關(guān)于MAH責(zé)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(jìn)行例行檢查的官方信息？地方當(dāng)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(dāng)檢查員檢查一個虛擬（虛擬醫(yī)藥研發(fā)公司）的MAH：“誰”負(fù)責(zé)質(zhì)量體系的實施，是注冊的負(fù)責(zé)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(zé)任由質(zhì)量(保證)負(fù)責(zé)人承擔(dān)。


  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”)。