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(1). Order of the State Food and Drug Administration

国家食品药品监督管理局令

(2). The Administrative Measures for the Import of Drugs have been adopted by the State Food and Drug Administration and the General Administration of Customs of the People’s Republic of China upon deliberation

《药品进口管理办法》经过国家食品药品监督管理局、中华人民共和国海关总署审议通过

(3). Administrative Measures for the Import of Drugs

药品进口管理办法

(4). In order to regulate the record keeping, customs declaration and port inspection work relating to the import of drugs, guarantee the quality of imported drugs

为规范药品进口备案、报关和口岸检验工作，保证进口药品的质量

(5). The present Measures are formulated in accordance with the Pharmaceutical Administration Law of the People’s Republic of China

根据《中华人民共和国药品管理法》、

(6). The Customs Law, the Rules for the Implementation of the Pharmaceutical Administration Law of the People’s Republic of China and the other relevant laws and regulations.

《中华人民共和国海关法》、《中华人民共和国药品管理法实施条例》(以下简称《药品管理法》、《海关法》、《药品管理法实施条例》)及相关法律法规的规定，制定本办法。

(7). The present Measures shall be applicable to the work of record keeping, customs declaration and port inspection relating to the import of drugs.

药品的进口备案、报关、口岸检验以及进口，适用本办法。

(8). The Drugs shall be imported through ports, which permit the entry of imported drugs upon the approval of the State Council.

药品必须经由国务院批准的允许药品进口的口岸进口。

(9). “Import record keeping” as mentioned in the present Measures refers to the process, in which import entities file applications to administrative departments for drugs of place where the ports are located for Customs Clearance Permit for Imported Drugs.

本办法所称进口备案，是指进口单位向允许药品进口的口岸所在地药品监督管理部门(以下称口岸药品监督管理局)申请办理《进口药品通关单》的过程。

(10). The import record keeping of narcotics and psychotropic drugs refers to the process that the import entities file applications to the drug administrations where the ports are located for Imported Drugs Port Inspection Notice.

麻醉药品、精神药品进口备案，是指进口单位向口岸药品监督管理局申请办理《进口药品口岸检验通知书》的过程。

(11). The term “port inspection” means that the medicine inspection institutions determined by the State Food and Drug Administration conduct examination on the imported Drugs, which have arrived at the ports, in accordance with the law.

本办法所称口岸检验，是指国家食品药品监督管理局确定的药品检验机构对抵达口岸的进口药品依法实施的检验工作。

(12). An import entity shall not go through the formalities for import record keeping and port inspection on imported drugs unless it has acquired the Drug Import Registration Certificate (or Pharmaceutical Products Registration Certificate).

进口药品必须取得国家食品药品监督管理局核发的《进口药品注册证》(或者《医药产品注册证》)，或者《进口药品批件》后，方可办理进口备案和口岸检验手续。

(13). In addition, an important entity shall have acquired the Import Permit for the import of narcotics and psychotropic drugs.

进口麻醉药品、精神药品，还必须取得国家食品药品监督管理局核发的麻醉药品、精神药品《进口准许证》。

(14). An import entity shall file a declaration to the customs upon the strength of Customs Clearance Permit for Imported Drugs, while the customs shall handle the procedures for the customs declaration and clearance of the imported drugs.

进口单位持《进口药品通关单》向海关申报，海关凭口岸药品监督管理局出具的《进口药品通关单》，办理进口药品的报关验放手续。

(15). As to the narcotics and psychotropic drugs, the customs shall handle the procedures for the customs declaration and clearance upon the strength of the Import Permit issued by State Food and Drug Administration.

进口麻醉药品、精神药品,海关凭国家食品药品监督管理局核发的麻醉药品、精神药品《进口准许证》办理报关验放手续。

(16). The catalogue of drugs to be imported shall be formulated, amended, and announced by the State Food and Drug Administration jointly with the General Administration of Customs.

