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Regulation on Veterinary Drug Administration (2020 Revision PKULAW Version) [Effective]
兽药管理条例(2020修订) [现行有效]
【法宝引证码】

Regulation on Veterinary Drug Administration 

兽药管理条例

(Promulgated by the Order No. 404 of the State Council of the People's Republic of China on April 9, 2004; revised for the first time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on July 29, 2014; and revised for the second time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016; and revised for the third time in accordance with the Decision of the State Council to Amend and Repeal Certain Administrative Regulations (2020) on March 27, 2020) (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)

Chapter I General Provisions 

第一章 总  则

Article 1 The present Regulation is formulated in order to strengthen veterinary drug administration, guarantee veterinary drug quality, prevent and control animal diseases, promote the development of breeding industry, and maintain human health.   第一条 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。
Article 2 The present Regulation shall apply to the research, production, operation, import, export, use or supervision of veterinary drugs inside the territory of the People's Republic of China.   第二条 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。
Article 3 The responsibility to supervise veterinary drugs nationwide shall remain with the veterinary administration under the State Council.   第三条 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 responsibility to supervise veterinary drugs within a certain jurisdiction shall remain with the veterinary administration under the local people's government at the county level or above. 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。
Article 4 The state applies a system of administering veterinary drugs by classifying them into prescription veterinary drugs and non-prescription ones. The measures for classifying prescription veterinary drugs and non-prescription ones as well as the specific implementing procedures shall be formulated by the veterinary administration under the State Council.   第四条 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。
Article 5 The state applies a veterinary drug reserve system.   第五条 国家实行兽药储备制度。
In case of any major animal epidemic situation, disaster situation or any other unexpected incident, the veterinary administration under the State Council may urgently put the state-reserved veterinary drugs into use. If necessary, it may also put veterinary drugs other than the state-reserve ones into use. 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。
Chapter II Research of New Veterinary Drugs 

第二章 新兽药研制

Article 6 The state encourages the research of new veterinary drugs, and protects the lawful rights and interests of the researchers in accordance with the law.   第六条 国家鼓励研制新兽药,依法保护研制者的合法权益。
Article 7 Whoever researches a new veterinary drug shall have the suitable site, devices, equipment, professionals, as well as safety management rules and measures.   第七条 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。
Whoever develops a new veterinary drug shall subject it to safety evaluation. An entity engaged in the safety evaluation of veterinary drugs shall abide by the quality control rules on the non-clinical research of veterinary drugs and the quality control rules on the clinical trial of veterinary drugs, as developed by the veterinary administrative department of the State Council. 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。
The veterinary administrative departments of the people's governments at or above the provincial level shall oversee and inspect whether entities engaged in the safety evaluation of veterinary drugs have abided by the quality control rules on the non-clinical research of veterinary drugs and the quality control rules on the clinical trial of veterinary drugs, and shall disclose the inspection results. 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。
Article 8 The developer of a new veterinary drug shall, before the clinical test of the drug, report to the veterinary administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government at the place where the clinical test is conducted for recordation, with the laboratory safety evaluation report and other preclinical study materials of such a new veterinary drug attached.   第八条 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。
If the new veterinary drug in research is a biological product, the researcher shall, prior to the clinical trial, file an application to the veterinary administration under the State Council. And the veterinary administration under the State Council shall, within 60 working days as of receipt of the application, notify the applicant in writing of the result of the examination. 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。
Whoever needs to use the first category of pathogenic microorganism when researching a new veterinary drug shall, in addition, meet the conditions provided for by the veterinary administration under the State Council, and shall report to the veterinary administration under the State Council prior to the laboratory stage for approval. 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。
Article 9 After the clinical trial is completed, the new veterinary drug researcher shall, when filing an application to the veterinary administration under the State Council for registration of the new veterinary drug, submit a sample of this new veterinary drug and the following information:   第九条 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:
(1) the name, main components, physical and chemical characteristics; (一)名称、主要成分、理化性质;
(2) the research method, production process, quality standards and testing method; (二)研制方法、生产工艺、质量标准和检测方法;
(3) the result of pharmacological and toxicological trial, the clinical trial report and the stability trial report; and (三)药理和毒理试验结果、临床试验报告和稳定性试验报告;
(4) the environmental impact report and the measures for prevention and control of pollution. (四)环境影响报告和污染防治措施。
If the researched new veterinary drug is a biological product, the researcher shall provide the relevant documents and information on culture (virus, worm seed) and cells, etc.. The culture (virus, worm seed) and cells shall be preserved by an institution designated by the veterinary administration under the State Council. 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。
When researching a new veterinary drug for edible animals, the researcher shall carry out a trial on veterinary drug remnants in accordance with the provisions of the veterinary administration under the State Council, and shall provide such information as the withdrawal period, the maximum limitation of remnants, the methods of testing remnants and the basis thereof, etc. 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。
The veterinary administration under the State Council shall, within 10 working days as of receipt of the application, deliver the documents on the new veterinary drug under acceptance to the veterinary drug review and adjudication office it has set up for review and adjudication, and deliver the sample of the new veterinary drug to its designated inspection office for re-check and inspection, and shall complete the examination within 60 working days as of receipt of the conclusion of the review and adjudication and the conclusion of the re-check and inspection. If it is examined as qualified, a new veterinary drug registration certificate shall be issued, and the quality standards on this veterinary drug shall be promulgated. Otherwise, the said veterinary administration shall notify the applicant in writing. 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。
Article 10 The state protects the undisclosed trial data and other data of the lawfully registered veterinary drug containing new compound, which are submitted by any applicant who has obtained such data by himself.   第十条 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。
If, within 6 years as of registration, any other applicant applies for a veterinary drug registration by using the data in the preceding paragraph without the consent of the applicant of such registered veterinary drug, the veterinary drug registration organ shall not register it, but the data obtained by the said other applicant himself which he submits shall be registered. 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。
Except the following circumstances, no veterinary drug registration organ may disclose the data provided for in Paragraph 1 of the present Article: 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:
(1) The data are needed for public benefits; (一)公共利益需要;
(2) The adopted measures could guarantee that such information would not be unjustly used for commercial purposes. (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。
Chapter III Veterinary Drug Production 

