Article 2 The provisions of this article apply to the province's territory of non-national mandatory immunization program for veterinary biological products (hereinafter referred to as "veterinary biological products") business management.
Article 3 The Provincial Department of Agriculture is responsible for the supervision and management of the province's veterinary biological products, municipal and county animal husbandry and veterinary administrative departments are responsible for the supervision and management of veterinary biological products within the administrative area.
Fourth, the operation of veterinary biological products of enterprises (hereinafter referred to as "business enterprises") shall obtain the Provincial Department of Agriculture issued by the "Veterinary Drug License".
"Veterinary Drug License" of the business scope, business location changes, the business enterprise shall apply for changes in accordance with the law.
Article V The person in charge of the business enterprise should be familiar with the national veterinary drug management laws, regulations and policies.
Article VI of the business enterprise shall be equipped with professional and technical personnel. Professional and technical personnel shall have junior or above veterinary professional and technical title or with veterinary medicine, veterinary medicine related professional college degree or above or veterinary medicine, veterinary medicine professional secondary school education and have engaged in veterinary work for more than 5 years of experience, familiar with national veterinary drug management laws, regulations and policies, and have professional knowledge of veterinary biological products.
Article VII of the business enterprise professional and technical personnel should be full-time employees of the enterprise, shall not be part-time in other units; full-time technical personnel change, should be timely to the location of the county level above the animal husbandry and veterinary administrative departments and the original licensing authority.
Article VIII of the operating enterprises engaged in purchasing, storage, sales and other staff, should have to meet the job requirements of the veterinary medicine, veterinary and other related professional knowledge.
Article IX operating enterprises shall develop personnel training programs, regular training, assessment of employees, and establish training files; professional and technical personnel should be subject to animal husbandry and veterinary administrative departments at or above the county level organization of veterinary medicine management knowledge training.
Article 10 of the business enterprise shall have a legal, fixed and operating veterinary biological products varieties, scale of business premises. Business premises and livestock and poultry farms at a distance of not less than 500 meters. In the business premises shall not be engaged in animal diagnostic and treatment activities and raising livestock, poultry and pets, no source of pollution.
Article XI of the operating companies should set up a separate warehouse for the specialized storage of veterinary biological products, the warehouse should have room temperature library, cool storage (cabinet), cold storage (cabinet) and other equipment, facilities, and with the operation of veterinary biological products varieties, scale, and can meet the qualified products, non-qualified products, according to the requirements of the zoning of storage.
Article XII of the operating companies should be equipped with thermometers, vacuum testers, generators and other instruments and equipment, regularly calibrate the relevant instruments and equipment, and be identified.
Article XIII of the operating enterprises shall, in accordance with the laws and regulations, the development of job responsibilities and procurement, storage, sales and other management systems, and regularly check the implementation of the system.
Article XIV of the operating enterprises shall sign a sales agency contract with the veterinary biological products manufacturers, a clear scope of agency.
Article XV of the operating enterprises shall be based on the quality standards of veterinary drugs and veterinary biological products manufacturer signed a procurement contract. Purchase contract shall contain the name of the veterinary biological products, specifications, procurement of quantities and so on.
Article XVI of the operating companies shall, in accordance with the quality standards and contract provisions, the veterinary biological products for acceptance into the warehouse, batch by batch check the packaging, labeling, instructions, quality certification and other relevant documents, and records of the veterinary biological products, common name, trade names, production units, approval number, specifications, production batch size, date of production, expiration date, the number of purchases, the date of purchase and so on.
Article XVII of the business enterprise shall take the necessary refrigeration, freezing, anti-pollution measures to ensure the quality of veterinary biological products; according to veterinary biological products on the requirements of temperature and humidity in separate warehouses, batches of storage of veterinary biological products, and strictly differentiate between qualified and unqualified products, veterinary biological products, storage location, and set up a clear sign.