国家食品药品监督管理局会同海关总署制定、修订、公布进口药品目录。

(17). The port drug administrations shall be responsible for the work of drug import record keeping, which shall be subject to the guidance of the State Food and Drug Administration. Their duties and functions are

口岸药品监督管理局负责药品的进口备案工作。口岸药品监督管理局承担的进口备案工作受国家食品药品监督管理局的领导，其具体职责包括

(18). To accept the applications for import record keeping, and examine relevant materials; To handle relevant matters related to import record keeping

受理进口备案申请，审查进口备案资料;办理进口备案或者不予进口备案的有关事项

(19). To contact with the customs for handling matters relating to import record keeping; To notify the port drug inspection offices to make port inspections over the imported drugs

联系海关办理与进口备案有关的事项;通知口岸药品检验所对进口药品实施口岸检验

(20). To supervise and address the problems found in import record keeping and port inspection; Other matters as provided for by the Sate Food and Drug Administration.

对进口备案和口岸检验中发现的问题进行监督处理;国家食品药品监督管理局规定的其他事项。

(21). Only as an independent legal person holding a Drug Business License may an entity apply for drug inspection.

报验单位应当是持有《药品经营许可证》的独立法人。

(22). When a pharmaceutical production enterprise has to import crude drugs and intermediate preparations (including those repackaged within China)needed by this enterprise itself, it shall hold a Pharmaceutical Production License.

药品生产企业进口本企业所需原料药和制剂中间体(包括境内分包装用制剂)，应当持有《药品生产许可证》。

(23). Under any of the following circumstances, the import record keeping procedures shall not be handled until the imported drugs have been inspected by the port drug inspection offices and have been confirmed as meeting the prescribed standards.

下列情形的进口药品，必须经口岸药品检验所检验符合标准规定后，方可办理进口备案手续。

(24). For the imported drugs not meeting the prescribed standards, the port drug administrations shall not make import record keeping.

检验不符合标准规定的，口岸药品监督管理局不予进口备案

(25). The biological products as prescribed by the State Food and Drug Administration; The drugs sold within China for the first time; Other drugs as prescribed by the State Council

国家食品药品监督管理局规定的生物制品;首次在中国境内销售的药品;国务院规定的其他药品。

(26). When an import entity signs a purchase contract, it shall select a port from those permitting the entry of imported drugs as the destination of cargo.

进口单位签订购货合同时，货物到岸地应当从允许药品进口的口岸选择。

(27). The drugs listed in Article 10 shall pass through the ports with a special approval of the state, permitting the entry of imported drugs.

其中本办法第十条规定情形的药品，必须经由国家特别批准的允许药品进口的口岸进口。

(28). An application for import record keeping shall be filed to the destination port drug administration. The imported drugs shall be inspected by the port drug inspection office responsible for the inspection of drugs at the port.

进口备案，应当向货物到岸地口岸药品监督管理局提出申请，并由负责本口岸药品检验的口岸药品检验所进行检验。

(29). When applying for import record keeping, an applicant shall fill in the Imported Drugs Inspection Application Form

办理进口备案，报验单位应当填写《进口药品报验单》

(30). And submit other relevant materials of the imported drugs (in duplicate)to the local port drug administration upon the strength of the original Drug Import Registration Certificate

持《进口药品注册证》原件，进口麻醉药品、精神药品还应当持麻醉药品、精神药品《进口准许证》原件

(31). And the original Import Permit of narcotics and psychotropic drugs when importing such drugs.

向所在地口岸药品监督管理局报送所进口品种的有关资料一式两份

(32). Copy of Drug Import Registration Certificate (or Pharmaceutical Product Registration Certificate (original or duplicate)), the Import Permit of narcotics and psychotropic drugs

《进口药品注册证》(或者《医药产品注册证》)(正本或者副本)复印件;麻醉药品、精神药品的《进口准许证》复印件

(33). Copy of the applicant’s Drug Business License or Enterprise Legal Person Business License

报验单位的《药品经营许可证》和《企业法人营业执照》复印件

(34). Copy of certificate of origin; Copy of the purchase contract; Copies of the packing lists, bills of lading, and invoices of freight

原产地证明复印件;购货合同复印件;装箱单、提运单和货运发票复印件

(35). Copy of the report about the factory inspection;Drug directions and the package and label styles (except for the crude drugs and intermediate preparations)

出厂检验报告书复印件;药品说明书及包装、标签的式样(原料药和制剂中间体除外)

(36). For a biological product within the range of examination, approval and issuance specified by the State Food and Drug Administration

