(Promulgated by the State Council on May 21, 1987, and revised in accordance with the Decision of the State Council on Amending the Regulations on the Administration of Veterinary Drugs on November 29, 2001)文章源自FOFCC-http://fofcc.org.cn/am/11220/
Chapter I General Provisions文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 1 These Regulations are formulated to strengthen the supervision and administration of veterinary drugs, ensure the quality of veterinary drugs, effectively prevent and treat diseases of livestock, poultry, and other animals, promote the development of the animal husbandry industry, and safeguard human health.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 2 The production, operation, and use of veterinary drugs must ensure quality and safety and efficacy.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 3 The animal husbandry and veterinary administrative department of the State Council shall be responsible for the administration of veterinary drugs nationwide, and the animal husbandry and veterinary administrative departments of local people's governments at or above the county level shall be responsible for the administration of veterinary drugs within their respective jurisdictions.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 4 All persons engaged in the production, operation, and use of veterinary drugs shall comply with the provisions of these Regulations.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Chapter II Administration of Veterinary Drug Manufacturing Enterprises文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 5 Veterinary drug manufacturing enterprises must meet the following conditions:文章源自FOFCC-http://fofcc.org.cn/am/11220/
(1) Having technical personnel and skilled workers with technical positions of engineer, veterinarian, or above commensurate with the veterinary drugs to be produced;文章源自FOFCC-http://fofcc.org.cn/am/11220/
(2) Having factory buildings, facilities, and sanitary conditions commensurate with the veterinary drugs to be produced;文章源自FOFCC-http://fofcc.org.cn/am/11220/
(3) Having facilities and conditions conforming to national labor safety and sanitary standards;文章源自FOFCC-http://fofcc.org.cn/am/11220/
(4) Having a quality inspection institution, full-time inspection personnel, and necessary instruments and equipment;文章源自FOFCC-http://fofcc.org.cn/am/11220/
(5) Enterprises not specializing in the production of veterinary drugs but concurrently producing veterinary drugs must have a separate veterinary drug production area.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 6 To establish a veterinary drug manufacturing enterprise, the enterprise must be examined and approved by the animal husbandry and veterinary administrative department of the county-level people's government where the enterprise is located, and upon examination and approval by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, be issued a Veterinary Drug Manufacturing License. The veterinary drug manufacturing enterprise shall, with the Veterinary Drug Manufacturing License, apply to the local administrative department for industry and commerce for registration, and upon approval, obtain a Business License.文章源自FOFCC-http://fofcc.org.cn/am/11220/
The Veterinary Drug Manufacturing License shall specify a period of validity, and upon expiration, a new license shall be issued after re-examination and qualification.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 7 Veterinary drug manufacturing enterprises must conduct production in accordance with technical procedures, production records must be complete and accurate, and the required raw materials, auxiliary materials, and containers and packaging materials directly contacting veterinary drugs must meet pharmaceutical requirements.