食品药品监管总局办公厅 国家卫生计生委办公厅关于加强药品经营企业药品销售监督管理工作的通知
食品药品监管总局办公厅 国家卫生计生委办公厅关于加强药品经营企业药品销售监督管理工作的通知 |
食药监办药化监〔2014〕156号 |
2014年08月01日 发布 |
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各省、自治区、直辖市食品药品监督管理局、卫生计生委（卫生厅局）： 今年以来，媒体连续报道个别幼儿园违规使用处方药和个别零售药店违规销售抗生素等问题，引发较大社会反响，公众对规范药品销售问题日益关注。为加强药品销售环节监管，督促药品经营企业严格执行新修订《药品经营质量管理规范》有关规定，现将有关要求通知如下： 一、药品批发企业应当严格审核购货单位资质，只能将药品销售给具有合法资质的企业或单位,并与其经营和使用范围相适应。要加强对购货单位采购人员身份的核实，防止无资质企业、单位和个人冒用他人合法资质套购药品。 二、药品零售企业应当严格执行处方药与非处方药分类管理的规定，对于必须凭处方销售的药品，销售时应当认真执行处方审核、签章和留存等规定，不能提供医师处方的，一律严禁销售。要认真落实执业药师在岗执业的要求,为消费者提供必要的药学服务和合理用药指导。开展诊疗活动，如坐堂行医、开具处方等，必须依法取得《医疗机构执业许可证》，并符合相关管理规定。 三、地方各级食品药品监管部门要加强对药品经营企业购销药品行为的日常监督，加大对企业在经营活动中的审核资质、开具票据或销售凭证、执行处方药与非处方药分类管理制度，以及执业药师在岗执业情况等方面的检查力度。对违反上述规定的企业，应当按照《中华人民共和国药品管理法》第七十九条严肃查处；情节严重的，依法吊销《药品经营许可证》。发现药品零售企业未取得《医疗机构执业许可证》开展诊疗活动或存在非医师行医行为的，应当及时移送当地卫生计生行政部门依法处理。
为督促各地切实加强监管，了解相关规定执行情况，食品药品监管总局和国家卫生计生委将开展联合督查，重点检查处方药销售和诊疗活动的监管情况。对监督检查中发现工作不力的地方和部门，将予以通报批评。
国家食品药品监督管理总局办公厅 国家卫生计生委办公厅
2014年8月1日 |
相关链接：http://www.sda.gov.cn/WS01/CL0844/104835.html
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