国家食品药品监督管理局规定批签发的生物制品

(37). The summary of the production examination records and the original approval issued by the administrative department for drugs of the country or region of origin shall be submitted

需要提供生产检定记录摘要及生产国或者地区药品管理机构出具的批签发证明原件

(38). For the drugs listed in Article 10, a copy of the recent Report on the Inspection of Imported Drugs and the Customs Clearance Form for Imported Drugs shall be submitted

本办法第十条规定情形以外的药品，应当提交最近一次《进口药品检验报告书》和《进口药品通关单》复印件。....(please sign in for more)

(39). When a pharmaceutical production enterprise applies for import record keeping for the crude drugs and intermediate preparations needed by itself

药品生产企业自行进口本企业生产所需原料药和制剂中间体的进口备案....(please sign in for more)

(40). It shall submit a copy of both the Pharmaceutical Production License and the Enterprise Legal Person Business License as the materials specified in Item (2)of the present Article.

第(二)项资料应当提交其《药品生产许可证》和《企业法人营业执照》复印件。....(please sign in for more)

(41). For the imported drugs transited from other countries , the complete set materials including the purchase contract, packing list, bills of lading, and freight invoices from the place of origin to all the transit places shall be submitted at the same time.

经其他国家或者地区转口的进口药品，需要同时提交从原产地到各转口地的全部购货合同、装箱单、提运单和货运发票等。....(please sign in for more)

(42). Each of the copies of the above-mentioned materials shall be affixed with the seal of the import entity.

上述各类复印件应当加盖进口单位公章。....(please sign in for more)

(43). After a port drug administration has accepted an Imported Drugs Inspection Application Form and other relevant materials, it shall examine them in compliance with the requirements as below

口岸药品监督管理局接到《进口药品报验单》及相关资料后，按照下列程序的要求予以审查....(please sign in for more)

(44). To examine the above-mentioned materials item by item to see whether they are complete and authentic

逐项核查所报资料是否完整、真实....(please sign in for more)

(45). To examine the authenticity of the original Drug Import Registration Certificate (or the Pharmaceutical Product Registration Certificate (original or duplicate)), or the original Import Permit for narcotics and psychotropic drugs

查验《进口药品注册证》(或者《医药产品注册证》)(正本或者副本)原件，或者麻醉药品、精神药品的《进口准许证》原件真实性....(please sign in for more)

(46). If there is no discrepancy upon examination, the original Drug Import Registration Certificate (or the Pharmaceutical Product Registration Certificate (original or duplicate))

审查无误后，将《进口药品注册证》(或者《医药产品注册证》)(正本或者副本)原件....(please sign in for more)

(47). Or the original Import Permit for narcotics and psychotropic drugs shall be returned to the applicant, and the relevant procedures for import record keeping shall be completed within the same day.

或者麻醉药品、精神药品的《进口准许证》原件，交还报验单位，并于当日办结进口备案的相关手续。....(please sign in for more)

(48). For the drugs listed in Article 10 of the present Measures, after the port drug administration has confirmed, upon examination, that there is no discrepancy in the complete set of materials

本办法第十条规定情形的药品，口岸药品监督管理局审查全部资料无误后....(please sign in for more)

(49). It shall send an Imported Drugs Port Inspection Notice, attaching a set of the materials as specified in Article 13 of the present Measures, to the competent port drug inspection office

应当向负责检验的口岸药品检验所发出《进口药品口岸检验通知书》，附本办法第十三条规定的资料一份....(please sign in for more)

(50). And shall send an Imported Drugs Sampling Notice to the customs office at the same time.

同时向海关发出《进口药品抽样通知书》。....(please sign in for more)

(51). The pertinent administrative provisions on the port drug inspection offices’ sampling by entering into the supervisory area of the customs office

有关口岸药品检验进入海关监管场所抽样的管理规定....(please sign in for more)

(52). Shall be separately formulated by the State Food and Drug Administration and the General Administration of Customs.

由国家食品药品监督管理局与海关总署另行制定。....(please sign in for more)

(53). The port drug inspection office shall fetch the inspection samples at the sampling place specified in the Imported Drugs Port Inspection Notice

口岸药品检验所按照《进口药品口岸检验通知书》规定的抽样地点，抽取检验样品....(please sign in for more)

(54). Conduct quality inspection on them and shall send the inspection result to the local port drug administration.

