KYB CHINA(2004年4月9日中华人民共和国国务院令第404号公布 根据2014年7月29日《国务院关于修改部分行政法规的决定》第一次修订 根据2016年2月6日《国务院关于修改部分行政法规的决定》第二次修订 根据2020年3月27日《国务院关于修改和废止部分行政法规的决定》第三次修订)
(Promulgated by Decree No. 404 of the State Council of the People's Republic of China on April 9, 2004; first revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on July 29, 2014; second revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on February 6, 2016; third revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on March 27, 2020)
总则
General Provisions
为了加强兽药管理，保证兽药质量，防治动物疾病，促进养殖业的发展，维护人体健康，制定本条例。
This Regulation is formulated to strengthen the management of veterinary drugs, ensure the quality of veterinary drugs, prevent and treat animal diseases, promote the development of the breeding industry, and safeguard human health.
在中华人民共和国境内从事兽药的研制、生产、经营、进出口、使用和监督管理，应当遵守本条例。
The research, production, operation, import, export, use, and supervision of veterinary drugs within the territory of the People's Republic of China shall comply with this Regulation.
国务院兽医行政管理部门负责全国的兽药监督管理工作。
The veterinary administrative department of the State Council shall be responsible for the supervision and administration of veterinary drugs nationwide.
县级以上地方人民政府兽医行政管理部门负责本行政区域内的兽药监督管理工作。
The veterinary administrative departments of local people's governments at or above the county level shall be responsible for the supervision and administration of veterinary drugs within their respective administrative regions.
国家实行兽用处方药和非处方药分类管理制度。兽用处方药和非处方药分类管理的办法和具体实施步骤，由国务院兽医行政管理部门规定。
The State implements a classified management system for veterinary prescription drugs and non-prescription drugs. The measures and specific implementation steps for the classified management of veterinary prescription drugs and non-prescription drugs shall be prescribed by the veterinary administrative department of the State Council.
国家实行兽药储备制度。
The State implements a veterinary drug reserve system.
发生重大动物疫情、灾情或者其他突发事件时，国务院兽医行政管理部门可以紧急调用国家储备的兽药；必要时，也可以调用国家储备以外的兽药。
In the event of a major animal epidemic, disaster, or other emergency, the veterinary administrative department of the State Council may urgently call upon the state-reserved veterinary drugs; if necessary, it may also call upon veterinary drugs other than those in the state reserve.
新兽药研制
Development of New Veterinary Drugs
国家鼓励研制新兽药，依法保护研制者的合法权益。
The State encourages the research and development of new veterinary drugs and protects the legitimate rights and interests of the developers in accordance with the law.
研制新兽药，应当具有与研制相适应的场所、仪器设备、专业技术人员、安全管理规范和措施。
To research and develop a new veterinary drug, one shall have the appropriate premises, instruments and equipment, professional technical personnel, and safety management norms and measures.
研制新兽药，应当进行安全性评价。从事兽药安全性评价的单位应当遵守国务院兽医行政管理部门制定的兽药非临床研究质量管理规范和兽药临床试验质量管理规范。
Safety evaluation shall be conducted for the research and development of new veterinary drugs. Units engaged in veterinary drug safety evaluation shall comply with the veterinary drug non-clinical research quality management norms and veterinary drug clinical trial quality management norms formulated by the veterinary administrative department of the State Council.
省级以上人民政府兽医行政管理部门应当对兽药安全性评价单位是否符合兽药非临床研究质量管理规范和兽药临床试验质量管理规范的要求进行监督检查，并公布监督检查结果。
The veterinary administrative departments of the people's governments at or above the provincial level shall supervise and inspect whether veterinary drug safety evaluation units comply with the requirements of the veterinary drug non-clinical research quality management norms and veterinary drug clinical trial quality management norms, and shall publish the results of the supervision and inspection.
研制新兽药，应当在临床试验前向临床试验场所所在地省、自治区、直辖市人民政府兽医行政管理部门备案，并附具该新兽药实验室阶段安全性评价报告及其他临床前研究资料。
To research and develop a new veterinary drug, one shall file a record with the veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial site is located before the clinical trial, and attach the safety evaluation report of the new veterinary drug at the laboratory stage and other preclinical research materials.
研制的新兽药属于生物制品的，应当在临床试验前向国务院兽医行政管理部门提出申请，国务院兽医行政管理部门应当自收到申请之日起60个工作日内将审查结果书面通知申请人。
If the new veterinary drug under research and development is a biological product, an application shall be submitted to the veterinary administrative department of the State Council before the clinical trial. The veterinary administrative department of the State Council shall notify the applicant in writing of the review result within 60 working days from the date of receiving the application.
研制新兽药需要使用一类病原微生物的，还应当具备国务院兽医行政管理部门规定的条件，并在实验室阶段前报国务院兽医行政管理部门批准。
If the research and development of a new veterinary drug requires the use of a class I pathogen, the conditions stipulated by the veterinary administrative department of the State Council shall also be met, and approval from the veterinary administrative department of the State Council shall be obtained before the laboratory stage.
临床试验完成后，新兽药研制者向国务院兽医行政管理部门提出新兽药注册申请时，应当提交该新兽药的样品和下列资料：
After the completion of the clinical trial, when the developer of the new veterinary drug submits an application for registration of the new veterinary drug to the veterinary administrative department of the State Council, it shall submit the sample of the new veterinary drug and the following materials:
(一)名称、主要成分、理化性质；
(1) Name, main components, physical and chemical properties;
(二)研制方法、生产工艺、质量标准和检测方法；
(2) Research and development methods, production processes, quality standards, and testing methods;
(三)药理和毒理试验结果、临床试验报告和稳定性试验报告；
(3) Results of pharmacological and toxicological tests, clinical trial reports, and stability test reports;
(四)环境影响报告和污染防治措施。
(4) Environmental impact report and pollution prevention measures.
研制的新兽药属于生物制品的，还应当提供菌(毒、虫)种、细胞等有关材料和资料。菌(毒、虫)种、细胞由国务院兽医行政管理部门指定的机构保藏。
If the new veterinary drug under development is a biological product, relevant materials and information such as strains (viruses, parasites) and cells shall also be provided. The strains (viruses, parasites) and cells shall be deposited in an institution designated by the veterinary administrative department of the State Council.
研制用于食用动物的新兽药，还应当按照国务院兽医行政管理部门的规定进行兽药残留试验并提供休药期、最高残留限量标准、残留检测方法及其制定依据等资料。
If the new veterinary drug under development is intended for use in food-producing animals, veterinary drug residue tests shall also be conducted in accordance with the regulations of the veterinary administrative department of the State Council, and information such as withdrawal period, maximum residue limit standards, residue detection methods, and the basis for their establishment shall be provided.
国务院兽医行政管理部门应当自收到申请之日起10个工作日内，将决定受理的新兽药资料送其设立的兽药评审机构进行评审，将新兽药样品送其指定的检验机构复核检验，并自收到评审和复核检验结论之日起60个工作日内完成审查。审查合格的，发给新兽药注册证书，并发布该兽药的质量标准；不合格的，应当书面通知申请人。
The veterinary administrative department of the State Council shall, within 10 working days from the date of receipt of the application, submit the accepted new veterinary drug materials to the veterinary drug evaluation institution established by it for evaluation, and submit the new veterinary drug samples to the designated inspection institution for re-inspection. The review shall be completed within 60 working days from the date of receipt of the evaluation and re-inspection conclusions. If the review is passed, a new veterinary drug registration certificate shall be issued, and the quality standard for the veterinary drug shall be published; if not passed, the applicant shall be notified in writing.
