Ministry of Agriculture Order No. 3

"Measures for the Administration of veterinary biological products" was February 14, 2007 by the Ministry of Agriculture No. 3 executive meeting, is hereby promulgated, May 1, 2007 shall come into force.
Minister Sun Zhengcai
March 29, 2007

Measures for the Administration of veterinary biological products

In order to strengthen the management of veterinary biological products, veterinary biological products to ensure quality, according to the "Veterinary Regulations", to develop this approach.
Article in the PRC engaged in the distribution of veterinary biological products, management and supervision, shall comply with these measures.
Article veterinary biological products are divided into national immunization programs required mandatory veterinary biological products (hereinafter referred to as compulsory vaccination with biological products) and non-state mandatory immunization program required veterinary biological products (hereinafter referred to as non-state compulsory vaccination of biological products ).
National list of mandatory immunization with biological products and the announcement by the Ministry of Agriculture.
Article Ministry of Agriculture is responsible for the national veterinary supervision and management of biological products.
Local people's governments above the county level and veterinary administrative department in charge of the administrative area of ​​veterinary biological products supervision and management.
The state compulsory vaccination of biological products specified by the Ministry of Agriculture production, according to government procurement, the provincial people's government veterinary administration organized distribution.
Major animal epidemics, disasters or other emergencies, the state compulsory vaccination with the Ministry of Agriculture and Biological Products by the call, the production company shall not sell.
Ministry of Agriculture designated production enterprise of dynamic management.
Article provincial people's government veterinary administration should establish national mandatory immunization biological product storage, transportation management system.
Distribution of state compulsory vaccination with biological products, should establish a true and complete record of the distribution. Distribution records should be kept to the product after the expiration of 2 years.
Article farm with the following conditions can be designated by the Ministry of Agriculture producers purchase their own use of the national compulsory vaccination of biological products, but should be purchased varieties, production enterprises, the number of the local people's governments above the county level and veterinary administrative departments for the record :
(A) with the appropriate veterinary technicians;
(B) with the appropriate transport, storage conditions;
(C) acceptance of a complete purchase, storage storage, verification and management system.
Farms should be established a true, complete procurement, the use of record, and save to the product after the expiration of 2 years.
Article producers designated by the Ministry of Agriculture will only country with compulsory vaccination of biological products sold to the provincial people's government veterinary administration and in line with Article VII of the farm, not to other units and individual sales.
Veterinary biological products manufacturers can be the production of non-state compulsory vaccination of biological products sold directly to users, distributors can also be commissioned.
Article IX of veterinary biological products manufacturer shall establish a true and complete sales records, batch release should be to provide proof of purchase of a copy. Sales records shall include the product name, lot number, product specifications, product number, production date, expiry date, receiving unit and address, delivery date and so on.
Article compulsory vaccination with non-state dealers shall obtain biological products "veterinary drug license," and business license.
The preceding paragraph of the "veterinary drug license," the commission shall set forth the scope of business of veterinary biological products manufacturer name and product category sales commission and so on. Changes in the scope of business, dealers should process the change.
Article XI veterinary biologics manufacturers could self-identify, adjust the distributor and dealer signed a sales agency contract with a clear scope of agency issues.
Article XII of the dealer business of the agent can only produce veterinary biologics production of veterinary biological products, may not operate without the other commissioned production of veterinary biological products.
Dealers can only sell the product to the user agent, may not be sold to other veterinary drug business.
Manufacturers of veterinary biological products without commission, enterprises may not operate veterinary veterinary biological products.
Article XIII of farmers, farm, animal clinics and other users of the procurement agency or distributed by the government limited access to veterinary biological products for personal use, not resale sales.
Article XIV local people's governments above the county level and veterinary administrative department shall strengthen the veterinary biological products, enterprises and users of supervision and inspection, found to have violated the "Veterinary Regulations" and the circumstances specified in this way, it should be done according to law out of the decision or report to the higher veterinary administration.
Article XV at all levels of veterinary administration, veterinary inspection agencies, animal health oversight agencies and their staff shall not participate in the production of veterinary biological products, business activities, not recommended in its own name or supervising sales of veterinary biological products and advertising.
Article XVI farmers, farm, animal clinics and other user agencies resale sales of veterinary biological products, veterinary drugs or the operator beyond the "veterinary drug license," stated the scope of business operations of veterinary biological products, are no card business, in accordance with the "Veterinary Regulations" provisions of Article 56 punishment.
Article XVII of the Ministry of Agriculture designated production enterprise that violates the "Veterinary Regulations" and the provisions hereof, the abolition of compulsory vaccination of its national production of biological products with qualifications and in accordance with the "Veterinary Regulations" to be punished.
Article 18 The term refers to veterinary biological products of natural or artificial modification of microbes, parasites, biological toxins or metabolites in biological tissues and materials, such as the use of biology, molecular biology or biochemistry, bioengineering, etc. made the appropriate technology for the prevention, treatment, diagnosis of animal diseases animal performance or change of veterinary drugs.
The term non-state compulsory vaccination of biological products is the Ministry of Agriculture to determine the compulsory vaccination of biological products other than veterinary biological products.
Article 19 The import of veterinary biological products business management application, "veterinary import management approach."
Article 20 These Measures May 1, 2007 shall come into force.