进行质量检验，并将检验结果送交所在地口岸药品监督管理局。....(please sign in for more)

(55). If the inspection result shows that the imported drugs meet the prescribed standards, the import record keeping shall be approved and a Customs Clearance Form for Imported Drugs shall be issued by the port drug administration

检验符合标准规定的，准予进口备案，由口岸药品监督管理局发出《进口药品通关单》....(please sign in for more)

(56). If the inspection shows an adverse result, the import record keeping shall not be approved, and a Notice of Disapproval of Drug Import record keeping shall be issued by the port drug administration.

不符合标准规定的，不予进口备案，由口岸药品监督管理局发出《药品不予进口备案通知书》。....(please sign in for more)

(57). For the drugs other than those listed in Article 10 of the present Measures, after the port drug administration has confirmed that, upon examination, there is no discrepancy in the complete set of materials

本办法第十条规定情形以外的药品，口岸药品监督管理局审查全部资料无误后....(please sign in for more)

(58). It shall approve of the import record keeping and issue a Notice of Customs Clearance for Imported Drugs.

准予进口备案，发出《进口药品通关单》。....(please sign in for more)

(59). At the same time, it shall be responsible for the issuance of Imported Drugs Port Inspection Notice to the port drug inspection office in charge of inspection, and attach to the Notice a complete set of materials as required in Article 13.

同时向负责检验的口岸药品检验所发出《进口药品口岸检验通知书》，附本办法第十三条规定的资料一份。....(please sign in for more)

(60). Under any of the following circumstances, the imported drugs shall be rejected to be put on import record keeping and a Notice of Disapproval of Putting the Imported Drug on Import Record Keeping shall be issued by the port drug administration

下列情形之一的进口药品，不予进口备案，由口岸药品监督管理局发出《药品不予进口备案通知书》....(please sign in for more)

(61). For narcotics and psychotropic drugs, the port drug administration shall not issue an Imported Drugs Port Inspection Notice

对麻醉药品、精神药品，口岸药品监督管理局不予发放《进口药品口岸检验通知书》....(please sign in for more)

(62). An applicant fails to provide the original Drug Import Registration Certificate (or Pharmaceutical Product Registration Certificate (original or duplicate))or the Import Permit for narcotics and psychotropic drugs

不能提供《进口药品注册证》(或者《医药产品注册证》)(正本或者副本)、《进口药品批件》或者麻醉药品、精神药品的《进口准许证》原件的....(please sign in for more)

(63). When an applicant goes through the formalities for import record keeping, the valid term of Drug Import Registration Certificate (or Pharmaceutical Products Registration Certificate)or the Import Permit for narcotics and psychotropic drugs has expired

办理进口备案时，《进口药品注册证》(或者《医药产品注册证》)，或者麻醉药品、精神药品的《进口准许证》已超过有效期的....(please sign in for more)

(64). Or the Origin Certification issued by regional international institutions fails to give a clear indication of the production place as specified in the Drug Import Registration Certificate (or in the Pharmaceutical Products Registration Certificate)

或者区域性国际组织出具的原产地证明未标明《进口药品注册证》(或者《医药产品注册证》)规定产地的....(please sign in for more)

(65). The import entity fails to obtain a Drug Business License (For the production enterprise, it shall have obtained Pharmaceutical Production License and Enterprise Legal Person Business License)

进口单位未取得《药品经营许可证》(生产企业应当取得《药品生产许可证》)和《企业法人营业执照》的....(please sign in for more)

(66). The packages and labels of the drugs that have arrived at the port are inconsistent with the requirements of the State Food and Drug Administration

到岸品种的包装、标签与国家食品药品监督管理局的规定不符的....(please sign in for more)

(67). There is no Chinese language directions for the drug preparations or the Chinese directions is inconsistent with the approved ones

药品制剂无中文说明书或者中文说明书与批准的说明书不一致的....(please sign in for more)

(68). The applicant fails to organize the import at a port permitting the entry of imported drugs upon the approval of the State Council; the destination place of the cargo doesn’t fall within the jurisdiction of the local port administration

未在国务院批准的允许药品进口的口岸组织进口的，或者货物到岸地不属于所在地口岸药品监督管理局管辖范围的....(please sign in for more)

