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中华人民共和国疫苗管理法（征求意见稿）(33)
<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><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%; mso-ansi-language: ZH-TW; mso-fareast-language: ZH-TW" lang=ZH-TW>第三十四条【疫苗产品退市】 对于同品种疫苗中生产工艺落后、质量控制水平明显劣于其他同品种疫苗现有水平的，国务院药品监督管理部门责令疫苗上市许可持有人限期进行工艺优化和质量提升。在规定期限内仍达不到要求的，疫苗上市许可持有人应当主动申请注销疫苗的上市许可证明文件。未主动申请注销的，国务院药品监督管理部门撤销疫苗的上市许可证明文件。<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; mso-ansi-language: ZH-TW; mso-fareast-language: ZH-TW" lang=ZH-TW><o: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>第三十五条【疫苗品种淘汰】 国务院药品监督管理部门可以根据疾病预防控制需要和疫苗行业技术发展情况，组织对疫苗品种开展上市后评价，发现该类疫苗的产品设计、生产工艺、风险获益比明显劣于预防同种疾病的其他类疫苗的，撤销该类品种的所有上市许可证明文件及相应国家药品标准。<o:p>

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