鼎丰盛业供应链|打扮品备案除了弄懂流程外，这几个关注点亦很重要！
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">说到“<span style="color: black;">打扮</span>品备案”相信<span style="color: black;">非常多</span>人都不陌生，<span style="color: black;">然则</span>你真的<span style="color: black;">认识</span>关于“<span style="color: black;">打扮</span>品备案”的<span style="color: black;">关联</span>知识吗？你的<span style="color: black;">制品</span>是不是会存在“备案不<span style="color: black;">经过</span>”“备案难<span style="color: black;">经过</span>”等问题呢？</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">“知己知彼”<span style="color: black;">才可</span>无案<span style="color: black;">不外</span>！拿出您<span style="color: black;">宝贵</span>的几分钟时间，耐心读完这篇<span style="color: black;">文案</span>，保准您能够轻<span style="color: black;">容易</span>松<span style="color: black;">认识</span>关于“<span style="color: black;">打扮</span>品注册备案”的<span style="color: black;">关联</span>知识，让您的<span style="color: black;">制品</span><span style="color: black;">再也不</span>“难过”审！</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q6.itc.cn/images01/20240606/649721d4d23148728bd2a6f792d31c59.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">1、</span>什么是<span style="color: black;">打扮</span>品？</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">打扮</span>品的范畴是属于什么？<span style="color: black;">那些</span>不是<span style="color: black;">打扮</span>品？</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（1）<span style="color: black;">打扮</span>品的范畴</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">按照</span>国家质检总局<span style="color: black;">颁布</span>的《<span style="color: black;">打扮</span>品标识管理规定》 ，第三条 本规定所<span style="color: black;">叫作</span><span style="color: black;">打扮</span>品<span style="color: black;">指的是</span>以涂抹、喷、洒<span style="color: black;">或</span>其她类似<span style="color: black;">办法</span>，施于人体(皮肤、毛发、指趾甲、口唇齿等)，以达到清洁、保养、美化、修饰和变化外观，<span style="color: black;">或</span>修正人体气味，保持良好状态为目的的<span style="color: black;">制品</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">注：中国的<span style="color: black;">打扮</span>品仅能<span style="color: black;">功效</span>于皮肤表层。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（2）<span style="color: black;">那些</span>不属于<span style="color: black;">打扮</span>品？</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">功效</span>于女性私密部位的<span style="color: black;">制品</span>；口服的美白<span style="color: black;">制品</span>；减肥<span style="color: black;">制品</span>；微针，注射类针剂等破皮<span style="color: black;">制品</span>。这些<span style="color: black;">制品</span>都不在<span style="color: black;">打扮</span>品的范畴内，不属于<span style="color: black;">打扮</span>品。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">中国的<span style="color: black;">打扮</span>品合规<span style="color: black;">行业</span>中是不<span style="color: black;">准许</span>宣传“医美级”“药妆”“抗衰”等<span style="color: black;">关联</span>词汇的。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（例如医用冷敷贴，医美面膜，药妆等<span style="color: black;">便是</span>典型的不符合<span style="color: black;">打扮</span>品定义的<span style="color: black;">制品</span>。）</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q8.itc.cn/images01/20240606/0c5d0f888cdb447689e15cf673503d59.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">2、</span>正确区分<span style="color: black;">打扮</span>品注册与备案</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">打扮</span>品注册与备案有所差别，<span style="color: black;">不可</span>混为一谈！</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（1）<span style="color: black;">那些</span><span style="color: black;">打扮</span>品<span style="color: black;">必须</span>注册，<span style="color: black;">那些</span><span style="color: black;">打扮</span>品<span style="color: black;">必须</span>备案？</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">《条例》第四条：<span style="color: black;">打扮</span>品分为特殊<span style="color: black;">打扮</span>品和普通<span style="color: black;">打扮</span>品。国家对特殊<span style="color: black;">打扮</span>品实行注册管理，对普通<span style="color: black;">打扮</span>品实行备案管理。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（2）<span style="color: black;">怎样</span>区分普通<span style="color: black;">打扮</span>品和特殊<span style="color: black;">打扮</span>品？