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 8 Veterinary drug packaging must bear a label indicating the words “For Veterinary Use” and be accompanied by instructions. The label or instructions must indicate the trademark, veterinary drug name, specifications, enterprise name, product batch number, and approval number, and clearly state the main ingredients, content, action, indications, usage, dosage, period of validity, and precautions of the veterinary drug.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 9 The subpackaging of veterinary drugs must have complete and accurate subpackaging records, and the packaging must indicate the veterinary drug name, specifications, enterprise name, product batch number, approval number, subpackaging unit, and subpackaging batch number, and be accompanied by instructions. For veterinary drugs with a specified period of validity, the period of validity must be indicated after subpackaging.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 10 Veterinary drugs must undergo quality inspection before leaving the factory, and those not conforming to quality standards shall not leave the factory.文章源自FOFCC-http://fofcc.org.cn/am/11220/
When veterinary drugs leave the factory, a product quality inspection certificate must be attached; if there is no certificate, veterinary drug operating enterprises shall not deal in them.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Chapter III Administration of Veterinary Drug Operating Enterprises文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 11 Veterinary drug operating enterprises must meet the following conditions:文章源自FOFCC-http://fofcc.org.cn/am/11220/
(1) Having veterinary drug technical personnel commensurate with the veterinary drugs to be operated;文章源自FOFCC-http://fofcc.org.cn/am/11220/
(2) Having business premises, equipment, and warehouse facilities commensurate with the veterinary drugs to be operated.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 12 To establish a veterinary drug operating enterprise, upon approval by the animal husbandry and veterinary administrative department of the local people's government at or above the county level, a Veterinary Drug Operating License shall be issued. The veterinary drug operating enterprise shall, with the Veterinary Drug Operating License, apply to the local administrative department for industry and commerce for registration, and upon approval, obtain a Business License.文章源自FOFCC-http://fofcc.org.cn/am/11220/
The Veterinary Drug Operating License shall specify a period of validity, and upon expiration, a new license shall be issued after re-examination and qualification.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 13 The purchase of veterinary drugs must undergo quality acceptance inspection. Those with unqualified quality shall not be purchased.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 14 The storage of veterinary drugs must establish and implement a warehousing and preservation system to ensure the quality and safety of veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 15 The sale of veterinary drugs must ensure quality, verify accuracy, and correctly explain the action, indications, usage, dosage, and precautions of the veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 16 Those operating veterinary drugs in urban and rural fair trade markets must hold a Veterinary Drug Operating License and a Business License.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Chapter IV Pharmaceutical Administration of Veterinary Medical Units文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 17 Veterinary medical units must be equipped with veterinary drugs and veterinary technical personnel commensurate with their medical tasks, establish and improve a veterinary drug management system, and strengthen pharmaceutical administration.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 18 To prepare veterinary drug preparations, veterinary medical units must have facilities and inspection instruments that ensure the quality of the preparations, and upon examination and approval by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, be issued a Veterinary Drug Preparation License.文章源自FOFCC-http://fofcc.org.cn/am/11220/
