【中英文对照版】进口药材管理办法.docx

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1、进口药材管理办法Measures for the Administration of Imported Medicinal Materials制定机关：国家市场监督管理总局发文字号：国家市场监督管理总局令第9号公布日期：施行日期：效力位阶：部门规章法规类别：药品管理医疗器械药品药材进出口Issuing Authority ： State Administration for Market RegulationDocument Number ： Order No. 9 of the State Administration for Market RegulationDate Issued ： 0

2、5-16-2019Effective Date ： 01-01-2020Level of Authority ： Departmental RulesArea of Law ： Pharmaceutical Administration Import and Export of Medical Devices, Drugs, and Medicine Materials国家市场监督管理总局令国家市场监督管理总局令Order of the State Administration for Market Regulation(No. 9)(No. 9)（第9号）进口药材管理办法已于2019 年4月

3、28日经国家市场监督管 理总局2019年第8次局务会议 审议通过，现予公布，自2020 年1月1日起施行。进口药材管理办法已于2019 年4月28日经国家市场监督管 理总局2019年第8次局务会议 审议通过，现予公布，自2020 年1月1日起施行。局长张茅The Measures for the Administration of Imported Medicinal Materials, as deliberated and adopted at the eighth executive meeting of the State Administration for Market Regul

4、ation (“SAMR) on April 28, 2019, are hereby issued, and shall come into force on January 1, 2020.Director General: Zhang MaoMay 16, 2019May 16, 20192019年5月16日Article 16 The provincial medical products administration shall, within 20 days after accepting the supplementary application, complete the ex

5、amination and approval, and issue a supplementary application第十六条省级药品监督管 理部门应当在补充申请受理后20 日内完成审批。对符合要求的，approval document for the import of medicinal materials.发给进口药材补充申请批件。Article 17 If it decides to approve the application, the provincial medical products administration shall, within ten days after

6、 making the decision, serve on the.第十七条省级药品监督管 理部门决定予以批准的，应当在applicant the approval document for the import of medicinal materials or the supplementary application approval document for the import of medicinal materials; and if it decides to reject the application, the provincial medical products ad

7、ministration department shall, within ten days after making the decision, serve on the applicant a Notification of Examination Opinions, explain the reasons therefor, and notify the applicant of the right to apply for administrative reconsideration, or to bring an administrative lawsuit.作出批准决定后10日内，

8、向申 请人送达进口药材批件或者进口 药材补充申请批件；决定不予批 准的，应当在作出不予批准决定 后10日内，向申请人送达审查 意见通知书，并说明理由，告知 申请人享有依法申请行政复议或 者提起行政诉讼的权利。Chapter III Record Filing第三章备案Article 18 The applicant for the initial import of medicinal materials shall, within one year after obtaining the approval document, arrange the import of medicinal m

9、aterials at the port of destination as specified on the approval document.第十八条首次进口药材申 请人应当在取得进口药材批件后 1年内，从进口药材批件注明的 到货口岸组织药材进口。Article 19 The importer shall file the medicinal materials for recordation at the port medical products administration, fill out the Report List for Inspection of the Import

10、ed Medicinal Materials, and submit the following documents:1. original of the Report List for Inspection of the Imported Medicinal Materials;a photocopy of the certificate of origin;2. standards of medicinal materials and sources of standards;a photocopy of the packing list, bill of lading and freig

11、ht invoice;第十九条进口单位应当向 口岸药品监督管理部门备案，通 过信息系统填报进口药材报验 单，并报送以下资料：（一）进口药材报验单原件;（二）产地证明复印件;（三）药材标准及标准来源;（四）装箱单、提运单和货运发 票复印件；5. a photocopy of the complete set of materials including the purchasing contracts, packing lists, bills of lading, and freight invoices from the place of origin to all the transit

12、places for the imported medicinal materials transited from other countries (regions); and（五）经其他国家（地区）转口 的进口药材，应当同时提交产地 到各转口地的全部购货合同、装 箱单、提运单和货运发票复印 件；6. a photocopy of the certificate on import/export permission issued upon verification by the state administrative organ in charge of the import and e