</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">《条例》第十六条：用于染发、烫发、祛斑美白、防晒、防脱发的<span style="color: black;">打扮</span>品以及宣<span style="color: black;">叫作</span>新功效的<span style="color: black;">打扮</span>品为特殊<span style="color: black;">打扮</span>品。特殊<span style="color: black;">打扮</span>品以外的<span style="color: black;">打扮</span>品为普通<span style="color: black;">打扮</span>品。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">*何为新功效<span style="color: black;">打扮</span>品呢？</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">根据</span>《<span style="color: black;">打扮</span>品<span style="color: black;">归类</span>规则和<span style="color: black;">归类</span>目录》，宣传孕妇<span style="color: black;">运用</span>的<span style="color: black;">打扮</span>品就为新功效，要<span style="color: black;">根据</span>特殊<span style="color: black;">打扮</span>品进行注册。但<span style="color: black;">日前</span>新功效<span style="color: black;">打扮</span>品很难<span style="color: black;">得到</span>审批，<span style="color: black;">因此</span>只要记住宣<span style="color: black;">叫作</span>了五大功效的产品属于特殊<span style="color: black;">打扮</span>品就<span style="color: black;">能够</span>了。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（3）举例说明：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">①某款<span style="color: black;">打扮</span>品<span style="color: black;">功效</span>于皮肤表面，<span style="color: black;">功效</span>宣<span style="color: black;">叫作</span>为保湿且符合<span style="color: black;">打扮</span>品的定义，即为普通<span style="color: black;">打扮</span>品，<span style="color: black;">必须</span>进行<span style="color: black;">打扮</span>品备案。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">②某款<span style="color: black;">打扮</span>品宣<span style="color: black;">叫作</span><span style="color: black;">拥有</span>防晒/祛斑美白/防脱发/染发/烫发功效，那就<span style="color: black;">能够</span><span style="color: black;">判断</span>为这是属于特殊<span style="color: black;">打扮</span>品中的某类<span style="color: black;">打扮</span>品，<span style="color: black;">必须</span>进行<span style="color: black;">打扮</span>品注册。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q5.itc.cn/images01/20240606/2121823edf3844258530c834031983f6.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">3、</span>管理<span style="color: black;">打扮</span>品注册和备案的<span style="color: black;">分部</span>如</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国产特殊<span style="color: black;">打扮</span>品和进口特殊<span style="color: black;">打扮</span>品：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">这两个类别的<span style="color: black;">打扮</span>品的管辖<span style="color: black;">分部</span>均为国家<span style="color: black;">药物</span>监督管理局（NMPA）。特殊<span style="color: black;">打扮</span>品<span style="color: black;">必须</span>经国务院<span style="color: black;">药物</span>监督管理<span style="color: black;">分部</span>注册后方可生产、进口。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国产普通<span style="color: black;">打扮</span>品：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国产普通<span style="color: black;">打扮</span>品的备案管理由省级<span style="color: black;">药物</span>监督管理<span style="color: black;">分部</span>负责。<span style="color: black;">倘若</span>企业想进行国产普通<span style="color: black;">打扮</span>品备案，<span style="color: black;">能够</span>直接在所在地的省级<span style="color: black;">药物</span>监督管理<span style="color: black;">分部</span>提交备案。<span style="color: black;">有些</span><span style="color: black;">打扮</span>品发达的省份还会延伸到市级乃至区级<span style="color: black;">药物</span>监督管理<span style="color: black;">分部</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">进口普通<span style="color: black;">打扮</span>品：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">进口普通<span style="color: black;">打扮</span>品的管辖<span style="color: black;">分部</span><span style="color: black;">按照</span>省份<span style="color: black;">区别</span>有所区别。部<span style="color: black;">掰开</span>放了进口普通<span style="color: black;">打扮</span>品审核权限的省（市），如广东、北京、上海、天津、福建等，备案<span style="color: black;">能够</span>直接在境内责任人所在省（市）的省级<span style="color: black;">药物</span>监督管理<span style="color: black;">分部</span>完成。而<span style="color: black;">无</span>权限下放的省份，如黑龙江、吉林、山西等，还<span style="color: black;">必须</span>在国家药监局申请备案。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">4、</span>.