Details of the Announcements

食品审评中心丨已批准注册产品中,原料已纳入保健食品原料目录,但产品剂型形态不在可备案范围的,这类产品如何注册或备案?
保健食品原料
2025-01-20

答:已批准注册产品可在产品到期前申请延续注册。依据现行法律法规,经延续注册、换证变更注册技术审评认为,已批准上市的产品剂型合理、质量安全可控的,我中心将启动相应备案剂型增补工作。待增补剂型正式发布后,确认该产品原注册人资质,允许按原申请注册的配方、剂型转为备案管理。注册转备案完成后再注销原注册证书。

对于已申请延续注册的产品,因增补剂型工作未发布正式文件而导致注册证书已到有效期内未能转为备案管理的,在特殊食品信息平台标注“产品经技术审查属于注册转备案管理范围,在注册转备案审查期间,原注册证书继续有效”。

 

官方链接:国家市场监督管理总局食品审评中心

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