State management system of veterinary medicine

Central

The Department of Animal Health is the State management agency for animal health under the Ministry of Agriculture and Rural Development. The Department is responsible for:

a) Preside over the development and submission of national technical regulations on veterinary drugs; promulgate the list of veterinary drugs permitted for circulation, restricted use, and prohibited use according to the provisions of law;

b) Regulations on research, testing, trials, registration procedures, recognition of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine produced and circulated in Vietnam; national technical regulations on veterinary drugs;

List of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine that must be applied and must be certified for quality in accordance with national technical regulations;

Permit the import of veterinary drugs and vaccines not included in the list of those permitted for circulation in Vietnam according to regulations and authorization of the Minister;

Biosafety poultry farming

c) Guiding and handling the registration of circulation, export, import, temporary import for re-export, temporary export for re-import, border transfer, transit, production, testing, processing, bottling, repackaging of veterinary drugs; raw materials for veterinary drugs; biological products; microorganisms; products for environmental treatment and improvement and chemicals used in veterinary medicine (hereinafter referred to as veterinary drugs);

d) Direct, guide, inspect, supervise and carry out testing, experimentation, examination and quality control of veterinary drugs according to the provisions of law;

d) Direct, guide and inspect the implementation of regulations on practice certificates, conditions for trading veterinary drugs and the destruction or return of veterinary drugs to the place of origin. Inspect and issue certificates of eligibility for production and trading of veterinary drugs in accordance with the provisions of law;

e) Inspect and supervise the export, import, temporary import for re-export, temporary export for re-import, border transfer, transit, production, testing, processing, repackaging, circulation, trading and use of veterinary drugs;

g) Check the use of veterinary supplements in animal feed;

h) Submit to the Ministry the establishment and use of national veterinary drug reserves. Provide guidance on the establishment of local veterinary drug reserves, management regimes, and methods of using veterinary drug reserves at the provincial and centrally-run city levels.

Locally

The Veterinary Department is the provincial-level state veterinary management agency responsible for:

a) Organize training, professional development, and legal training for entities trading in veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine; issue veterinary practice certificates; Inspect and issue certificates of eligibility to trade in veterinary drugs according to the provisions of law.

b) Inspect and examine the conditions of establishments trading in veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine; and the destruction and recall of fake veterinary drugs, drugs of unknown origin; expired drugs; drugs of poor quality, prohibited from use, drugs not on the list of drugs permitted for circulation; drugs without labels or drugs with labels that do not comply with the provisions of law;

System of legal documents in the field of veterinary drug management

- Veterinary Ordinance dated April 29, 2004;

- Decree No. 33/2005/ND-CP dated March 15, 2005 of the Government detailing the implementation of a number of articles of the Veterinary Ordinance;

1. Testing and trial of veterinary drugs

- Decision 71/2007/QD-BNN dated August 6, 2007 regulating the order and procedures for testing and examining veterinary drugs;

- Decision No. 18/2002/QD-BTS dated June 3, 2002 of the Minister of Fisheries stipulating the promulgation of Regulations on testing aquatic breeds, feed, drugs, chemicals and biological products used in aquaculture;

- Decision No. 98/2007/QD-BNN dated December 3, 2007 of the Minister of Agriculture and Rural Development on supplementing and amending Decision No. 71/2007/QD-BNN dated August 6, 2007;

- Circular No. 47/2010/TT-BNNPTNT dated August 3, 2010 amending and supplementing a number of provisions on administrative procedures of Decision 71/2007/QD-BNN dated August 6, 2007 according to Resolution 25 of the Government.

2. Production, import and circulation of veterinary drugs

- Decision No. 10/2006/QD-BNN dated February 10, 2006 of the Minister of Agriculture and Rural Development regulating procedures for registration of production, import, and circulation of veterinary drugs, raw materials for veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine;

- Decision No. 99/2007/QD-BNN dated December 3, 2007 of the Minister of Agriculture and Rural Development on amending and supplementing Decision No. 10/2006/QD-BNN dated February 10, 2006;

- Circular No. 20/2011/TT-BNNPTNT dated April 6, 2011 of the Minister of Agriculture and Rural Development on amending, supplementing and abolishing a number of regulations on administrative procedures in the veterinary field according to Resolution 57/NQ-CP dated October 15, 2010.

- Circular No. 03/2009/TT-BNN dated January 14, 2009, Regulations on labeling of veterinary drugs;

- Circular No. 88/2011/TT-BNNPTNT dated December 28, 2011 guiding the implementation of Decree No. 12/2006/ND-CP dated January 23, 2006 of the Government detailing the implementation of the Commercial Law on international trade in goods and agents, purchase, sale, processing and transit of goods with foreign countries in the fields of agriculture, forestry and fisheries.

- Circular No. 08/2012/TT-BNNPTNT dated February 13, 2012 of the Minister of Agriculture and Rural Development regulating procedures for registration of veterinary drug processing production.

3. Production and trading of veterinary medicine

- Circular No. 51/2009/BNNPTNT dated August 21, 2009 regulating the inspection and certification of eligibility for production and trading of veterinary drugs, biological products, microorganisms, and chemicals used in veterinary medicine.

- Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011 regulating the inspection and evaluation of establishments producing and trading agricultural materials and agricultural, forestry and fishery products.

- Circular No. 07/2012/TT-BNNPTNT dated February 13, 2012 regulating procedures for registration, inspection and certification of veterinary drug manufacturing facilities meeting good manufacturing practice (GMP) standards.

4. Veterinary medicine quality control

- Decision No. 72/2007/QD-BNN dated August 6, 2007 regulating the inspection of veterinary drug quality;

- Decision No. 100/2007/QD-BNN dated December 3, 2007 on supplementing and amending Decision No. 72/2007/QD-BNN dated August 6, 2007 of the Minister of Agriculture and Rural Development on regulations on veterinary drug quality inspection;

- Circular No. 02/2009/TT-BNN dated January 14, 2009 guiding the procedures for recalling and handling veterinary drugs;

5. Distribution and circulation management

- Circular No. 15/2009/TT-BNN dated March 17, 2009 List of drugs, chemicals, antibiotics banned from use, restricted from use;

- Circular No. 03/2012/TT-BNNPTNT dated January 16, 2012 on amending and supplementing Circular No. 15/2009/TT-BNN dated March 17, 2009 on the List of drugs, chemicals, and antibiotics banned from use or restricted from use.

- Circular No. 28/2013/TT-BNNPTNT dated May 31, 2013 promulgating the List of veterinary drugs, vaccines, biological products, microorganisms, and chemicals used in veterinary medicine permitted for circulation in Vietnam.

- Circular No. 25/2012/TT-BNNPTNT dated June 22, 2012 promulgating the List of veterinary drugs, biological products, microorganisms, and chemicals used in aquatic veterinary medicine permitted for circulation in Vietnam.

According to NNVN