(69). The applicant fails to provide any evidential document for the biological products within the range of examination, approval and issuance specified by the administrative department for drugs in the production country or region

国家食品药品监督管理局规定批签发的生物制品未提供有效的生产国或者地区药品管理机构出具的生物制品批签发证明文件的....(please sign in for more)

(70). An applicant forges or alters the relevant documents and vouchers; The Drug Import Registration Certificate (or the Pharmaceutical Registration Certificate)has been canceled

伪造、变造有关文件和票据的;《进口药品注册证》(或者《医药产品注册证》)已被撤销的....(please sign in for more)

(71). The drugs fall within the scope as specified in Article 10 of the present Measures and shall not be sampled by the port drug inspection office in accordance with Article 25 of the present Measures

本办法第十条规定情形的药品，口岸药品检验所根据本办法第二十五条的规定不予抽样的....(please sign in for more)

(72). The drugs fall within the scope as specified in Article 10 of the present Measures and have confirmed as not meeting the prescribed standards upon port inspection; Other circumstances contrary to relevant regulations of our country on drug administration.

本办法第十条规定情形的药品，口岸检验不符合标准规定的;其他不符合我国药品管理有关规定的。....(please sign in for more)

(73). For the imported drugs rejected to be put on import record keeping, they shall be returned to the consignor by the import entity. If unable to be returned, they shall be delivered to and dealt with by the port drug administration.

对不予进口备案的进口药品，进口单位应当予以退运。无法退运的，由海关移交口岸药品监督管理局监督处理。....(please sign in for more)

(74). The import of clinical drugs in urgent need, the donated drugs, the samples or comparative drugs needed for the research on new drugs and drug registration shall be subject to the approval of the State Food and Drug Administration

进口临床急需药品、捐赠药品、新药研究和药品注册所需样品或者对照药品等，必须经国家食品药品监督管理局批准....(please sign in for more)

(75). And the import record keeping formalities shall be gone through upon the strength of the Drug Import Approval Document issued by the State Food and Drug Administration in accordance with Article 16 of the present Measures.

并凭国家食品药品监督管理局核发的《进口药品批件》，按照本办法第十六条的规定，办理进口备案手续。....(please sign in for more)

(76). The port drug inspection offices shall be established by the State Food and Drug Administration in light of the port inspection work related to the imported drugs.

口岸药品检验所由国家食品药品监督管理局根据进口药品口岸检验工作的需要确定。....(please sign in for more)

(77). A port drug inspection office shall exercise the following functions

口岸药品检验所的职责包括....(please sign in for more)

(78). To conduct spot inspection on the cargos arrived at the port; To examine the factory inspection report and the Certificate of Origin

对到岸货物实施现场核验;核查出厂检验报告书和原产地证明原件....(please sign in for more)

(79). To fetch samples under the relevant requirements; To conduct port inspection on the imported drugs

按照规定进行抽样;对进口药品实施口岸检验....(please sign in for more)

(80). To conduct re-inspection on a disputed inspection result; Other matters as provided for by the State Food and Drug Administration.

对有异议的检验结果进行复验;国家食品药品监督管理局规定的其他事项。....(please sign in for more)

(81). The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for the guidance and cooperation of the port inspection on the imported drugs.

中国药品生物制品检定所负责进口药品口岸检验工作的指导和协调。....(please sign in for more)

(82). The standard and comparative samples needed by the port inspection offices shall be examined and labeled by the National Institute for the Control of Pharmaceutical and Biological Products.

口岸检验所需标准品、对照品由中国药品生物制品检定所负责审核、标定。....(please sign in for more)

(83). The port drug inspection offices shall conduct inspections on the imported drugs according to the standards specified in the Drug Import Registration Certificate (or the Pharmaceutical Products Registration Certificate).

口岸药品检验所应当按照《进口药品注册证》(或者《医药产品注册证》)载明的注册标准对进口药品进行检验。....(please sign in for more)

(84). A port inspection office shall contact with the import entity within 2 days from the day it receives the Imported Drugs Port Inspection Notice, and shall fetch samples in the specified storage place of the cargos.

