the following terms are understood as follow:
1. Good Manufacturing Practice(GMP) in production of veterinary medicine: are principles, regulations, guidelines on the requirements for production of medicine to ensure the quality of the medicine.
2. GMP-WHO are Good Manufacturing Practices issued by the World Health Organization(WHO) which consist of Good Manufacturing Practice(GMP), Good Laboratory Practice (GLP), Good Store Practice (GSP).
3. GMP-ASEAN are Good Manufacturing Practices issued by the Association of the South East Asian Nations (ASEAN).
Chapter II
SPECIFIC REGULATIONS
Section 1
THE ANIMAL HEALTH MANAGEMENT AGENCIES NETWORK AND MECHANISM AND POLICIES FOR ANIMAL HEALTH WORKERS IN COMMUNES, WARDS AND TOWNS
Article4.The animal health management agencies network
- At central level:
Department of Animal Healthunder theMinistry of Agriculture and Rural Development’s functions are to advice and help theMinister of Agriculture and Rural Developmentin State management of and making arrangements in carrying out legal regulations in the field of animal diseases prevention and control; quarantine of animals and animal products; control of animal slaughtering, preliminary treatment and processing of animal and animal products; examining veterinary hygiene; management of veterinary medicine; carrying out veterinary work throughout the country.
2. In localities:
a) The sub-department in charge of veterinary management is under the Department of Agriculture and Rural Development of provinces and centrally-governed cities (hereafter referred to as provincial veterinary management agency), helping the director of the Department in providing advice to the provincial People’s Committee in its performance of such functions as State management and law enforcement in the prevention, control and treatment of animal diseases; quarantine of animals and animal products; control of animal slaughtering, preliminary treatment and processing of animals and animal products; examination of veterinary sanitation and hygiene; management of veterinary medicine; veterinary practices in the provinces and centrally-governed cities. The sub-department is under professional instruction from Department of Animal Health;
b) Station under the sub-department with veterinary management function, located in district/town/provincial city and equivalent administrative unit (hereafter referred to as veterinary management agency at district level) is responsible for carrying out its assigned tasks in the district and coordinating with the district’s Agriculture and Rural Development Division or Economic Division to help thePeople’s Committee of district levelin its State management in the field of prevention, control and treatment of animal diseases; quarantine of animals and animal products; control of animal slaughtering, preliminary treatment and processing of animals and animal products; examination of veterinary sanitation and hygiene; management of veterinary medicine; veterinary practices in the locality of district level.
Article5. Mechanism and policies for animal health workers in communes, wards, towns
1.Based on the requirements for veterinary activities in the locality and the local capability of resources balance, the People’s Committees of provinces and centrally-governed cities may request the People’s Council of the equivalent level to consider and make decision on the arrangement of animal health workers for communes, wards and towns (hereafter referred to as commune animal health workers) in accordance with regulations stipulated in Provision2 Article 6 of the Animal Health Law.
2. Commune animal health workers are entitled to allowances and health care insurance regulations stipulated in Provision3 Article 1 of Decree No 29/2013/NĐ-CP dated 08 April 2013 of the Government on amendments and supplements to some articles of Decree No 2/2009/NĐ-CP dated 22 October 10 2009 of the Government on titles and quantity regarding certain regulations and policies for staff, civil servants in communes, wards, towns and those part-time people at commune level and enjoy health care insurance policy as stipulated in Social Insurance Law 2014.
3. Commune animal health workersare trained as per regulations stipulated in Provision1 Article 15 of Decree No 92/2009/NĐ-CP dated 22 October 2009 of the Government on titles and quantity regarding certain regulations and policies for staff, civil servants in communes, wards, towns and those part-time people at commune level.
Section 2
BUDGET FOR PREVENTION AND CONTROL OF ANIMAL DISEASES
Article 6. Budget for prevention and control of animal diseases
1. The budget sources for prevention and control of animal diseases are implemented in accordance with regulations stipulated in Provision2 Article 23 of the Animal Health Law.
2. Utility of budget for prevention and control of animal diseases:
a) State budget:
The central budget is allocated to Ministries, central agencies in accordance with regulations of the State Budget Law.
Budget for prevention and control of animal diseases in the locality is allocated from the local budget; in case the budget for prevention and control of animal diseases in the locality exceeds the local budget balance capability, the provincial People’s Committee is requested to report, in written form, to the Ministry of Agriculture and Rural Development, the Ministry of Finance for submission to the Prime Minister for consideration and decision in accordance with regulations at Point d Provision3 Article 27 of the Animal Health Law.
b)Budget of livestock owners:
Expenses for prevention and control of diseases that are not from the State budget source, financial assistance from domestic and foreign individuals and organizations.
c) Financial contributions, sponsorship from domestic and foreign individuals and organizations are used in accordance with the State Budget Law, documents that provides guidance to the implementation of the State Budget Law and other relevant legal regulations.
