互联网药品信息服务网上申报手册

互互联联网网药药品品信信息息服服务务网网上上申申报报手手册册22000099--1100目录1浏览器设置·······························································································································11.1错误提示·································································································································11.2解决方法（设置受信任的站点）··························································································12提交申请···································································································································43首次申请···································································································································53.1填报新申请·····························································································································53.2查询申请状态·························································································································93.3申请表修改···························································································································104变更申请·································································································································124.1填报变更申请·······················································································································124.2查询变更申请状态···············································································································154.3变更申请修改·······················································································································155换证申请·································································································································155.1填报换证申请·······················································································································155.2查询换证申请状态···············································································································195.3换证申请修改·······················································································································19互联网药品信息服务网上申报手册11浏览器设置使用本系统前，请将本系统站点设置为“受信任的站点”1.1错误提示本系统中的“打印表单”模块是基于ActiveX插件实现，当IE浏览器安全级别过高时打印插件可能会被IE浏览器禁用，造成打印表单时出错，错误如下图：1.2解决方法（设置受信任的站点）1、打开IE浏览器，在【工具】菜单中，点击【Internet选项】，如图：互联网药品信息服务网上申报手册22、在弹出的【Internet选项】选项页中，点击【安全】。在【安全】对话框中点击【受信任的站点】，再点击【站点】按钮。3、在弹出的【可信站点】对话框中，如果“对该区域中的所有站点要求服务验证（https:）”复选框被勾选中，则将其取消。