生物制药出口流程

生物制药-出口流程

Biotechnology-ExportGuidance2023.01ShippingfromSitetoclients出口流程图V1.0系统运输需求单Onlineshipmentrequest申请出口许可证ExportPermit客户申请进口许可证ClientsapplyforimportPermitifneededlocally国外确认后提货Pick-upafterconsigneeOktosend完成国外进口清关CompleteDestinationCustomsclearance货交客户DeliveredtoClients5.出口报关ExportCustomsclearance2.出口证

Permit1.开始

Initiation4.提货Pick-up3.报检CustomsInspectionandQuarantine6.运输Shipping7.进口报关ImportCustomsclearance8.陆路送货Deliveryandreceipt出口报检CustomsInspectionandQuarantine出口报关CustomsClearanceforexport*生物制品出口过程（从资料齐全到送达收货人）所需时间约3至5周；化学品约2周；DP/DS若需申报FDA约4至6周;Theleadtimeofthewholetransportationwillbe3~5weeksforbiologicalproducts,2weeksforchemicalproducts；4~6weeksforDP/DSifneedtodeclareFDAinUS;*根据不同的贸易条款确定责任范围DefinetheliabilityaccordingtoIncoterms安排国际空运运输ArrangetheAirtransport*整个药物出口过程从资料齐全到送达收货人所需时间约3至5周;Theleadtimeofthewholetransportationwillbe3~5weeks;进出口准备PreparedbyI/E:发票箱单合同Invoice&packinglist&contract商品编码HScode特殊物品审批单Specialgoodsapprovalform报检单Customsinspectionapproval申请人提供preparedbyapplicant：检测报告COA样品标签照片Productlabelpictures采购订单（一般贸易）PO(ifavailable)产品信息说明（Productinformation）(名称、规格、成分、来源、生产流程、用途Name,

Specification,Ingredients,Origin,Preparationprocess,Usage)合作协议Contract/Agreement(ifavailable)系统申请ApplicationinI/EsystemBiologicalProductsExportGuidanceProtein,Antibody,Cellline生物制品出口流程(蛋白，抗体，细胞)进出口准备PreparedbyI/E:发票箱单合同Invoice&packinglist&contract商品编码HScode运输鉴定Certificationfortransportappraisal报检单Customsinspectionapproval报关单BillofCustomsdeclaration出口报关ExportCustomsclearance空运Shippingbyair5.出口报关ExportCustomsclearance送货至收货人Delivertoconsignee3个工作日3workingdays系统运输需求单Onlineshipmentrequest申请特殊物品审批单Exportpermitapplication国外确认后提货Pick-upafterconsigneeOktosend2.出口证

Permit1.开始

Initiation一周1week4.提货Pick-up一周1week3.报检CustomsInspectionandQuarantine报检申请ApplyforCustomsInspectionandQuarantine6.运输Shipping2个工作日2workingdays7.进口报关ImportCustomsclearance进口报关ImportCustomsclearance2个工作日2workingdays8.陆路送货Deliveryandreceipt2个工作日2workingdays*整个药物出口过程从资料齐全到送达收货人所需时间约4至6周;Theleadtimeofthewholetransportationwillbe4~6weeks;BiologicalProductsExportGuidanceDrugSubstance,Drugproduct生物制品（原液、制剂）出口流程出口报关ExportCustomsclearance空运Shippingbyair5.出口报关ExportCustomsclearance送货至收货人Delivertoconsignee3个工作日3workingdays系统运输需求单Onlineshipmentrequest申请特殊物品审批单Exportpermitapplication进口许可证(如需要,进口方提供）importPermitprovidedbyClientsifneededlocally运输鉴定transportappraisal无菌检测Non-bacteriatestreport国外确认后提货Pick-upafterconsigneeOktosend2.出口/进口许可证

Export&ImportPermit1.开始

Initiation一周1week4.提货Pick-up一周1week3.报检CustomsInspectionandQuarantine报检申请ApplyforCustomsInspectionandQuarantine6.运输Shipping2个工作日2workingdays7.进口报关ImportCustomsclearance进口报关ImportCustomsclearance2个工作日2workingdays8.美国FDA备案USFDAdeclarationIfneededinlocal3个工作日3workingdays9.陆路送货Delivery2个工作日2workingdays进出口准备PreparedbyI/E:发票箱单合同Invoice&packinglist&contract商品编码HScode特殊物品审批单Specialgoodsapprovalform无菌检测Non-bacteriatestreport报检单Customsinspectionapproval申请人提供preparedbyapplicant：检测报告COA样品标签照片Productlabelpictures采购订单（一般贸易）PO(ifavailable)产品信息说明（Productinformation）(名称、规格、成分、来源、生产流程、用途Name,

Specification,Ingredients,Origin,Preparationprocess,Usage)合作协议Contract/Agreement(ifavailable)系统申请ApplicationinI/Esystem进出口准备PreparedbyI/E:发票箱单合同Invoice&packinglist&contract商品编码HScode运输鉴定Certificationfortransportappraisal报检单Customsinspectionapproval报关单BillofCustomsdeclaration*整个试剂出口过程（从资料齐全到送达收货人）所需时间约2周。Theleadtimeofthewholetransportationwillbe2weeks.进出口准备PreparedbyI/E:发票箱单合同Invoice&packinglist&contract商品编码HScode运输鉴定Certificationfortransportappraisal报关单BillofCustomsdeclaration申请人提供preparedbyapplicant：试剂标签照片Productlabelpictures采购订单（一般贸易）PO(ifavailable)产品信息说明（Productinformation）(名称、规格、成分、来源、生产流程、用途Name,

Specification,Ingredients,Origin,Preparationprocess,Usage)系统申请ApplicationinI/EsystemChemicalProductsExportGuidance化学试剂等出口流程3个工作日3workingdays系统运输需求单Onlineshipmentrequest国外确认后提货Pick-upafterconsigneeOktosend1.开始

Initiation3.提货Pick-up2个工作日2workingdays2个工作日2workingdays2个工作日2workingdays4.出口报关ExportCustomsclearance5.运输Sh