Details of the Announcements
食品审评中心丨“双无”保健食品转让技术,应当如何办理?
清理换证
保健食品
2024-12-17

答:《保健食品注册与备案管理办法》规定,保健食品注册人转让技术的,受让方应当在转让方的指导下重新提出产品注册申请,产品技术要求等应当与原申请材料一致。符合要求的,国家市场监督管理总局应当为受让方核发新的保健食品注册证书,并对转让方保健食品注册予以注销。《保健食品注册申请服务指南(2016年版)》2.11项规定,拟申请转让技术,如该产品正在办理其他注册事项的,在完成相关注册事项前,暂不受理该产品转让技术事项申请。正在办理转让技术注册事项的,注册申请人可同时提出变更或延续注册申请。但变更或延续注册申请受理的同时,转让技术注册申请终止办理。《在产在售“无有效期和无产品技术要求”保健食品集中换证审查要点》明确,“双无”换证属于变更注册申请。

“双无”换证申请涉及省级局核实实际生产的配方、工艺、产品技术要求,并可能调整产品名称、配方、功能、产品技术要求等内容,而转让技术申请涉及证书持有人的变化和转受让双方的权益,从以往工作经验看,极易产生纠纷。建议申请人在完成“双无”换证后,再申请转让技术。对于“双无”保健食品转让技术,我中心已发布风险提示https://www.cfe-samr.org.cn/sldt/zxfw/202407/t20240710_5454.html),供参考。

 

官方链接:国家市场监督管理总局食品审评中心

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