国家对依法获得注册的、含有新化合物的兽药的申请人提交的其自己所取得且未披露的试验数据和其他数据实施保护。
The State provides protection for test data and other data that have not been disclosed and are submitted by the applicant of a veterinary drug containing a new compound that has been legally obtained registration.
自注册之日起6年内，对其他申请人未经已获得注册兽药的申请人同意，使用前款规定的数据申请兽药注册的，兽药注册机关不予注册；但是，其他申请人提交其自己所取得的数据的除外。
Within 6 years from the date of registration, if another applicant uses the data specified in the preceding paragraph to apply for veterinary drug registration without the consent of the applicant who has obtained the registration of the veterinary drug, the veterinary drug registration authority shall not register; however, this does not apply if the other applicant submits data obtained by itself.
除下列情况外，兽药注册机关不得披露本条第一款规定的数据：
Except in the following circumstances, the veterinary drug registration authority shall not disclose the data specified in the first paragraph of this Article:
(一)公共利益需要；
(1) Necessary for the public interest;
(二)已采取措施确保该类信息不会被不正当地进行商业使用。
(2) Measures have been taken to ensure that such information will not be improperly used for commercial purposes.
兽药生产
Veterinary Drug Production
从事兽药生产的企业，应当符合国家兽药行业发展规划和产业政策，并具备下列条件：
Enterprises engaged in the production of veterinary drugs shall comply with the national veterinary drug industry development plan and industrial policies, and shall meet the following conditions:
(一)与所生产的兽药相适应的兽医学、药学或者相关专业的技术人员；
(1) Having technical personnel in veterinary medicine, pharmacy, or related disciplines appropriate to the veterinary drugs produced;
(二)与所生产的兽药相适应的厂房、设施；
(2) Having factory buildings and facilities appropriate to the veterinary drugs produced;
(三)与所生产的兽药相适应的兽药质量管理和质量检验的机构、人员、仪器设备；
(3) Having institutions, personnel, and instruments and equipment for veterinary drug quality management and quality inspection appropriate to the veterinary drugs produced;
(四)符合安全、卫生要求的生产环境；
(4) Having a production environment that meets safety and hygiene requirements;
(五)兽药生产质量管理规范规定的其他生产条件。
(5) Other production conditions specified in the Good Manufacturing Practice for veterinary drugs.
符合前款规定条件的，申请人方可向省、自治区、直辖市人民政府兽医行政管理部门提出申请，并附具符合前款规定条件的证明材料；省、自治区、直辖市人民政府兽医行政管理部门应当自收到申请之日起40个工作日内完成审查。经审查合格的，发给兽药生产许可证；不合格的，应当书面通知申请人。
An applicant who meets the conditions specified in the preceding paragraph may submit an application to the veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, along with supporting documents proving compliance with the said conditions. The veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall complete the review within 40 working days from the date of receiving the application. If the review is passed, a veterinary drug production license shall be issued; if not, the applicant shall be notified in writing.
兽药生产许可证应当载明生产范围、生产地点、有效期和法定代表人姓名、住址等事项。
A veterinary drug production license shall specify the production scope, production location, validity period, and the name and address of the legal representative.
兽药生产许可证有效期为5年。有效期届满，需要继续生产兽药的，应当在许可证有效期届满前6个月到发证机关申请换发兽药生产许可证。
The validity period of a veterinary drug production license is five years. If it is necessary to continue producing veterinary drugs upon expiration, an application for renewal of the veterinary drug production license shall be submitted to the issuing authority within six months before the expiration of the license.
兽药生产企业变更生产范围、生产地点的，应当依照本条例第十一条的规定申请换发兽药生产许可证；变更企业名称、法定代表人的，应当在办理工商变更登记手续后15个工作日内，到发证机关申请换发兽药生产许可证。
If a veterinary drug production enterprise changes its production scope or production location, it shall apply for a new veterinary drug production license in accordance with Article 11 of these Regulations; if it changes its enterprise name or legal representative, it shall apply to the license-issuing authority for a new veterinary drug production license within 15 working days after completing the industrial and commercial change registration procedures.
兽药生产企业应当按照国务院兽医行政管理部门制定的兽药生产质量管理规范组织生产。
Veterinary drug production enterprises shall organize production in accordance with the Good Manufacturing Practice for Veterinary Drugs formulated by the veterinary administrative department of the State Council.
省级以上人民政府兽医行政管理部门，应当对兽药生产企业是否符合兽药生产质量管理规范的要求进行监督检查，并公布检查结果。
The veterinary administrative departments of the people's governments at or above the provincial level shall supervise and inspect whether veterinary drug production enterprises comply with the requirements of the Good Manufacturing Practice for Veterinary Drugs, and publish the inspection results.
兽药生产企业生产兽药，应当取得国务院兽医行政管理部门核发的产品批准文号，产品批准文号的有效期为5年。兽药产品批准文号的核发办法由国务院兽医行政管理部门制定。
To produce veterinary drugs, a veterinary drug production enterprise shall obtain a product approval number issued by the veterinary administrative department of the State Council, and the validity period of the product approval number is 5 years. The measures for issuing veterinary drug product approval numbers shall be formulated by the veterinary administrative department of the State Council.
兽药生产企业应当按照兽药国家标准和国务院兽医行政管理部门批准的生产工艺进行生产。兽药生产企业改变影响兽药质量的生产工艺的，应当报原批准部门审核批准。
Veterinary drug production enterprises shall produce in accordance with the national standards for veterinary drugs and the production processes approved by the veterinary administrative department of the State Council. If a veterinary drug production enterprise changes a production process that affects the quality of veterinary drugs, it shall report to the original approving department for review and approval.
兽药生产企业应当建立生产记录，生产记录应当完整、准确。
Veterinary drug production enterprises shall establish production records, which shall be complete and accurate.
生产兽药所需的原料、辅料，应当符合国家标准或者所生产兽药的质量要求。
The raw materials and auxiliary materials required for the production of veterinary drugs shall meet the national standards or the quality requirements of the veterinary drugs being produced.
直接接触兽药的包装材料和容器应当符合药用要求。
Packaging materials and containers that directly contact veterinary drugs shall meet pharmaceutical requirements.
兽药出厂前应当经过质量检验，不符合质量标准的不得出厂。
Veterinary drugs shall undergo quality inspection before leaving the factory; those that do not meet the quality standards shall not leave the factory.
兽药出厂应当附有产品质量合格证。
Veterinary drugs leaving the factory shall be accompanied by a product quality certificate.
禁止生产假、劣兽药。
The production of counterfeit and substandard veterinary drugs is prohibited.
兽药生产企业生产的每批兽用生物制品，在出厂前应当由国务院兽医行政管理部门指定的检验机构审查核对，并在必要时进行抽查检验；未经审查核对或者抽查检验不合格的，不得销售。
Each batch of veterinary biological products produced by a veterinary drug manufacturing enterprise shall, before leaving the factory, be reviewed and verified by an inspection institution designated by the veterinary administrative department of the State Council, and shall be subject to random inspection when necessary; those that have not been reviewed and verified or have failed the random inspection shall not be sold.
强制免疫所需兽用生物制品，由国务院兽医行政管理部门指定的企业生产。
Veterinary biological products required for compulsory immunization shall be produced by enterprises designated by the veterinary administrative department of the State Council.
兽药包装应当按照规定印有或者贴有标签，附具说明书，并在显著位置注明“兽用”字样。
Veterinary drug packaging shall be printed or affixed with labels and accompanied by instructions in accordance with regulations, and the words "For Veterinary Use Only" shall be clearly marked in a prominent position.
兽药的标签和说明书经国务院兽医行政管理部门批准并公布后，方可使用。
The labels and instructions of veterinary drugs may only be used after being approved and published by the veterinary administrative department of the State Council.
