国家市场监管总局发文:医疗、药品、保健品大督查来了

2019-01-10 于小渔 基层医师公社

最新一波打假行动来了!涉及多个领域,其中包括医疗、药品、保健食品等领域。 9日上午,国家市场监管总局发布《假冒伪劣重点领域治理工作方案(2019-2021)》(以下简称《方案》)。


最新一波打假行动来了!涉及多个领域,其中包括医疗、药品、保健食品等领域。

9日上午,国家市场监管总局发布《假冒伪劣重点领域治理工作方案(2019-2021)》(以下简称《方案》)。

《方案》要求通过稳步有序开展专项治理,查办一批假冒伪劣大案要案,净化生产源头和流通网络,有效遏制假冒伪劣高发多发势头。

到2021年,市场监管综合执法能力和监管现代化水平明显提升,工作机制更加完善,营商环境进一步优化,老百姓买得更加放心,用得更加放心,吃得更加放心。

对医疗、药品、保健品等展开重点督查

《方案》指出,开展保健食品质量安全提升行动,重点检查保健食品标签标识、宣传材料、广告等未经批准声称保健功能、宣称具有疾病预防或治疗功能、含有虚假宣传功效等违法行为,以及不按照批准内容组织生产、擅自改变生产工艺、非法添加非食用物质(药物)等违法行为,并依法从严处罚。

强化广告导向监管,加大医疗、药品、食品、保健食品、金融投资等领域广告监管力度。制定出台药品、医疗器械、保健食品、特殊医学用途配方食品广告的审查标准和程序。

医生开保健品,违法!

那么,这跟医生有啥关系呢?关系大了。我们昨天也提到了,医生销售保健品是违法的。眼看马上要大督查了,这里再详细为大家科普一下,以免一些人在不知不觉中就犯了错。

首先我们先了解下究竟什么是假药:

《中华人民共和国药品管理法》第四十八条规定,禁止生产(包括配制,下同)、销售假药。

有下列情形之一的,为假药:

(一)药品所含成份与国家药品标准规定的成份不符的;

(二)以非药品冒充药品或者以他种药品冒充此种药品的。

有下列情形之一的药品,按假药论处:

(一)国务院药品监督管理部门规定禁止使用的;

(二)依照本法必须批准而未经批准生产、进口,或者依照本法必须检验而未经检验即销售的;

(三)变质的;

(四)被污染的;

(五)使用依照本法必须取得批准文号而未取得批准文号的原料药生产的;

(六)所标明的适应症或者功能主治超出规定范围的。

要尤其注意的是这一条:以非药品冒充药品或者以他种药品冒充此种药品的。这里就涉及到医生开保健品的问题了。

有些医生为了加强辅助治疗,会在处方上加上一些保健品,但这是绝对不可以的。

要知道,医生推荐保健食品不违法,但如果在处方上体现有保健品,按照相关法规规定,可认定为使用假劣药被处罚。

因为,医疗机构凭处方使用“保健食品”会被认定其为药品,依据《中华人民共和国药品管理法》,会发生以下两种情况:

一是保健食品若与药品同名,则视为“以非药品冒充药品”,依照被冒充药品的标准进行检验,并载明检验结果”。

二是保健食品与药品不同名的,则视为使用未获得药品批准文号的药品,即依据《药品管理法》第四十八条第三款第(二)项,认定为假药。

相关处罚如下:

参照《处方管理办法》第五十七条第二款规定,未按照该办法规定开具药品处方的行为,将由县级以上卫生行政部门给予警告或责令暂停六个月以上一年以下执业活动;情节严重的甚至将被吊销执业证书。

《药品管理法》第七十三条规定,生产、销售假药的,没收违法生产、销售的药品和违法所得,并处违法生产、销售药品货值金额二倍以上五倍以下的罚款;有药品批准证明文件的予以撤销,并责令停产、停业整顿;情节严重的,吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》;构成犯罪的,依法追究刑事责任。

严格执行基药目录 基层医生需谨慎

临近农历新年,年底的检查总是特别多。2018年新版基药目录出炉,国家要求坚持基药主导地位。尽管有些地方允许有一定金额比例的非基药,但基药的比例始终都是占主体地位的。

因此,大家在应对检查时,除了要按规定摆放、陈列药品,保证药品在有效期内等之外,一定要注意清查货架上的药是否符合基药目录要求,如果检查时发现有私自从第三方渠道进购的药品,那么就难逃处罚了。

所以,面对即将到来的新一波大检查,大家一定要慎之又慎,遵守规范须知,防微杜渐,以便在检查来临时可以安然面对。

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    2019-01-11 wxl882001

    了解一下

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  5. [GetPortalCommentsPageByObjectIdResponse(id=1749167, encodeId=ef101e4916721, content=<a href='/topic/show?id=a2c7e306196' target=_blank style='color:#2F92EE;'>#督查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73061, encryptionId=a2c7e306196, topicName=督查)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=af2436239757, createdName=wodejia-dayu, createdTime=Wed Sep 04 14:29:00 CST 2019, time=2019-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2031982, encodeId=59f92031982aa, content=<a href='/topic/show?id=9ac5483622f' target=_blank style='color:#2F92EE;'>#市场监管总局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48362, encryptionId=9ac5483622f, topicName=市场监管总局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=bioon1, createdTime=Sat Dec 07 14:29:00 CST 2019, time=2019-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1371594, encodeId=212413e15940a, content=<a href='/topic/show?id=bf1ce2339d0' target=_blank style='color:#2F92EE;'>#监管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72339, encryptionId=bf1ce2339d0, topicName=监管)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Jan 12 07:29:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=357884, encodeId=488d35e88461, content=了解一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOgo3iaicb1Imgk1yIfnvr6oXzibcAFB6puAyNJXbzWhNuLqaFYBVRWjh7rghkvFLPxMAfD5ib3nXwVD/0, createdBy=bed21972958, createdName=wxl882001, createdTime=Fri Jan 11 22:05:40 CST 2019, time=2019-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=357775, encodeId=ec8935e77578, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Thu Jan 10 21:02:08 CST 2019, time=2019-01-10, status=1, ipAttribution=)]
    2019-01-10 明月清辉

    谢谢分享,学习了

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