3. State budget is allocated for the following content:
a) Propagandize, popularize, train and make arrangements for the prevention and control of animal diseases;
b) Purchase facilities, equipments, veterinary medicine (vaccines, disinfectants) and labor costs for those taking part in the prevention and control of animal diseases;
c) Surveillance, sample taking and testing activities; breeding environmental monitoring and warning; assessment of animal diseases risks;
d) Predict, warn animal diseases; investigate and study animal diseases;
đ) Assistance for the establishment of animal disease-free zones;
e) Assistance to the loss caused by animal diseases or by the application of compulsory measures of treatment at the request by the State competent agencies and the treatment costs;
g) Assistance to recover livestock production and aquaculture environment;
4. Levels of assistance from the State budget:
a) The levels of assistance to the loss caused by animal diseases or by the application of compulsory measures of treatment at the request by the State competent agencies are implemented in accordance with current regulations.
For those contents without regulations of assistance levels, the Ministry of Finance is assigned, in coordination with the Ministry of Agriculture and Rural Development, to submit to the Prime Minister to issue the decisions in accordance with regulations in Point b Provision 2 Article 27 andProvision3 Article 30 of theAnimal Health Law; Provincial People’s Committee is responsible for submitting to the Provincial People’s Council to decide the suitable levels of assistance in conformity with the local budget capacity.
b) Levels of assistance for the recovery of livestock production and aquaculture environment.
Based on the capability of budget balance, guidance from the Ministry of Agriculture and Rural Development and the actual demands of the locality, Provincial People’s Committee is responsible for submitting to the Provincial People’s Council to decide the suitable levels of assistance in conformity with the local budget capacity.
Section 3
TEMPORARY HALT OF IMPORT, EXPORT; BAN OF IMPORT, EXPORT OF ANIMALS AND ANIMAL PRODUCTS
Article7. Temporary halt of import, export of animals and animal products
1. Export of animals and animal productsis temporarily halted in the following cases:
a) Animals, animal products are liable to carrying subjects for animal and animal products quarantine or subjects for animal health hygienic examination according to regulations of the import countries and have yet been thoroughly treated in animal health hygiene.
b) Animals, animal productsfor export that violate regulations of the import countries; have been warned by import countries and have not had measures to thoroughly overcome the shortcomings that lead to violations and threaten to lose Vietnam’s export markets.
2. Import of animals and animal productsis temporarily halted in the following cases:
a) Animals, animal productsfrom countries and territories where there are animal diseases which are in the List of Animal Diseases that Required Disease Announcement or in the List of Zoonosis or new infectious disease agents;
b) Animals, animal productsfrom countries and territorieswhich are found to be infected by subjects of animals, animal productsquarantine or subjects of animal health hygienic examination of Viet Nam, have been warned by the Department of Animal Healthbut fail to meet Viet Nam’s regulations;
c) Animals, animal productsfrom countries and territories with high risk of carrying along subjects for animal and animal products quarantine or subjects for animal health hygienic examination according to Viet Nam’s regulations and have yet been thoroughly treated.
Article 8. Requirements for continued import, export of animals, animal products
1. Requirementsto resume import, export of animals, animal products:
a) Animals, animal productswithout risks of carrying along subjects for animal and animal products quarantine or subjects for animal health hygienic examination and have been applied with measures to meet veterinary requirements as requested by the import countries;
b)Animals, animal products that have been inspected, monitored, certified for implementation of measures to overcome the shortcomings that lead to violations as requested by the import countries.
2. Requirements to resume import of animals, animal products:
a) Animals, animal productsthat are temporarily halted from import in accordance with regulations in Point a Provision 2Article7 of this Decree are permitted to be imported to Viet Nam provided that the competent authorities of the export countries certify that the diseases or new infectious agents have been controlled and measures have been applied to ensure that there are no risks of disease transmission according to Viet Nam’s requirements;
b) Animals, animal productsstipulated in Point b Provision 2 Article7 of this Decree are permitted to be imported to Viet Nam provided that the competent authorities of the export countries have had reports identifying the reasons for infection of subjects for animal and animal products quarantine or subjects for animal health hygienic examination and measures have been applied for thorough treatment.
c) Animals, animal productsstipulated in Point cProvision 2 Article7 of this Decree are permitted to be imported to Viet Nam provided the competent authorities of the export countries have inspected, monitored, certified for overcoming shortcomings and ensured of no high risks.
Article 9. Ban of import, export of animals, animal products
1. Exports of animals, animal productswith subjects for animal and animal products quarantine or subjects for animal health hygienic examination without any measures of treatment or measures have been applied but fail to meet the requirements by the import countries will be banned.
