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Veterinary Biological Products Management

Original Language Title: 兽用生物制品经营管理办法

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(March 29, 2007 the Ministry of Agriculture announced as of May 1, 2007, 3rd) the first veterinary Biologics section in order to strengthen the management, guarantee the quality of veterinary biological products, in accordance with the regulations on the management of veterinary drugs, these measures are formulated.
    Article People's Republic of China territory of veterinary bio-distribution, operation, supervision and management, should comply with these measures.
    Veterinary Biologics section III is divided into national immunization programs required veterinary biologics (hereinafter referred to as the national compulsory vaccination Biologics) and non-compulsory immunization programs required of veterinary biological products (hereinafter referred to as non-State compulsory immunization Biologics).
    National compulsory vaccination used biological products by the Ministry of agriculture to determine and publicly announce it.
    The fourth Ministry of agriculture is responsible for the supervision and administration of the national veterinary Biologics.
    Local veterinary Administrative Department under the people's Governments at or above the county level shall be responsible for the supervision and management of biological products for animal uses in their administrative areas.
    Fifth national compulsory vaccination with biological products produced by enterprises designated by the Ministry of agriculture, government procurement law, the provincial veterinary administration organizations.
    When major animal epidemics, disasters or other emergencies occur, the State compulsory immunization Biologics called centrally by the Ministry of agriculture, manufacturers may not be sold on its own.
    Dynamic management of production enterprise of agriculture.
    Sixth provincial veterinary administrative departments should establish national compulsory vaccination Biologics storage and transportation management system. Distributed national compulsory vaccination Biologics, true, complete distribution records should be established.
    Distribution records shall be kept until the product expires after 2 years.
    Seventh article has following conditions of farms can to Ministry of agriculture specified of production enterprise procurement use of national forced immune with biological products, but should will procurement of varieties, and production enterprise, and number to location County above place Government veterinary administration sector record: (a) has corresponding of veterinary technicians; (ii) has corresponding of transport, and storage conditions; (three) has perfect of purchased into acceptance, and storage custody, and using check, management system.
    Farms should establish real and complete record of the purchase, use, and save it to the products after the expiration of 2 years.
    Eighth Ministry of agriculture specifies national compulsory immunization Biologics manufacturers can only be sold to the provincial veterinary administrative departments and in accordance with the provisions of the seventh fish farms, may not be sold to other entities or individuals.
    Veterinary Biologics production the production of non-national can be immuno-biological products for direct sale to the consumer, or may appoint distributors. Nineth veterinary Biologics production enterprises shall establish real and complete sales records, certify copies of documents should be provided to the purchaser.
    Sales records shall include the product name, lot number, product specifications, product number, production date, expiry date, consignee and address, delivery date, and so on.
    Tenth non-State biological products distributor shall obtain a compulsory vaccination, veterinary license and business license. Prescribed in the preceding paragraph of the license shall specify the scope of business of veterinary drugs veterinary Biologics production commissioned by business name and delegate sales product categories, and so on.
    Scope changes, dealers should handle change.
    11th veterinary Biologics production enterprises can independently determine, adjust the Distributor and sales agent contract with the dealer, clearly acting range and so on.
    12th dealers can only operate the acting veterinary Biologics production of biological products for animal uses, shall not operate without the Commission's veterinary Biologics produced in other enterprises.
    Dealer only the products sold to the consumer shall not be sold to other veterinary drug enterprises.
    Without a veterinary Biologics enterprise, veterinary Biologics veterinary drug enterprises does not operate.
    13th breeders, farms, animal clinics in consumer purchasing or distribution by the Government to obtain veterinary biologics are available only for personal use, may not be sold changed hands.
    14th veterinary Administrative Department under the people's Governments at and above the county level shall strengthen the veterinary Biologics production, supervision and inspection of enterprises and users, found a violation of the regulations on the management of veterinary drugs and circumstances as provided herein, shall make a decision according to law or report to the higher administrative department.
    15th levels of veterinary administrative departments, veterinary drug inspection agency, animal health supervision institutions and their staff, veterinary Biologics shall not engage in production and business activities, shall not be featured in its own name or supervise, supervision of sales of veterinary biological products and advertising.
    The 16th breeders, farms, animal clinics in users hands sale of biological products for animal uses, or operators out of business contained in the veterinary drugs veterinary drugs veterinary Biologics business scope, operating without a licence, in accordance with the provisions of the veterinary medicines regulations 56th penalty.
    17th Ministry of agriculture designated production enterprise in violation of the veterinary medicines regulations and the provisions of these measures, canceled its national compulsory immunization of Biologics production qualification, and in accordance with the provisions of the regulations on the management of veterinary drugs.
    18th of veterinary biological products in these measures refers to the natural or artificial microbes, parasites, toxins and metabolites, such as materials or biological tissues, biology, molecular biology or biochemistry, bio-technology, such as for prevention, treatment and diagnosis of animal diseases or change the performance of animal veterinary medicine.
    Non-State forces immune-biological products in these measures refers to the Department of agriculture to determine other than the compulsory immunization of Biologics, veterinary biological products.
    19th imported veterinary Biologics business management application of the regulation on imports of veterinary drugs.
                                                                                            20th these measures shall come into force on May 1, 2007.