兽药的标签或者说明书，应当以中文注明兽药的通用名称、成分及其含量、规格、生产企业、产品批准文号(进口兽药注册证号)、产品批号、生产日期、有效期、适应症或者功能主治、用法、用量、休药期、禁忌、不良反应、注意事项、运输贮存保管条件及其他应当说明的内容。有商品名称的，还应当注明商品名称。
The labels or instructions of veterinary drugs shall indicate in Chinese the generic name, ingredients and their content, specifications, manufacturing enterprise, product approval number (import veterinary drug registration certificate number), batch number, production date, expiration date, indications or functions, usage, dosage, withdrawal period, contraindications, adverse reactions, precautions, conditions for transportation, storage and preservation, and other content that should be explained. If there is a trade name, it shall also be indicated.
除前款规定的内容外，兽用处方药的标签或者说明书还应当印有国务院兽医行政管理部门规定的警示内容，其中兽用麻醉药品、精神药品、毒性药品和放射性药品还应当印有国务院兽医行政管理部门规定的特殊标志；兽用非处方药的标签或者说明书还应当印有国务院兽医行政管理部门规定的非处方药标志。
In addition to the content specified in the preceding paragraph, the labels or instructions of veterinary prescription drugs shall also be printed with warning content prescribed by the veterinary administrative department of the State Council, among which veterinary narcotic drugs, psychotropic drugs, toxic drugs, and radioactive drugs shall also be printed with special marks prescribed by the veterinary administrative department of the State Council; the labels or instructions of veterinary non-prescription drugs shall also be printed with the non-prescription drug mark prescribed by the veterinary administrative department of the State Council.
国务院兽医行政管理部门，根据保证动物产品质量安全和人体健康的需要，可以对新兽药设立不超过5年的监测期；在监测期内，不得批准其他企业生产或者进口该新兽药。生产企业应当在监测期内收集该新兽药的疗效、不良反应等资料，并及时报送国务院兽医行政管理部门。
The veterinary administrative department of the State Council may, based on the need to ensure the quality and safety of animal products and human health, establish a monitoring period of no more than 5 years for new veterinary drugs; during the monitoring period, no other enterprise shall be approved to produce or import such new veterinary drugs. The manufacturing enterprise shall collect data on the efficacy, adverse reactions, etc. of the new veterinary drug during the monitoring period and promptly submit it to the veterinary administrative department of the State Council.
兽药经营
Veterinary Drug Business
经营兽药的企业，应当具备下列条件：
Enterprises engaged in the business of veterinary drugs shall meet the following conditions:
(一)与所经营的兽药相适应的兽药技术人员；
(1) Veterinary drug technical personnel suitable for the veterinary drugs being operated;
(二)与所经营的兽药相适应的营业场所、设备、仓库设施；
(2) Business premises, equipment, and warehouse facilities suitable for the veterinary drugs being operated;
(三)与所经营的兽药相适应的质量管理机构或者人员；
(3) Quality management organization or personnel suitable for the veterinary drugs being operated;
(四)兽药经营质量管理规范规定的其他经营条件。
(4) Other operating conditions stipulated in the veterinary drug business quality management standards.
符合前款规定条件的，申请人方可向市、县人民政府兽医行政管理部门提出申请，并附具符合前款规定条件的证明材料；经营兽用生物制品的，应当向省、自治区、直辖市人民政府兽医行政管理部门提出申请，并附具符合前款规定条件的证明材料。
Applicants who meet the conditions specified in the preceding paragraph may submit an application to the veterinary administrative department of the people's government at the city or county level, along with supporting documents proving compliance with the conditions; for operating veterinary biological products, the application shall be submitted to the veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, along with supporting documents proving compliance with the conditions.
县级以上地方人民政府兽医行政管理部门，应当自收到申请之日起30个工作日内完成审查。审查合格的，发给兽药经营许可证；不合格的，应当书面通知申请人。
The veterinary administrative department of the local people's government at or above the county level shall complete the review within 30 working days from the date of receiving the application. If the review is passed, a veterinary drug business license shall be issued; if not, the applicant shall be notified in writing.
兽药经营许可证应当载明经营范围、经营地点、有效期和法定代表人姓名、住址等事项。
The veterinary drug business license shall specify the business scope, business location, validity period, and the name and address of the legal representative, among other matters.
兽药经营许可证有效期为5年。有效期届满，需要继续经营兽药的，应当在许可证有效期届满前6个月到发证机关申请换发兽药经营许可证。
The validity period of the veterinary drug business license is 5 years. If it is necessary to continue operating veterinary drugs after the expiration, an application for renewal of the veterinary drug business license shall be submitted to the issuing authority within 6 months before the expiration of the license.
兽药经营企业变更经营范围、经营地点的，应当依照本条例第二十二条的规定申请换发兽药经营许可证；变更企业名称、法定代表人的，应当在办理工商变更登记手续后15个工作日内，到发证机关申请换发兽药经营许可证。
If a veterinary drug business enterprise changes its business scope or business location, it shall apply for a renewal of the veterinary drug business license in accordance with Article 22 of these Regulations; if it changes its enterprise name or legal representative, it shall apply to the issuing authority for a renewal of the veterinary drug business license within 15 working days after completing the industrial and commercial change registration procedures.
兽药经营企业，应当遵守国务院兽医行政管理部门制定的兽药经营质量管理规范。
Veterinary drug business enterprises shall comply with the veterinary drug business quality management standards formulated by the veterinary administrative department of the State Council.
县级以上地方人民政府兽医行政管理部门，应当对兽药经营企业是否符合兽药经营质量管理规范的要求进行监督检查，并公布检查结果。
The veterinary administrative department of the local people's government at or above the county level shall supervise and inspect whether veterinary drug business enterprises comply with the requirements of the Veterinary Drug Business Quality Management Standards, and shall publish the inspection results.
兽药经营企业购进兽药，应当将兽药产品与产品标签或者说明书、产品质量合格证核对无误。
When purchasing veterinary drugs, a veterinary drug business enterprise shall verify the veterinary drug product against the product label or instructions and the product quality certificate to ensure consistency.
兽药经营企业，应当向购买者说明兽药的功能主治、用法、用量和注意事项。销售兽用处方药的，应当遵守兽用处方药管理办法。
A veterinary drug business enterprise shall explain to the purchaser the functions, indications, usage, dosage, and precautions of the veterinary drug. When selling veterinary prescription drugs, it shall comply with the measures for the administration of veterinary prescription drugs.
兽药经营企业销售兽用中药材的，应当注明产地。
When selling Chinese medicinal materials for veterinary use, a veterinary drug business enterprise shall indicate the place of origin.
禁止兽药经营企业经营人用药品和假、劣兽药。
Veterinary drug business enterprises are prohibited from dealing in human drugs or counterfeit or inferior veterinary drugs.
兽药经营企业购销兽药，应当建立购销记录。购销记录应当载明兽药的商品名称、通用名称、剂型、规格、批号、有效期、生产厂商、购销单位、购销数量、购销日期和国务院兽医行政管理部门规定的其他事项。
A veterinary drug business enterprise shall establish purchase and sale records for the purchase and sale of veterinary drugs. The purchase and sale records shall include the trade name, generic name, dosage form, specification, batch number, expiry date, manufacturer, purchasing/selling unit, quantity, date, and other matters prescribed by the veterinary administrative department of the State Council.
兽药经营企业，应当建立兽药保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保持所经营兽药的质量。
A veterinary drug business enterprise shall establish a veterinary drug storage system, take necessary measures such as refrigeration, freeze protection, moisture protection, insect control, and rodent control, and maintain the quality of the veterinary drugs it deals in.
兽药入库、出库，应当执行检查验收制度，并有准确记录。
The receipt and dispatch of veterinary drugs shall be subject to an inspection and acceptance system, and accurate records shall be kept.
