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—其他
111100000000271742200017200200016
1111000000002717422000172002000
0
3afc66d6-0dfe-4b2a-8fcb-da0e94f12e2d
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
医疗机构制剂补充申请审批—其他
北京市
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到现场次数
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9工作日
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(承诺时限为办理流程中“审查与决定”环节的计时时限)