关于上报山东省药品安全风险因素分级管理信息的通知

发布作者：市场科     发布时间：

<span id="conten"> <p> </p> <div><span style="font-size: 16pt"> </span></div> <div> </div> <div> </div> <div align="center"><span style="font-size: 22pt">关于上报山东省药品安全风险因素</span></div> <div align="center"><span style="font-size: 22pt">分级管理信息的通知</span></div> <div> </div> <div><span style="font-size: 16pt">各县市区食品药品监督管理局（分局）：</span></div> <div style="text-indent: 32.25pt"><span style="font-size: 16pt">根据《山东省药品安全风险因素分级管理办法（试行）》和我局《转发省局关于进一步做好药品安全风险因素分级管理工作的通知》（济食药监办[2009]161号）要求，现就药品经营企业、医疗机构分级管理信息报送事宜通知如下：</span></div> <div style="text-indent: 32pt"><span style="font-size: 16pt">一、对辖区内药品批发企业、三级医疗机构，填报《山东省药品安全风险因素分级管理信息采集表》（附件1），并附相关资料，报我局市场监督科进行等级确定。</span></div> <div><span style="font-family: 仿宋"><span style="font-size: 16pt">   </span><span style="font-size: 16pt">二、对辖区内药品零售（连锁）企业、二级以下医疗机构填写《山东省药品安全风险因素分级管理情况备案表》（附件2）报我局市场监督科进行备案。</span></span></div> <div><span style="font-family: 仿宋"><span style="font-size: 16pt">    </span><span style="font-size: 16pt">三、以上表格同时报送电子版（邮箱：lfm643@126.com）。</span></span></div> <div style="text-indent: 32pt"><span style="font-family: 仿宋"><span style="font-size: 16pt">四、上报时间：2010年1月31日前。</span></span></div> <div style="text-indent: 32.25pt"><span style="font-family: 仿宋"><span style="font-size: 16pt">                         </span><span style="font-size: 16pt">二</span><span style="font-size: 16pt">〇</span><span style="font-size: 16pt">一</span><span style="font-size: 16pt">〇</span><span style="font-size: 16pt">年一月二十日</span></span></div> <div style="text-indent: 32.25pt"> </div> <div>附件1</div> <div> </div> <div align="center"><b><span style="font-size: 18pt">山东省</span></b><b><span style="font-size: 18pt">药品安全风险因素分级管理信息采集</span></b><b><span style="font-size: 18pt">表</span></b></div> <div align="center"><b> </b></div> <p> <table cellspacing="0" cellpadding="0" width="100%" border="1" style="border-right: medium none; border-top: medium none; border-left: medium none; width: 100%; border-bottom: medium none; border-collapse: collapse"> <tbody> <tr> <td width="21%" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 21.06%; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div><span style="font-size: 12pt">涉药单位名称</span></div> </td> <td valign="top" width="78%" colspan="2" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 78.94%; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> <div> </div> </td> </tr> <tr style="height: 30.1pt"> <td width="21%" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 21.06%; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 30.1pt; background-color: transparent"> <div style="text-indent: 12pt"><span style="font-size: 12pt">单位类别</span></div> </td> <td valign="top" width="78%" colspan="2" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 78.94%; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 30.1pt; background-color: transparent"> <div> </div> </td> </tr> <tr style="height: 201.4pt"> <td width="21%" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 21.06%; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 201.4pt; background-color: transparent"> <div align="center"><span style="font-size: 12pt">主要内容</span></div> <div align="center"><span style="font-size: 12pt">（资料原件或复印件附后）</span></div> </td> <td valign="top" width="78%" colspan="2" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 78.94%; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 201.4pt; background-color: transparent"> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> <div> </div> </td> </tr> <tr style="height: 95.5pt; page-break-inside: avoid"> <td width="52%" colspan="2" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 52.84%; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 95.5pt; background-color: transparent"> <div><span style="font-size: 12pt">信息采集人：（签字）</span></div> <div> </div> <div style="text-indent: 108pt"><span style="font-size: 12pt">年<span>   </span>月 日</span></div> </td> <td width="47%" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 47.16%; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 95.5pt; background-color: transparent"> <div align="left"><span style="font-size: 12pt">信息采集部门：（盖章）</span></div> <div align="left"> </div> <div style="text-indent: 96pt"><span style="font-size: 12pt">年<span>   </span>月 日</span></div> </td> </tr> </tbody> </table> </p> <div style="line-height: 19pt"> </div> <div style="line-height: 19pt">说明：</div> <div style="margin: 0cm 0cm 0pt 10.5pt; text-indent: -10.5pt; line-height: 19pt">⒈“单位类别”：药物非临床研究机构、药物临床试验机构、药品生产企业、医疗机构制剂室、药品批发企业、药品零售企业、医疗器械生产企业、医疗器械经营企业、药品使用单位、医疗器械使用单位。</div> <div style="margin: 0cm 0cm 0pt 10.5pt; text-indent: -10.5pt; line-height: 19pt">⒉“主要内容”：根据风险因素描述和所采取的处理措施填写，标明评定标准中对应的代码和分值，写明有关证明文件或处罚文书的名称和编号。</div> <div> </div> <div> </div> <div>附件2：</div> <div align="center"><b><span style="font-size: 18pt">山东省药品安全风险因素分级管理备案表</span></b></div> <div align="center"><b> </b></div> <div><span style="font-size: 12pt">报送单位（盖章）：<span>                             </span>报送日期<span>     </span>年<span>   </span>月<span>   </span>日</span></div> <div> </div> <p> <table cellspacing="0" cellpadding="0" border="1" style="border-right: medium none; border-top: medium none; border-left: medium none; border-bottom: medium none; border-collapse: collapse"> <tbody> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div align="center"><span style="font-size: 14pt">涉药单位名称</span></div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div align="center"><span style="font-size: 14pt">类 别</span></div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div align="center"><span style="font-size: 14pt">等 级</span></div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div align="center"><span style="font-size: 14pt">备 注</span></div> </td> </tr> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> </tr> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; 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width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> </tr> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> </tr> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> </tr> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> </tr> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> </tr> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> </tr> <tr> <td width="199" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 149.4pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="168" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 126pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="84" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 63pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> <td valign="top" width="175" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ebe9ed; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ebe9ed; width: 131.6pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; background-color: transparent"> <div> </div> </td> </tr> </tbody> </table> </p> <div align="center"> </div> <div style="text-indent: 32.25pt"> </div></span>