2
01
111100000000271742
北京市药品监督管理局
医疗单位使用放射性药品许可
1111000000002717422000172023000
0
f82b610a-a6cd-49e3-b118-9ecb82e2f526
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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) 北京城市副中心政务服务中心：北京市通州区新华东街48号二区（东南角）（综合窗口）
1．申请事项依法属于本行政机关职权范围； 2．申请材料应完整、清晰，要求签字的须签字，每份加盖企业公章。使用A4纸打印或复印，装订成册； 3．凡申请材料需提交复印件的，申请人须在复印件上注明日期，加盖企业公章； 4．核对真实性的自我保证声明应包括对承担法律责任的承诺且应有法定代表人或负责人签字并加盖企业公章； 5．核对申请单位填报的表格，编写的申报材料应为A4规格纸张，政府及其他机构出具的文件按原件尺寸比例提供，所报材料应清楚、整洁； 6．核对每份申报材料应加盖企业公章，所有申报材料左页边距应大于20mm（用于装订）； 7．核对申报材料中同一项目的填写应一致，提供的复印件与原件一致、清晰。
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否\n\t\t\t1.2.1.2 否\n\t\t1.2.2 是否变更“科室负责人”\n\t\t\t1.2.2.1 是\n\t\t\t1.2.2.2 否\n\t\t1.2.3 申请人是否为法定代表人或负责人本人\n\t\t\t1.2.3.1 是\n\t\t\t1.2.3.2 否\n\t1.3 《放射性药品使用许可证》（一、二类）换证\n\t\t1.3.1 是否仅申请第一类、且碘-125体外放射性免疫试剂的最大日使用量不超过1.0E+6贝可\n\t\t\t1.3.1.1 是\n\t\t\t1.3.1.2 否\n\t\t1.3.2 是否仅申请第一类\n\t\t\t1.3.2.1 是\n\t\t\t1.3.2.2 否\n\t\t1.3.3 申请人是否为法定代表人或负责人本人\n\t\t\t1.3.3.1 是\n\t\t\t1.3.3.2 否","CD_TIME":"Oct 27, 2023 11:28:31 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政务服务> 办事指南

医疗单位使用放射性药品许可

北京市

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  • 20工作日

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  • 0.5工作日

    承诺办结时限

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办件承诺办结时限说明：对于仅申办《放射性药品使用许可证》（一、二类）的实行告知承诺制，申请人承诺符合审批条件并提交加盖公章的告知承诺书和申请材料，经审查申请材料齐全、符合法定形式的，当场作出行政许可决定，办理时限为0.5个工作日。按照《国务院关于深化“证照分离”改革进一步激发市场主体发展活力的通知》（国发〔2021〕7号）、《北京市人民政府行政审批制度改革办公室关于印发《北京市关于深化“证照分离”改革进一步激发市场主体发展活力的工作方案》的通知》（京审改办发〔2021〕5号）规定，在本市自由贸易试验区所属的朝阳区、海淀区、通州区、顺义区、昌平区、大兴区、北京经济技术开发区全域范围内取消《放射性药品使用许可证》（一、二类）审批事项。 申请《放射性药品使用许可证》含（三、四类）的，按照一般程序办理，承诺办理时限为10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）

办件承诺办结时限说明：

对于仅申办《放射性药品使用许可证》（一、二类）的实行告知承诺制，申请人承诺符合审批条件并提交加盖公章的告知承诺书和申请材料，经审查申请材料齐全、符合法定形式的，当场作出行政许可决定，办理时限为0.5个工作日。按照《国务院关于深化“证照分离”改革进一步激发市场主体发展活力的通知》（国发〔2021〕7号）、《北京市人民政府行政审批制度改革办公室关于印发《北京市关于深化“证照分离”改革进一步激发市场主体发展活力的工作方案》的通知》（京审改办发〔2021〕5号）规定，在本市自由贸易试验区所属的朝阳区、海淀区、通州区、顺义区、昌平区、大兴区、北京经济技术开发区全域范围内取消《放射性药品使用许可证》（一、二类）审批事项。 申请《放射性药品使用许可证》含（三、四类）的，按照一般程序办理，承诺办理时限为10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

基本信息

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．申请事项依法属于本行政机关职权范围； 2．申请材料应完整、清晰，要求签字的须签字，每份加盖企业公章。使用A4纸打印或复印，装订成册； 3．凡申请材料需提交复印件的，申请人须在复印件上注明日期，加盖企业公章； 4．核对真实性的自我保证声明应包括对承担法律责任的承诺且应有法定代表人或负责人签字并加盖企业公章； 5．核对申请单位填报的表格，编写的申报材料应为A4规格纸张，政府及其他机构出具的文件按原件尺寸比例提供，所报材料应清楚、整洁； 6．核对每份申报材料应加盖企业公章，所有申报材料左页边距应大于20mm（用于装订）； 7．核对申报材料中同一项目的填写应一致，提供的复印件与原件一致、清晰。
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) 北京城市副中心政务服务中心：北京市通州区新华东街48号二区（东南角）（综合窗口） 查看详情
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(010)89150275【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) 北京城市副中心政务服务中心：北京市通州区新华东街48号二区（东南角）（综合窗口）【展开】
投诉监督方式
基本编码 000172023000 事项编码 1111000000002717422000172023000
业务办理项编码 111100000000271742200017202300001 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 否
所属机构 北京市药品监督管理局 委托部门 无
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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
下载		 受理标准 提供材料
依据		 其他要求
申请材料总要求对于申请许可证类别涉及第二类的注意事项 1.《放射性药品使用许可证申请表》中： （1）“医疗机构名称”、“法人代表”、“注册地址”应与《医疗机构执业许可证》相应内容一致。 （2）“使用放药科（室）名称”应为核医学科。“使用放药类别”应为二类。 （3）“科（室）地址”、负责人“姓名”应与《辐射安全许可证》副本中“涉源部门”中相应的“地址”“负责人”相符。 2.《放射诊疗许可证》副本“放射诊疗许可范围”中“诊疗项目”项下“核医学”应至少包含下列1项内容：（1）PET影像诊断（2）SPECT影像诊断（3）籽粒插植治疗（4）放射性药物治疗。 3.《医疗机构执业许可证》《辐射安全许可证》《放射诊疗许可证》为必要材料，且应在有效期内。《放射诊疗许可证》校验记录在效期内。 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》。
线上办理 线下办理
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
申请材料总要求对于申请许可证类别涉及第二类的注意事项 1.《放射性药品使用许可证申请表》中： （1）“医疗机构名称”、“法人代表”、“注册地址”应与《医疗机构执业许可证》相应内容一致。 （2）“使用放药科（室）名称”应为核医学科。“使用放药类别”应为二类。 （3）“科（室）地址”、负责人“姓名”应与《辐射安全许可证》副本中“涉源部门”中相应的“地址”“负责人”相符。 2.《放射诊疗许可证》副本“放射诊疗许可范围”中“诊疗项目”项下“核医学”应至少包含下列1项内容：（1）PET影像诊断（2）SPECT影像诊断（3）籽粒插植治疗（4）放射性药物治疗。 3.《医疗机构执业许可证》《辐射安全许可证》《放射诊疗许可证》为必要材料，且应在有效期内。《放射诊疗许可证》校验记录在效期内。 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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