关于MAH责任概念文件,有几个问题:

  1. Regarding the de-harmonised approach across EU on MAHinspections, is there official information published on which countries areroutinely inspected? Do the local authorities use a risk based approach totarget those inspections? Is there anywhere published which are the most commonfinding?

    关于欧盟各国对MAH检查的不一致做法,是否公布了关于对哪些国家进行例行检查的官方信息?地方当局是否使用基于风险的方法来针对这些检查?是否有发表过哪些常见缺陷?


    No.

    没有。


  2. When inspectors as yourself inspect a virtual MAH'who' would you held responsible for the implementation of a QualitySystem, is the Head of Regulatory? Marketing Director?

    当检查员检查一个虚拟(虚拟医药研发公司)的MAH:“谁”负责质量体系的实施,是注册的负责人吗?市场总监?


    Acc. EU-GMP Guideline Part I,chap. 1 responsibility lies with the Head of Quality (Assurance) Unit.

    根据欧盟GMP指南第一部分,第1章。此责任由质量(保证)负责人承担。


  3. Is the advertisement material management within scope of MAHroutine inspection?

    广告材料管理是否在MAH常规检查范围内?


    That depends on type of advertising material and the additionalnational legislations in the respective EU-member state (e.g. somemember-states have special “advertising laws for medicinal products”).

    这取决于广告材料的类型和欧盟各成员国的其他国家立法(例如,一些成员国有专门的”药品广告法”)。



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