Article 2 These Provisions shall apply to the operation and management of veterinary biological products (hereinafter referred to as "veterinary biological products") required by non-national compulsory immunization projects in this province.
Article 3 The Provincial Department of Agriculture is responsible for the supervision and management of veterinary biological products in the province, and the municipal and county animal husbandry and veterinary administrative departments are responsible for the supervision and management of veterinary biological products within their respective administrative areas.
Article 4 A business enterprise of veterinary biological products (hereinafter referred to as the business enterprise) shall obtain the Veterinary Drug Business License issued by the Provincial Department of Agriculture according to law.
Where the business scope and business location of the veterinary drug business license are changed, the business enterprise shall go through the formalities of change according to law.
Article 5 The person in charge of an enterprise shall be familiar with the laws, regulations and policies of the state on the administration of veterinary drugs.
Sixth operating enterprises should be equipped with professional and technical personnel. Professional and technical personnel should have a junior or above veterinary professional technical title, or have a junior college degree or above in veterinary or veterinary related major or a technical secondary school degree or above in veterinary major and have been engaged in veterinary work for more than five years, be familiar with national laws, regulations and policies on veterinary management, and have professional knowledge of veterinary biological products.
Seventh professional and technical personnel operating enterprises should be full-time personnel of the enterprise, and may not work part-time in other units; When full-time technical personnel change, they shall promptly report to the local animal husbandry and veterinary administrative department at or above the county level and the original issuing authority.
Article 8 The personnel engaged in purchasing, storing and selling of an enterprise shall have the professional knowledge of veterinary drugs and veterinary related to their posts.
Article 9 An operating enterprise shall formulate a personnel training plan, regularly train and assess its employees, and establish training files; Professional and technical personnel shall accept the training of veterinary drug management knowledge organized by the animal husbandry and veterinary administrative department at or above the county level.
Article 10 A business enterprise shall have a legal and fixed business place suitable for the variety and scale of veterinary biological products it deals in. The distance between the business premises and livestock and poultry farms shall not be less than 500 meters. Do not engage in animal diagnosis and treatment activities and raise livestock, poultry and pets in the business premises, and there is no pollution source.
Article 11 An operating enterprise shall set up a separate warehouse to store biological products for animals. The warehouse should be equipped with normal temperature warehouse, cold warehouse (cabinet), cold storage (cabinet) and other equipment and facilities. (1) It shall be suitable for the variety and scale of the veterinary biological products it deals in, and can meet the requirements of storage according to qualified products and unqualified products.
Twelfth operating enterprises should be equipped with thermometers, vacuum testers, generators and other instruments and equipment, regularly check the relevant instruments and equipment, and identify them.
Thirteenth operating enterprises shall, in accordance with the provisions of laws and regulations, formulate job responsibilities and procurement, warehousing, sales and other management systems, and regularly check the implementation of the system.
Article 14 An operating enterprise shall sign a sales agency contract with an enterprise producing veterinary biological products, and define the agency scope.
Fifteenth operating enterprises shall sign a purchase contract with the veterinary biological products production enterprises according to the quality standards of veterinary drugs. The purchase contract shall specify the name, specifications and purchase quantity of veterinary biological products.
Article 16 An operating enterprise shall, in accordance with the quality standards and the provisions of the contract, examine the packaging, labels, instructions, quality certificates and other relevant documents in batches, and record the common name, trade name, production unit, approval number, specification, production batch number, production date, expiration date, purchase quantity and purchase date of veterinary biological products.
Seventeenth operating enterprises should take necessary measures such as cold storage, freezing and pollution prevention to ensure the quality of veterinary biological products; According to the requirements of temperature and humidity of veterinary biological products, veterinary biological products should be stored in different warehouses and batches, and the storage positions of qualified and unqualified veterinary biological products should be strictly distinguished, and obvious signs should be set up.
Eighteenth operating enterprises should regularly monitor the storage facilities, equipment operation and storage environment conditions of veterinary biological products, and make records.