13、xport of endangered species for the import of medicinal materials relating to the endangered wild fauna and flora whose import or export is restricted by the Convention on the International Trade of Endangered Species of Wild Fauna and Flora.（六）进口药材涉及濒危野生 动植物种国际贸易公约限制进 出口的濒危野生动植物的，还应 当提供国家濒危物种进出口管理

14、机构核发的允许进出口证明书复 印件。To file for recordation the initially imported medicinal materials, the importer shall, in addition to the documents as provided for in paragraph 1, submit a photocopy of the approval document for the import of办理首次进口药材备案的，除第 一款规定资料外，还应当报送进 口药材批件和进口药材补充申请medicinal materials and the

15、supplementary application 扑匕件 (如有)复印件。 approval document for the import of medicinalmaterials (if available).办理非首次进口药材备案的，除 第一款规定资料外，还应当报送 进口单位的药品生产许可证或者 药品经营许可证复印件、出口商 主体登记证明文件复印件、购货 合同及其公证文书复印件。进口 单位为中成药上市许可持有人 的，应当提供相关药品批准证明 文件复印件。第二十条口岸药品监督管 理部门应当对备案资料的完整 性、规范性进行形式审查，符合 要求的，发给进口药品通关单， 收回首次进口药材批件

16、，同时向 口岸药品检验机构发出进口药材 口岸检验通知书，并附备案资料 一份。To file for recordation the non-initially imported medicinal materials, the importer shall, in addition to the documents as provided for in paragraph 1, submit a photocopy of the Permit for Pharmaceutical Manufacture or Permit for Drug Operation, a photocopy of

17、the registration certification document for the exporter, and photocopies of the purchasing contract and notarial documents. If the importer is a marketing license holder of Chinese patent medicine, it shall also provide a photocopy of relevant approval certificate of pharmaceuticals.Article 20 The

18、port medical products administration shall make a formal examination of the conformity and completeness of the record-filing documents. If the documents meet the requirements, it shall issue a List of Customs Clearance of Imported Drugs, take back the approval document for the initial import of medi

19、cinal materials, issue a port inspection notification to the port drug inspection institution, and provide a set of record-filing documents.第二十一条 进口单位持进 口药品通关单向海关办理报关验 放手续。第四章口岸检验Article 21 The importer shall go through the procedures of customs declarations using a List of Customs Clearance of Impo

20、rted Drugs.Chapter IV Port Inspection第二十二条口岸药品检验 机构收到进口药材口岸检验通知 书后，应当在2日内与进口单位 商定现场抽样时间，按时到规定第二十二条口岸药品检验 机构收到进口药材口岸检验通知 书后，应当在2日内与进口单位 商定现场抽样时间，按时到规定Article 22 After receiving a port inspection notification, the port drug inspection institution shall, within two days, discuss with the importer about

21、 the on-site sampling time, and conduct an on-site sampling at the prescribed place for goods storage. At the time of on-site sampling, the importer shall present the original of the certificate of origin.的存货地点进行现场抽样。现场 抽样时，进口单位应当出示产地 证明原件。Article 23 The port drug inspection institution shall verify

22、 the consistency between the original copy of the certificate of origin and the actual arrival of goods against the record-filing documents provided by the port medical products administration. If the documents meet the requirements, it shall make the sampling, fill out a List of Sampling Records on

23、 the Imported Medicinal Materials, indicate the word sampled” on the List of Customs Clearance of the Imported Drugs possessed by the importer, and affix the seal of the sampling entity on it. If the documents do not meet the requirements, it shall refuse to make the sampling, and, within two days,

24、report it to the port medical products administration of the place where it is located.第二十三条口岸药品检验 机构应当对产地证明原件和药材 实际到货情况与口岸药品监督管 理部门提供的备案资料的一致性 进行核查。符合要求的，予以抽 样，填写进口药材抽样记录单， 在进口单位持有的进口药品通关 单原件上注明“已抽样”字样， 并加盖抽样单位公章；不符合要 求的，不予抽样，并在2日内报 告所在地口岸药品监督管理部 门。第二十四条口岸药品检验 机构一般应当在抽样后20日内 完成检验工作，出具进口药材检 验报告书。因客观

