中华人民共和国疫苗管理法（征求意见稿）(79)
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; punctuation-wrap: simple" class=MsoNormal><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">（一）执行质量管理规范存在严重缺陷的；</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; FONT-SIZE: 16pt; mso-fareast-font-family: 仿宋_GB2312" lang=EN-US><o:p></SPAN></FONT></P>
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; punctuation-wrap: simple" class=MsoNormal><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">（二）生产工艺、设施设备和场地变更等按规定应当审批而未经批准的；</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; FONT-SIZE: 16pt; mso-fareast-font-family: 仿宋_GB2312" lang=EN-US><o:p></SPAN></FONT></P>
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; punctuation-wrap: simple" class=MsoNormal><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">（三）发现上市销售的疫苗存在质量问题或者其他安全隐患，采取召回措施不力的。</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; FONT-SIZE: 16pt; mso-fareast-font-family: 仿宋_GB2312" lang=EN-US><o:p></SPAN></FONT></P>
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-list: l1 level1 lfo1; mso-char-indent-count: 2.0; punctuation-wrap: simple" class=MsoNormal><SPAN style="LAYOUT-GRID-MODE: line; FONT-FAMILY: 黑体; COLOR: black; FONT-SIZE: 16pt; mso-bidi-font-family: 黑体; mso-font-kerning: 0pt; mso-font-width: 0%" lang=EN-US><SPAN style="mso-list: Ignore">第八十九条</SPAN></SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">【</FONT></SPAN><SPAN style="FONT-FAMILY: 黑体; COLOR: black; FONT-SIZE: 16pt; mso-bidi-font-weight: bold; mso-font-kerning: 0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">严重违法行为处罚</SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">】</FONT></SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; FONT-SIZE: 16pt; mso-fareast-font-family: 仿宋_GB2312"> <SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; FONT-SIZE: 16pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">疫苗上市许可持有人有下列情形之一的，没收违法所得，责令停产停业，撤销上市许可证明文件，并处货值金额五倍以上十倍以下罚款；货值金额不足五十万元的，处以一百万元以上五百万元以下罚款，对疫苗上市许可持有人的法定代表人、主要负责人和关键岗位人员，没收其在违法期间自本单位所获收入，并处以百分之五十以上、一倍以下罚款，十年内不得从事药品生产经营活动：</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; FONT-SIZE: 16pt; mso-fareast-font-family: 仿宋_GB2312" lang=EN-US><o:p></SPAN></FONT></P>


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