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01
111100000000271742
北京市药品监督管理局
进口药品通关单核发
1111000000002717422110146017000
0
24c701d7-9565-11e9-8300-507b9d3e4710
8c4e376b-f7b1-4c7e-9348-0c00a526a38a
2^3
01
市药监局
110000000000
北京市药品监督管理局
北京市政务服务中心:法定工作日: 上午: 09:00 - 12:00; 下午: 13:30 - 17:00; (延时服务时间: 工作日上午08:30 - 09:00; 下午17:00 - 17:30; 周六上午09:00 - 13:00; )
北京市政务服务中心:北京市丰台区西三环南路1号(六里桥西南角)综合窗口
1、申请材料应完整、清晰,需将复印件逐页加盖单位公章,要求签字的须签字,扫描为PDF文件后上传。2、进口药品合法身份证明性文件原件真实,原件与复印件内容一致且在有效期内; 3、报验单位合法资质证明性文件齐全、有效。
{"IS_GUIDE":"1","ONLINE_DECLARE_SYSTEM_MODE":"","ITEM_REALITY_USELEVEL":"","SERVICE_OBJCT":"","IS_CONSTRUCTION":"0","CL_SERVICE_TYPE":"","APP_CODE_ID":"","YESNO_CITY_UNICOM":"99","CROSS_AREA":"","ISSHOHCENTER":"0","WECHAT_CODE_ID":"","FINANCIAL":"","LITTLEPROGRAM_CODE_NAME":"","CROSS_AREA_ALL":"","CROSS_PROVINCE":"","ALIAS_NAME":"","EAR_DISABILITY_GRAD":"","LIB_DISABILITY_GRAD":"","SPEAK_DISABILITY_GRAD":"","REGISTER":"","ONLINE_HANDLING_DEPTH_STANDARD":"04","APPROVAL_TYPE":"0","MIND_DISABILITY_GRAD":"","ACCEPTSERVICE":"99","YWBLX_ID":"8c4e376b-f7b1-4c7e-9348-0c00a526a38a","ONLINE_DECLARE_SYSTEM_DEPT":"","EMPOWER":"0","EXEMPT_MATERIALS":"","LITTLEPROGRAM_CODE_ID":"","EYE_DISABILITY_GRAD":"","ISMONVEINCENTER":"0","DATA_FLAG":"","BUSINESS_APPROVAL_DEPT":"中华人民共和国海关总署","POWER_NAME":"进口药品通关单核发","ITEM_ATTRIBUTE":"01^03^04^07^11","CROSS_AREA_ATEXT":"","AGE":"","BGSYSTEM_APPROVAL_OTHER":"单一窗口","WIT_DISABILITY_GRAD":"","WECHAT_CODE_NAME":"","POWER_CODE":"B4605300","DISABILITY_TYPE":"","IS_ENABLE_CERTIFICATE_SHARE":"","POWER_ATTRIBUTE":"1","ONLY_ID":"0e98a32e-81ed-11ea-8de7-fa163e4f9ad9","YES_NO_OPEN":"1","BGSYSTEM_APPROVAL_NAME":"其他","APP_CODE_NAME":"","HOLDER":"","VERSION":"20240415"}