Article XVIII of the operating companies should be regularly on the veterinary biological products storage facilities, equipment, storage of environmental conditions for monitoring, and make records.
Article XIX of the operating companies should follow the principle of first-in, first-out and batch number out of the warehouse, in the appearance and properties of the warehouse inspection, verification of labels; to provide the buyer with a copy of the documents certifying the issuance of the batch; the establishment of a true and complete sales records, sales records should be set out in the common name, trade names, manufacturing units, production batch number, specifications, quantities, purchasers and their addresses, telephone and shipment date and so on. Content.
Article 20 of the operating enterprises shall take appropriate thermal insulation measures to transport veterinary biological products, to ensure the quality of veterinary biological products.
Article 21 The records of the operating enterprises shall be true, accurate, clear and complete, and shall not be falsified, and if there is a need for modification, it shall be signed and dated, and the original data shall be clearly legible.
Article 22 of the business enterprise shall establish a true and complete business records, set up a special file cabinet, a person to keep; business records should be kept until the expiration of the validity of the veterinary biological products after 2 years. Files shall include the following:
(a) veterinary drug management regulations, documents;
(b) quality management documents;
(c) personnel, equipment, facilities files;
(d) sales agency contracts, purchase contracts and quality assessment of the manufacturer's documents and materials, including production licenses, veterinary drug GMP certificates, certificates of batch issue, product approval number approvals and test reports. Approval number approval and copies of test reports, etc.;
(e) the requirements of the records, including: personnel training, assessment records; facilities, equipment, operational status, maintenance records; storage environment temperature and humidity monitoring records; purchasing, warehousing, sales records; adverse reactions, quality complaints, quality accidents, records; unqualified and failure of the veterinary biological products processing records.
Article 23 of the operating companies found fake or shoddy veterinary biological products or other veterinary biological products do not comply with the relevant provisions of the state, should be promptly reported to the local animal husbandry and veterinary administrative departments.
Article 24 of the operating enterprises of animal husbandry and veterinary administrative departments announced in accordance with the law unqualified, fake and shoddy veterinary biological products, should be organized in a timely manner to inventory, recycling, in the local animal husbandry and veterinary administration under the supervision of the destruction, and make a good record.
Article 25 of the operating companies can only sell veterinary biological products to animal farms (households), animal diagnostic and therapeutic institutions and other users, and shall not be sold to other veterinary medicine business enterprises.
Article 26 An application for a Veterinary Drug Operation License shall be submitted as follows:
(1) three copies of the application form for a Veterinary Drug Operation License;
(2) organization or staffing, professional and technical personnel, staff qualifications and certificates of copies;
(3) the business premises, warehouse plan and proof of property rights or the right to use the building Copies;
(d) cool storage (cabinet), cold storage (cabinet), thermometer, vacuum tester, generator, transportation equipment or facilities list, and indicate the main parameters;
(e) management system (job responsibilities, procurement, storage, sales and other systems);
(f) in and out of the warehouse records (samples), sales records (samples), quality complaint records ( (sample), ledger (sample).
(VII) veterinary biological products manufacturer issued by the sales agency contract.
Article 27 of the municipal animal husbandry and veterinary administrative departments bear the acceptance of application materials and on-site review.
Article 28 of the on-site audit of the existence of unqualified items of the application for enterprises, should be for unqualified items for rectification. Enterprise county animal husbandry and veterinary administrative departments of the enterprise rectification review, and will review the results reported to the municipal animal husbandry and veterinary administrative departments.
Article 29 The municipal animal husbandry and veterinary administrative departments will be the enterprise declaration materials, audit opinions reported to the Provincial Department of Agriculture administrative licensing service center. Provincial Department of Agriculture after receiving the materials, review, meet the conditions, the applicant issued "veterinary license"; does not meet the conditions, notify the applicant in writing, and explain the reasons.
Article 30 These provisions shall be implemented from the date of publication. (Issued on August 28, 2007)
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