Detailed rules for the implementation of the regulations on the administration of veterinary drugs (revised in 1998)

Chapter I General Provisions Article 1 These Detailed Rules are formulated in accordance with the provisions of Article 49 of the Regulations on the Administration of Veterinary Drugs. Article 2 Anyone who engages in the production, marketing, use, research, publicity, inspection, supervision and management of veterinary drugs must abide by the provisions of these Detailed Rules. Article 3 The State implements a licensing system for the production, marketing, import and preparation of veterinary drugs by medical units. Without permission, it is forbidden to produce, manage or import veterinary drugs and prepare veterinary drug preparations. Chapter II Management of Veterinary Drug Production Enterprises Article 4 Veterinary drug production enterprises refer to enterprises specializing in the production of veterinary drugs and enterprises concurrently engaged in veterinary drugs, including branch factories of the above enterprises and various forms of joint ventures, Sino-foreign joint ventures, Sino-foreign cooperative enterprises and foreign-funded enterprises that produce veterinary drugs. Article 5 The establishment of an enterprise producing veterinary biological products must be examined and approved by the agricultural (animal husbandry) departments (bureaus) of provinces, autonomous regions and municipalities directly under the Central Government, and submitted to the Ministry of Agriculture for examination and approval. Article 6 Newly-built, expanded and rebuilt veterinary drug production enterprises must comply with the provisions of the "Standards for Quality Management of Veterinary Drug Production" formulated by the Ministry of Agriculture.

The existing veterinary drug production enterprises shall, in accordance with the requirements of the "Standards for the Quality Management of Veterinary Drug Production", formulate plans and report them to the agriculture (animal husbandry) departments (bureaus) of provinces, autonomous regions and municipalities directly under the Central Government for examination and approval, and then gradually implement them. Seventh veterinary drug production enterprises must have institutions and personnel capable of quality inspection of veterinary drugs produced, and have corresponding instruments and equipment. Veterinary drug quality inspection institutions shall not be attached to the production technology institutions of enterprises. Article 8 Each veterinary drug variety produced by a veterinary drug production enterprise must be produced in accordance with the veterinary drug quality standards and technological procedures approved by the administrative department of agriculture and animal husbandry. Where the production process, prescription, dosage form, use, usage, dosage and specifications are changed, an application must be submitted to the administrative department of agriculture and animal husbandry according to the original examination and approval procedures, and production can only be carried out after approval. Ninth veterinary drug production enterprises must have complete production records and inspection records, and keep them for at least three years. Tenth veterinary drug labels must be printed in accordance with the prescribed format and content. The main components of veterinary drugs refer to effective components. Any veterinary drug that may reduce its efficacy within a certain period of time must be marked with the expiration date. Eleventh veterinary narcotic drugs, psychotropic drugs, toxic drugs, radioactive drugs and drugs for external use must be printed in accordance with unified regulations. Article 12 The internal and external packaging of veterinary drugs must meet the requirements for ensuring the quality, storage, transportation and use of veterinary drugs. If the seals and labels are defective and the packaging is damaged, they are not allowed to leave the factory. Article 13 The sealing, labeling and packaging of veterinary drugs are prohibited from being transferred and sold. Article 14 Veterinary drugs must be inspected by enterprise drug inspection institutions before leaving the factory. If it meets the quality standards, the inspection mark shall be affixed to the inner package and the inspection certificate shall be affixed to the packing box. Do not meet the quality standards, shall not leave the factory. Chapter III Management of Veterinary Drug Trading Enterprises Article 15 Veterinary drug trading enterprises refer to enterprises specializing in veterinary drugs and enterprises concurrently engaged in veterinary drugs, including wholesale and retail companies or shops and enterprises engaged in import and export business. Sixteenth veterinary drug enterprises, directly engaged in the procurement, storage, sale, dispensing and inspection of veterinary drugs, should have pharmacists, veterinary technicians and above. Non-pharmaceutical technicians and veterinary technicians can engage in veterinary drug business activities only after passing the veterinary drug business knowledge examination issued by the administrative department of agriculture and animal husbandry or its designated unit. Seventeenth veterinary drug trading enterprises and veterinary medical units must conduct inspection and acceptance when purchasing veterinary drugs. The contents of inspection and acceptance include: the name, specification, manufacturer, production batch number, expiration date, inspection certificate, approval number, packaging and appearance quality of veterinary drugs. Article 18 When purchasing, keeping and selling veterinary drugs, a veterinary drug management enterprise must establish and improve the systems of quality inspection, warehousing acceptance, warehousing inspection, distribution and sales verification. Chapter IV Drug Management of Veterinary Medical Units Article 19 The veterinary drug preparation room of a veterinary medical unit shall have the equipment and environment to ensure the quality of the preparation, as well as the corresponding quality inspection equipment and drug inspection technicians. Article 20 The varieties of veterinary drug preparations prepared by veterinary medical units must be reported to the agricultural (animal husbandry) departments (bureaus) of provinces, autonomous regions and municipalities directly under the Central Government for the record. Twenty-first veterinary drug preparations should strictly implement the operating rules, quality inspection and hygiene system. Each batch of preparation must have detailed and complete preparation records and inspection records. If the inspection is qualified, a certificate will be issued, and if it is unqualified, it will not be used. Chapter V Veterinary Drug Production License, Veterinary Drug Business License and Article 22 To start a veterinary drug production enterprise, in addition to going through the examination and approval procedures for capital construction in accordance with state regulations, it must also go through the examination and approval procedures in accordance with the following provisions:

(a) the enterprise or the competent department of the enterprise shall report to the agricultural (animal husbandry) department (bureau) at or above the county level where the enterprise is located, and report to the agricultural (animal husbandry) department (bureau) of the province, autonomous region or municipality directly under the central government for examination after examination and approval;

(two) approved by the agriculture (animal husbandry) department (bureau) of the province, autonomous region and municipality directly under the central government, and issued a "veterinary drug production license";

(3) Veterinary drug production enterprises apply for registration to the local administration for industry and commerce with the veterinary drug production license and relevant documents and materials, and obtain a business license after approval.

Chinese-foreign equity joint ventures, Chinese-foreign cooperative ventures and foreign-funded enterprises engaged in the production of veterinary drugs shall go through the examination and approval procedures for the Veterinary Drug Production License according to special provisions.

The administrative department of agriculture and animal husbandry that accepts the audit shall make a decision on whether to agree or approve within one month after receiving all the application materials.