第三章 兽药生产

Article 11 Whoever intends to engage in veterinary drug production shall conform to the national development planning and policies of the veterinary drug industry, and shall meet the following conditions:   第十一条 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:
(1) Having a number of technicians in veterinary medicine, pharmaceutics or in the related specialties suitable for the production of veterinary drug; (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;
(2) Having the plant and relevant facilities suitable for the production of veterinary drug; (二)与所生产的兽药相适应的厂房、设施;
(3) Having the offices, staff, apparatus and equipment for veterinary drug quality management and quality inspection suitable for the production of veterinary drug; (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;
(4) Having a producing environment conforming to safety and sanitation requirements; (四)符合安全、卫生要求的生产环境;
(5) Other production conditions provided for in the Veterinary Drug Production Quality Management Rules. (五)兽药生产质量管理规范规定的其他生产条件。
Only after the conditions prescribed in the preceding paragraph are met may the applicant file an application with the veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, along with documents proving that the conditions in the preceding paragraph are met. The veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall, within 40 working days of receipt of the application, complete the examination of the application. If the application passes the examination, a veterinary drug production permit shall be issued; otherwise, the applicant shall be notified in writing of its failure to pass the examination. 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。
Article 12 A veterinary drug production permit shall indicate the scope of production, producing location, validity period, and the name of legal representative, and domicile, etc.   第十二条 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。
The validity period for a veterinary drug production permit shall be 5 years. If, at expiry of the validity period, the production of the veterinary drug needs to be continued, the producer shall, 6 months prior to the expiry of the validity period for the permit, apply to the permit issuing organ for issuance of a new veterinary drug production permit. 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。
Article 13 A veterinary drug production enterprise that modifies its scope or place of production shall, under the provisions of Article 11 of this Regulation, apply for replacement of its veterinary drug production permit; and one that modifies its enterprise name or legal representative shall, within 15 working days of undergoing the formalities for modifying its industrial and commercial registration, apply to the permit issuing authority for replacement of its veterinary drug production permit.   第十三条 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。
Article 14 A veterinary drug production enterprise shall organize the production in accordance with the Veterinary Drug Production Quality Management Rules formulated by the veterinary administration under the State Council.   第十四条 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。
The veterinary administrative department of the people's government at or above the provincial level shall supervise and inspect whether the veterinary drug production enterprises conform to the requirements in the Veterinary Drug Production Quality Management Rules爬数据可耻, and shall promulgate the result of such inspection. 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。
Article 15 A veterinary drug production enterprise shall, for the sake of producing veterinary drugs, obtain a product approval document number checked and issued by the veterinary administration under the State Council. The validity period for the product approval document number shall be 5 years. The measures for checking and issuing veterinary drugs' product approval document numbers shall be formulated by the veterinary administration under the State Council.   第十五条 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。
Article 16 A veterinary drug production enterprise shall carry out the production pursuant to the national standards on veterinary drugs and the production process approved by the veterinary administration under the State Council. If a veterinary drug production enterprise changes the production process that might affect the veterinary drug quality, it shall report to the original approval organ for verification and approval.   第十六条 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。
A veterinary drug production enterprise shall set up its production records, which shall be kept integral and accurate. 兽药生产企业应当建立生产记录,生产记录应当完整、准确。
Article 17 The raw materials and auxiliary materials needed for producing a veterinary drug shall conform to the national standards or the quality requirements of the produced veterinary drug.   第十七条 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 packing materials and containers which are directly in contact with a veterinary drug shall meet the medicinal requirements. 直接接触兽药的包装材料和容器应当符合药用要求。
Article 18 A veterinary drug shall be subject to the quality inspection before leaving factory, and the veterinary drug failing to conform to the quality standards shall not leave the factory.   第十八条 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。
A veterinary drug shall, when leaving factory, be attached with a certificate of product quality. 兽药出厂应当附有产品质量合格证。
It is prohibited to produce fake or inferior veterinary drugs. 禁止生产假、劣兽药。
Article 19 Each batch of veterinary biological products produced by a veterinary drug production enterprise shall, before leaving factory, be examined and checked by an inspection office designated by the veterinary administration under the State Council, and random inspections may be carried out when necessary. Any veterinary biological product that has not been examined and checked or that is randomly inspected as unqualified shall not be sold.   第十九条 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。
The veterinary biological products needed in compulsory immunity shall be produced by enterprises designated by the veterinary administration under the State Council. 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。
Article 20 The packing of a veterinary drug shall be printed or stuck with a label as provided, with instructions being attached, and shall be marked with the words "for veterinary use" at an eye-catching position.   第二十条 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。
The label and instructions of a veterinary drug may not be put into use until they have been approved and promulgated by the veterinary administration under the State Council. 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。
On the label or instructions of a veterinary drug shall be indicated in Chinese the generally used name, components and the content thereof, specifications, production enterprise, product approval document number (the registration certificate number of imported veterinary drug), product batch number, date of production, validity period, indications, functions, usage, dosage, withdrawal period, contraindication, ill response, points for attention, conditions for transport, storage or custody, as well as other contents which ought to be stated. The commodity name, if any, shall also be indicated. 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。
Besides the contents in the preceding paragraph, the label or instructions of a prescription veterinary drug shall be printed with the warning contents as provided for by the veterinary administration under the State Council. For the veterinary narcotic drugs, psychotropic drugs, toxic drugs and radioactive drugs, the label or instructions shall be additionally printed with a particular mark as provided for by the veterinary administration under the State Council. For the non-prescription veterinary drugs, the label or instructions shall be additionally printed with a mark of non-prescription drug as provided for by the veterinary administration under the State Council. 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。
Article 21 The veterinary administration under the State Council may, upon the needs for guaranteeing animal product quality safety and human health, set up a monitoring period of not more than 5 years for the new veterinary drugs. Within the monitoring period, no other enterprise shall be approved to produce or import this new veterinary drug. The production enterprise shall collect the information on curative effect, ill response, etc. of this new veterinary drug within the monitoring period, and shall timely submit such information to the veterinary administration under the State Council.   第二十一条 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。
Chapter IV Operation of Veterinary Drugs 