The Veterinary Drug Preparation License shall specify a period of validity, and upon expiration, a new license shall be issued after re-examination and qualification.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 19 Veterinary drug preparations prepared by veterinary medical units must meet qualified standards before they may be used for clinical use by the unit and in the medical area under its responsibility, but they shall not be sold on the market.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 20 Veterinary medical units purchasing veterinary drugs must implement a quality acceptance inspection system, and unqualified ones shall not be used.文章源自FOFCC-http://fofcc.org.cn/am/11220/
To facilitate the purchase of veterinary drugs by farmers and herdsmen, veterinary medical units may concurrently engage in retail business of veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Chapter V Approval of New Veterinary Drugs and Administration of Import and Export Veterinary Drugs文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 21 Veterinary drug standards are divided into national standards, industry standards, and local standards.文章源自FOFCC-http://fofcc.org.cn/am/11220/
To produce veterinary drugs for which national standards, industry standards, or local standards already exist, examination and approval by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government is required, and an approval number shall be issued.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 22 The State encourages the research and creation of new veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/
To develop new veterinary drugs, the research and development methods, production process, quality standards, pharmacology, toxicology, clinical trial reports, environmental impact reports, pollution prevention and control measures, and other relevant materials and samples of the new veterinary drugs must be submitted to the animal husbandry and veterinary administrative department of the State Council. After the new veterinary drugs are reviewed and appraised by the national veterinary drug supervisory institution and proven safe and effective, they shall be examined and approved by the animal husbandry and veterinary administrative department of the State Council, listed as national standards or industry standards, and a New Veterinary Drug Certificate shall be issued. Without a New Veterinary Drug Certificate, they shall not be listed as formal scientific research achievements or be subject to technology transfer.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 23 To develop new veterinary drug preparations, the formulation and preparation process, quality standards, clinical trial reports, and other materials of the new preparations must be submitted to the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located. After review and appraisal by the veterinary drug supervisory institute of the province, autonomous region, or municipality directly under the Central Government and proof of safety and efficacy, they shall be examined and approved by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government and listed as local standards.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 24 To produce new veterinary drugs and new veterinary drug preparations, they must pass inspection by the veterinary drug supervisory institute of the province, autonomous region, or municipality directly under the Central Government, and upon approval by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, an approval number shall be issued.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 25 For the import of veterinary drugs, examination and approval by the animal husbandry and veterinary administrative department of the State Council or the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government is required, and an Import Veterinary Drug License shall be issued. Import may be carried out only after passing inspection by the veterinary drug supervisory institute designated by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government or by the animal husbandry and veterinary administrative department of the State Council.