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进口药材通关单核发\n\t\t1.4.1 是否为经其他国家(地区)转口的进口药材\n\t\t\t1.4.1.1 是\n\t\t\t1.4.1.2 否\n\t\t1.4.2 进口药材是否涉及《濒危野生动植物种国际贸易公约》限制进出口的濒危野生动植物\n\t\t\t1.4.2.1 是\n\t\t\t1.4.2.2 否\n\t\t1.4.3 是否办理首次进口药材备案\n\t\t\t1.4.3.1 是\n\t\t\t1.4.3.2 否\n\t\t1.4.4 进口单位是否为中成药上市许可持有人\n\t\t\t1.4.4.1 是\n\t\t\t1.4.4.2 否\n\t\t1.4.5 申请企业申报材料时,通关单领取人是否是法定代表人或负责人本人\n\t\t\t1.4.5.1 是\n\t\t\t1.4.5.2 否\n\t1.5 进口药品质量标准复核和临床研究所需标准品、样品和对照品\n\t1.6 涉及捐赠药品的","CD_TIME":"Mar 16, 2025 5:49:41 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PM","CD_BATCH":"2025031600026","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"","newOrderNum":"001.001.001.002","itemGuideConditionRelatedList":[{"ID":25574579,"TASKGUID":"24c701d7-9565-11e9-8300-507b9d3e4710","T_ID":"90382f67-32c1-47b4-b39f-7cedaef145eb","G_ID":"7f8bf301-2262-4b8a-aff7-d14c6f3eaab9","M_CODE":"346212","MATERIAL_ID":"779cd30e-7435-4fe6-a0a1-73dbb219363e","CD_TIME":"Mar 16, 2025 5:49:41 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PM","CD_BATCH":"2025031600026","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"1","proOrder":"2","newOrderNum":"001.001.002","itemGuideConditionRelatedList":[]},{"ID":6646404,"TASKGUID":"24c701d7-9565-11e9-8300-507b9d3e4710","T_ID":"7aa17835-b4a8-4bbb-9847-e15719474232","P_ID":"e94cce56-d8df-46e3-bb89-332435b0e26d","NAME":"是","NODE_LEVEL":4,"NODE_PATH":"/9aab8a01-bfe3-42df-9c1f-e1937602fc31/ae2e96e3-db9c-49c0-99c0-20059941d4f5/e94cce56-d8df-46e3-bb89-332435b0e26d/7aa17835-b4a8-4bbb-9847-e15719474232","CHILD_COUNT":0,"ORDER_NUM":1,"SERIAL_NUMBER":"1.1.2.1","CONDITION_ATTR":"02","IS_RADIO":"","IS_SUPPORT":"","SUMMARY":"","CD_TIME":"Mar 16, 2025 5:49:41 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进口药品通关单核发

