2
01
111100000000271742
北京市药品监督管理局
医疗机构制剂注册审批
111100000000271742200017200200022
1111000000002717422000172002000
0
bf16a552-04ac-4cc4-86a5-ed9b3780b524
2d96f2eb-5221-4055-a037-3f2c17586ffd
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．申报事项正确。 2．申请表填写正确、完整、规范，签字、盖章及份数符合要求。 3．证明性文件齐全、有效。 4．全部申报资料项目、份数齐全，体例格式规范，符合要求。（1）申请资料应采用A4纸张打印或复印，字号一般采用简体中文4号。（2）申请资料按照资料目录顺序装订成册，首页为申报资料目录。（3）每一项申请资料须附有封面，封面内容应完整准确。（4）加盖印章：《医疗机构制剂补充申请表》、《医疗机构制剂临床前研究情况报告表》、《医疗机构制剂临床研究情况报告表》等申请表格应按申请表要求加盖单位公章。申报资料应以项目为单位，逐个封面加盖申请人印章，封面与骑缝处加盖骑缝章，封面印章应加盖在文字处。加盖的印章应符合国家有关用章规定，并具法律效力。（5）凡申请资料需提交复印件的，申请人须在复印件上逐页注明日期，加盖单位公章。 5．申请人具备相应的申报资质。
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2
2^3
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政务服务> 办事指南

医疗机构制剂注册审批

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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

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．申报事项正确。 2．申请表填写正确、完整、规范，签字、盖章及份数符合要求。 3．证明性文件齐全、有效。 4．全部申报资料项目、份数齐全，体例格式规范，符合要求。（1）申请资料应采用A4纸张打印或复印，字号一般采用简体中文4号。（2）申请资料按照资料目录顺序装订成册，首页为申报资料目录。（3）每一项申请资料须附有封面，封面内容应完整准确。（4）加盖印章：《医疗机构制剂补充申请表》、《医疗机构制剂临床前研究情况报告表》、《医疗机构制剂临床研究情况报告表》等申请表格应按申请表要求加盖单位公章。申报资料应以项目为单位，逐个封面加盖申请人印章，封面与骑缝处加盖骑缝章，封面印章应加盖在文字处。加盖的印章应符合国家有关用章规定，并具法律效力。（5）凡申请资料需提交复印件的，申请人须在复印件上逐页注明日期，加盖单位公章。 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) 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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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 000172002000 事项编码 1111000000002717422000172002000
业务办理项编码 111100000000271742200017200200022 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
联办机构 无 实施主体性质 法定机关
办理进程查询途径
行使层级 市级 运行系统 市级自建（垂管）
物流快递 是 办理方式 自办件
预约办理 数量限制 无
中介服务 无 权限划分 无
通办范围 全市 特别程序 无
行使内容 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
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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》。
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