注册备案取得凭证<span style="color: black;">叫作</span>谓区分</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">关于<span style="color: black;">打扮</span>品注册备案取得的凭证<span style="color: black;">叫作</span>谓，<span style="color: black;">能够</span>清晰地区分为以下两类：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">普通<span style="color: black;">打扮</span>品：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">制度：备案制</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">证书全<span style="color: black;">叫作</span>：普通<span style="color: black;">打扮</span>品备案凭证</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">简<span style="color: black;">叫作</span>：备案凭证</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">特殊<span style="color: black;">打扮</span>品：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">制度：注册制</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">证书全<span style="color: black;">叫作</span>：特殊<span style="color: black;">打扮</span>品注册证</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">简<span style="color: black;">叫作</span>：特证</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">针对</span>进口<span style="color: black;">打扮</span>品，大<span style="color: black;">都数</span><span style="color: black;">状况</span>下，通关<span style="color: black;">机构</span>将其<span style="color: black;">叫作</span>为“批文”，这个“批文”<span style="color: black;">实质</span>上是对特证和备案凭证的统<span style="color: black;">叫作</span>。<span style="color: black;">这般</span>的<span style="color: black;">叫作</span>谓<span style="color: black;">表现</span>了进口<span style="color: black;">打扮</span>品在注册备案过程中<span style="color: black;">必须</span>满足的特殊<span style="color: black;">需求</span>和流程。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">5、</span>注册证和备案凭证的有效日期</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">①国产普通<span style="color: black;">打扮</span>品的备案凭证<span style="color: black;">日前</span><span style="color: black;">无</span>有效期，进口普通<span style="color: black;">打扮</span>品的有效期<span style="color: black;">按照</span>授权书的授权期限来决定。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">②特殊<span style="color: black;">打扮</span>品注册证的有效期为5年，有效期期满前90个工作日到30个工作日<span style="color: black;">时期</span><span style="color: black;">能够</span>申请延续。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">6、</span>三个专有名词</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">注册人，备案人，境内责任人</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">注册人、备案人<span style="color: black;">便是</span>以自己的名义将<span style="color: black;">制品</span>推向市场的企业主体。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">作为</span>注册人，备案人是<span style="color: black;">必须</span><span style="color: black;">必定</span>门槛的</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">按照</span>《条例》第十八条：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">打扮</span>品注册申请人、备案人应当具备下列<span style="color: black;">要求</span>：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（一）是依法设立的企业<span style="color: black;">或</span>其他组织；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（二）有与申请注册、进行备案的<span style="color: black;">制品</span>相适应的质量管理体系；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（三）有<span style="color: black;">打扮</span>品不良反应监测与<span style="color: black;">评估</span>能力。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">①<span style="color: black;">针对</span>国产<span style="color: black;">制品</span>，注册人、备案人<span style="color: black;">便是</span>指国内申请特殊<span style="color: black;">打扮</span>品注册<span style="color: black;">或</span>进行<span style="color: black;">打扮</span>品备案的申请企业。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">②<span style="color: black;">针对</span>进口<span style="color: black;">打扮</span>品<span style="color: black;">来讲</span>，注册人、备案人<span style="color: black;">便是</span>指国外申请特殊<span style="color: black;">打扮</span>品注册<span style="color: black;">或</span>进行<span style="color: black;">打扮</span>品备案的申请企业，<span style="color: black;">便是</span>品牌方。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">*进口<span style="color: black;">打扮</span>品<span style="color: black;">必须</span>设置境内的责任人。<a style="color: black;"><span style="color: black;">返回搜</span></a>狐，查看<span style="color: black;">更加多</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">责任编辑：网友投稿</span></p>
祝福你、祝你幸福、早日实现等。 “BS”（鄙视的缩写） 你的努力一定会被看见，相信自己，加油。
页:
[1]