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兰州拟建药品召回制度 确保医疗卫生安全--亲稳网络舆情监测室
2012-11-27

  11月26日下午,省十一届人大常委会第三十次会议分组审议了兰州市人大常委会报请批准的《兰州市药品医疗器械流通监督管理条例》。该《条例》参照食品安全法有关食品召回制度的规定,建立了药品医疗器械不良反应报告制度及安全隐患召回制度。

November 26, afternoon,Province the first session of the 11th National People's Congress standing committee meeting 30 during deliberation, the lanzhou city people's congress standing committee for approval[Lanzhou city drugs and medical devices circulation supervision and management regulations].this[regulations]With reference to food safety about the provisions of the food recall system,Established the drugs and medical devices adverse reaction report system and safety hidden trouble recall system.

  《条例》规定,药品和医疗器械经营企业和使用单位发现可能与用药、用械有关的严重不良反应,必须及时向市、县(区)药监部门报告。药品和医疗器械经营企业、使用单位发现其经营使用的药品和医疗器械存在安全隐患,应当立即停止销售、使用,并主动召回相关产品。

[regulations]provisions,Drugs and medical devices business enterprise and use the unit findings may and medicine/The soldiers with serious adverse reaction,Must promptly to the city/county(area)Also department report.Drugs and medical devices business enterprise/Use the unit found its business use of drugs and medical devices exist safety hidden trouble,It shall immediately stop the sale/use,Voluntary recall and related products.

  《条例》明确,医疗器械使用单位对一次性使用的医疗器械不得重复使用;使用过的,应当按照国家有关规定销毁,并作记录。医疗器械经营企业,不得向个人销售高风险植入性医疗器械。医疗器械使用单位内设机构及人员,不得私自采购、使用医疗器械。

[regulations]clear,Medical equipment use the unit for single use shall not re-use medical devices;used,In accordance with the relevant provisions of the state shall be destroyed,And record.Medical equipment management enterprise,Can not to personal selling high risk implantable medical devices.Medical equipment use the unit internal institutions and personnel,Shall not stock purchase/Use of medical equipment.

  《条例》同时规定,药品和医疗器械经营企业和使用单位应当依法执行政府价格政策,按照规定明码标价。价格行政主管部门应当向社会公布依法实行政府定价和政府指导价的药品价格,加强日常监督,及时查处价格违法行为。(甘肃经济日报 记者 陈彩虹)

[regulations]At the same time provisions,Drugs and medical devices business enterprise and use the unit shall, in accordance with law, carry out the price policy,According to the regulation plain code marks a price.The price administrative departments shall publish to the society practice in accordance with the government guidance pricing and government pricing drug price,Strengthen routine supervision and,An illegal pricing act in time.(Gansu economic daily reporter ChenCaiHong)


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