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 26 When China first imports a certain veterinary drug produced or operated by a foreign enterprise, the foreign enterprise selling the veterinary drug must also apply to the animal husbandry and veterinary administrative department of the State Council for inspection and registration, and provide the quality standards, inspection methods, pharmacological and toxicological test results, clinical trial reports, instructions, and other materials of the veterinary drug, as well as documentary proof that the exporting country (region) has approved its production or sale. After inspection and review and proof of safety and efficacy, an Import Veterinary Drug Registration License shall be issued.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 27 The State shall protect the undisclosed test data and other data submitted by applicants for veterinary drugs containing new compounds that have been approved or registered in accordance with law and that were obtained by the applicants themselves.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Within 6 years from the date of approval or registration, if other applicants apply for veterinary drug approval or registration using the data specified in the preceding paragraph without the consent of the applicant that has obtained approval or registration, the approval or registration authority shall not approve or register; except where other applicants submit data obtained by themselves.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Except under the following circumstances, the approval or registration authority shall not disclose the data specified in the first paragraph:文章源自FOFCC-http://fofcc.org.cn/am/11220/
(1) where required by the public interest;文章源自FOFCC-http://fofcc.org.cn/am/11220/
(2) where measures have been taken to ensure that such information will not be improperly used for commercial purposes.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 28 For the import and export of veterinary narcotic drugs and psychotropic drugs, an Import Permit or Export Permit issued by the health administrative department of the State Council must be held.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Chapter VI Veterinary Drug Supervision文章源自FOFCC-http://fofcc.org.cn/am/11220/
第二十九条 禁止生产、经营假兽药。有下列情形之一的为假兽药：文章源自FOFCC-http://fofcc.org.cn/am/11220/
（一）以非兽药冒充兽药的；文章源自FOFCC-http://fofcc.org.cn/am/11220/
（二）兽药所含成分的种类、名称与国家标准、行业标准或者地方标准不符合的。文章源自FOFCC-http://fofcc.org.cn/am/11220/
禁止生产、经营有下列情形之一的兽药：文章源自FOFCC-http://fofcc.org.cn/am/11220/
（一）未取得批准文号的；文章源自FOFCC-http://fofcc.org.cn/am/11220/
（二）国务院畜牧兽医行政管理部门明文规定禁止使用的。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十条 禁止生产、经营劣兽药。有下列情形之一的兽药为劣兽药：文章源自FOFCC-http://fofcc.org.cn/am/11220/
（一）兽药成分含量与国家标准、行业标准或者地方标准规定不符合的；文章源自FOFCC-http://fofcc.org.cn/am/11220/
（二）超过有效期的；文章源自FOFCC-http://fofcc.org.cn/am/11220/
（三）因变质不能药用的；文章源自FOFCC-http://fofcc.org.cn/am/11220/
（四）因被污染不能药用的；文章源自FOFCC-http://fofcc.org.cn/am/11220/
（五）其他与兽药标准规定不符合，但不属于假兽药的。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十一条 县级以上人民政府畜牧兽医行政管理部门行使兽药监督管理权。文章源自FOFCC-http://fofcc.org.cn/am/11220/
国家和省、自治区、直辖市的兽药监察机构，以及经省、自治区、直辖市人民政府批准设立的城市兽药监察机构，协助畜牧兽医行政管理部门，分别负责全国和本辖区的兽药质量监督、检验工作。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十二条 各级畜牧兽医行政管理部门对已经批准生产的兽药，应当经常组织调查、验证、审评，对疗效不确、不能保证用药安全的，应当依据职权撤销其批准文号。被撤销批准文号的兽药，不得继续生产或者经营。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十三条 县级以上人民政府畜牧兽医行政管理部门选任兽药监督员。兽药监督员必须由兽药、兽医技术人员担任，凭所在人民政府发给的《兽药监督员证》开展工作。文章源自FOFCC-http://fofcc.org.cn/am/11220/
兽药监督员有权按照本条例规定，对辖区内的兽药生产、经营和使用单位的兽药质量进行监督、检查，必要时可以按照规定抽取样品和索取必需的资料，有关单位不得拒绝和隐瞒。兽药监督员对兽药生产和科研单位提供的技术资料，负有保密义务。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十四条 兽药生产企业、经营企业和兽医医疗单位，应当经常检查本单位所生产、经营和使用的兽药质量、疗效和安全性。文章源自FOFCC-http://fofcc.org.cn/am/11220/