Nineteenth operating enterprises should follow the principle of first-in first-out and outbound by batch number, and check the appearance and label when leaving the warehouse; Provide the buyer with a copy of the batch issuance certificate; Establish a true and complete sales record, which should include common name, trade name, production unit, production batch number, specification, quantity, buyer, address, telephone number, delivery date, etc.
Article 20 An operating enterprise shall take appropriate heat preservation measures to ensure the quality of veterinary biological products when transporting them.
Article 21 All records of a business enterprise shall be true, accurate, clear and complete, and shall not be forged. If it is really necessary to modify, it shall be signed and dated, and the original data shall be legible.
Twenty-second operating enterprises should establish true and complete business files, set up special filing cabinets, and keep them by special personnel; Business records shall be kept for 2 years after the expiration of the validity period of veterinary biological products. The archives shall include the following contents:
(a) veterinary drug management regulations and documents;
(2) quality management documents;
(three) personnel, equipment and facilities files;
(4) Sales agency contract, purchase contract and quality evaluation documents of the production enterprise, including production license, veterinary drug GMP certificate, batch issuance certificate, product approval number and copy of test report;
(5) Records required by these Provisions, including: personnel training and assessment records; Operation status and maintenance records of facilities and equipment; Store monitoring records of ambient temperature and humidity; Purchasing, warehousing and sales records; Adverse reactions, quality complaints and quality accident records; Disposal records of unqualified and invalid veterinary biological products, etc.
Twenty-third business enterprises found fake and inferior veterinary biological products or other veterinary biological products that do not meet the relevant provisions of the state, it shall promptly report to the local animal husbandry and veterinary administrative department.
Twenty-fourth operating enterprises shall promptly organize the inventory and recovery of unqualified and counterfeit veterinary biological products announced by the animal husbandry and veterinary administrative department according to law, and destroy them under the supervision of the local animal husbandry and veterinary administrative department, and make records.
Twenty-fifth business enterprises can only sell veterinary biological products to animal farms (households), animal clinics and other users, and may not sell them to other veterinary drug business enterprises.
Article 26 To apply for a veterinary drug business license, the following materials shall be submitted:
(1) Application Form for Veterinary Drug Business License in triplicate;
(two) the organization or staffing, professional and technical personnel, staff qualification certificate copy;
(three) the plan of the business premises and warehouse and a copy of the certificate of the property right or the right to use the house;
(four) a list of cold storage (cabinet), cold storage (cabinet), thermometer, vacuum tester, generator, transportation equipment or facilities, and indicate the main parameters;
(five) management system (job responsibilities, procurement, warehousing, sales and other systems);
(six) storage records (samples), sales records (samples), quality complaint records (samples), accounting (samples).
(seven) the sales agency contract issued by the veterinary biological products production enterprise.
Twenty-seventh districts and cities animal husbandry and veterinary administrative departments to undertake the acceptance of enterprise application materials and on-site audit work.
Twenty-eighth after the on-site audit, the applicant enterprises should rectify the unqualified items. The animal husbandry and veterinary administrative department at the county level where the enterprise is located shall review the rectification of the enterprise and report the results of the review to the animal husbandry and veterinary administrative department of the city divided into districts.
Twenty-ninth districts of the city animal husbandry and veterinary administrative departments shall submit the application materials and audit opinions of enterprises to the administrative licensing service center of the Provincial Department of Agriculture. The Provincial Department of Agriculture shall review the materials after receiving them, and issue a veterinary drug business license to the applicant if they meet the requirements; Do not meet the conditions, notify the applicant in writing, and explain the reasons.
Thirtieth the provisions shall come into force as of the date of promulgation. (Promulgated on August 28th, 2007)
Recent readers
Akibo
Chenming 276
Share (0) Comments (0) Category: Default Category 53 Reading 2007- 10-04 0 1:37
I want to log in->
Company Profile-Contact Information-Recruitment Information-Customer Service-Relevant Laws-User Feedback-Reporting Bad Information-
Copyright of Netease Company? 1997-2007