强制免疫所需兽用生物制品的经营，应当符合国务院兽医行政管理部门的规定。
The business of veterinary biological products required for compulsory immunization shall comply with the provisions of the veterinary administrative department of the State Council.
兽药广告的内容应当与兽药说明书内容相一致，在全国重点媒体发布兽药广告的，应当经国务院兽医行政管理部门审查批准，取得兽药广告审查批准文号。在地方媒体发布兽药广告的，应当经省、自治区、直辖市人民政府兽医行政管理部门审查批准，取得兽药广告审查批准文号；未经批准的，不得发布。
The content of a veterinary drug advertisement shall be consistent with the content of the veterinary drug instructions. For advertisements published in national key media, approval from the veterinary administrative department of the State Council shall be obtained, and an approval number for veterinary drug advertisement review shall be obtained. For advertisements published in local media, approval from the veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall be obtained, and an approval number for veterinary drug advertisement review shall be obtained; without approval, no advertisement shall be published.
兽药进出口
Import and Export of Veterinary Drugs
首次向中国出口的兽药，由出口方驻中国境内的办事机构或者其委托的中国境内代理机构向国务院兽医行政管理部门申请注册，并提交下列资料和物品：
For veterinary drugs to be exported to China for the first time, the exporting party's office in China or its entrusted agent in China shall apply for registration to the veterinary administrative department of the State Council, and submit the following materials and items:
(一)生产企业所在国家(地区)兽药管理部门批准生产、销售的证明文件。
(1) Certificates of approval for production and sale issued by the veterinary drug administration of the country (region) where the manufacturer is located.
(二)生产企业所在国家(地区)兽药管理部门颁发的符合兽药生产质量管理规范的证明文件。
(2) Certificates issued by the veterinary drug administration of the country (region) where the manufacturer is located, confirming compliance with Good Manufacturing Practice for veterinary drugs.
(三)兽药的制造方法、生产工艺、质量标准、检测方法、药理和毒理试验结果、临床试验报告、稳定性试验报告及其他相关资料；用于食用动物的兽药的休药期、最高残留限量标准、残留检测方法及其制定依据等资料。
(3) Manufacturing methods, production processes, quality standards, testing methods, pharmacological and toxicological test results, clinical trial reports, stability test reports, and other relevant materials; for veterinary drugs used in food animals, information on withdrawal periods, maximum residue limits, residue testing methods, and the basis for their establishment.
(四)兽药的标签和说明书样本。
(4) Samples of labels and package inserts of the veterinary drug.
(五)兽药的样品、对照品、标准品。
(5) Samples, reference substances, and standards of the veterinary drug.
(六)环境影响报告和污染防治措施。
(6) Environmental impact report and pollution prevention measures.
(七)涉及兽药安全性的其他资料。
(7) Other materials related to the safety of the veterinary drug.
申请向中国出口兽用生物制品的，还应当提供菌(毒、虫)种、细胞等有关材料和资料。
For applications to export veterinary biological products to China, relevant materials and information such as strains (viruses, parasites), cells, etc., shall also be provided.
国务院兽医行政管理部门，应当自收到申请之日起10个工作日内组织初步审查。经初步审查合格的，应当将决定受理的兽药资料送其设立的兽药评审机构进行评审，将该兽药样品送其指定的检验机构复核检验，并自收到评审和复核检验结论之日起60个工作日内完成审查。经审查合格的，发给进口兽药注册证书，并发布该兽药的质量标准；不合格的，应当书面通知申请人。
The veterinary administrative department of the State Council shall, within 10 working days from the date of receiving the application, organize a preliminary review. If the preliminary review is passed, it shall submit the veterinary drug materials decided to be accepted to the veterinary drug evaluation institution established by it for evaluation, and submit the veterinary drug samples to the designated inspection institution for re-inspection, and complete the review within 60 working days from the date of receiving the evaluation and re-inspection conclusions. If the review is passed, an import veterinary drug registration certificate shall be issued, and the quality standard of the veterinary drug shall be published; if not passed, the applicant shall be notified in writing.
在审查过程中，国务院兽医行政管理部门可以对向中国出口兽药的企业是否符合兽药生产质量管理规范的要求进行考查，并有权要求该企业在国务院兽医行政管理部门指定的机构进行该兽药的安全性和有效性试验。
During the review process, the veterinary administrative department of the State Council may inspect whether the enterprise exporting veterinary drugs to China complies with the requirements of the Good Manufacturing Practice for Veterinary Drugs, and has the right to require the enterprise to conduct safety and efficacy tests of the veterinary drug at an institution designated by the veterinary administrative department of the State Council.
国内急需兽药、少量科研用兽药或者注册兽药的样品、对照品、标准品的进口，按照国务院兽医行政管理部门的规定办理。
The import of veterinary drugs urgently needed domestically, veterinary drugs for small-scale scientific research, or samples, reference substances, and standard substances of registered veterinary drugs shall be handled in accordance with the provisions of the veterinary administrative department of the State Council.
进口兽药注册证书的有效期为5年。有效期届满，需要继续向中国出口兽药的，应当在有效期届满前6个月到发证机关申请再注册。
The validity period of the import veterinary drug registration certificate is 5 years. If it is necessary to continue exporting veterinary drugs to China after the expiration of the validity period, an application for re-registration shall be made to the issuing authority 6 months before the expiration of the validity period.
境外企业不得在中国直接销售兽药。境外企业在中国销售兽药，应当依法在中国境内设立销售机构或者委托符合条件的中国境内代理机构。
Overseas enterprises shall not directly sell veterinary drugs in China. Overseas enterprises selling veterinary drugs in China shall establish a sales institution in China or entrust a qualified domestic agency in China in accordance with the law.
进口在中国已取得进口兽药注册证书的兽药的，中国境内代理机构凭进口兽药注册证书到口岸所在地人民政府兽医行政管理部门办理进口兽药通关单。海关凭进口兽药通关单放行。兽药进口管理办法由国务院兽医行政管理部门会同海关总署制定。
For the import of veterinary drugs that have obtained an import veterinary drug registration certificate in China, the domestic agency in China shall, with the import veterinary drug registration certificate, go to the veterinary administrative department of the local people's government at the port to handle the import veterinary drug customs clearance form. The customs shall release the goods upon the import veterinary drug customs clearance form. The measures for the administration of veterinary drug import shall be formulated by the veterinary administrative department of the State Council jointly with the General Administration of Customs.
兽用生物制品进口后，应当依照本条例第十九条的规定进行审查核对和抽查检验。其他兽药进口后，由当地兽医行政管理部门通知兽药检验机构进行抽查检验。
After the import of veterinary biological products, they shall be reviewed, checked, and sampled for inspection in accordance with the provisions of Article 19 of these Regulations. After the import of other veterinary drugs, the local veterinary administrative department shall notify the veterinary drug inspection institution to conduct random inspection.
禁止进口下列兽药：
The import of the following veterinary drugs is prohibited:
(一)药效不确定、不良反应大以及可能对养殖业、人体健康造成危害或者存在潜在风险的；
(1) Those with uncertain efficacy, large adverse reactions, and those that may cause harm or potential risks to the aquaculture industry or human health;
(二)来自疫区可能造成疫病在中国境内传播的兽用生物制品；
(2) Veterinary biological products from epidemic areas that may cause the spread of epidemic diseases within China.
(三)经考查生产条件不符合规定的；
(3) The production conditions are found to be non-compliant after inspection;
(四)国务院兽医行政管理部门禁止生产、经营和使用的。
(4) The veterinary drug is prohibited from production, operation, and use by the veterinary administrative department of the State Council.
