【中英文对照版】兽药管理条例(2020修订).docx

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1、兽药管理条例(2020修订)Regulation on Veterinary Drug Administration ( 2020 Revision )【中英文对照版】发布部门：国务院发文字号：中华人民共和国国务院令第726号发布日期：实施日期：效力级别：行政法规 法规类别：兽医兽药 Issuing Authority : State CouncilDocument Number ： Order No. 726 of the State Council of the Peoples Republic of China Date Issued : 03-27-2020 Effective Dat

2、e ： 03-27-2020兽药管理条例（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 于修改局部行政法规的决定第 一次修订根据2016年2月6 日国务院关于修改局部行政法 规的决定第二次修订根据 2020年3月27日国务院关于 修改和废止局部行政法规的决 定第三次修订）Level of Authority : Administrative Regulations Area of Law : Veterinarian and Veterinary DrugsRegulation on Veterinary Drug Administration(P

3、romulgated by the Order No. 404 of the State Council of the Peoples 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

4、 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)第一章总那么第一章总那么理,病,第一条为了加强兽药管 保证兽药质量，防治动物疾

5、促进养殖业的开展，维护人Chapter I General ProvisionsArticle 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.Article 22 An

6、enterprise that operates veterinary drugs shall第二十二条 经营兽药的企meet the following conditions:业，应当具备以下条件：(1) Having a number of veterinary drug technicians who are suitable for the veterinary drugs operated;Having a business site, the equipment, warehouses and facilities suitable for the veterinary drugs

7、 operated;(2) Having a quality management office or such employees who are suitable for the veterinary drugs operated; andOther operational conditions provided for in the Veterinary Drug Operation Quality Management Rules.Only when the conditions in the preceding paragraph are met may the applicant

8、file an application to the veterinary administration under the city or county peoples 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 adm

9、inistration under the peoples 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.The veterinary administration under the local peoples governmen

10、t 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.

11、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.The validity period of a veterinary drug operation permit shall be 5 years. If, at expiry of the validity period, the

12、 operator needs（一）与所经营的兽药相适应的兽 药技术人员；（一）与所经营的兽药相适应的兽 药技术人员；（二）与所经营的兽药相适应的营 业场所、设备、仓库设施；（三）与所经营的兽药相适应的质 量管理机构或者人员；（四）兽药经营质量管理规范规定 的其他经营条件。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。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

13、格的，发给兽药经营许可 证；不合格的，应当书面通知申 请人。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。兽药经营许可证有效期为5年。10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 op

14、eration permit.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

15、 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

16、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。The veterinary administration under the loc

17、al peoples government at the county level or above shall supervise and inspect whether the veterinary drug operation enterprises meet the requirements in Veterinary Drug Operation Quality Management Rules, and shall promulgate the result of its inspections.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

18、范 的要求进行监督检查，并公布检 查结果。Article 26 A veterinary drug operation enterprise shall, when purchasing veterinary drugs, check whether the veterinary drug products are consistent with the product label or instructions, and the product quality certificate.第二十六条兽药经营企业 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。Artic

19、le 27 A veterinary drug operation enterprise shall explain to the buyer the involved veterinary drug*s functions, indications, usage, dosage, and points for attention. If it sells prescription veterinary drugs, it shall abide by the measures for the administration of prescription veterinary drugs.第一

20、十七条兽药经营企 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 守兽用处方药管理方法。兽药经营企业销售兽用中药材 的，应当注明产地。A veterinary drug operation enterprise selling materials of Chinese traditional veterinary drugs 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 operation enterprises are prohibited from o

21、perating human drugs and fake or inferior veterinary drugs.第二十八条 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。Article 28 A veterinary drug operation enterprise shall, when purchasing or selling a veterinary drug, set up records on purchase and s

22、ale. The records on purchase and sale shall indicate the veterinary drugs commodity name, general name, form, specifications, batch number, validity period, producer, purchaser and seller, quantity of purchase and sale, date of purchase and sale, as well as other details provided for by the veterina

23、ry administration under the State Council.第二十九条兽药经营企 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。Article 29 A veterinary drug operation enterprise shall set up a veterinary drug custody system, and take necessary cold storage, anti-freezing, moisture-proof, worm resistant or mouse proof measur

24、es, etc., so as to maintain the quality of the veterinary drugs in operation.兽药入库、出库，应当执行检查 验收制度，并有准确记录。Veterinary drugs entering or exiting the storeroom shall be under an inspection and acceptance system, and accurate records shall be kept.第三十条强制免疫所需兽 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。第三十一条兽药广告的内 容应当与兽

25、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Article 3() The operation of veterinary biological products needed in compulsory immunity shall conform to the provisions of the veterinary administration under the State Council.Article 31 The contents in a veterinary

26、 drug advertisement shall be consistent with those in the veterinary drug instructions. Where a veterinary drug advertisement is published in any of the major media throughout the country, it shall be examined and approved by the veterinary administration under the State Council. And the examination

