国家食品药品监督管理局令
Order of the State Food and Drug Administration
《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,
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
Administrative Measures for the Import of 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,
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,
根据《中华人民共和国药品管理法》、
the present Measures are formulated in accordance with the Pharmaceutical Administration Law of the People’s Republic of China,
《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。
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.
药品的进口备案、报关、口岸检验以及进口,适用本办法。
The present Measures shall be applicable to the work of record keeping, customs declaration and port inspection relating to the import of drugs.
药品必须经由国务院批准的允许药品进口的口岸进口。
The Drugs shall be imported through ports, which permit the entry of imported drugs upon the approval of the State Council.
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。
“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.
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。
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.
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。
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.
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。
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》。
In addition, an important entity shall have acquired the Import Permit for the import of narcotics and psychotropic 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。
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.
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