2
01
111100000000271742
北京市药品监督管理局
医疗机构制剂补充申请审批--增加中药制剂的功能主治或者化学制剂的适应症
111100000000271742200017200200019
1111000000002717422000172002000
0
e33230a0-c599-40cc-9014-733d3e239b18
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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医疗机构制剂补充申请审批--增加中药制剂的功能主治或者化学制剂的适应症
北京市
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