關(guān)于MAH責任概念文件，有幾個問題:

  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?

    關(guān)于歐盟各國對MAH檢查的不一致做法，是否公布了關(guān)于對哪些國家進行例行檢查的官方信息？地方當局是否使用基于風(fēng)險的方法來針對這些檢查？是否有發(fā)表過哪些常見缺陷？


    No.

    沒有。


  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?

    當檢查員檢查一個虛擬（虛擬醫(yī)藥研發(fā)公司）的MAH：“誰”負責質(zhì)量體系的實施，是注冊的負責人嗎？市場總監(jiān)？


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

    根據(jù)歐盟GMP指南第一部分，第1章。此責任由質(zhì)量(保證)負責人承擔。


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

    廣告材料管理是否在MAH常規(guī)檢查范圍內(nèi)？


    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”).

    這取決于廣告材料的類型和歐盟各成員國的其他國家立法(例如，一些成員國有專門的”藥品廣告法”)。