婴幼儿配方乳粉产品配方注册管理办法（征求意见稿）(12)
<P style="TEXT-JUSTIFY: inter-ideograph; TEXT-ALIGN: justify; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-char-indent-count: 2.0"><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-bidi-font-family: 仿宋">（一）婴幼儿配方乳粉产品配方变更注册申请书；<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN>
<P style="TEXT-JUSTIFY: inter-ideograph; TEXT-ALIGN: justify; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-char-indent-count: 2.0"><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-bidi-font-family: 仿宋">（二）产品配方变更论证报告；<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN>
<P style="TEXT-JUSTIFY: inter-ideograph; TEXT-ALIGN: justify; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-char-indent-count: 2.0"><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-bidi-font-family: 仿宋">（三）与变更事项有关的材料。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN>
<P style="TEXT-JUSTIFY: inter-ideograph; TEXT-ALIGN: justify; TEXT-INDENT: 32.15pt; MARGIN: 0cm 0cm 0pt; mso-pagination: none; mso-char-indent-count: 2.0; punctuation-wrap: simple"><B><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-bidi-font-family: 仿宋">第二十三条</SPAN></B><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-bidi-font-family: 仿宋">　申请人申请产品配方变更等可能影响产品配方科学性、安全性的，审评机构应当根据实际需要按照本办法第十二条的规定组织开展审评，并作出审评结论。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN>
<P style="TEXT-JUSTIFY: inter-ideograph; TEXT-ALIGN: justify; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-pagination: none; mso-char-indent-count: 2.0; punctuation-wrap: simple"><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-bidi-font-family: 仿宋">申请人申请企业名称、生产地址名称（非实际地址）变更的，审评机构当场核实后予以变更。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN>
<P style="TEXT-JUSTIFY: inter-ideograph; TEXT-ALIGN: justify; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-char-indent-count: 2.0"><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-bidi-font-family: 仿宋">申请人申请产品名称、产品标签（说明书）涉及产品配方变更等不影响产品配方科学性、安全性的，审评机构应当自受理之日起<SPAN lang=EN-US>10</SPAN>个工作日内作出结论。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN>
<P style="TEXT-JUSTIFY: inter-ideograph; TEXT-ALIGN: justify; TEXT-INDENT: 32pt; MARGIN: 0cm 0cm 0pt; mso-char-indent-count: 2.0"><SPAN style="FONT-FAMILY: 仿宋; FONT-SIZE: 16pt; mso-bidi-font-family: 仿宋">国家市场监督管理总局自接到审评结论之日起<SPAN lang=EN-US>10</SPAN>个工作日内根据审评结论作出准予变更或者不予变更的决定。对符合条件的，依法办理变更手续，注册证书发证日期以变更批准日期为准，原注册号不变，证书有效期保持不变；不予变更注册的，作出不予变更注册决定。<SPAN lang=EN-US><o:p></o:p></SPAN></SPAN>


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