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1个工作日(承诺时限为办理流程中“审查与决定”环节的计时时限)

基本信息

实施主体 北京市药品监督管理局 服务对象 企业法人、事业法人
事项类型 行政许可 办理形式 窗口办理、网上办理
受理条件 1、申请材料应完整、清晰,需将复印件逐页加盖单位公章,要求签字的须签字,扫描为PDF文件后上传。2、进口药品合法身份证明性文件原件真实,原件与复印件内容一致且在有效期内; 3、报验单位合法资质证明性文件齐全、有效。
办理时间 北京市政务服务中心:法定工作日: 上午: 09:00 - 12:00; 下午: 13:30 - 17:00; (延时服务时间: 工作日上午08:30 - 09:00; 下午17:00 - 17:30; 周六上午09:00 - 13:00; ) 查看详情
办理地点 北京市政务服务中心:北京市丰台区西三环南路1号(六里桥西南角)综合窗口 查看详情
咨询方式

咨询电话:

(010)89150290【展开】

咨询窗口地址:

北京市政务服务中心:北京市丰台区西三环南路1号(六里桥西南角)(1-3层综合窗口) 【展开】

投诉监督方式

投诉监督电话:

(010)12345【展开】

基本编码 110146017000 事项编码 1111000000002717422110146017000
业务办理项编码 111100000000271742211014601700001 进驻大厅类型 政务服务中心
权力来源 法定本级行使 网上支付
所属机构 北京市药品监督管理局 委托部门
联办机构 实施主体性质 法定机关
办理进程查询途径 电话查询:(010)89150280
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物流快递 办理方式 自办件
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必须现场办理原因说明 按照国家药监局规定办事人必须到现场核对材料并领取通关单
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序号 材料名称 材料来源 材料
必要性
数量要求 介质要求 表格及样例
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受理标准 提供材料
依据
其他要求
申请材料总要求依据《市场监督管理行政许可程序暂行规定》第三十条第(一)项的规定,申请人申请终止实施行政许可的,需提交由法定代表人签字并加盖公章的终止申请书一份(内容应包括但不限于许可事项受理编号、申请终止的理由等),办理人不是法定代表人本人的还应提供《授权委托书》。
序号 材料名称 材料来源 材料
必要性
数量要求 介质要求 表格及样例
下载
受理标准 提供材料
依据
其他要求
一、申报资料
(一)、进口药品通关单核发
1、进口药品合法身份文件
进口药品批件政府部门核发来源说明>必要原件1份;复印件1份结果文书类;纸质、电子不涉及核对是否与《进口药品报验单》的商品名称、批件号、HS商品编码、药品生产厂、产地、剂型、规格、包装规格一致。【展开】中华人民共和国药品管理法【展开】原件现场核验后返还【展开】
进口药品注册证政府部门核发来源说明>必要原件1份;复印件1份结果文书类;纸质、电子不涉及核对是否与《进口药品报验单》的商品名称、批件号、HS商品编码、药品生产厂、产地、剂型、规格、包装规格一致。【展开】中华人民共和国药品管理法【展开】原件现场核验后返还【展开】
医药产品注册证政府部门核发来源说明>必要原件1份;复印件1份结果文书类;纸质、电子不涉及核对是否与《进口药品报验单》的商品名称、批件号、HS商品编码、药品生产厂、产地、剂型、规格、包装规格一致。【展开】中华人民共和国药品管理法【展开】原件现场核验后返还【展开】
药品监督管理部门核发的药品进口准许证政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及核对是否与《进口药品报验单》的商品名称、批件号、HS商品编码、药品生产厂、产地、剂型、规格、包装规格一致。【展开】中华人民共和国药品管理法【展开】进口麻醉药品、精神药品、蛋白同化制剂和肽类激素的,还必须提交《进口准许证》,原件现场核验后返还【展开】
2、报验单位合法资质文件
药品经营许可证政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及核对与《进口药品报验单》中的收货单位、报验单位一致。【展开】中华人民共和国药品管理法【展开】【展开】
药品生产许可证政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及核对与《进口药品报验单》中的收货单位、报验单位一致。【展开】中华人民共和国药品管理法【展开】药品生产企业自行进口本企业生产所需原料药和制剂中间体的进口备案的提交【展开】
营业执照政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及核对与《进口药品报验单》中的收货单位、报验单位一致。【展开】中华人民共和国药品管理法【展开】【展开】
3原产地说明材料申请人自备必要复印件1份文本类;电子不涉及核对是否与《进口药品报验单》的产地信息等一致。【展开】中华人民共和国药品管理法【展开】【展开】
购货合同申请人自备必要复印件1份文本类;电子不涉及核对是否与《进口药品报验单》的产地信息等一致。【展开】中华人民共和国药品管理法【展开】【展开】
装箱单申请人自备必要复印件1份文本类;电子不涉及核对是否与《进口药品报验单》的产地信息等一致。【展开】中华人民共和国药品管理法【展开】【展开】
提运单申请人自备必要复印件1份文本类;电子不涉及核对是否与《进口药品报验单》的产地信息等一致。【展开】中华人民共和国药品管理法【展开】【展开】