第四章 兽药经营

Article 22 An enterprise that operates veterinary drugs shall meet the following conditions: 北大法宝,版权所有  第二十二条 经营兽药的企业,应当具备下列条件:
(1) Having a number of veterinary drug technicians who are suitable for the veterinary drugs operated; (一)与所经营的兽药相适应的兽药技术人员;
(2) Having a business site, the equipment, warehouses and facilities suitable for the veterinary drugs operated; (二)与所经营的兽药相适应的营业场所、设备、仓库设施;
(3) Having a quality management office or such employees who are suitable for the veterinary drugs operated; and (三)与所经营的兽药相适应的质量管理机构或者人员;
(4) Other operational conditions provided for in the Veterinary Drug Operation Quality Management Rules. (四)兽药经营质量管理规范规定的其他经营条件。
Only when the conditions in the preceding paragraph are met may the applicant file an application to the veterinary administration under the city or county people's government, and the documents proving that the conditions in the preceding paragraph have been met shall be attached. Whoever operates veterinary biological products shall file the application to the veterinary administration under the people's government of the province, autonomous region, or municipality directly under the Central Government, and the documents proving that the conditions in the preceding paragraph have been met shall be attached. 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。
The veterinary administration under the local people's government at the county level or above shall complete the examination within 30 working days as of receipt of the application. If the application is examined as qualified, a veterinary drug operation permit shall be issued; otherwise, the said veterinary administration shall notify the applicant in writing. 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。
Article 23 A veterinary drug operation permit shall indicate such details as the scope of business, place of business, validity period, name of the legal representative, and domicile.   第二十三条 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 validity period of a veterinary drug operation permit shall be 5 years. If, at expiry of the validity period, the operator needs to continue operating veterinary drugs, it shall, 6 months prior to the expiry, apply to the original permit issuing organ for issuance of a new veterinary drug operation permit. 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。
Article 24 Where a veterinary drug operation enterprise modifies its scope of business or place of business, it shall, in accordance with Article 22 of the present Regulation, apply for issuance of a new veterinary drug operation permit. If it modifies the enterprise name or the legal representative, it shall, within 15 working days after making industrial and commercial modification registration, apply to the permit issuing organ for issuance of a new veterinary drug operation permit.   第二十四条 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。
Article 25 The veterinary drug operation enterprises shall abide by the Veterinary Drug Operation Quality Management Rules formulated by the veterinary administration under the State Council.
......
   第二十五条 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
......

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