25、原因无法按时 完成检验的，应当将延期的时 限、理由书面告知进口单位并报Article 24 The port drug inspection institution shall, in general, complete the inspection within 20 days after the sampling, and issue an Inspection Report on the Imported Medicinal Materials. If it is unable to complete the inspection within the prescribed time l

26、imit due to objective reasons, it shall notify the importer in writing of an extension and the reasons,and report it to the port medical products 告口岸药品监督管理部门。 administration.The port drug inspection institution shall submit the Inspection Report on the Imported Medicinal Materials to the port medica

27、l products administration, and notify the importer.口岸药品检验机构应当将进口药 材检验报告书报送口岸药品监督 管理部门，并告知进口单位。The imported medicinal materials shall not be sold or used until they are found to be qualified upon port inspection.经口岸检验合格的进口药材方可 销售使用。Article 25 If the importer has any objection to the inspection result

28、, it may apply for re-inspection in accordance with the provisions of the Drug Administration Law. The drug inspection institution shall, with 20 days after accepting the application for re-inspection, make a re-inspection conclusion, report it to the port medical products administration, and notify

29、 the importer.第二十五条 进口单位对检 验结果有异议的，可以依照药品 管理法的规定申请复验。药品检 验机构应当在复验申请受理后20 日内作出复验结论，并报告口岸 药品监督管理部门，通知进口单 位。Chapter V Supervision and Administration第五章监督管理Article 26 The port medical products administration shall, after receiving the notification on refusing to make the sampling, take mandatory adminis

30、trative measures against all the medicinal materials (such as sealing up or distraining upon them) that are proven to be potentially hazardous to human health and have completed the customs clearance procedures, , and shall make a decision within seven days on how to第二十六条口岸药品监督 管理部门收到进口药材不予抽样 通知书后，对

31、有证据证明可能危 害人体健康且已办结海关验放手 续的全部药材采取查封、扣押的 行政强制措施，并在7日内作出 处理决定。handle it.第二十七条对检验不符合 标准规定且已办结海关验放手续 的进口药材，口岸药品监督管理 部门应当在收到检验报告书后及 时采取查封、扣押的行政强制措 施，并依法作出处理决定，同时 将有关处理情况报告所在地省级 药品监督管理部门。Article 27 For the imported medicinal materials which fail to meet the inspection standards and for which the customs cl

32、earance procedures have been undergone, the port medical products administration shall, after receiving the inspection report, take mandatory administrative measures (such as sealing up or distraining upon the medicinal materials) in a timely manner, make a decision on how to handle it according to

33、law, and report the relevant information to the provincial medical products administration of the place where it is located.第二十八条国家药品监督 管理局根据需要，可以对进口药 材的产地、初加工等生产现场组 织实施境外检查。药材进口单位 应当协调出口商配合检查。Article 28 The NMPA may, according to actual needs, launch overseas inspections of the production sites of

34、imported medicinal materials, such as the place of origin and the primary processing site. The importer of medicinal materials shall coordinate the exporters efforts to cooperate in the inspection.第二十九条中成药上市许 可持有人、中药生产企业和药品 经营企业采购进口药材时，应当 查验口岸药品检验机构出具的进 药材检验报告书复印件和注明 “已抽样”并加盖公章的进口药 品通关单复印件，严格执行药品 追溯

35、管理的有关规定。Article 29 When purchasing imported medicinal materials, the marketing license holders of Chinese patent medicine, the TCM producers, and the business operators of medical products shall examine the photocopy of the Inspection Report on the Imported Medicinal Materials issued by the port dru

36、g inspection institution and the photocopy of the List of Customs Clearance of the Imported Drugs indicating the word “sampled and affixed with the seal of the sampling entity, and strictly implement the provisions regarding the drug traceability management.Article 30 The packaging of imported medic

