Legal Document

Title: Decree 35/2016/ND-CP on Guidelines for the Law of veterinary medicine
Type: Decree
Issuing Agency: Government
Responsible Agency: Ministry of Agriculture and Rural Development
Issuing Date: 15-02-2016

 

Decree No. 35/016/ND-CP provides guidelines for the Law on Veterinary Medicine, particularly in following contents:

- System of veterinary authorities and policies applied to veterinary staff of communes, wards or district-level towns;

- Funding for prevention and fighting against animal diseases;

- Suspension of export/import; ban on export/import of animals and animal products;

- Requirements for manufacturing, trade, import, testing and valuation of veterinary drugs; regulations on Good manufacturing practice (GMP) for veterinary drugs;

- Requirements for veterinary practice.

The Decree stipulates the cases in which the suspension of export or import of animals and animal products is applied, and requirements for continuation of export/import of animals and animal products. It also details the cases in which a ban on export/import of animals and animal products is applied, as well as the suspension of or ban on export/import of animals and animal products subject to quarantine.

With regard to requirement for manufacturing of veterinary drugs, organizations or individuals manufacturing veterinary drugs must meet such conditions as: separating from the residential areas, public establishments, hospitals, veterinary infirmaries; the workshops are designed appropriate to the scale and manufactured drugs; having warehouses containing materials, auxiliary materials and finished products; the quality inspection areas must be separated from the manufacturing areas, etc.

Particularly, manufacturer of veterinary drugs in form of medicinal products or vaccines, must apply standards of GMP.

For veterinary drugs traders, they shall meet following conditions: having fixed business location; having signboard(s), cabinets, shelves and racks containing suitable drugs; having equipment for the purpose of drug storage; and having books and invoices for tracking sale and purchase of products. Specifically, traders of vaccines and/or biological preparations must have refrigerators, freezers or cold storage for storage in conformity with the storage condition indicated on labels of products; and also have thermometers for checking the storage condition. They must also have standby generators, utilities and vehicles for distribution of vaccines.

This Decree becomes effective since July 1, 2016 and replaces the following legislation:

- Decree No. 33/2005/ND-CP dated March 15, 2005 on guidelines for the Ordinance on Veterinary Medicine;

Decree No. 119/2008/ND-CP dated November 28, 2008 on amendments to the Government's Decree No. 33/2005/ND-CP, and

- Article 4 of Decree No. 98/2011/ND-CP dated October 26, 2011 on amendments some articles of the Decrees on agriculture.

 

 

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