Existing veterinary drug manufacturers should be in accordance with the "Veterinary Drug Production Quality Management Standards," the requirements set out in the planning, reported in the provinces, autonomous regions, municipalities directly under the Central Agriculture (Animal Husbandry) Department (Bureau) for review and approval, and gradually implemented. Article VII veterinary drug manufacturers must have the production of veterinary drugs produced by the quality inspection organizations and personnel, and have the appropriate instruments and equipment. Veterinary drug quality inspection organization shall not be attached to the production of technical institutions within the enterprise. Article 8 Veterinary drug production enterprises to produce each species of veterinary drugs, must be in accordance with the agricultural and animal husbandry administrative organs approved by the quality standards of veterinary drugs and process procedures for production. Any change in the production process, prescription, dosage form, use, usage, dosage and specification must be applied to the agricultural and animal husbandry administrative organs in accordance with the original approval procedures, and the production can be carried out only after approval. Article 9 Veterinary drug manufacturers must have complete production records and inspection records, and keep them for at least 3 years. Article 10 The labeling of veterinary drugs must be printed in accordance with the prescribed format and content. The main ingredient of veterinary drugs refers to the composition of the efficacy. Where more than a certain period of time may reduce the efficacy of veterinary drugs, must indicate the expiration date. Article 11 The labels and packaging of veterinary narcotic drugs, psychotropic drugs, toxic drugs, radiopharmaceuticals and drugs for external use must be printed in accordance with the unified provisions of the logo. Article XII of veterinary drugs, internal and external packaging must comply with the requirements to ensure the quality of veterinary drugs, storage, transportation and use. Where the seal, labeling defects, packaging damage, are not allowed to leave the factory. Article XIII of the seal, labeling and packaging of veterinary drugs prohibited the transfer and sale. Article XIV of veterinary drugs before leaving the factory must be tested by the enterprise drug testing organizations, in line with quality standards should be accompanied by a qualified mark of inspection on the inner packaging, in the box with a certificate of inspection. Does not meet the quality standards, shall not leave the factory. Chapter III of the management of veterinary drug business enterprises Article XV of the veterinary drug business enterprises refers to specializing in veterinary drugs and veterinary drug business enterprises, including wholesale, retail companies or stores and import and export business enterprises. Article 16 Within the veterinary drug business enterprises, those directly engaged in the purchase, storage, sale, transfer and inspection of veterinary drugs shall be pharmacists, veterinary technicians and other technical personnel. Non-pharmacy, veterinary technicians must be issued by the "veterinary drug license" of the agricultural and animal husbandry administrative organs or their designated units, veterinary drug business knowledge assessment before being allowed to engage in veterinary drug business activities. Article XVII of veterinary drug business enterprises and veterinary medical units to purchase veterinary drugs, inspection and acceptance must be carried out. Inspection and acceptance include: the name of the veterinary drug, specifications, production enterprises, production lot number, expiration date, inspection certificate, approval number, packaging and appearance of quality. Article XVIII of veterinary drug business enterprises acquisition, storage, sales of veterinary drugs, must establish and improve the quality of inspection and acceptance of storage, maintenance in the warehouse, out of the warehouse inspection and issuance, sales checking system. Article 19 Individual veterinary drug operators in urban and rural bazaar trade market sales of veterinary drugs, only allowed to sell in the bazaar trade market within the jurisdiction of the licensing authority. Chapter IV of the veterinary medical unit of pharmaceutical management Article 20 of the veterinary medical unit of veterinary medicine preparation room should have to ensure the quality of the preparation of equipment, environment, with the appropriate quality inspection equipment and drug testing technicians. Article 21 of the veterinary medical units formulated veterinary drug preparations, must be reported to the province, autonomous region, municipality directly under the Central Agriculture (Animal Husbandry) Department (Bureau) for the record. Article 22 The preparation of veterinary preparations should be strictly enforced operating procedures, quality inspection and health systems. Each batch of preparations must have a detailed and complete preparation records and inspection records, qualified by the inspection, the issuance of certificates of compliance, unqualified are not allowed to use. Chapter V "Veterinary Drug Production License", "Veterinary Drug License", "Veterinary Drug Preparation License" approval process Article 23 The opening of veterinary drug production enterprises, in addition to the implementation of the state regulations for the approval of capital construction procedures must be carried out in accordance with the following provisions of the approval process:
(a) by the enterprise or the competent departments of the enterprise to the enterprise's county above the Department of Agriculture (Animal Husbandry) (Bureau) to declare that the examination and approval and then sent to the provincial, autonomous regions, autonomous regions, autonomous regions, autonomous regions, autonomous regions, autonomous regions, and autonomous regions. Agreed, sent to the province, autonomous regions and municipalities directly under the Central Agriculture (Animal Husbandry) Department (Bureau) audit;
(b) by the province, autonomous regions and municipalities directly under the Central Agriculture (Animal Husbandry) Department (Bureau) audit and approval, issued a "Veterinary Drug Manufacturing License";
(c) veterinary drug manufacturers with the "Veterinary Drug Manufacturing License" and the relevant documents and materials, to the local administrative bureau of industry and commerce to apply for registration, after approval receive a business license.
Sino-foreign joint ventures, Sino-foreign cooperative ventures and foreign-funded enterprises engaged in the production of veterinary drugs shall apply for approval of the Veterinary Drug Production License according to the special regulations.
The agricultural and animal husbandry administrative organ accepting the review and examination shall make a decision on whether to agree or approve within one month after receiving all the declaration materials.