37、inal materials shall meet the quality requirements for imported medicinal materials, and be easy for storage, transport and import inspection. On the package of each piece of goods, the Chinese name of the medicinal materials, the approval document number, the place of origin, the shipping mark, the

38、 name of the importer, the name of the exporter, the port of arrival, the weight and the date of processing and that of packing, etc. shall be indicated.第三十条进口药材的包装 必须适合进口药材的质量要求， 方便储存、运输以及进口检验。 在每件包装上，必须注明药材中 文名称、批件编号（非首次进口 药材除外）、产地、喽头号、进 口单位名称、出口商名称、到货 口岸、重量以及加工包装日期 等。Article 31 The application ac

39、ceptance, the examination and approval results, the relevant violations of laws and regulations, and the punishment results regarding the import of medicinal materials shall be disclosed to the public on the website of the NMPA.第三十一条 药材进口申请 受理、审批结果、有关违法违规 的情形及其处罚结果应当在国家 药品监督管理部门网站公开。Chapter VI Legal

40、 Liabilities第六章法律责任Article 32 The importer that obtains its Approval Document for the Initial Import of Medicinal Materials by providing any false proof, documents or samples, or by other fraudulent means shall be handled in accordance with the Drug Administration Law and other laws and regulations.

41、第三十二条 进口单位提供 虚假的证明、文件资料样品或者 采取其他欺骗手段取得首次进口 药材批件的，依照药品管理法等 法律法规的规定处理。Article 33 The importer that files the documents for recordation by providing any false proof, documents or samples, or by other fraudulent means shall be given a warning, and imposed a fine of RMB 10,000 up to RMB309000.第三十三条 进口单位提

42、供 虚假证明、文件资料或者采取其 他欺骗手段办理备案的，给予警 告，并处1万元以上3万元以下 罚款。Chapter VII Supplementary Provisions第七章附则Article 34 The numbering format for the approval document for the import of medicinal materials is: (the abbreviation of the province, autonomous region, or municipality directly under the Central Government)

43、+ Yaocaijinzi (药材进字，which literally means “import of medicinal materials)+ 4-digit number of the year + 4-digital sequential number.第三十四条进口药材批件 编号格式为：（省、自治区、直 辖市简称）药材进字+ 4位年号 + 4位顺序号。Article 35 The Measures shall come into force on January 1, 2020, and the Measures for the Administration of Imported

44、 Medicinal Materials (for Trial Implementation) issued by the former State Food and Drug Administration on November 24, 2005 shall be repealed concurrently.第三十五条本办法自2020 年1月1日起施行。原国家食品 药品监督管理局2005年n月24 日公布的进口药材管理办法 （试行）同时废止。Measures for the Administration of Imported Medicinal Materials进口药材管理办法(Issu

45、ed by Order No. 9 of the SAMR on May 16, 2019)（2019年5月16日国家市场监 督管理总局令第9号公布）Chapter I General Provisions第一章总则Article 1 For purposes of strengthening the supervision and administration of imported medicinal materials and guaranteeing the quality of imported medicinal materials, these Measures have bee

46、n developed in accordance with the Drug Administration Law of the Peoples Republic of China, and the Regulation for the Implementation of the Drug Administration Law of the Peoples Republic of China, as well as other relevant laws and administrative regulations.第一条 为加强进口药材监 督管理，保证进口药材质量，根 据中华人民共和国药品

47、管理 法中华人民共和国药品管理 法实施条例等法律、行政法 规，制定本办法。Article 2 These Measures shall apply to the application for, the examination, approval, record filing, port inspection, supervision and administration of imported medicinal materials.第二条进口药材申请、审 批、备案、口岸检验以及监督管 理，适用本办法。Article 3 Medicinal materials shall be imported via the ports permitting the import of drugs or the border ports permitting the import of medicinal materials as第三条药材应当从国务院 批准的允许药品进口的口岸或者approved by the State Council.允许药材进口的边境口岸进口。Article 4 The National Medical ProductsAdministration (“NMPA)s