向中国境外出口兽药，进口方要求提供兽药出口证明文件的，国务院兽医行政管理部门或者企业所在地的省、自治区、直辖市人民政府兽医行政管理部门可以出具出口兽药证明文件。
For veterinary drugs exported to destinations outside China, if the importer requires the provision of veterinary drug export certification documents, the veterinary administrative department of the State Council or the veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located may issue an export veterinary drug certification document.
国内防疫急需的疫苗，国务院兽医行政管理部门可以限制或者禁止出口。
For vaccines urgently needed for domestic epidemic prevention, the veterinary administrative department of the State Council may restrict or prohibit export.
兽药使用
Use of Veterinary Drugs
兽药使用单位，应当遵守国务院兽医行政管理部门制定的兽药安全使用规定，并建立用药记录。
Veterinary drug users shall comply with the safe use regulations for veterinary drugs formulated by the veterinary administrative department of the State Council and shall establish medication records.
禁止使用假、劣兽药以及国务院兽医行政管理部门规定禁止使用的药品和其他化合物。禁止使用的药品和其他化合物目录由国务院兽医行政管理部门制定公布。
It is prohibited to use counterfeit orinferior veterinary drugs, as well as drugs and other compounds prohibited by the veterinary administrative department of the State Council. The catalog of prohibited drugs and other compounds shall be formulated and published by the veterinary administrative department of the State Council.
有休药期规定的兽药用于食用动物时，饲养者应当向购买者或者屠宰者提供准确、真实的用药记录；购买者或者屠宰者应当确保动物及其产品在用药期、休药期内不被用于食品消费。
When veterinary drugs with a withdrawal period are used in food-producing animals, the breeder shall provide accurate and truthful medication records to the purchaser or slaughterer; the purchaser or slaughterer shall ensure that the animals and their products are not used for food consumption during the medication period and withdrawal period.
国务院兽医行政管理部门，负责制定公布在饲料中允许添加的药物饲料添加剂品种目录。
The veterinary administrative department of the State Council is responsible for formulating and publishing the catalog of drug feed additive varieties allowed to be added in feed.
禁止在饲料和动物饮用水中添加激素类药品和国务院兽医行政管理部门规定的其他禁用药品。
It is prohibited to add hormonal drugs and other prohibited drugs specified by the veterinary administrative department of the State Council to feed and animal drinking water.
经批准可以在饲料中添加的兽药，应当由兽药生产企业制成药物饲料添加剂后方可添加。禁止将原料药直接添加到饲料及动物饮用水中或者直接饲喂动物。
Veterinary drugs approved for addition to feed shall be added only after being made into medicated feed additives by veterinary drug manufacturers. It is prohibited to directly add active pharmaceutical ingredients to feed or animal drinking water, or to directly feed animals with such ingredients.
禁止将人用药品用于动物。
It is prohibited to use human drugs for animals.
国务院兽医行政管理部门，应当制定并组织实施国家动物及动物产品兽药残留监控计划。
The veterinary administrative department of the State Council shall formulate and organize the implementation of a national monitoring plan for veterinary drug residues in animals and animal products.
县级以上人民政府兽医行政管理部门，负责组织对动物产品中兽药残留量的检测。兽药残留检测结果，由国务院兽医行政管理部门或者省、自治区、直辖市人民政府兽医行政管理部门按照权限予以公布。
The veterinary administrative departments of the people's governments at or above the county level shall be responsible for organizing the detection of veterinary drug residues in animal products. The results of veterinary drug residue testing shall be published by the veterinary administrative department of the State Council or the veterinary administrative departments of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government within their respective authorities.
动物产品的生产者、销售者对检测结果有异议的，可以自收到检测结果之日起7个工作日内向组织实施兽药残留检测的兽医行政管理部门或者其上级兽医行政管理部门提出申请，由受理申请的兽医行政管理部门指定检验机构进行复检。
Producers and sellers of animal products who have objections to the test results may, within 7 working days from the date of receipt of the test results, submit an application to the veterinary administrative department that organized the veterinary drug residue test or its superior veterinary administrative department. The veterinary administrative department that accepts the application shall designate an inspection institution to conduct a re-test.
兽药残留限量标准和残留检测方法，由国务院兽医行政管理部门制定发布。
The maximum residue limits for veterinary drugs and residue detection methods shall be formulated and published by the veterinary administrative department of the State Council.
禁止销售含有违禁药物或者兽药残留量超过标准的食用动物产品。
It is prohibited to sell edible animal products that contain prohibited drugs or have veterinary drug residues exceeding the standards.
兽药监督管理
Supervision and Administration of Veterinary Drugs
县级以上人民政府兽医行政管理部门行使兽药监督管理权。
The veterinary administrative departments of the people's governments at or above the county level shall exercise the power of supervision and administration of veterinary drugs.
兽药检验工作由国务院兽医行政管理部门和省、自治区、直辖市人民政府兽医行政管理部门设立的兽药检验机构承担。国务院兽医行政管理部门，可以根据需要认定其他检验机构承担兽药检验工作。
Veterinary drug testing work shall be undertaken by veterinary drug testing institutions established by the veterinary administrative department of the State Council and the veterinary administrative departments of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government. The veterinary administrative department of the State Council may, as needed, designate other testing institutions to undertake veterinary drug testing work.
当事人对兽药检验结果有异议的，可以自收到检验结果之日起7个工作日内向实施检验的机构或者上级兽医行政管理部门设立的检验机构申请复检。
If a party disagrees with the inspection result of a veterinary drug, it may apply for a retest to the institution that conducted the inspection or to an inspection institution established by the superior veterinary administrative department within 7 working days from the date of receiving the inspection result.
兽药应当符合兽药国家标准。
Veterinary drugs shall comply with the national standards for veterinary drugs.
国家兽药典委员会拟定的、国务院兽医行政管理部门发布的《中华人民共和国兽药典》和国务院兽医行政管理部门发布的其他兽药质量标准为兽药国家标准。
The Veterinary Pharmacopoeia of the People's Republic of China, drafted by the National Veterinary Pharmacopoeia Committee and promulgated by the veterinary administrative department of the State Council, and other veterinary drug quality standards promulgated by the veterinary administrative department of the State Council constitute the national standards for veterinary drugs.
兽药国家标准的标准品和对照品的标定工作由国务院兽医行政管理部门设立的兽药检验机构负责。
The calibration of standard substances and reference substances for national standards of veterinary drugs shall be the responsibility of the veterinary drug inspection institution established by the veterinary administrative department of the State Council.
兽医行政管理部门依法进行监督检查时，对有证据证明可能是假、劣兽药的，应当采取查封、扣押的行政强制措施，并自采取行政强制措施之日起7个工作日内作出是否立案的决定；需要检验的，应当自检验报告书发出之日起15个工作日内作出是否立案的决定；不符合立案条件的，应当解除行政强制措施；需要暂停生产的，由国务院兽医行政管理部门或者省、自治区、直辖市人民政府兽医行政管理部门按照权限作出决定；需要暂停经营、使用的，由县级以上人民政府兽医行政管理部门按照权限作出决定。
When conducting supervision and inspection according to law, if the veterinary administrative department has evidence that a veterinary drug may be counterfeit or inferior, it shall take administrative compulsory measures such as seizure and detention, and shall decide whether to file a case within 7 working days from the date of taking the administrative compulsory measures; if inspection is required, it shall decide whether to file a case within 15 working days from the date of issuance of the inspection report; if the conditions for filing a case are not met, the administrative compulsory measures shall be lifted; if production needs to be suspended, the veterinary administrative department of the State Council or the veterinary administrative department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall make a decision according to its authority; if operation or use needs to be suspended, the veterinary administrative department of the people's government at or above the county level shall make a decision according to its authority.