兽药使用单位发现兽药中毒事故，必须及时向当地畜牧兽医行政管理部门报告。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十五条 兽药生产企业和兽药经营企业的兽药检验机构或者人员，受当地兽药监察所的业务指导。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十六条 兽用麻醉药品、精神药品、毒性药品和放射性药品等特殊药品，按照国家有关规定进行管理。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十七条 兽药使用单位和个人应当遵守国务院畜牧兽医行政管理部门制定的兽药安全使用规定。禁止使用假兽药、劣兽药和本条例第二十九条第二款禁止生产、经营的兽药以及未经批准进口的兽药。文章源自FOFCC-http://fofcc.org.cn/am/11220/
县级以上人民政府畜牧兽医行政管理部门应当加强对动物产品中兽药残留量的检测，并公布检测结果。兽药残留限量标准和检测方法由国务院畜牧兽医行政管理部门制定。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第七章 兽药的商标和广告管理文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十八条 兽药商标应当按照国家商标法规的规定，进行登记注册。文章源自FOFCC-http://fofcc.org.cn/am/11220/
注册商标必须在兽药的包装、标签、说明书上标明，并注明“注册商标”字样或者注册标记。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第三十九条 兽药广告必须经国务院畜牧兽医行政管理部门或者省、自治区、直辖市人民政府畜牧兽医行政管理部门审查批准。未经批准的，不得刊登、设置、印刷、播放、散发和张贴。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十条 兽药广告的内容必须以国务院畜牧兽医行政管理部门或者省、自治区、直辖市人民政府畜牧兽医行政管理部门批准的说明书为准。文章源自FOFCC-http://fofcc.org.cn/am/11220/
兽用麻醉药品和精神药品，不得进行广告宣传。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十一条 外国企业在我国申请办理兽药广告，必须持有国务院畜牧兽医行政管理部门核发的《进口兽药登记许可证》，并提供兽药说明书。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第八章 罚 则文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十二条 对生产、经营假兽药或者违反本条例第二十九条第二款规定的，依照刑法关于生产、销售伪劣产品罪或者生产、销售伪劣兽药罪的规定，依法追究刑事责任；尚不够刑事处罚的，责令其停止生产、经营该兽药，没收其药物和违法所得，处以违法所得1倍以上5倍以下的罚款；并可以责令该企业停产、停业整顿或者吊销《兽药生产许可证》、《兽药经营许可证》、《兽药制剂许可证》。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十三条 对生产、经营劣兽药的，依照刑法关于生产、销售伪劣产品罪或者生产、销售伪劣兽药罪的规定，依法追究刑事责任；尚不够刑事处罚的，责令其停止生产、经营该兽药，没收其药物和违法所得，处以违法所得1倍以上5倍以下的罚款；情节和后果严重的，并可以责令该企业停产、停业整顿或者吊销《兽药生产许可证》、《兽药经营许可证》、《兽药制剂许可证》。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十四条 未取得《兽药生产许可证》、《兽药经营许可证》、《兽药制剂许可证》，擅自生产、经营兽药或者配制兽药制剂的，依照刑法关于非法经营罪的规定，依法追究刑事责任；尚不够刑事处罚的，责令其停产、停业或者停止配制兽药制剂，没收全部兽药和违法所得，可以并处违法所得1倍以上5倍以下的罚款。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十五条 违反本条例关于兽药进口有关规定的，依照刑法关于非法经营罪的规定，依法追究刑事责任；尚不够刑事处罚的，根据情节轻重，予以警告或者没收该兽药；擅自销售的，没收违法所得，并处以违法所得1倍以上5倍以下的罚款。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十六条 未按照国家有关兽药安全使用规定使用兽药的，予以警告，可以并处3万元以下的罚款。文章源自FOFCC-http://fofcc.org.cn/am/11220/
使用假兽药、劣兽药和其他禁止使用的兽药的，责令其停止使用，没收其药物，可以并处1万元以上5万元以下的罚款。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十七条 本条例规定的行政处罚，由县级以上人民政府畜牧兽医行政管理部门决定。但是，违反本条例第十六条和第七章规定应当予以行政处罚的；根据本条例第四十五条的规定应当没收违法所得和处以罚款的；在兽药的生产或者经营中违反《工业产品质量责任条例》有关规定，应当没收违法所得和处以罚款的，由工商行政管理机关决定，畜牧兽医行政管理部门协助查处。文章源自FOFCC-http://fofcc.org.cn/am/11220/
罚款和没收的违法所得一律上缴国库。没收的假、劣药物以及国家明文规定禁止使用的其他药物，由畜牧兽医行政管理部门负责销毁。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十八条 当事人不服行政处罚决定的，可以在接到处罚决定通知之日起15天内向人民法院起诉。但是，对畜牧兽医行政管理部门作出的兽药控制的决定，当事人必须执行。对处罚决定不履行，期满又不起诉的，由作出行政处罚决定的机关申请人民法院强制执行。文章源自FOFCC-http://fofcc.org.cn/am/11220/
第四十九条 违反本条例规定，造成中毒事故或者对畜禽等动物造成其他危害后果的，致害单位或者个人应当承担赔偿责任。受害的一方可以请求县级以上人民政府畜牧兽医行政管理部门处理。当事人对处理决定不服的，可以在接到通知之日起15天内向人民法院起诉。文章源自FOFCC-http://fofcc.org.cn/am/11220/
受害的一方也可以直接向人民法院起诉。文章源自FOFCC-http://fofcc.org.cn/am/11220/
赔偿的请求，应当从受害一方知道或者应当知道其权利被侵害之日起1年内提出；超过期限的，不予受理。文章源自FOFCC-http://fofcc.org.cn/am/11220/
Chapter IX Supplementary Provisions文章源自FOFCC-http://fofcc.org.cn/am/11220/
第五十条 本条例下列用语的含义是：文章源自FOFCC-http://fofcc.org.cn/am/11220/
（一）畜禽等动物：指家畜、家禽、鱼类、蜜蜂、蚕及其他人工饲养的动物。文章源自FOFCC-http://fofcc.org.cn/am/11220/
（二）兽药：指用于预防、治疗、诊断畜禽等动物疾病，有目的地调节其生理机能并规定作用、用途、用法、用量的物质（含饲料药物添加剂）。包括：文章源自FOFCC-http://fofcc.org.cn/am/11220/
1.血清、菌（疫）苗、诊断液等生物制品；文章源自FOFCC-http://fofcc.org.cn/am/11220/
2.兽用的中药材、中成药、化学原料药及其制剂；文章源自FOFCC-http://fofcc.org.cn/am/11220/
3.抗生素、生化药品、放射性药品。文章源自FOFCC-http://fofcc.org.cn/am/11220/
（三）新兽药：指我国新研制出的兽药原料药品。文章源自FOFCC-http://fofcc.org.cn/am/11220/
(4) New veterinary drug preparations: refer to veterinary drug preparations newly developed and processed from veterinary drug raw materials.文章源自FOFCC-http://fofcc.org.cn/am/11220/
Article 51 These Regulations shall come into force on January 1, 1988, and the Interim Regulations on the Administration of Veterinary Drugs approved and transmitted by the State Council on August 26, 1980 shall be repealed simultaneously.文章源自FOFCC-http://fofcc.org.cn/am/11220/