货运发票申请人自备必要复印件1份文本类;电子不涉及核对是否与《进口药品报验单》的产地信息等一致。【展开】中华人民共和国药品管理法【展开】【展开】
出厂检验报告申请人自备必要复印件1份文本类;电子不涉及核对是否与《进口药品报验单》的产地信息等一致。【展开】中华人民共和国药品管理法【展开】研制过程中所需研究用对照药品一次性进口除外【展开】
4药品说明书及包装、标签的式样申请人自备必要复印件1份文本类;电子不涉及核对是否为该批药品的药品说明书及包装、标签(原料药和制剂中间体除外)。【展开】中华人民共和国药品管理法【展开】原料药和制剂中间体除外【展开】
5经其他国家(地区)转口的进口药品,应当同时提交产地到各转口地的全部购货合同申请人自备必要复印件1份文本类;电子不涉及材料是否齐全。【展开】中华人民共和国药品管理法【展开】【展开】
经其他国家(地区)转口的进口药品,应当同时提交产地到各转口地的全部装箱单申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
经其他国家(地区)转口的进口药品,应当同时提交产地到各转口地的全部提运单申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
经其他国家(地区)转口的进口药品,应当同时提交产地到各转口地的全部货运发票申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
6、国家药品监督管理局规定批签发的生物制品,需要
生产检定记录摘要申请人自备必要原件1份文本类;纸质、电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】原件需现场核验后收回【展开】
生产国家或者地区药品管理机构出具的批签发证明批签发材料申请人自备必要原件1份文本类;纸质、电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】原件需现场核验后收回【展开】
7申报材料真实性自我保证声明申请人自备必要原件1份文本类;电子样例下载可从北京药品监督管理局官网下载推荐使用的模板,按照目录填写、修改、保存、打印。申报时应当提供纸质版,原件1份。加盖委托人单位公章、被委托人签字,日期的填写格式为××××年××月××日。【展开】中华人民共和国药品管理法【展开】对材料做出如有虚假承担法律责任的承诺【展开】
法定代表人授权委托书申请人自备必要原件1份文本类;电子样例下载可从北京药品监督管理局官网下载推荐使用的模板,按照目录填写、修改、保存、打印。申报时应当提供纸质版,原件1份。加盖委托人单位公章、被委托人签字,日期的填写格式为××××年××月××日。【展开】中华人民共和国药品管理法【展开】凡申请企业申报材料时,通关单领取人不是法定代表人或负责人本人,企业应当提交:《授权委托书》【展开】
(二)、进口药材通关单核发
1原产地证书申请人自备必要复印件1份文本类;电子不涉及材料是否齐全。【展开】中华人民共和国药品管理法【展开】产地证明【展开】
2药材标准及标准来源申请人自备必要复印件1份文本类;电子不涉及材料是否齐全。【展开】中华人民共和国药品管理法【展开】【展开】
3装箱单申请人自备必要复印件1份文本类;电子不涉及材料是否齐全。【展开】中华人民共和国药品管理法【展开】【展开】
提运单申请人自备必要复印件1份文本类;电子不涉及材料是否齐全。【展开】中华人民共和国药品管理法【展开】【展开】
货运发票申请人自备必要复印件1份文本类;电子不涉及材料是否齐全。【展开】中华人民共和国药品管理法【展开】【展开】
4、经其他国家(地区)转口的进口药材,应当同时
产地到各转口地的全部购货合同申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
产地到各转口地的全部装箱单申请人自备必要复印件1份文本类;电子不涉及海关受理申报后,应当在指定地点及申报人在场的情况下,对毛坯钻石原产地的真实性等进行核实,对毛坯钻石的克拉重量(数量)进行检验,并对申报金额进行核定。在确认申报人所申报的内容正确无误后,对符合金伯利进程国际证书制度要求的毛坯钻石及其包装容器进行封识,加施原产地注册标记,并签发《金伯利进程国际证书》。【展开】中华人民共和国药品管理法【展开】【展开】
产地到各转口地的全部提运单申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
产地到各转口地的全部货运发票申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
5、进口药材涉及《濒危野生动植物种国际贸易公约》限制进出口的濒危野生动植物的,还应当
国家濒危物种进出口管理机构核发的《允许进出口证明书》政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
6、办理首次进口药材备案的,除上述规定资料外,还应当
进口药材批件政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
进口药材补充申请批件(如有)政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
7、办理非首次进口药材备案的,除上述规定资料外,还应当
进口单位的药品生产许可证政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
药品经营许可证政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
供货方合法资质证明性文件申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】出口商主体登记文件【展开】
购货合同申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
