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GSP认证取消后 开药店更难了?

2017-10-26 夕语 药店经理人

食药总局刚发文,正式取消GSP认证,就有网友@昌文忠(哈健康医药连锁)担忧“取消了可以,日常监管应更严格,但是基层监管局有那么多人么?”

食药总局刚发文,正式取消GSP认证,就有网友@昌文忠(哈健康医药连锁)担忧“取消了可以,日常监管应更严格,但是基层监管局有那么多人么?”

这不,文件还未具体落实,监管却早已跟进,药监已经开始招兵买马了。

近日,陕西省渭南市药监局发布通知,经过基层推荐、条件审查、培训考核和综合素质评定等环节,决定聘任王育泓等111名同志为市级药品GSP认证员,希望被聘任的GSP认证员积极参加认证检查工作。

如此看来,GSP证书所要求的标准,药店还是必须实行,只是将行政审批哪些不必要的流程给省去了。

当然,征稿意见修改部分也明确提到,将原先的第十六条第一款“药品监督管理部门按照规定对药品经营企业是否符合《药品经营质量管理规范》的要求进行认证;对认证合格的,发给认证证书”修改为“药品经营企业必须按照国务院药品管理监督管理部门依据本法制定的《药品经营质量管理规范》经营药品”。

这么看来,如果按照征稿意见执行,原先的GSP认证员就要改转变“角色”了,变为GSP日常检查人员。

认证取消后就要日常监管,药店别高兴的太早

关于GSP认证取消,不少网友预言监管会更严格。

网友@粘忠立:说明以后会更严,让你每天都认为在认证!

网友@罗斌华:不认证,那就说明必须符合GSP条款后才发给许可证。不符合认证规定的,许可证也可被收回,责令停业整顿。由职业检查员提请发证机构收回。所以说GSP不再是天花板,而是地板。

网友@梦开始的地方:取消了认证的程序,并不代表完全自由了~~由天花板变成了地板,就要求经营者要做的更好,原来的那种为了检查而做的事情以后将变成日常常规要做的事情了,这才是真正的提供合格安全质量保障的药品。以后经营全靠商家的诚信和良知。投机取巧的事情将会越来越难让自身生存,更别提有所发展了。

当然,确实如此,监管只会更严格。

早在九月中旬,第二届药品监管科学大会上,食药总局监管人员就表示,“GSP、GMP认证只是一个标准,目前大家在认证要求方面已达标,所以没有认证的必要了。但是,取消认证不代表不监管了,监管只会更严格。”

附渭南市药品GSP认证员名单(图表来源医药手机报)



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