| 1. | An international airport shall also have the conditions for operating international air transport and be provided with customs and other port inspection organs 国际机场还应当具备国际通航条件,设立海关和其他口岸检查机关。 |
| 2. | 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。 |
| 3. | 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。 |
| 4. | 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。 |
| 5. | 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。 |
| 6. | 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。 |
| 7. | 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。 |
| 8. | 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。 |
| 9. | 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。 |
| 10. | 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。 |