未经行政强制措施决定机关或者其上级机关批准，不得擅自转移、使用、销毁、销售被查封或者扣押的兽药及有关材料。
Without the approval of the authority that decided the administrative compulsory measures or its superior authority, no one may transfer, use, destroy, or sell the seized or detained veterinary drugs and related materials.
有下列情形之一的，为假兽药：
A veterinary drug shall be considered counterfeit in any of the following circumstances:
(一)以非兽药冒充兽药或者以他种兽药冒充此种兽药的；
(1) A non-veterinary drug is passed off as a veterinary drug, or one type of veterinary drug is passed off as another type;
(二)兽药所含成分的种类、名称与兽药国家标准不符合的。
(2) The type or name of the ingredients contained in the veterinary drug does not conform to the national standards for veterinary drugs.
有下列情形之一的，按照假兽药处理：
A veterinary drug shall be treated as counterfeit in any of the following circumstances:
(一)国务院兽医行政管理部门规定禁止使用的；
(1) Those prohibited by the veterinary administrative department of the State Council;
(二)依照本条例规定应当经审查批准而未经审查批准即生产、进口的，或者依照本条例规定应当经抽查检验、审查核对而未经抽查检验、审查核对即销售、进口的；
(2) Those produced or imported without the required examination and approval according to these Regulations, or those sold or imported without the required sampling inspection, examination, and verification according to these Regulations;
(三)变质的；
(3) Those that have deteriorated;
(四)被污染的；
(4) Those that are contaminated;
(五)所标明的适应症或者功能主治超出规定范围的。
(5) Those whose indicated indications or functional indications exceed the prescribed scope.
有下列情形之一的，为劣兽药：
A veterinary drug shall be considered substandard in any of the following circumstances:
(一)成分含量不符合兽药国家标准或者不标明有效成分的；
(1) The content of ingredients does not meet the national standards for veterinary drugs, or the active ingredients are not indicated;
(二)不标明或者更改有效期或者超过有效期的；
(2) The expiration date is not indicated or is altered, or the drug has exceeded its expiration date;
(三)不标明或者更改产品批号的；
(3) The batch number is not indicated or is altered;
(四)其他不符合兽药国家标准，但不属于假兽药的。
(4) Other circumstances where the drug does not meet the national standards for veterinary drugs but does not constitute a counterfeit veterinary drug.
禁止将兽用原料药拆零销售或者销售给兽药生产企业以外的单位和个人。
It is prohibited to sell veterinary drug raw materials in broken packages or to sell them to entities or individuals other than veterinary drug manufacturers.
禁止未经兽医开具处方销售、购买、使用国务院兽医行政管理部门规定实行处方药管理的兽药。
It is prohibited to sell, purchase, or use veterinary drugs that are subject to prescription management as prescribed by the veterinary administrative department of the State Council without a prescription issued by a veterinarian.
国家实行兽药不良反应报告制度。
The State implements a veterinary drug adverse reaction reporting system.
兽药生产企业、经营企业、兽药使用单位和开具处方的兽医人员发现可能与兽药使用有关的严重不良反应，应当立即向所在地人民政府兽医行政管理部门报告。
Veterinary drug manufacturers, business operators, veterinary drug users, and veterinarians who issue prescriptions shall immediately report to the veterinary administrative department of the local people's government when they discover serious adverse reactions that may be related to the use of veterinary drugs.
兽药生产企业、经营企业停止生产、经营超过6个月或者关闭的，由发证机关责令其交回兽药生产许可证、兽药经营许可证。
If a veterinary drug manufacturer or business operator ceases production or operation for more than six months or closes down, the issuing authority shall order it to return the veterinary drug production license or veterinary drug business license.
禁止买卖、出租、出借兽药生产许可证、兽药经营许可证和兽药批准证明文件。
It is prohibited to buy, sell, lease, or lend veterinary drug production licenses, veterinary drug business licenses, and veterinary drug approval certificates.
兽药评审检验的收费项目和标准，由国务院财政部门会同国务院价格主管部门制定，并予以公告。
The charging items and standards for veterinary drug evaluation and inspection shall be formulated by the finance department of the State Council jointly with the competent price department of the State Council and shall be announced.
各级兽医行政管理部门、兽药检验机构及其工作人员，不得参与兽药生产、经营活动，不得以其名义推荐或者监制、监销兽药。
Veterinary administrative departments at all levels, veterinary drug inspection institutions, and their staff shall not participate in veterinary drug production or business activities, nor recommend, supervise the production, or supervise the sale of veterinary drugs in their name.
法律责任
Legal Liability
兽医行政管理部门及其工作人员利用职务上的便利收取他人财物或者谋取其他利益，对不符合法定条件的单位和个人核发许可证、签署审查同意意见，不履行监督职责，或者发现违法行为不予查处，造成严重后果，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，依法给予行政处分。
If a veterinary administrative department or its staff, by taking advantage of their position, accepts property from others or seeks other benefits, issues licenses or signs review approval opinions to entities or individuals that do not meet the statutory conditions, fails to perform supervision duties, or fails to investigate and deal with illegal acts discovered, causing serious consequences, which constitutes a crime, criminal liability shall be pursued according to law; if it does not constitute a crime, administrative sanctions shall be imposed according to law.
违反本条例规定，无兽药生产许可证、兽药经营许可证生产、经营兽药的，或者虽有兽药生产许可证、兽药经营许可证，生产、经营假、劣兽药的，或者兽药经营企业经营人用药品的，责令其停止生产、经营，没收用于违法生产的原料、辅料、包装材料及生产、经营的兽药和违法所得，并处违法生产、经营的兽药(包括已出售的和未出售的兽药，下同)货值金额2倍以上5倍以下罚款，货值金额无法查证核实的，处10万元以上20万元以下罚款；无兽药生产许可证生产兽药，情节严重的，没收其生产设备；生产、经营假、劣兽药，情节严重的，吊销兽药生产许可证、兽药经营许可证；构成犯罪的，依法追究刑事责任；给他人造成损失的，依法承担赔偿责任。生产、经营企业的主要负责人和直接负责的主管人员终身不得从事兽药的生产、经营活动。
Whoever, in violation of these Regulations, produces or operates veterinary drugs without a veterinary drug production license or veterinary drug operation license, or produces or operates fake or inferior veterinary drugs despite having such licenses, or operates human drugs in a veterinary drug operation enterprise, shall be ordered to stop production or operation, and the raw materials, auxiliary materials, packaging materials used for illegal production, as well as the veterinary drugs produced or operated and illegal gains, shall be confiscated, and a fine of not less than 2 times but not more than 5 times the value of the veterinary drugs illegally produced or operated (including both sold and unsold veterinary drugs, the same below) shall be imposed; if the value cannot be verified, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed; if the production of veterinary drugs without a veterinary drug production license is serious, the production equipment shall be confiscated; if the production or operation of fake or inferior veterinary drugs is serious, the veterinary drug production license or veterinary drug operation license shall be revoked; if a crime is constituted, criminal liability shall be pursued according to law; if losses are caused to others, compensation liability shall be borne according to law. The principal responsible person and the directly responsible person in charge of the production or operation enterprise shall be prohibited from engaging in veterinary drug production or operation activities for life.
擅自生产强制免疫所需兽用生物制品的，按照无兽药生产许可证生产兽药处罚。
Whoever produces veterinary biological products required for compulsory immunization without authorization shall be punished as producing veterinary drugs without a veterinary drug production license.
