2
10
111100000000271742
北京市药品监督管理局
普通化妆品备案
1111000000002717422111046022000
0
967536d4-e7ca-4f86-a7c8-482a5b5aca4e
a00519db-b660-4970-a95f-8636050df1da
2
10
市药监局
110000000000
北京市药品监督管理局
工作日上午09:00-12:00,下午13:30-17:00
北京市丰台区西三环南路1号(六里桥西南角):北京市政务服务中心( 综合窗口)
材料符合国家药品监督管理局《化妆品注册备案资料管理规定》《化妆品注册备案资料提交技术指南(试行)》的要求。 一、境首次申请办理普通化妆品备案时,境内的注册申请人、备案人和境内责任人应通过国家药品监督管理局化妆品注册备案信息服务平台(https://zwfw.nmpa.gov.cn/web/user/login#person)提交用户信息相关资料,申请用户账号。申请人收到电子版资料的审核意见后,应当按照《化妆品注册备案资料提交技术指南(试行)》的要求至北京市政务服务中心办事窗口提交纸质版资料。其中,质量安全负责人简历、质量管理体系概述、不良反应检测和评价体系概述可免于提交纸质版资料,境外生产企业的生产质量管理规范证明资料可以提交北京市政务服务中心办事窗口核对后,由用户自行存档备查。在提交纸质资料时,需同时提交一致性声明,自我声明所提交纸质资料与信息服务平台填报内容的一致性,并由备案人签章确认。经核对纸质资料与网上电子资料一致的,北京市政务服务中心办事窗口予以接收。使用带有电子加密证书公章的无需提交纸质资料。 二、取得账号后,备案人、境内责任人按照法规要求通过国家药品监督管理局化妆品注册备案信息服务平台(https://zwfw.nmpa.gov.cn/web/user/login#person)提交备案资料后即完成备案。进行进口普通化妆品备案的,境内的备案人或者境内责任人应当在备案信息公布前,按照《化妆品注册备案资料提交技术指南(试行)》的要求将纸质版备案资料递交至北京市政务服务中心办事窗口。其中,化妆品所使用原料的原料来源和原料安全相关信息可免于提交纸质版资料。在提交纸质资料时,需同时提交一致性声明,自我声明所提交纸质资料与信息服务平台填报内容的一致性,并由备案人签章确认。经核对纸质资料与网上电子资料一致的,北京市政务服务中心办事窗口予以接收。纸质版备案资料原件递交后一经接收不再退回。使用带有电子加密证书公章的普通化妆品备案,无需提交纸质资料。
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产品生产来源\n\t\t\t\t\t\t\t2.1.1.2.2.1.1.1 进口产品\n\t\t\t\t\t2.1.1.2.2.2 否\n\t\t\t2.1.1.3 已备案产品所使用原料的生产商,原料质量价格规格增加或者发生改变的,原料在配方中的含量和原料中主要功能成分含量及溶剂未发生变化,为了保证原料质量而添加的微量稳定剂、抗氧化剂、防腐剂等成分发生种类或者含量变化的需提交\n\t\t\t\t2.1.1.3.1 具体变化类型\n\t\t\t\t\t2.1.1.3.1.1 涉及产品执行的标准发生变化\n\t\t\t\t\t2.1.1.3.1.2 拟变更事项涉及产品标签样稿中的全成分标注,安全警示用语等发生变化的,需提交\n\t\t\t2.1.1.4 产品执行的标准中生产工艺简述、微生物和理化指标及质量控制措施、使用方法、安全警示用语、贮存条件、使用期限等发生变化的需提交\n\t\t\t\t2.1.1.4.1 具体变化类型\n\t\t\t\t\t2.1.1.4.1.1 涉及生产工艺简述变化的需提交\n\t\t\t\t\t2.1.1.4.1.2 涉及产品使用方法变更的需提交\n\t\t\t\t\t2.1.1.4.1.3 涉及产品使用期限延长的需提交\n\t\t\t\t\t2.1.1.4.1.4 涉及产品安全评估资料内容发生变化的,需提交\n\t\t\t\t\t2.1.1.4.1.5 涉及进口产品原销售包装和标签变化的,需提交\n\t\t\t2.1.1.5 产品标签样稿内容发生变化的需提交\n\t\t\t\t2.1.1.5.1 是否涉及进口产品原销售包装和标签变化\n\t\t\t\t\t2.1.1.5.1.1 是\n\t\t\t\t\t2.1.1.5.1.2 否\n\t\t\t2.1.1.6 产品安全评估资料内容发生变化时提交\n\t\t\t\t2.1.1.6.1 化妆品安全评估人员是否发生变化\n\t\t\t\t\t2.1.1.6.1.1 是\n\t\t\t\t\t2.1.1.6.1.2 否\n\t\t\t2.1.1.7 产品分类发生变化,需提交\n\t\t\t2.1.1.8 涉及其他事项变更的,需提交\n\t\t\t2.1.1.9 已备案产品的销售包装发生变化的,需提交\n\t2.2 否","CD_TIME":"Jul 7, 2022 11:23:50 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政务服务> 办事指南

