|
|
| 31. | The sampling of imported drugs shall be conducted by a port inspection office that undertakes such inspection. |
| 进口药品抽样由承担该品种检验的口岸药品检验所负责进行。 |
|
|
| | |
| 32. | 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： |
|
|
| | |
| 33. | 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。 |
|
|
| | |
| 34. | Arrange the inland transportation from import ports to warehouse timely and properly. |
| 负责进口口岸到达仓库的运输安排，按规定时间到达制定地点。 |
|
|
| | |
| 35. | 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， |
|
|
| | |
| 36. | the import entity report the detailed information about the circulation and use of all the imported drugs to the local port drug administration. |
| 进口单位应当在收到《进口药品检验报告书》后2日内，将全部进口药品流通、使用的详细情况，报告所在地口岸药品监督管理局。 |
|
|
| | |
| 37. | 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。 |
|
|
| | |
| 38. | 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： |
|
|
| | |
| 39. | 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。 |
|
|
| | |
| 40. | 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。 |
|
|
| | |