购货合同公证文书申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
8、进口单位为中成药上市许可持有人的,应当
药品批准文件政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
9申报材料真实性自我保证声明申请人自备必要原件1份文本类;电子样例下载可从北京药品监督管理局官网下载推荐使用的模板,按照目录填写、修改、保存、打印。申报时应当提供纸质版,原件1份,加盖委托人单位公章、被委托人签字,日期的填写格式为××××年××月××日。【展开】中华人民共和国药品管理法【展开】对材料做出如有虚假承担法律责任的承诺【展开】
法定代表人授权委托书申请人自备必要原件1份文本类;电子样例下载可从北京药品监督管理局官网下载推荐使用的模板,按照目录填写、修改、保存、打印。申报时应当提供纸质版,原件1份,加盖委托人单位公章、被委托人签字,日期的填写格式为××××年××月××日。【展开】中华人民共和国药品管理法【展开】凡申请企业申报材料时,通关单领取人不是法定代表人或负责人本人,企业应当提交:《授权委托书》【展开】
二、特殊情形
(一)、进口列入国家药品监督管理局公布的非药用物品目录中物质
1营业执照政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及核对该批物品是否为国家药品监督管理局公布的非药用物品目录中物质或是否提供国家药品监督管理局批准进口的证明性文件。【展开】中华人民共和国药品管理法【展开】【展开】
2装箱单申请人自备必要复印件1份文本类;电子不涉及核对该批物品是否为国家药品监督管理局公布的非药用物品目录中物质或是否提供国家药品监督管理局批准进口的证明性文件。【展开】中华人民共和国药品管理法【展开】【展开】
3提运单申请人自备必要复印件1份文本类;电子不涉及核对该批物品是否为国家药品监督管理局公布的非药用物品目录中物质或是否提供国家药品监督管理局批准进口的证明性文件。【展开】中华人民共和国药品管理法【展开】【展开】
4货运发票申请人自备必要复印件1份文本类;电子不涉及核对该批物品是否为国家药品监督管理局公布的非药用物品目录中物质或是否提供国家药品监督管理局批准进口的证明性文件。【展开】中华人民共和国药品管理法【展开】【展开】
5出厂检验报告申请人自备必要复印件1份文本类;电子不涉及核对该批物品是否为国家药品监督管理局公布的非药用物品目录中物质或是否提供国家药品监督管理局批准进口的证明性文件。【展开】中华人民共和国药品管理法【展开】【展开】
6、进口尚未包含在目录中的非药用物品的
进口单位可持国家药品监督管理局进口批准文件及上述材料政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及核对该批物品是否为国家药品监督管理局公布的非药用物品目录中物质或是否提供国家药品监督管理局批准进口的证明性文件。【展开】中华人民共和国药品管理法【展开】【展开】
(二)、进口药品质量标准复核和临床研究所需标准品、样品和对照品:由注册申请人提交:
1药品检验通知单申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
国家药品监督管理局同意开展临床试验的文件申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
2报验单位合法资质文件申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
3装箱单申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
4提运单申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
5货运发票申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
6出厂检验报告申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
(三)、进口单位应在取得《进口药品通关单》15天内报关,如因客观原因延误报关的,需报送以下材料
1进口药品通关单政府部门核发来源说明>必要原件1份结果文书类;纸质不涉及是否15天内报关。【展开】中华人民共和国药品管理法【展开】申请单位应将《进口药品通关单》全部退回北京市药品监督管理局,并附延误原因说明,现场提交【展开】
(四)、涉及捐赠药品的,在进口药品通关单核发所需申请资料的基础上另需提交:
1捐赠药品进口备案的书面申请申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
2社会组织信息政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
中华人民共和国组织机构代码证政府部门核发来源说明>必要复印件1份结果文书类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
合法资质凭证政府部门核发来源说明>必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
捐赠协议申请人自备必要复印件1份文本类;电子不涉及材料是否齐全【展开】中华人民共和国药品管理法【展开】【展开】
申请材料总要求依据《市场监督管理行政许可程序暂行规定》第三十条第(一)项的规定,申请人申请终止实施行政许可的,需提交由法定代表人签字并加盖公章的终止申请书一份(内容应包括但不限于许可事项受理编号、申请终止的理由等),办理人不是法定代表人本人的还应提供《授权委托书》。
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查看流程图

