2
01
111100000000271742
北京市药品监督管理局
国产药品再注册审批
1111000000002717422000172031000
0
7e2d8561-ced0-4e5c-a86f-c0a59544c30d
655eb05a-9620-4b50-b6f7-9ab3d5285772
2
01
市药监局
110000000000
北京市药品监督管理局
工作日8:30-17:30（8:30-9:00、12:00-13:30、17:00-17:30为延时服务时间）、周六9:00-13:00（周六为延时服务时间，需预约办理）、法定节假日不对外服务。
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)
1．申报事项正确。 2..申请表填写正确、完整、规范，签字、盖章符合要求。 3．证明性文件齐全、有效。 4．全部申报资料项目齐全，体例格式规范，符合要求。 5．申请人具备相应的申报资质。
{"IS_GUIDE":"1","ITEM_REALITY_USELEVEL":"","SERVICE_OBJCT":"","LITTLEPROGRAM_CODE_ID":"","EYE_DISABILITY_GRAD":"","IS_CONSTRUCTION":"0","CL_SERVICE_TYPE":"","APP_CODE_ID":"","ISMONVEINCENTER":"0","YESNO_CITY_UNICOM":"99","CROSS_AREA":"","WECHAT_CODE_ID":"","FINANCIAL":"","LITTLEPROGRAM_CODE_NAME":"","BUSINESS_APPROVAL_DEPT":"国家药品监督管理局","CROSS_AREA_ALL":"","CROSS_PROVINCE":"","POWER_NAME":"国产药品再注册审批","ITEM_ATTRIBUTE":"03^04^05^07^11","EAR_DISABILITY_GRAD":"","LIB_DISABILITY_GRAD":"","CROSS_AREA_ATEXT":"","SPEAK_DISABILITY_GRAD":"","AGE":"","REGISTER":"","BGSYSTEM_APPROVAL_OTHER":"国家药监局政务服务平台","ONLINE_HANDLING_DEPTH_STANDARD":"05","WIT_DISABILITY_GRAD":"","APPROVAL_TYPE":"1","WECHAT_CODE_NAME":"","POWER_CODE":"B4602900","DISABILITY_TYPE":"","MIND_DISABILITY_GRAD":"","POWER_ATTRIBUTE":"1","ACCEPTSERVICE":"99","ONLY_ID":"1aff0b4c-81ed-11ea-8de7-fa163e4f9ad9","YES_NO_OPEN":"1","BGSYSTEM_APPROVAL_NAME":"2","APP_CODE_NAME":"","YWBLX_ID":"655eb05a-9620-4b50-b6f7-9ab3d5285772","HOLDER":"","VERSION":"20211231"}
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AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"","newOrderNum":"001.002","itemGuideConditionRelatedList":[{"ID":23760605,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"62daf686-07e5-47f7-9d1c-cbdf21f9c1ab","G_ID":"e57e0d4d-126a-4eff-bf6d-d276fcb1bd57","M_CODE":"206384","MATERIAL_ID":"cf5b9e52-ac57-4633-8a2b-ce6b25b83198","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20210903\"}"}]},{"ID":4189808,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"1f4b3ce3-0b3b-4960-b8c1-b168f359ed38","P_ID":"","NAME":"是否为首次申请再注册药品需要进行IV期临床试验的","NODE_LEVEL":1,"NODE_PATH":"/1f4b3ce3-0b3b-4960-b8c1-b168f359ed38","CHILD_COUNT":2,"ORDER_NUM":2,"SERIAL_NUMBER":"2","CONDITION_ATTR":"01","IS_RADIO":"1","IS_SUPPORT":"","SUMMARY":"2 是否为首次申请再注册药品需要进行IV期临床试验的\n\t2.1 是\n\t2.2 否","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"2","newOrderNum":"002","itemGuideConditionRelatedList":[]},{"ID":4189814,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"b6db050e-11b7-44ed-93a7-d56e5c8988b0","P_ID":"1f4b3ce3-0b3b-4960-b8c1-b168f359ed38","NAME":"是","NODE_LEVEL":2,"NODE_PATH":"/1f4b3ce3-0b3b-4960-b8c1-b168f359ed38/b6db050e-11b7-44ed-93a7-d56e5c8988b0","CHILD_COUNT":0,"ORDER_NUM":1,"SERIAL_NUMBER":"2.1","CONDITION_ATTR":"02","IS_RADIO":"","IS_SUPPORT":"","SUMMARY":"","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"","newOrderNum":"002.001","itemGuideConditionRelatedList":[{"ID":23760502,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"b6db050e-11b7-44ed-93a7-d56e5c8988b0","G_ID":"95ffc23a-0eac-4fd1-9f37-856b75b057d1","M_CODE":"206958","MATERIAL_ID":"a9cdcf4b-d9c4-4597-85f5-136d14325e06","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20210903\"}"}]},{"ID":4189819,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"fa54764f-41f9-420a-a720-0412820968c2","P_ID":"1f4b3ce3-0b3b-4960-b8c1-b168f359ed38","NAME":"否","NODE_LEVEL":2,"NODE_PATH":"/1f4b3ce3-0b3b-4960-b8c1-b168f359ed38/fa54764f-41f9-420a-a720-0412820968c2","CHILD_COUNT":0,"ORDER_NUM":2,"SERIAL_NUMBER":"2.2","CONDITION_ATTR":"02","IS_RADIO":"","IS_SUPPORT":"","SUMMARY":"","CD_TIME":"Oct 27, 2023 11:28:31 