违反本条例规定，提供虚假的资料、样品或者采取其他欺骗手段取得兽药生产许可证、兽药经营许可证或者兽药批准证明文件的，吊销兽药生产许可证、兽药经营许可证或者撤销兽药批准证明文件，并处5万元以上10万元以下罚款；给他人造成损失的，依法承担赔偿责任。其主要负责人和直接负责的主管人员终身不得从事兽药的生产、经营和进出口活动。
Whoever, in violation of these Regulations, obtains a veterinary drug production license, veterinary drug operation license, or veterinary drug approval certificate by providing false materials, samples, or other deceptive means, shall have the veterinary drug production license, veterinary drug operation license revoked or the veterinary drug approval certificate cancelled, and a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if losses are caused to others, compensation liability shall be borne according to law. The principal responsible person and the directly responsible person in charge shall be prohibited from engaging in veterinary drug production, operation, and import-export activities for life.
买卖、出租、出借兽药生产许可证、兽药经营许可证和兽药批准证明文件的，没收违法所得，并处1万元以上10万元以下罚款；情节严重的，吊销兽药生产许可证、兽药经营许可证或者撤销兽药批准证明文件；构成犯罪的，依法追究刑事责任；给他人造成损失的，依法承担赔偿责任。
Whoever buys, sells, leases, or lends a veterinary drug production license, veterinary drug operation license, or veterinary drug approval certificate shall have the illegal gains confiscated and a fine of not less than 10,000 yuan but not more than 100,000 yuan imposed; if the circumstances are serious, the veterinary drug production license, veterinary drug operation license shall be revoked or the veterinary drug approval certificate shall be cancelled; if a crime is constituted, criminal liability shall be pursued according to law; if losses are caused to others, compensation liability shall be borne according to law.
违反本条例规定，兽药安全性评价单位、临床试验单位、生产和经营企业未按照规定实施兽药研究试验、生产、经营质量管理规范的，给予警告，责令其限期改正；逾期不改正的，责令停止兽药研究试验、生产、经营活动，并处5万元以下罚款；情节严重的，吊销兽药生产许可证、兽药经营许可证；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, fails to implement the quality management standards for veterinary drug research and testing, production, or operation by a veterinary drug safety evaluation unit, clinical trial unit, production enterprise, or operation enterprise shall be given a warning and ordered to make corrections within a specified period; if no correction is made within the period, the veterinary drug research and testing, production, or operation activities shall be ordered to stop, and a fine of not more than 50,000 yuan shall be imposed; if the circumstances are serious, the veterinary drug production license or veterinary drug operation license shall be revoked; if losses are caused to others, compensation liability shall be borne according to law.
违反本条例规定，研制新兽药不具备规定的条件擅自使用一类病原微生物或者在实验室阶段前未经批准的，责令其停止实验，并处5万元以上10万元以下罚款；构成犯罪的，依法追究刑事责任；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, develops a new veterinary drug without the prescribed conditions and uses a class I pathogen without authorization or fails to obtain approval before the laboratory stage shall be ordered to stop the experiment, and a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if a crime is constituted, criminal liability shall be pursued according to law; if losses are caused to others, compensation liability shall be borne according to law.
违反本条例规定，开展新兽药临床试验应当备案而未备案的，责令其立即改正，给予警告，并处5万元以上10万元以下罚款；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, conducts a clinical trial of a new veterinary drug that should be filed but fails to do so shall be ordered to immediately correct, given a warning, and a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if losses are caused to others, compensation liability shall be borne according to law.
违反本条例规定，兽药的标签和说明书未经批准的，责令其限期改正；逾期不改正的，按照生产、经营假兽药处罚；有兽药产品批准文号的，撤销兽药产品批准文号；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, uses a label or package insert for a veterinary drug that has not been approved shall be ordered to make corrections within a specified period; if no correction is made within the period, the punishment for producing or operating fake veterinary drugs shall be imposed; if the veterinary drug has an approval number, the approval number shall be revoked; if losses are caused to others, compensation liability shall be borne according to law.
兽药包装上未附有标签和说明书，或者标签和说明书与批准的内容不一致的，责令其限期改正；情节严重的，依照前款规定处罚。
If a veterinary drug package is not accompanied by a label or package insert, or the label or package insert is inconsistent with the approved content, the party shall be ordered to make corrections within a specified period; if the circumstances are serious, punishment shall be imposed in accordance with the preceding paragraph.
违反本条例规定，境外企业在中国直接销售兽药的，责令其限期改正，没收直接销售的兽药和违法所得，并处5万元以上10万元以下罚款；情节严重的，吊销进口兽药注册证书；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, directly sells veterinary drugs in China by an overseas enterprise shall be ordered to make corrections within a specified period, the directly sold veterinary drugs and illegal gains shall be confiscated, and a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, the import veterinary drug registration certificate shall be revoked; if losses are caused to others, compensation liability shall be borne according to law.
违反本条例规定，未按照国家有关兽药安全使用规定使用兽药的、未建立用药记录或者记录不完整真实的，或者使用禁止使用的药品和其他化合物的，或者将人用药品用于动物的，责令其立即改正，并对饲喂了违禁药物及其他化合物的动物及其产品进行无害化处理；对违法单位处1万元以上5万元以下罚款；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, fails to use veterinary drugs in accordance with the national provisions on safe use of veterinary drugs, fails to establish medication records or the records are incomplete or untrue, uses prohibited drugs or other compounds, or uses human drugs on animals, shall be ordered to make immediate corrections, and the animals and their products that have been fed with prohibited drugs or other compounds shall be subjected to harmless treatment; the violating entity shall be fined not less than 10,000 yuan but not more than 50,000 yuan; if losses are caused to others, it shall bear compensation liability according to law.
违反本条例规定，销售尚在用药期、休药期内的动物及其产品用于食品消费的，或者销售含有违禁药物和兽药残留超标的动物产品用于食品消费的，责令其对含有违禁药物和兽药残留超标的动物产品进行无害化处理，没收违法所得，并处3万元以上10万元以下罚款；构成犯罪的，依法追究刑事责任；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, sells animals or their products that are still in the medication period or withdrawal period for food consumption, or sells animal products containing prohibited drugs or with veterinary drug residues exceeding the standards for food consumption, shall be ordered to carry out harmless treatment of the animal products containing prohibited drugs or with veterinary drug residues exceeding the standards, confiscate the illegal gains, and be fined not less than 30,000 yuan but not more than 100,000 yuan; if a crime is constituted, criminal liability shall be investigated according to law; if losses are caused to others, it shall bear compensation liability according to law.
违反本条例规定，擅自转移、使用、销毁、销售被查封或者扣押的兽药及有关材料的，责令其停止违法行为，给予警告，并处5万元以上10万元以下罚款。
Whoever, in violation of these Regulations, without authorization, transfers, uses, destroys, or sells veterinary drugs or related materials that have been sealed up or detained, shall be ordered to cease the illegal act, given a warning, and be fined not less than 50,000 yuan but not more than 100,000 yuan.
违反本条例规定，兽药生产企业、经营企业、兽药使用单位和开具处方的兽医人员发现可能与兽药使用有关的严重不良反应，不向所在地人民政府兽医行政管理部门报告的，给予警告，并处5000元以上1万元以下罚款。
Whoever, in violation of these Regulations, being a veterinary drug production enterprise, business enterprise, veterinary drug user, or a veterinarian issuing prescriptions, fails to report to the veterinary administrative department of the local people's government when discovering serious adverse reactions that may be related to the use of veterinary drugs, shall be given a warning and be fined not less than 5,000 yuan but not more than 10,000 yuan.
生产企业在新兽药监测期内不收集或者不及时报送该新兽药的疗效、不良反应等资料的，责令其限期改正，并处1万元以上5万元以下罚款；情节严重的，撤销该新兽药的产品批准文号。
If a production enterprise fails to collect or timely submit information on the efficacy, adverse reactions, etc. of a new veterinary drug during the monitoring period, it shall be ordered to make corrections within a time limit and be fined not less than 10,000 yuan but not more than 50,000 yuan; if the circumstances are serious, the product approval number of the new veterinary drug shall be revoked.
