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| 21. | a port; a seaport; a river port; a harbor |
| 口岸 |
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| 22. | 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。 |
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| 23. | 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。 |
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| 24. | 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。 |
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| 25. | 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： |
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| 26. | The crude drugs unlisted in the catalogue of the import catalogue of drugs shall be in line with the present Measures, shall be subject to the import record keeping formalities in accordance with the law. |
| 进口暂未列入进口药品目录的原料药，应当遵照本办法的规定，到口岸药品监督管理局办理进口备案手续。 |
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| 27. | 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》； |
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| 28. | 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： |
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| 29. | 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》。 |
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| 30. | 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。 |
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