27、 and approval document number shall be obtained. If the veterinary drug advertisement is published in a local medium, it shall be examined and approved12by the veterinary administration under the peoples government of the province, autonomous region, or municipality directly under the Central Govern

28、ment. And the examination and approval document number shall be obtained. No veterinary drug advertisement shall be published without approval.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。Chapter V Import and Export of Veterinary Drugs第五章兽药进出口Article 32 For the veterinary drugs exported to China

29、 for the first time, the exporters office in China or the Chinese domestic agency it has authorized shall apply to the veterinary administration under the State Council for registration, and submit the following documents and articles:第三十二条 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

30、，并提交以下资 料和物品：(1) the documents on proof of production or sale, which were approved by the veterinary drug administration of the country (region) where the production enterprise is located;（-）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。(2) the proof documents on conformity to the Veterinary Drugs Production Qua

31、lity Management Rules, which were issued by the veterinary drug administration of the country (region) where the production enterprise is located;（-）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。(3) the manufacturing method, production process, quality standards, testing method, results of pharmacologica

32、l and toxicological trials, clinical trial report and stability trial report of the veterinary drug involved, as well as other relevant documents; the withdrawal period, the maximum limitation of remnants, and remnant-testing method for the veterinary drugs used for edible animals, as well as the ba

33、sis thereof, etc.;（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。(4) the sample of label and instructions of the veterinary drug involved;（四）兽药的标签和说明书样本。(5) the sample, contrast product and standard product of the veterinary drug involved;（五）兽药

34、的样品、对照品、标准 品。(6) the environmental impact report and the measures for (六)环境影响报告和污染防治措 prevention and control of pollution; and施。13(7) other documents involving veterinary drug safety.（七）涉及兽药平安性的其他资 料。Whoever applies to export veterinary biological products to China shall provide the relevant documen

35、ts on culture (virus, worm seed), cells, etc., in addition.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。Article 33 The veterinary administration under the State Council shall organize the preliminary examination within 10 working days as of receipt of the application. If the application is preliminarily

36、 examined as qualified, the veterinary administration shall deliver the veterinary drug documents, which it has decided to accept, to the veterinary drug review and adjudication office it has set up for review and adjudication, and deliver the sample of this veterinary drug to its designated inspect

37、ion office for re-check and inspection, and shall complete the examination within 60 working days as of receipt of the conclusions of review and adjudication and of re-check and inspection. If the documents are examined as qualified, the said veterinary administration shall issue a registration cert

38、ificate for the imported veterinary drug, and promulgate the quality standards of this veterinary drug; otherwise, it shall notify the applicant in writing.第三十三条国务院兽医行 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

39、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。In the process of examination, the veterinary administration under the State Council may investigate whether the enterprises exporting veterinary drugs to China meet the requirements in the Veterinary Drug Production Quality Management Rules, and shall be entit

40、led to require such enterprises to carry out safety and validity trial of the said veterinary drug in the institution designated by the veterinary administration under the State Council.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 平安性和有效性试验。The veterinary

41、 drugs urgently needed in our country, a few veterinary drugs used in scientific research or the samples, contrast products and standard products of the registered veterinary drugs shall be imported in accordance with the provisions of the veterinary administration under the State Council.国内急需兽药、少量科

42、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。Article 34 The validity period of a registration certificate for the imported veterinary drug shall be 5 years. If, at expiry of the validity period, the certificate holder needs to continue exporting veterinary drugs to China, it shall, 6 months prior

43、to第三十四条进口兽药注册 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14the expiry of the validity period, apply to the certificate issuing 至U发证机关 申 请再注册。 organ for re-registration.第三十五条境外企业不得 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。Article 35 Overseas enterprises are not permitted to sell vete

44、rinary drugs directly in China. Where an overseas enterprise intends to sell veterinary drugs in China, it shall lawfully set up a sales agency within the territory of China or authorize a Chinese domestic agency meeting the requirements.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

45、进口兽药通关单。海关凭进 口兽药通关单放行。兽药进口管 理方法由国务院兽医行政管理部 门会同海关总署制定。To import any veterinary drug for which the registration certificate for the imported veterinary drug has been obtained in China, the Chinese domestic agency shall, based on the registration certificate for the imported veterinary drug, apply to t

46、he veterinary administrative department of the peoples government at the place where the port is located for the customs clearance form for the imported veterinary drug. The Customs shall release the imported veterinary drug based on the customs clearance form for the drug. The Administrative Measur

47、es for the Import of Veterinary Drugs shall be developed by the veterinary administrative department of the State Council in conjunction 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 a veterinary biological product is impor

48、ted, it shall be subject to the examination, check and random inspection in accordance with Article 19 of the present Regulation. After any other veterinary drug is imported, the local veterinary administration shall notify the veterinary drug inspection office to make a random inspection on it.禁止进口以下Article 36 It is prohibited to import the following veterinary 第三十六条 drugs:兽药：（一）药效不确定、不良反响大以 及可能对养殖业、人体健康造成(1) those whose effectiveness is uncertain, or whose i