中华人民共和国疫苗管理法（征求意见稿）(18)
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0; punctuation-wrap: simple" class=a><FONT size=5><SPAN style="LAYOUT-GRID-MODE: line; FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-family: 黑体; mso-bidi-font-size: 16.0pt; mso-font-width: 0%" lang=EN-US><SPAN style="mso-list: Ignore">第十八条</SPAN></SPAN><SPAN style="FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">【紧急授权】</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 黑体; mso-bidi-font-size: 16.0pt" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">出现特别重大突发公共卫生事件或者其他严重威胁公众健康安全紧急事件，国务院卫生行政部门提出紧急使用未获批准疫苗建议的，国务院药品监督管理部门组织专家论证认为可能获益的，可以决定在一定范围和期限内使用尚未批准上市的疫苗。</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 仿宋_GB2312; mso-bidi-font-size: 16.0pt" lang=EN-US><o:p></SPAN></FONT></FONT></P>
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-list: none; mso-char-indent-count: 2.0; punctuation-wrap: simple" class=a><FONT size=5><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">应急响应结束或者该疫苗在应急使用过程中被证实无效、存在重大安全风险的，国务院药品监督管理部门应当及时终止该疫苗的紧急使用授权。</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 仿宋_GB2312; mso-bidi-font-size: 16.0pt" lang=EN-US><o:p></SPAN></FONT></FONT></P>
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-line-height-rule: exactly; mso-char-indent-count: 2.0; punctuation-wrap: simple" class=a><FONT size=5><SPAN style="LAYOUT-GRID-MODE: line; FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-family: 黑体; mso-bidi-font-size: 16.0pt; mso-font-width: 0%" lang=EN-US><SPAN style="mso-list: Ignore">第十九条</SPAN></SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">【</FONT></SPAN><SPAN style="FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">注册标准和</SPAN><SPAN style="FONT-FAMILY: 黑体; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">说明书、标签</SPAN><SPAN style="FONT-FAMILY: 黑体; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">核准</SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; 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; mso-bidi-font-weight: bold; mso-fareast-font-family: 仿宋_GB2312; mso-bidi-font-size: 16.0pt" lang=EN-US><SPAN style="mso-spacerun: yes"> </SPAN></SPAN><SPAN style="FONT-FAMILY: 仿宋_GB2312; COLOR: black; mso-bidi-font-weight: bold; mso-bidi-font-size: 16.0pt; mso-ascii-font-family: 'Times New Roman'; mso-hansi-font-family: 'Times New Roman'">国务院药品监督管理部门在批准疫苗上市许可时，对该疫苗的生产工艺和质量控制标准予以核准。</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; COLOR: black; mso-bidi-font-weight: bold; mso-fareast-font-family: 仿宋_GB2312; mso-bidi-font-size: 16.0pt" lang=EN-US><o:p></SPAN></FONT></FONT></P>


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