将本系统的IP地址填写到“将该网站添加到区域中”并点击【添加】按钮。互联网药品信息服务网上申报手册34、点击【自定义级别】按钮。5、启用“ActiveX控件和插件”下所有选项。互联网药品信息服务网上申报手册42提交申请“互联网药品信息服务企业审批”事项包括互联网信息服务首次申请、变更申请和换证申请，以上事项的申请，均应在国家食品药品监督管理局政府网站（网址）在线填报相应的申请表信息并在线打印申请表，同时按照《互联网药品信息服务管理办法》（局令第9号）的要求，向所在省（食品）药品监督管理部门提交与在线申请内容一致的纸质申请表及相关资料。填写申请网址：首先访问国家局网站（），然后选择“网上申请”，再选择“互联网药品信息服务申请”进行填报。页面如下图所示。请根据所申报事项填写相应内容进行申报，以下详细说明首次申请、变更申请、换证申请的填写步骤。互联网药品信息服务网上申报手册53首次申请3.1填报新申请申报单位在首次填信息报服务申请的时候，点击“互联网药品信息服务申请”栏目中的【新建申请】按钮，如下图所示。填写申请表：进入填写页面（如下图所示），按照实际情况填写相关信息，其中，带“★”的为必填项。如下图所示：互联网药品信息服务网上申报手册6打印申请表：填写完成后，确认所填内容无误后，点击上图中的【打印】按钮，如果申请表尚未保存，系统会弹出对话框。提示用户是否保存所填写的信息，选择【是】，系统将保存所填写信息（保互联网药品信息服务网上申报手册7存成功的同时，系统自动提交了本次申请），并展示保存后的信息（如下图所示），此时申请的“企业ID号”显示在页面的左上角。点击【打印】按钮，进入打印预览界面（如下图所示）。互联网药品信息服务网上申报手册8互联网药品信息服务网上申报手册9点击【打印】按钮，完成申请表的打印。提交申请表：如果填写完毕后没有直接打印，可以点击【提交】按钮完成申请表的提交工作。系统自动生成“企业ID号”（如下图所示），请牢记此ID号，申报单位对申请表进行状态查询或者修改时，需同时输入“企业ID号”和填报的“单位名称”。取消填报：填写后，点击【取消】按钮，所有填写的信息将丢失，页面返回申请首页，慎用！注：若填报后直接提交，而没有进行打印，可凭“企业ID号”和单位名称从申请首页中的【修改】按钮进入申请表界面，并完成打印，详细操作同《1.1.3申请表修改》。3.2查询申请状态申报单位提交申请后，在申请首页中输入获取的“企业ID号”和填报的“单位名称”（如下图所示），点击【状态查询】按钮查询申请的当前审批状态。状态查询的结果包括“申请”、“签收”、“补正资料”、“受理”、“不予受理”、互联网药品信息服务网上申报手册10“受理审查中”、“不予核发资格证书”、“审定”。当点击【查看状态描述】时，会列出所有审批状态的详细说明，如下图所示：3.3申请表修改注：只有当前申请的状态为“申请”时，即申请信息尚未进入审批系统，才可以进行修改操作，否则，表单中的内容是不可修改的。申报单位提交申请后，在申请首页中输入获取的“企业ID号”和填报的“单位名称”，点击【修改】按钮进入修改页面（如下图所示）。互联网药品信息服务网上申报手册11修改完毕后，点击【打印】按钮，将直接打开打印预览界面并且可以对申请表进行打印。点击【提交】按钮，系统对所修改内容进行保存，提交到审批系统。点击【取消】按钮，系统将不对所修改的内容进行保存，并返回填报首页。提示：向相应的管理部门提交的纸质申请表的内容必须与在线申请内容一互联网药品信息服务网上申报手册12致，所以在修改了申请信息后，务必重新打印申请表，以保证一致性。4变更申请注：本申请适用于互联网药品信息服务提供者变更《互联网药品信息服务管理办法》中规定的事项时，填写并打印《互联网药品信息服务项目变更申请表》。4.1填报变更申请申报单位进行变更申请时，在“互联网药品信息服务项目变更申请”栏目中填写“资格证书编号”后点击【申请变更】按钮，如下图所示。进入申请表填写页面（如下图所示）。互联网药品信息服务网上申报手册13系统自动显示各数据项变更前信息，申请人在“变更标识”区域中，勾选发生了变更的数据项的“变更”图标，并填写变更后的信息。例如变更“互联网药品信息服务单位名称”和“网站主服务器域名”，可按下图所示操作。互联网药品信息服务网上申报手册14填写完毕，点击【提交】按钮，将填写的申请表信息提交到审批系统。点击【打印】按钮，自动保存所填写的内容，并完成打印功能。点击【取消】按钮，系统不对所填信息进行保存。具体操作详同《3.1填报新申请》。注：提出变更申请单位的“企业ID号”并不会改变，与首次申请后得到的“企业ID号”一致。互联网药品信息服务网上申报手册154.2查询变更申请状态查询变更申请状态的操作与查询首次申请的申请状态操作相同，详细操作详见《3.2查询申请状态》小节。4.3变更申请修改注：只有当前申请的状态为“申请”时，即申请信息尚未进入审批系统，才可以进行修改操作，否则，表单中的内容是不可修改的。修改变更申请的操作与修改首次申请的操作相同，具体操作详同《3.3申请修改》小节。5换证申请注：本申请适用于持有《互联网药品信息服务资格证书》，有效期届满前需要继续从事互联网药品信息服务的网站，在线填报《互联网药品信息服务换证申请表》。5.1填报换证申请申报单位进行换证申请时，选择填报“互联网药品信息服务项目换证申请”互联网药品信息服务网上申报手册16中的“申请换证”，填写“资格证书编号”后点击【申请换证】按钮，如下图所示。进入换证申请信息填写页面，如下图所示：互联网药品信息服务网上申报手册17打开换证申请填写界面，界面中显示的是已获批准的原证书信息，对于《互联网药品信息服务管理办法》中规定的变更申请事项，界面中已“不可修改项目”方式显示（即不可修改状态），其他项目以“可修改项目”方式显示（可修改状态）。对于“可修改项目”，申报人在上图所示界面中进行填写或修改，确认无误后，点击【打印】按钮打印换证申请表，或点击【提交】将此