中英对照2021国务院关于同意在河南省开展跨境电子商务零售进口药品试点的批复.docx

OfficialReplyoftheStateCouncilRegardingApprovingtheLaunchofthePilotProgramofRetailDrugImportsinCross-BorderE-CommerceinHenanProvinceDocumentNumber：LelterNo.512021of(heStateCouncilAreaofLaw:OptimizationofDoingBusiness1.evelofAuthority：RegulatoryDocumentsoftheStateCouncilIssuingAuthority：StateCouncilDateIssued：05-08-2021EffectiveDate:05-08-2021Status：EffectiveTopic:E-CommerceOfficialReplyoftheStateCouncilRegardingApprovingtheLaunchofthePilotProgramofRetailDrugImportsinCross-BorderE-CommerceinHenanProvince(LetterNo.512021oftheStaleCouncil)ThePeople'sGovernmentofHenanProvince,theStateAdministrationforMarketRegulation,andtheNationalMedicalProductsAdministration:Yourrequestforinstructionsonthelaunchofthepilotprogramofretaildrugimportsincross-bordere-commerceinHenanProvincehasbeenreceived.Thefollowingofficialreplyisherebygiven:I. Thelaunchofthepilotprogramofretaildrugimportsincross-bordere-commerceinHenanProvincehasbeenapprovedforaperiodofthreeyears,commencingfromthedateofapproval.Youshallconscientiouslyorganizeand国务院关于同意在河南省开展跨境电子商务零售进口药品试点的批复(国函(2021)51号)河南省人民政府，市场监管总局、国家药监局：你们关于在河南省开展跨境电子商务零售进口药品试点的请示收悉。现批复如下：一、同意在河南省开展跨境电子商务零售进口药品试点，试点期为自批复之日起3年，请认真组织实施。conductthepilotprogram.II. Thepilotprogramshall,undertheguidanceoftheXiJinpingThoughtonSocialismwithChineseCharacteristicsinaNewEra,becarriedoutwithintheexistinglegalframeworkinaccordancewiththerelevantprovisionsoftheDrugAdministrationLawofthePeople'sRepublicofChinabythoroughlyimplementingtheguidingprinciplesofthe19thCPCNationalCongressandthesecond,third,fourth,andfifthplenarysessionsofthe19thCPCCentralCommitteeandconscientiouslyimplementingtherequirementsofapplyingthestrictestpossiblestandards,oversight,punishment,andaccountability.Productsunderthepilotprogramare13nonprescriptiondrugsforwhichdrugmarketingauthorizationinsideChinahasbeenobtained.ThecatalogueofproductsunderthepilotprogramisjointlyissuedbytheMinistryofFinance,theMinistryofCommerce,theGeneralAdministrationofCustoms,theStateTaxationAdministration,theStateAdministrationforMarketRegulation,andtheNationalMedicalProductsAdministration.Inprinciple,thecatalogueofproductsunderthepilotprogramwillnolongerbeexpandedduringthepilotprogram.III. Withrespecttothedrugsincludedinthecatalogueofproductsunderthepilotprogram,suchdrugsshallbeimportedinaccordancewiththerequirementsofcustomsclearancemanagementassetoutintheAnnouncementonMattersConcerningtheSupervisionofRetailImportsandExportsinCross-BorderE-commerce(AnnouncementNo.19420181,GACC);thecustomsclearanceformsforimporteddrugswillnotbecheckedduringcustomsclearance;therelevanttax二、试点工作要以习近平新时代中国特色社会主义思想为指导，深入贯彻落实党的十九大和十九届二中、三中、四中、五中全会精神，认真贯彻落实“四个最严”要求，按照中华人民共和国药品管理法相关规定，在现有法律框架内开展。试点品种为已取得我国境内上市许可的13个非处方药，试点目录由财政部、商务部、海关总署、税务总局、市场监管总局、国家药监局等部门联合印发，试点期内原则上不再扩大试点目录。三、对纳入试点目录的药品，按照关于跨境电子商务零售进出口商品有关监管事宜的公告（海关总署公告2018年第194号）规定的通关管理要求开展进口业务，在通关环节不验核进口药品通关单，参照执行跨境电商零售进口相关税收政策，相关交易纳入个人年度交易总额管理，适用跨境电商零售进口商品单次、年度交易限值相关规定，在交易限值内，关税税率暂设为0%,进口环节增值税、消费税暂按法定应纳税额的70%征收。policiesforretailimportsincross-bordere-commerceshallapply,ITiutatismutandis,tosuchdrugs;therelevanttransactionsshallbeincludedinthetotalamountofindividuals'annualtransactionsformanagement,towhichtherelevantprovisionsonthesingleandannualtransactionlimitsofretailimportsincross-bordere-commerceapply.Asforthosewithinthelimits,theapplicabletariffratewillbetemporarilysetas0%,andimportvalue-addedtaxandexcisetaxwillbetemporarilyleviedat70%ofthestatutoryamountoftaxpayable.四、河南省人民政府要加强对试点工作的组织领导, 认真落实属地监管责任，会同国务院有关部门研究细化试 点方案和有关监管措施，加强进口药品质量监管，保障人 民群众用药安全和合法权益。IV. ThePeople'sGovernmentofHenanProvinceshallstrengthentheorganizationandleadershipofthepilotprogram,conscientiouslyimplementtheresponsibilityofterritorialjurisdictionoverregulation,andinconjunctionwiththeappropriatedepartmentsoftheStateCouncil,studyanddetailthepilotprogramandrelatedregulatorymeasures,strengthenthequalitysupen,isionofimporteddrugs,andensurethesafetyofdrugusebyandlawfulrightsandinterestsofthepublic.五、国务院有关部门要按照职责分工，积极支持河南 省开展试点，加强信息和数据共享，确保通关、质量监管 等工作可操作、可落地。试点中的重大问题，河南省人民 政府和市场监管总局、国家药监局要及时向国务院请示报 告。V. TheappropriatedepartmentsoftheStateCouncilshall,basedonthedivisionoftheirduties,activelysupportHenanProvinceinthelaunchofthepilotprogram,strengtheninformationanddatasharing,andensurethatthework,suchascustomsclearanceandqualityregulation,areoperationalandfeasible.ThePeople'sGovernmentofHenanProvince,theStateAdministrationforMarketRegulation,andtheNationalMedicalProductsAdministrationshallpromptlyreportthemorissuesinthepilotprogramtotheStateCouncilforinstructions.Stale Council国务院May 8, 20212021年5月8日