口岸药品检验所接到《进口药品口岸检验通知书》后，应当在2日内与进口单位联系，到规定的存货地点按照《进口药品抽样规定》进行现场抽样。....(please sign in for more)

(85). Before sampling, the import entity shall provide the factory inspection report and the original origin certification.

进口单位应当在抽样前，提供出厂检验报告书和原产地证明原件。....(please sign in for more)

(86). If the port drug inspection office has to fetch samples in the supervisory area of the customs, the port drug inspection office shall contact the customs about the matters related to the sampling, and shall obtain the consent of the customs.

对需进入海关监管区抽样的，口岸药品检验所应当与海关联系抽样事宜，并征得海关同意。....(please sign in for more)

(87). When sampling, the personnel of the import entity and those of the customs shall be on the spot at the same time.

抽样时，进口单位和海关的人员应当同时在场。....(please sign in for more)

(88). When a port drug inspection office fetches samples on the spot, it shall pay attention to the imported drugs actually arrived, shall carefully record the samples and fill in the Imported Drugs Sampling Record Form.

口岸药品检验所现场抽样时，应当注意核查进口品种的实际到货情况，做好抽样记录并填写《进口药品抽样记录单》。....(please sign in for more)

(89). For the drugs other than those specified in Article 10, after the port drug inspection office has completed the sampling

本办法第十条规定情形以外的药品，抽样完成后....(please sign in for more)

(90). It shall give an clear indication of “Sampled” on the original Customs Clearance Permit for the Imported Drugs, and to which it shall affix its official seal.

口岸药品检验所应当在进口单位持有的《进口药品通关单》原件上注明“已抽样”的字样，并加盖抽样单位的公章。....(please sign in for more)

(91). For narcotics and psychotropic drugs, after the port drug inspection office has completed the sampling, it shall give a clear indication of “Sampled” on the original Import Permit, and to which it shall affix its official seal.

对麻醉药品、精神药品，抽样完成后，应当在《进口准许证》原件上注明“已抽样”的字样，并加盖抽样单位的公章。....(please sign in for more)

(92). A port inspection office shall not fetch samples from the imported drugs under any of the following circumstances

对有下列情形之一的进口药品，口岸药品检验所不予抽样....(please sign in for more)

(93). No original factory inspection report or origin certificate has been provided, or the original certificates are inconsistent with the photocopies, which are submitted when the application for import record keeping is filed

未提供出厂检验报告书和原产地证明原件，或者所提供的原件与申报进口备案时的复印件不符的....(please sign in for more)

(94). The shipping mark is inconsistent with the documents; The batch number or quantity of the imported drugs is inconsistent with that in the documents

装运唛头与单证不符的;进口药品批号或者数量与单证不符的....(please sign in for more)

(95). The package and the label of the imported drugs are inconsistent with those in the documents; Other circumstances not meeting the laws, regulations and rules of the state concerning the control of food and drug.

进口药品包装及标签与单证不符的;其他不符合国家药品监督管理法律、法规和规章规定的。....(please sign in for more)

(96). For the drugs that are exempt from sampling, the drug inspection office of the port shall, within two days, deliver the Imported Drugs Sampling Record Keeping Form to the drug supervision and regulation administration of the port where it is located.

对不予抽样的药品，口岸药品检验所应当在2日内，将《进口药品抽样记录单》送交所在地口岸药品监督管理局。....(please sign in for more)

(97). The port drug inspection office shall conduct inspection on the samples it fetched in good time, complete the inspection within 20 days from the day when the sampling is done

口岸药品检验所应当及时对所抽取的样品进行检验，并在抽样后20日内，完成检验工作....(please sign in for more)

(98). And shall issue an Imported Drug Inspection Report.

出具《进口药品检验报告书》。....(please sign in for more)

(99). If it is unable to complete the inspection within the time limit for special drugs or under special circumstances, it may extend the time limit reasonably, and shall notify the import entity and port drug administration.

特殊品种或者特殊情况不能按时完成检验时，可以适当延长检验期限，并通知进口单位和口岸药品监督管理局。....(please sign in for more)

(100). The inspection conclusions of “Meeting the Prescribed Standards” or “Not Meeting the Prescribed Standards” shall be clearly specified in the Imported Drug Inspection Report.

《进口药品检验报告书》应当明确标有“符合标准规定”或者“不符合标准规定”的检验结论。....(please sign in for more)