切换简洁版

北京市

普通化妆品备案 [展开]

事项引导 网上办理 网上预约 网上预约 移动端办理
自助终端办理
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基本信息

基本编码 111046022000 事项编码 1111000000002717422111046022000
业务办理项编码 111100000000271742211104602200001 事项类型 其他行政权力
实施主体 北京市药品监督管理局 服务对象
办理时间 工作日上午09:00-12:00,下午13:30-17:00 查看详情
办理地点 北京市丰台区西三环南路1号(六里桥西南角):北京市政务服务中心( 综合窗口) 查看详情
权力来源 法定本级行使 网上支付
所属机构 北京市药品监督管理局 委托部门
联办机构 实施主体性质 法定机关
进驻大厅类型 政务中心 办理进程查询途径
行使层级 市级 运行系统 国家级垂管系统
物流快递 办理方式 自办件
预约办理 办理形式
中介服务 数量限制
通办范围 全市 行使内容
权限划分 特别程序
受理条件 材料符合国家药品监督管理局《化妆品注册备案资料管理规定》《化妆品注册备案资料提交技术指南(试行)》的要求。 一、境首次申请办理普通化妆品备案时,境内的注册申请人、备案人和境内责任人应通过国家药品监督管理局化妆品注册备案信息服务平台(https://zwfw.nmpa.gov.cn/web/user/login#person)提交用户信息相关资料,申请用户账号。申请人收到电子版资料的审核意见后,应当按照《化妆品注册备案资料提交技术指南(试行)》的要求至北京市政务服务中心办事窗口提交纸质版资料。其中,质量安全负责人简历、质量管理体系概述、不良反应检测和评价体系概述可免于提交纸质版资料,境外生产企业的生产质量管理规范证明资料可以提交北京市政务服务中心办事窗口核对后,由用户自行存档备查。在提交纸质资料时,需同时提交一致性声明,自我声明所提交纸质资料与信息服务平台填报内容的一致性,并由备案人签章确认。经核对纸质资料与网上电子资料一致的,北京市政务服务中心办事窗口予以接收。使用带有电子加密证书公章的无需提交纸质资料。 二、取得账号后,备案人、境内责任人按照法规要求通过国家药品监督管理局化妆品注册备案信息服务平台(https://zwfw.nmpa.gov.cn/web/user/login#person)提交备案资料后即完成备案。进行进口普通化妆品备案的,境内的备案人或者境内责任人应当在备案信息公布前,按照《化妆品注册备案资料提交技术指南(试行)》的要求将纸质版备案资料递交至北京市政务服务中心办事窗口。其中,化妆品所使用原料的原料来源和原料安全相关信息可免于提交纸质版资料。在提交纸质资料时,需同时提交一致性声明,自我声明所提交纸质资料与信息服务平台填报内容的一致性,并由备案人签章确认。经核对纸质资料与网上电子资料一致的,北京市政务服务中心办事窗口予以接收。纸质版备案资料原件递交后一经接收不再退回。使用带有电子加密证书公章的普通化妆品备案,无需提交纸质资料。
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办理流程 查看流程图