违反本条例规定，未经兽医开具处方销售、购买、使用兽用处方药的，责令其限期改正，没收违法所得，并处5万元以下罚款；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, sells, purchases, or uses veterinary prescription drugs without a prescription issued by a veterinarian, shall be ordered to make corrections within a time limit, confiscate the illegal gains, and be fined not more than 50,000 yuan; if losses are caused to others, it shall bear compensation liability according to law.
违反本条例规定，兽药生产、经营企业把原料药销售给兽药生产企业以外的单位和个人的，或者兽药经营企业拆零销售原料药的，责令其立即改正，给予警告，没收违法所得，并处2万元以上5万元以下罚款；情节严重的，吊销兽药生产许可证、兽药经营许可证；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, being a veterinary drug production or business enterprise, sells bulk pharmaceutical chemicals to entities or individuals other than veterinary drug production enterprises, or being a veterinary drug business enterprise, sells bulk pharmaceutical chemicals in broken packages, shall be ordered to make immediate corrections, given a warning, confiscate the illegal gains, and be fined not less than 20,000 yuan but not more than 50,000 yuan; if the circumstances are serious, the veterinary drug production license or veterinary drug business license shall be revoked; if losses are caused to others, it shall bear compensation liability according to law.
违反本条例规定，在饲料和动物饮用水中添加激素类药品和国务院兽医行政管理部门规定的其他禁用药品，依照《饲料和饲料添加剂管理条例》的有关规定处罚；直接将原料药添加到饲料及动物饮用水中，或者饲喂动物的，责令其立即改正，并处1万元以上3万元以下罚款；给他人造成损失的，依法承担赔偿责任。
Whoever, in violation of these Regulations, adds hormonal drugs or other prohibited drugs specified by the veterinary administrative department of the State Council to feed or drinking water for animals, shall be punished in accordance with the relevant provisions of the Regulations on Administration of Feed and Feed Additives; whoever directly adds bulk pharmaceutical chemicals to feed or drinking water for animals, or feeds animals with such, shall be ordered to make immediate corrections and be fined not less than 10,000 yuan but not more than 30,000 yuan; if losses are caused to others, it shall bear compensation liability according to law.
有下列情形之一的，撤销兽药的产品批准文号或者吊销进口兽药注册证书：
Under any of the following circumstances, the product approval number of a veterinary drug shall be revoked or the import veterinary drug registration certificate shall be cancelled:
(一)抽查检验连续2次不合格的；
(1) The product fails spot checks twice consecutively;
(二)药效不确定、不良反应大以及可能对养殖业、人体健康造成危害或者存在潜在风险的；
(2) Those with uncertain efficacy, significant adverse reactions, or that may cause harm or potential risks to the breeding industry or human health;
(三)国务院兽医行政管理部门禁止生产、经营和使用的兽药。
(3) Veterinary drugs prohibited from production, sale, and use by the veterinary administrative department of the State Council.
被撤销产品批准文号或者被吊销进口兽药注册证书的兽药，不得继续生产、进口、经营和使用。已经生产、进口的，由所在地兽医行政管理部门监督销毁，所需费用由违法行为人承担；给他人造成损失的，依法承担赔偿责任。
Veterinary drugs whose product approval number has been revoked or whose import veterinary drug registration certificate has been cancelled shall not continue to be produced, imported, sold, or used. Those already produced or imported shall be destroyed under the supervision of the local veterinary administrative department, and the costs shall be borne by the violator; if losses are caused to others, compensation shall be paid according to law.
本条例规定的行政处罚由县级以上人民政府兽医行政管理部门决定；其中吊销兽药生产许可证、兽药经营许可证，撤销兽药批准证明文件或者责令停止兽药研究试验的，由发证、批准、备案部门决定。
The administrative penalties stipulated in these Regulations shall be decided by the veterinary administrative departments of the people's governments at or above the county level; among them, the revocation of veterinary drug production licenses, veterinary drug operation licenses, cancellation of veterinary drug approval documents, or orders to stop veterinary drug research and testing shall be decided by the issuing, approving, or filing departments.
上级兽医行政管理部门对下级兽医行政管理部门违反本条例的行政行为，应当责令限期改正；逾期不改正的，有权予以改变或者撤销。
The higher-level veterinary administrative department shall order the lower-level veterinary administrative department to correct any administrative actions that violate these Regulations within a specified period; if not corrected within the period, the higher-level department has the authority to change or revoke such actions.
本条例规定的货值金额以违法生产、经营兽药的标价计算；没有标价的，按照同类兽药的市场价格计算。
The value of goods stipulated in these Regulations shall be calculated based on the marked price of illegally produced or sold veterinary drugs; if there is no marked price, it shall be calculated based on the market price of similar veterinary drugs.
附则
Supplementary Provisions
本条例下列用语的含义是：
The meanings of the following terms in these Regulations are:
(一)兽药，是指用于预防、治疗、诊断动物疾病或者有目的地调节动物生理机能的物质(含药物饲料添加剂)，主要包括：血清制品、疫苗、诊断制品、微生态制品、中药材、中成药、化学药品、抗生素、生化药品、放射性药品及外用杀虫剂、消毒剂等。
(1) Veterinary drugs refer to substances (including medicated feed additives) used for the prevention, treatment, and diagnosis of animal diseases or for the purposeful regulation of animal physiological functions, mainly including: serum products, vaccines, diagnostic products, microecological products, Chinese medicinal materials, Chinese patent medicines, chemical drugs, antibiotics, biochemical drugs, radioactive drugs, and external insecticides, disinfectants, etc.
(二)兽用处方药，是指凭兽医处方方可购买和使用的兽药。
(2) Prescription veterinary drugs refer to veterinary drugs that can only be purchased and used with a veterinary prescription.
(三)兽用非处方药，是指由国务院兽医行政管理部门公布的、不需要凭兽医处方就可以自行购买并按照说明书使用的兽药。
(3) Over-the-counter veterinary drugs refer to veterinary drugs that are published by the veterinary administrative department of the State Council and can be purchased without a prescription and used according to the instructions.
(四)兽药生产企业，是指专门生产兽药的企业和兼产兽药的企业，包括从事兽药分装的企业。
(4) Veterinary drug manufacturing enterprises refer to enterprises that specialize in producing veterinary drugs and enterprises that concurrently produce veterinary drugs, including enterprises engaged in repackaging veterinary drugs.
(五)兽药经营企业，是指经营兽药的专营企业或者兼营企业。
(5) Veterinary drug business enterprises refer to specialized enterprises or concurrent enterprises that deal in veterinary drugs.
(六)新兽药，是指未曾在中国境内上市销售的兽用药品。
(6) New veterinary drugs refer to veterinary drugs that have not been marketed in China.
(七)兽药批准证明文件，是指兽药产品批准文号、进口兽药注册证书、出口兽药证明文件、新兽药注册证书等文件。
(7) Veterinary drug approval documents refer to documents such as veterinary drug product approval numbers, import veterinary drug registration certificates, export veterinary drug certificates, and new veterinary drug registration certificates.
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，依照国家有关规定管理。
Special drugs such as veterinary narcotic drugs, psychotropic drugs, toxic drugs, and radioactive drugs shall be managed in accordance with relevant state regulations.
水产养殖中的兽药使用、兽药残留检测和监督管理以及水产养殖过程中违法用药的行政处罚，由县级以上人民政府渔业主管部门及其所属的渔政监督管理机构负责。
The use of veterinary drugs in aquaculture, testing and supervision of veterinary drug residues, and administrative penalties for illegal drug use in aquaculture shall be the responsibility of the fishery administrative departments of the people's governments at or above the county level and their subordinate fishery supervision and management agencies.
本条例自2004年11月1日起施行。
These Regulations shall come into force as of November 1, 2004.