  • 申请与受理1

    办理步骤办理时限办理人员办理结果
    受理0个工作日综窗人员即时办理

    审查标准

    1.申请材料应完整、清晰,要求签字的须签字,每份加盖单位公章,使用A4纸打印或复印,按照申请材料目录顺序装订成册;
    2.凡申请材料需提交复印件的,申请人须在复印件上加盖单位公章,并注明日期;
    3. 《进口药品注册证》或《医药产品注册证》原件真实,原件与复印件内容一致;
    4. 进口药品证明性文件在有效期内;
    5. 申报单位核发资质证明性文件齐全、有效;
    6.《进口药品报验单》相关信息与进口药品证明性文件内容相符。
    【展开】
  • 审查与决定2

    办理步骤办理时限办理人员办理结果
    决定1个工作日首席代表或部门负责人申请单位在网上申请端收到领取《进口药品通关单》的通知后,需携带相关进口药品(含药材)合法身份证明性文件原件至市政务服务中心通关备案窗口现场领取纸质《进口药品通关单》和《进口药品口岸检验通知书》。

    审查标准

    1.申请材料应完整、清晰,要求签字的须签字,每份加盖单位公章,使用A4纸打印或复印,按照申请材料目录顺序装订成册;
    2.凡申请材料需提交复印件的,申请人须在复印件上加盖单位公章;
    3. 进口药品、进口药材批准证明文件原件真实有效,原件与复印件内容一致;
    4. 申报单位资质证明性文件齐全、有效;
    5.《进口药品报验单》相关信息与进口药品证明性文件内容相符。
    【展开】
  • 颁证与送达3

    办理步骤办理时限办理人员结果名称
    发证0个工作日综窗人员

    1、进口药材口岸检验通知书

    2、进口药品口岸检验通知书

    3、进口药品通关单

    送达方式
    窗口领取

进口药材口岸检验通知书
结果名称进口药材口岸检验通知书
结果文书类型其他
结果样本进口药材口岸检验通知书结果样本.pdf
有效时间无时限
进口药品口岸检验通知书
结果名称进口药品口岸检验通知书
结果文书类型其他
结果样本进口药品口岸检验通知书结果样本.pdf
有效时间无时限
进口药品通关单
结果名称进口药品通关单
结果文书类型其他
结果样本进口药品通关单结果样本.pdf
有效时间无时限

【法律】中华人民共和国药品管理法
制定机关中华人民共和国全国人民代表大会常务委员会
依据名称中华人民共和国药品管理法
发布号令(文号)1984年9月20日第六届全国人民代表大会常务委员会第七次会议通过 2001年2月28日第九届全国人民代表大会常务委员会第二十次会议第一次修订 根据2013年12月28日第十二届全国人民代表大会常务委员会第六次会议《关于修改〈中华人民共和国海洋环境保护法〉等七部法律的决定》第一次修正 根据2015年4月24日第十二届全国人民代表大会常务委员会第十四次会议《关于修改〈中华人民共和国药品管理法〉的决定》第二次修正 2019年8月26日第十三届全国人民代表大会常务委员会第十二次会议第二次修订
法条(具体规定)内容第六十四条 药品应当从允许药品进口的口岸进口,并由进口药品的企业向口岸所在地药品监督管理部门备案。海关凭药品监督管理部门出具的进口药品通关单办理通关手续。无进口药品通关单的,海关不得放行。 口岸所在地药品监督管理部门应当通知药品检验机构按照国务院药品监督管理部门的规定对进口药品进行抽查检验。 允许药品进口的口岸由国务院药品监督管理部门会同海关总署提出,报国务院批准。【展开】
【部门规章】药品进口管理办法
制定机关中华人民共和国国家食品药品监督管理局
依据名称药品进口管理办法
发布号令(文号)国家食品药品监督管理局令第4号
法条(具体规定)内容第四条 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。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。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(以下称口岸药品检验所)对抵达口岸的进口药品依法实施的检验工作。
【展开】
【部门规章】进口药材管理办法
制定机关中华人民共和国国家市场监督管理总局
依据名称进口药材管理办法
发布号令(文号)国家市场监督管理总局令第9号
法条(具体规定)内容第四条 国家药品监督管理局主管全国进口药材监督管理工作。国家药品监督管理局委托省、自治区、直辖市药品监督管理部门(以下简称省级药品监督管理部门)实施首次进口药材审批,并对委托实施首次进口药材审批的行为进行监督指导。省级药品监督管理部门依法对进口药材进行监督管理,并在委托范围内以国家药品监督管理局的名义实施首次进口药材审批。允许药品进口的口岸或者允许药材进口的边境口岸所在地负责药品监督管理的部门(以下简称口岸药品监督管理部门)负责进口药材的备案,组织口岸检验并进行监督管理。【展开】

是否收费:

1、办理进口药品通关单是否一定需要出厂检验报告书的复印件?
研制过程中所需研究用对照药品一次性进口可不需要提供出厂检验报告书的复印件。

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