办理环节 办理步骤 办理时限 办理人员 审查标准 办理结果

申请材料

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
样表下载
其他要求
申请材料总要求一、网上提交资料应符合下列要求: 1.化妆品备案资料应当使用国家公布的规范汉字。除注册商标、网址、专利名称、境外企业的名称和地址等必须使用其他文字的,或约定俗成的专业术语(如维生素C等),所有其他文字均应完整、规范地翻译为中文,并将原文附在相应的译文之后。 2.化妆品备案资料应当符合国家有关用章规定,签章齐全,具有法律效力。境外企业及其他组织不使用公章的,应当由法定代表人或者企业(其他组织)负责人签字。 除政府主管部门或者有关机构、注册和备案检验机构、公证机关等出具的资料原件外,备案资料均应由备案人或者境内责任人逐页加盖公章。使用带有电子加密证书的公章的,可直接在电子资料上加盖电子公章。备案资料中如需境外化妆品注册人、备案人签章的,其法定代表人或者负责人可授权该备案人或者境内责任人的签字人签字。授权委托签字的,应当提交授权委托书原件及其公证书原件,授权委托书中应当写明授权签字的事项和范围。 3.化妆品备案资料内容应完整、清晰,不得有涂改、粘贴,不得含有无关内容。 4.化妆品备案资料中应使用我国法定计量单位,使用其他计量单位时,应当折算为我国法定计量单位;应当准确引用参考文献,标明出处,确保有效溯源;应当规范使用标点符号、图表、术语等,保证资料内容准确规范。 5.化妆品备案文本资料中主体文字颜色应为黑色,内容易于辨认,设置合适的行间距和页面边距,确保在打印或者装订中不丢失文本信息。 6.普通产品注销后再次备案时,应当提交情况说明。对于非安全性原因注销的,再次申请备案时可使用原备案资料的复印件。 7. 已备案普通产品因备案人、境内责任人地址变化导致备案管理部门改变,备案人主动注销原备案信息后重新办理备案的,可使用原备案资料。 二、进口普通化妆品网上提交资料后,境内责任人应按要求将纸质备案资料交至政务服务中心办事窗口,并符合下列要求: 1.应与上传至国家局信息服务平台的电子备案资料完全一致。 2.除检验报告、公证文书、官方证明文件及第三方证明文件外,申报资料原件应由境内责任人逐页加盖公章或骑缝章。 3.化妆品备案的纸质资料应当使用国际标准A4型规格纸张,内容完整清晰、不得涂改。化妆品的包装展开图片等确需更大尺寸纸张的,可使用其他规格纸张,确保妥善置于A4规格资料内。纸质文件资料的载体和书写材料应当符合耐久性的要求。 4.使用中国法定计量单位。
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结果名称及样本

设定依据

收费标准及依据

服务承诺

办件类型 承诺件

到现场次数0次

法定办结时限 10(工作日)

承诺办结时限 10(工作日)

承诺办结时限说明

10个工作日为普通化妆品备案用户账号申请信息审核办理时限。备案人、境内责任人按照法规要求通过国家药品监督管理局化妆品注册备案信息服务平台提交备案资料后即完成备案。产品备案信息在产品完成备案之日起5个工作日内通过国家局网站向社会公布,备案人、境内责任人可通过国家局网站自行查询产品备案信息。(承诺时限为办理流程中“审查与决定”环节的计时时限)

咨询方式

咨询电话:

(010)83513069【展开】

咨询窗口地址:

北京市丰台区西三环南路1号(六里桥西南角):北京市政务服务中心( 综合窗口)【展开】

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