2. Imports of animals, animal products will be banned as per the following cases:
a) Animals, animal products originating from countries and territories with disease agents in the List of Animal Diseases that Required Disease Announcement or in the List of Zoonosis or new infectious disease agents; having risks of spreading diseases to domestic livestock, affecting the health of the local people.
b) Animals, animal products that have been temporarily halted from exports and still fail to apply measures to overcome shortcomings, or measures have been applied by fail to meet Viet Nam’s regulations;
Article10. Regulations for temporary halt or ban of import, export of animals, animal productsthat require quarantine
1. Based on the regulations in Article7and Article9of this Decree, theDepartment of Animal Healthis responsible for identifying specifically the type of animals, animal products that are temporarily halted or banned from imports, exports; the reasons for the temporary halt or ban of import, export for certain countries and territories and report to the Minister of Agriculture and Rural Development.
2. The Minister of Agriculture and Rural Development, based on the reports from the Department of Animal Health, considers and decide on temporary halt or ban of import, export of animals, animal products.
3. Decision on the temporary halt or ban of import, export of animals, animal productsmust include the following details:
a) Names of the animals, animal products(including scientific names);
b) Names of the countries or territories where the animals, animal products are exported to Viet Nam or imported from Viet Nam;
c) Reasons for temporary halt or ban of import, export (including scientific and legal basis).
4. The temporary halt or ban of import, export of animals, animal products since the decision becomes effective; announce immediately on mass media and relevant Vietnamese agencies as well as the competent agencies of the export countries or territories.
Article 11. Regulations for resuming export, import of animals, animal products
1. Based on regulations in Article8 of this Decree, the Department of Animal Healthinspect, monitor, certify the implementation of measures to overcome shortcomings and reports to the Minister of Agriculture and Rural Development.
2. The Minister of Agriculture and Rural Development, based on the reports by theDepartment of Animal Health, consider and decide for resuming import, export of animals, animal products;announce the decision immediately on mass media, relevant Vietnamese agencies as well as the competent agencies of the export/import countries or territories.
Section 4
REQUIREMENTS FOR PRODUCTION, TRADE, IMPORT, TEST AND EXPERIMENT VETERINARY MEDICINE
Article12. General requirements for production of veterinary medicine
Organizations, individuals involving in the production of veterinary medicine are requested to follow regulations in Article90 of the Animal Health Law;legal regulations on fire control; legal regulations on environmental protection; legal regulations on labor safety and hygiene and meet the following requirements:
1. Location:
a)Are requested to be separated from residential areas, public works, hospitals, animal health policlinics, establishments for diagnoses of animal diseases, other sources of pollution;
b) Are not polluted from outside environment;
c) Do not affect to the surrounding environment;
2. Facilities:
a) are designed so that they are suitable with the scale as well as the type of medicine to be produced, avoiding inundation, humidity and the penetration of insects and other animals; are separated from sources of pollution from outside;
b) Use of strong, suitable materials, ensuring safety in labor and production;
c) The foundation is high; the floor is smooth without cracks or water stagnation, is not slippery, water-resistant, easy to clean and disinfect;
d) Wall and ceilings are made of durable, strong and easy-to-clean materials;
đ) there is a suitable lighting system;
e) There is a clean water treatment and supply system that meet the production demands; the drainage and waste and liquid waste treatment system meets the veterinary hygienic requirements in accordance with legal regulations on environmental protection;
g) There is a fire warning, fire-fighting system; and emergency exits for people according to legal regulations.
3. Storehouse for raw materials, accessories, medicine finished products are requested to have sufficient areas corresponding to the production scale and must meet the following requirements:
a) Separate storehouse for raw materials, accessories, medicine finished products;
b) Separate storehouse outside for solvent and inflammable materials;
c) Avoiding inundation, humidity and penetration of insects and other animals;
d) Foundation and floor is high, water-resistant without water stagnation;
đ) There is a suitable lighting system;
e) There is a fire warning, fire-fighting system; and emergency exits for people according to legal regulations on fire prevention and control.
g) There are shelves for storing raw materials, accessories, packaging, medicine finished products; there is equipment and facilities that meet storing requirements;
4. Equipment, tools must be arranged, assembled in a suitable way, corresponding to the scale and type of medicine to be produced; with operational guidance; with maintenance plans; with hygienic procedures to ensure hygienic requirements are met without causing pollution or cross-contamination between products.
5. Examination of the quality of the veterinary medicine:
a) Area for quality examination must be separated from the production area; is designed in a suitable manner to avoid cross-contamination; areas for carrying out biological and micro-biological tests;
b) Samples, standard substances must be stored in a separate area with storing requirements ensured;
c) Sufficient equipment are required.
Article 13. Requirements for establishments that produce veterinary medicine in the form of pharmaceutical products, vaccines