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AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"3","newOrderNum":"003","itemGuideConditionRelatedList":[]},{"ID":4189816,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"c751e72c-3079-4301-a437-4536b4b2ac37","P_ID":"d0ee0f5a-d165-4155-961a-53ce74f25fe4","NAME":"否","NODE_LEVEL":2,"NODE_PATH":"/d0ee0f5a-d165-4155-961a-53ce74f25fe4/c751e72c-3079-4301-a437-4536b4b2ac37","CHILD_COUNT":0,"ORDER_NUM":1,"SERIAL_NUMBER":"3.1","CONDITION_ATTR":"02","IS_RADIO":"","IS_SUPPORT":"","SUMMARY":"","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"","newOrderNum":"003.001","itemGuideConditionRelatedList":[]},{"ID":4189811,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"7f4f72a6-48cb-4e3b-a23c-16252fe3473f","P_ID":"d0ee0f5a-d165-4155-961a-53ce74f25fe4","NAME":"是","NODE_LEVEL":2,"NODE_PATH":"/d0ee0f5a-d165-4155-961a-53ce74f25fe4/7f4f72a6-48cb-4e3b-a23c-16252fe3473f","CHILD_COUNT":0,"ORDER_NUM":2,"SERIAL_NUMBER":"3.2","CONDITION_ATTR":"02","IS_RADIO":"","IS_SUPPORT":"","SUMMARY":"","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"","newOrderNum":"003.002","itemGuideConditionRelatedList":[{"ID":23760557,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"7f4f72a6-48cb-4e3b-a23c-16252fe3473f","G_ID":"6905e0a1-0c55-4ff7-a711-9fa9c452d5d0","M_CODE":"206959","MATERIAL_ID":"a751fcb6-d0bd-4219-ab87-256e217f2ce0","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20210903\"}"}]},{"ID":4189812,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"7fad77dc-8fdd-4533-a1ee-e6cfd676cb1c","P_ID":"","NAME":"报送资料人是否为法定代表人或负责人本人","NODE_LEVEL":1,"NODE_PATH":"/7fad77dc-8fdd-4533-a1ee-e6cfd676cb1c","CHILD_COUNT":2,"ORDER_NUM":4,"SERIAL_NUMBER":"4","CONDITION_ATTR":"01","IS_RADIO":"1","IS_SUPPORT":"","SUMMARY":"4 报送资料人是否为法定代表人或负责人本人\n\t4.1 否\n\t4.2 是","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"4","newOrderNum":"004","itemGuideConditionRelatedList":[]},{"ID":4189810,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"6c86140e-d131-4bee-86dd-6f96d36b914e","P_ID":"7fad77dc-8fdd-4533-a1ee-e6cfd676cb1c","NAME":"否","NODE_LEVEL":2,"NODE_PATH":"/7fad77dc-8fdd-4533-a1ee-e6cfd676cb1c/6c86140e-d131-4bee-86dd-6f96d36b914e","CHILD_COUNT":0,"ORDER_NUM":1,"SERIAL_NUMBER":"4.1","CONDITION_ATTR":"02","IS_RADIO":"","IS_SUPPORT":"","SUMMARY":"","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"","newOrderNum":"004.001","itemGuideConditionRelatedList":[{"ID":23760371,"TASKGUID":"7e2d8561-ced0-4e5c-a86f-c0a59544c30d","T_ID":"6c86140e-d131-4bee-86dd-6f96d36b914e","G_ID":"d97b0c73-8210-4633-8491-b8b2a693de8d","M_CODE":"200025","MATERIAL_ID":"8d0886f9-7d2c-4b69-ae30-34c48d56cf39","CD_TIME":"Oct 27, 2023 11:28:31 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2
2
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基本信息申请材料办理流程结果名称及样本设定依据收费标准及依据常见问题

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实施主体 北京市药品监督管理局 服务对象
事项类型 行政许可 办理形式
受理条件 1．申报事项正确。 2..申请表填写正确、完整、规范，签字、盖章符合要求。 3．证明性文件齐全、有效。 4．全部申报资料项目齐全，体例格式规范，符合要求。 5．申请人具备相应的申报资质。
办理时间 工作日8:30-17:30（8:30-9:00、12:00-13:30、17:00-17:30为延时服务时间）、周六9:00-13:00（周六为延时服务时间，需预约办理）、法定节假日不对外服务。 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)(1-3层综合窗口) 查看详情
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基本编码 000172031000 事项编码 1111000000002717422000172031000
业务办理项编码 111100000000271742200017203100001 进驻大厅类型 政务服务中心
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申请材料总要求注： 1. 具体申报资料要求详见《国家药品监督管理局贯彻落实国务院深化“证照分离”改革进一步激发市场主体发展活力的实施方案》（2021年8月30日发布）附件1 2. 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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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
申请材料总要求注： 1. 具体申报资料要求详见《国家药品监督管理局贯彻落实国务院深化“证照分离”改革进一步激发市场主体发展活力的实施方案》（2021年8月30日发布）附件1 2. 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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