您好，保健食品片剂包衣属于生产工艺，根据《保健食品生产许可审查细则》5.1.4的规定，保健食品注册或者备案的生产工艺发生变化的，申请人应当办理注册或者备案的变更手续后，再申请保健食品生产许可的变更；以“拟备案品种”申请生产许可，具体要求和办理程序请登录广东政务服务网，查询食品生产许可（保健食品、婴幼儿配方乳粉、特殊医学用途配方食品、食盐）核发事项的办事指南，保健食品备案证明材料可不提供（以拟备案品种情况说明替代）。
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1、保健食品生产许可认证的片剂为不包衣，如果以后需要生产包衣片剂，是否需要重新现场核查？ 2、以“拟备案品种”进行生产许可，是否有具体要求和操作指南？是否产品拿到三批的检验报告即可？
保健食品
保健食品生产许可
2023-11-03
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