中华人民共和国疫苗管理法（征求意见稿）(30)
<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">第三十条</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'">【企业信息公示制度】</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'">疫苗上市许可持有人应当建立信息公示制度，及时在企业网站公示疫苗产品信息、说明书和标签、质量管理规范执行情况、批签发情况、产品召回情况及保险等信息。</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; LAYOUT-GRID-MODE: char; mso-line-height-rule: exactly; mso-list: none; mso-char-indent-count: 2.0; punctuation-wrap: simple; mso-layout-grid-align: none" class=a><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><FONT size=5> </FONT></SPAN></P>
<P style="TEXT-ALIGN: center; LINE-HEIGHT: 28pt; TEXT-INDENT: 0cm; MARGIN: 0cm 0cm 0pt 21pt; mso-line-height-rule: exactly; mso-add-space: auto; mso-char-indent-count: 0; punctuation-wrap: simple; mso-para-margin-left: 2.0gd" class=ListParagraph1 align=center>第四章 上市后研究和管理<o:p></SPAN></SPAN></P>
<P style="LINE-HEIGHT: 28pt; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; LAYOUT-GRID-MODE: char; mso-line-height-rule: exactly; mso-char-indent-count: 2.0; punctuation-wrap: simple; mso-layout-grid-align: none" 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">第三十一条</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'">上市后持续研究要求</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'">疫苗上市许可持有人应当建立健全疫苗质量管理体系，制定并实施疫苗上市后风险管理计划，主动开展疫苗上市后研究，对疫苗的安全性、有效性进行进一步确证。必要时，国务院药品监督管理部门可以责令疫苗上市许可持有人开展上市后评价或者直接组织开展上市后评价。</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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