《医药代表备案管理办法(试行)》,不得统方! 不得卖药! 不得提供赞助!

2020-09-30 E药经理人 E药经理人

刚刚,国家药监局发布《医药代表备案管理办法(试行)》,使得近段时间业界热议的医药代表备案管理,有了更明确指向。该文件共17条,2045个字,从医药代表定义到上市许可持有人对医药代表的管理方式,再到医药

刚刚,国家药监局发布《医药代表备案管理办法(试行)》,使得近段时间业界热议的医药代表备案管理,有了更明确指向。该文件共17条,2045个字,从医药代表定义到上市许可持有人对医药代表的管理方式,再到医药代表可为与不可为的领域都做了明确规定。

各方人士对此反应不一,律师说我们又将迎来一波药品推广服务合同的修改工作;还有人说,这是正规军的利好,但“游击队”自有对策;也有人说,这是真正的医药人和医药销售人的分水岭。

文件首先明确了医药代表的定义,是指代表药品上市许可持有人在中华人民共和国境内从事药品信息传递、沟通、反馈的专业人员。其主要任务包括:
(一)拟订医药产品推广计划和方案;
(二)向医务人员传递医药产品相关信息;
(三)协助医务人员合理使用本企业医药产品;
(四)收集、反馈药品临床使用情况及医院需求信息。
但是,从事以上活动,必须获得医疗机构同意。该文件第二十一条规定:医药代表在医疗机构开展学术推广等活动应当遵守卫生健康部门的有关规定,并获得医疗机构同意。
对医药代表不能做什么,也有了明确规定,包括:
(一)未经备案开展学术推广等活动;
(二)未经医疗机构同意开展学术推广等活动;
(三)承担药品销售任务,实施收款和处理购销票据等销售行为;
(四)参与统计医生个人开具的药品处方数量;
(五)对医疗机构内设部门和个人直接提供捐赠、资助、赞助;
(六)误导医生使用药品,夸大或者误导疗效,隐匿药品已知的不良反应信息或者隐瞒医生反馈的不良反应信息;
(七)其他干预或者影响临床合理用药的行为。
同时,文件明确,药品上市许可持有人作为管理对的第一责任人,对医药代表的备案和管理负责。
此外,该文件也进一步明确,药品上市许可持有人或者医药代表给予使用其药品的有关人员财物或者其他不正当利益的,依照《中华人民共和国药品管理法》《中华人民共和国反不正当竞争法》等相关法律法规进行调查处理。按照《中华人民共和国药品管理法》第八十八条规定,使用其药品的有关人员包括:医疗机构的负责人、药品采购人员、医师、药师等。
以下附上《医药代表备案管理办法(试行)》全文。

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    2022-10-14 ms4000000541478676

    刚刚看了您的文章,然后发现多打了一个字,应该是“该文件第十一条规定:医药代表在医疗机构开展学术推广等活动应当遵守卫生健康部门的有关规定,并获得医疗机构同意。”

    0

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    2020-10-24 fengyqf
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    2021-07-24 yahu
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    2020-10-02 cathymary
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    2020-10-02 cenghis

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