中华人民共和国疫苗管理法（征求意见稿）(19)
<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" 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'">疫苗说明书、标签应当经过国务院药品监督管理部门核准。国务院药品监督管理部门应当在网站上及时公布疫苗说明书、标签。</SPAN><SPAN style="FONT-FAMILY: 'Times New Roman','serif'; mso-fareast-font-family: 仿宋_GB2312" 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'">疫苗上市许可持有人应当根据疫苗上市后研究、异常反应情况等持续更新说明书。</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><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>第三章 疫苗生产和批签发<o:p></SPAN></SPAN></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">第二十条</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'">【生产严格准入</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'">国家对疫苗生产企业实行严于一般药品生产企业的准入制度。从事疫苗生产活动，应当经省、自治区、直辖市药品监督管理部门批准。</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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