|
|
| 11. | 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。 |
|
|
| | |
| 12. | The port drug administration and port drug inspection office shall establish a strict management system for the import record keeping materials and port inspection materials, |
| 口岸药品监督管理局和口岸药品检验所应当建立严格的进口备案资料和口岸检验资料的管理制度， |
|
|
| | |
| 13. | 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， |
|
|
| | |
| 14. | 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》； |
|
|
| | |
| 15. | "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。 |
|
|
| | |
| 16. | 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。 |
|
|
| | |
| 17. | 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； |
|
|
| | |
| 18. | 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； |
|
|
| | |
| 19. | 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， |
|
|
| | |
| 20. | After the local drug administration has accepted the Imported Drug Inspection Report, |
| 所在地口岸药品监督管理局收到《进口药品检验报告书》后， |
|
|
| | |