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Measures for the Administration of Imported Medicinal Materials [Not Yet Effective]
进口药材管理办法 [尚未生效]
【法宝引证码】

Order of the State Administration for Market Regulation 

国家市场监督管理总局令

(No. 9) (第9号)

The Measures for the Administration of Imported Medicinal Materials, as deliberated and adopted at the eighth executive meeting of the State Administration for Market Regulation (“SAMR”) on April 28, 2019, are hereby issued, and shall come into force on January 1, 2020. 《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。
Director General: Zhang Mao 局长 张茅
May 16, 2019 2019年5月16日
Measures for the Administration of Imported Medicinal Materials 进口药材管理办法
(Issued 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, the Measures are developed in accordance with the Drug Administration Law of the People's Republic of China, and the Regulation for the Implementation of the Drug Administration Law of the People's 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 The Measures shall apply to the application for, the examination and 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 approved by the State Council.   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允许药材进口的边境口岸进口。
Article 4 The National Medical Products Administration (“NMPA”) shall be responsible for the supervision and administration of imported medicinal materials throughout the country. The NMPA shall authorize the medical products administrations in provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as the “provincial medical products administrations”) to conduct examination on and grant approval to the initial import of medicinal materials, and supervise and guide the authorized examination and approval activities.   第四条 国家药品监督管理局主管全国进口药材监督管理工作。国家药品监督管理局委托省、自治区、直辖市药品监督管理部门(以下简称省级药品监督管理部门)实施首次进口药材审批,并对委托实施首次进口药材审批的行为进行监督指导。
The provincial medical products administrations shall supervise and administer the imported medicinal materials according to law, and conduct examination on and grant approval to the initial import of medicinal materials in the name of the NMPA within the scope of authorization. 省级药品监督管理部门依法对进口药材进行监督管理,并在委托范围内以国家药品监督管理局的名义实施首次进口药材审批。
The medical products administration at the place of a port permitting the import of drugs or a border port permitting the import of medicinal materials (hereinafter referred to as the “port medical products administration departments”) shall be responsible for the record filing of imported medicinal materials, organize port inspections, and conduct supervision and administration. 允许药品进口的口岸或者允许药材进口的边境口岸所在地负责药品监督管理的部门(以下简称口岸药品监督管理部门)负责进口药材的备案,组织口岸检验并进行监督管理。
Article 5 For the purpose of the Measures, “importers of medicinal materials” mean the applicants who apply for the examination and approval of the initial import of medicinal materials or the entities that conduct record filing for imported medicinal materials.   第五条 本办法所称药材进口单位是指办理首次进口药材审批的申请人或者办理进口药材备案的单位。
Importers of medicinal materials shall include marketing license holders of Chinese patent medicines, traditional Chinese medicine (“TCM”) producers, and business operators of TCM decoction pieces. 药材进口单位,应当是中国境内的中成药上市许可持有人、中药生产企业,以及具有中药材或者中药饮片经营范围的药品经营企业。
Article 6 For the initial import of medicinal materials, the importers shall obtain the Approval Document for Import of Medicinal Materials according to the provisions of the Measures, and file them for recordation at the port medical products administrations. Initially imported medicinal materials refer to the medicinal materials imported for the first time with a different original plant, from a different country (region), and by a different applicant than before.   第六条 首次进口药材,应当按照本办法规定取得进口药材批件后,向口岸药品监督管理部门办理备案。首次进口药材,是指非同一国家(地区)、非同一申请人、非同一药材基原的进口药材。
For non-initially imported medicinal materials, the importers shall directly file them for recordation at the port medical products administrations according to the provisions of the Measures. Non-initially imported medicinal materials shall be administered with a specific catalogue prepared and adjusted by the NMPA. Those not listed in the catalogue but with the applicant, original plant, and country (region) remaining unchanged shall be administered as non-initially imported medicinal materials. 非首次进口药材,应当按照本办法规定直接向口岸药品监督管理部门办理备案。非首次进口药材实行目录管理,具体目录由国家药品监督管理局制定并调整。尚未列入目录,但申请人、药材基原以及国家(地区)均未发生变更的,按照非首次进口药材管理。
Article 7 Imported medicinal materials shall comply with the state pharmaceutical standards. The varieties not included in the current Pharmacopoeia of China shall follow the standards of imported medicinal materials; and those included neither in the current Pharmacopoeia of China nor in the standards of imported medicinal materials shall follow the pharmaceutical standards of other countries. If the imported medicinal materials traditionally used by an ethnic minority group in an ethnic minority area have no state pharmaceutical standard, they shall comply with the standards of medicinal materials in the relevant province or autonomous region.   第七条 进口的药材应当符合国家药品标准。中国药典现行版未收载的品种,应当执行进口药材标准;中国药典现行版、进口药材标准均未收载的品种,应当执行其他的国家药品标准。少数民族地区进口当地习用的少数民族药药材,尚无国家药品标准的,应当符合相应的省、自治区药材标准。
Chapter II Application for, Examination and Approval of the Initial Import of Medicinal Materials 

