Ministry Of Agriculture Issued Administrative Measures Of Veterinary Biological Products -

The first order to strengthen the management of veterinary biological products

, under the "Veterinary Regulations" and the "Implementation Rules of veterinary drugs" formulated.

Second in China and the veterinary biological products in research, production, operation, import and export, supervision, use and other activities of the units and individuals must comply with these measures.

Third application of veterinary biological products are natural or man-modified microbes, parasites, biological toxins or biological tissues and metabolic products as raw materials, using biology, molecular biology or biochemistry and other related technologies made , and its potency or safety testing of biological methods must be used for animal diseases and other disease prevention, diagnosis and treatment of biological agents. Including Phytophthora (bacteria) vaccine, toxin, toxoid, immune serum, blood products, antigens, antibodies and other probiotics. One infected (bacteria) vaccine, toxoid for the prevention of use of biological products.

Ministry of Agriculture may, when necessary to prevent changes in the species with biological products.

Article MOA is responsible for the management of veterinary biological products. Above the county level administrative authority responsible for animal husbandry area in the management of veterinary biological products.

Chapter II Production Management Article veterinary biologics manufacturing enterprises operate (including research and teaching unit of bio-products, workshops and joint ventures) (same) before the unit must be in the project application approval by the local province, autonomous region, pastoral administrative authorities and municipalities (hereinafter referred to as the provincial animal husbandry administration) review comments made after the approval of the Ministry of Agriculture reported.

Article approved veterinary biologics manufacturers offer units must follow "good manufacturing practices veterinary medicine" (hereinafter referred to veterinary GMP) regulations for the design and construction.

Ministry of Agriculture is responsible for organizing the production of veterinary biological products business GMP inspection work, and issued "veterinary drug GMP certificate." Provincial administrations with farming, "veterinary drug GMP certificate" issued by the "Veterinary Drug Manufacturing Licence."

Prior to the implementation of this approach has been made, "Veterinary Drug Manufacturing license" veterinary biologics manufacturers must carry out technological transformation in accordance with the provisions of veterinary drug GMP and within the time stipulated in the Ministry of Agriculture to veterinary medicine GMP standard.

Prohibited without obtaining the production of veterinary biological products "veterinary drug production license" units and individuals that produce veterinary biologics.

Article veterinary biologics manufacturers must set up quality control departments (hereinafter referred to as quality control department), responsible for enterprise product quality inspection and production process quality monitoring.

Quality control department should be equipped with the appropriate technical staff. Quality control department shall not concurrently produce other administrative or management positions.

Quality control department should be with the production scale, variety, compatible with laboratory test items, equipment and management systems.

Article VIII of veterinary biological products produced by manufacturers of veterinary biological products to obtain product approval number.

Article veterinary biologics manufacturers of veterinary biological products must be strictly in accordance with national standards or quality standards issued by the Ministry of Agriculture production and testing.

Article veterinary biological products used in the manufacture and test bacteria (viruses or insects) and so should be a unified code, the implementation of the seed batch system, grade preparation, identification, storage and supply.

Article veterinary biological products used in the production and testing of raw materials and experimental animals should be in line with national veterinary standards, professional standards or standardized distribution of the relevant provisions of the management.

Article XII of the description and veterinary biological products bottle label content must comply with national standards or Department of Agriculture standards.

13th state shall implement batch release system for veterinary biological products.

Production of veterinary biologics production of veterinary biological products, must test each batch of product samples and reports the China Veterinary Drug Control. Product samples can be sent once every 15 days concentrated. Veterinary Drug Control in China where the receipt of samples submitted by manufacturers and quality of inspection reports within 7 working days, to determine whether sales and notify the manufacturer.

Veterinary Drug Control for the necessary review of that inspection can be monitored by veterinary medicine in China, or its designated units, review of test sites. Review test must be received by the Chinese enterprises of Veterinary Drug Control samples submitted and quality of inspection reports completed within 2 months. After review of inspection by the Veterinary Drug Control in China make a ruling and notify the manufacturer; When products fail to judge, it shall also report the Ministry of Agriculture.

Manufacturer of Veterinary Drug Control made the "allow the sale notice" before they are allowed by the provisions of Chapter III of this approach to sell.

State shall promote and encourage research, teaching units through technology transfer, paid services or technology shares, the form and veterinary biological products manufacturers to cooperate.

by: gaga

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