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湖南规范疫苗配送企业资质:委托配送储存企业不超2家
2017-08-14 17:06:07 中国经济网
经济日报·中国经济网北京8月14日讯(记者 施晓娟)据湖南省食品药品监督管理局消息,为加强对疫苗委托配送储存的管理,做好疫苗委托配送储存备案工作,根据《疫苗流通和预防接种管理条例》和《国家食品药品监管总局 国家卫生计生委关于贯彻实施新修订<疫苗流通和预防接种管理条例>的通知》要求,湖南省食品药品监督管理局制定了《湖南省疫苗委托配送(储存)备案事项的办事指南》(以下简称《指南》)。《指南》明确规范了疫苗配送企业在储存、运输方面的资质及相关备案工作审批流程。
《指南》要求,疫苗生产企业委托配送储存疫苗的药品批发企业不能超过2家,受委托配送储存的企业应配备2名以上专业技术人员负责疫苗质量管理和验收工作,并配独立冷库、冷藏或保温运输设备、温湿度检测设备及备用供电系统。
湖南省食药监管局表示,对疫苗生产企业委托配送储存疫苗备案符合要求的,应在备案程序结束后3个工作日内将备案情况抄送到受委托配送储存企业所在地的市州食品药品监督管理局,抄送时应填写《疫苗委托配送(储存)备案信息抄送通知书》。
湖南省食药监管局要求,疫苗生产企业变更备案事项的,应及时向湖南省食品药品监督管理局报备,并提交相关资料,经湖南省食品药品监督管理审核后在其官方网站公示。
此前福建、山西、上海等省市已相继发布了规范疫苗委托配送储存等相关通告。
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