第二章 首次进口药材申请与审批

 
Article 8 To apply for the initial import of medicinal materials, an applicant shall fill out an application form for the import of medicinal materials through the information system of the NMPA (hereinafter referred to as the “information system”), and submit the following documents to the provincial medical products administration of the place where the applicant is located:   第八条 首次进口药材,申请人应当通过国家药品监督管理局的信息系统(以下简称信息系统)填写进口药材申请表,并向所在地省级药品监督管理部门报送以下资料:
1. an application form for the import of medicinal materials; (一)进口药材申请表;
2. (if the applicant is a marketing license holder of Chinese patent medicine) a photocopy of the applicant's Permit for Pharmaceutical Manufacture or Permit for Drug Operation, as well as a photocopy of relevant approval certificate of pharmaceuticals; (二)申请人药品生产许可证或者药品经营许可证复印件,申请人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;
3. a photocopy of the registration certification document for the exporter; (三)出口商主体登记证明文件复印件;
4. photocopies of the purchasing contract and notarial documents; (四)购货合同及其公证文书复印件;
5. ecological environment, resource reserves, wild-growing or planting and breeding conditions, harvesting, primary processing, and other information of the place of origin of medicinal materials; (五)药材产地生态环境、资源储量、野生或者种植养殖情况、采收及产地初加工等信息;
6. standards of medicinal materials and sources of standards; and (六)药材标准及标准来源;
7. original copy of the authentication certificate of the origin of medicinal materials issued by a Chinese institution with the qualification of authenticating the animal and plant origin (including such information as authentication basis, authentication result, sample pictures, authenticator, authentication institution, and official seal). (七)由中国境内具有动、植物基原鉴定资质的机构出具的载有鉴定依据、鉴定结论、样品图片、鉴定人、鉴定机构及其公章等信息的药材基原鉴定证明原件。
The applicant shall be responsible for the authenticity of the application documents submitted. 申请人应当对申报资料的真实性负责。
Article 9 After receiving the application documents, the provincial medical products administration shall make a formal examination of the conformity and completeness of the application documents. Where the application documents contain any error which can be corrected on the spot, the applicant shall be allowed to correct it immediately; and where the application documents are incomplete or do not meet the legal requirements, the provincial medical products administration shall, either on the spot or within five days, notify the applicant once for all of the contents to be supplemented. If it fails to so notify the applicant, the application shall be deemed as being accepted on the date of receiving the application documents.   第九条 省级药品监督管理部门收到首次进口药材申报资料后,应当对申报资料的规范性、完整性进行形式审查。申报资料存在可以当场更正的错误的,应当允许申请人当场更正;申报资料不齐全或者不符合法定形式的,应当当场或者5日内一次告知申请人需要补正的全部内容,逾期不告知的,自收到申报资料之日起即为受理。
The provincial medical products administration shall send a notification on accepting or refusing to accept the application for the initial import of medicinal materials; and if it refuses to accept the application, it shall explain the reasons in writing. 省级药品监督管理部门受理或者不予受理首次进口药材申请,应当出具受理或者不予受理通知书;不予受理的,应当书面说明理由。
Article 10 After receiving the notification, the applicant shall promptly submit the inspection samples and the documents as provided for in Article 8 herein to the provincial drug inspection institution of the place where the applicant is located.   第十条 申请人收到首次进口药材受理通知书后,应当及时将检验样品报送所在地省级药品检验机构,同时提交本办法第八条规定的资料。
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