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(guó)對(duì)MAH檢查的不一致做法，是否公布了關(guān)于對(duì)哪些國(guó)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(xiǎn)的方法來(lái)針對(duì)這些檢查？是否有發(fā)表過(guò)哪些常見(jiàn)缺陷？

No.

沒(méi)有。

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(gè)虛擬（虛擬醫(yī)藥研發(fā)公司）的MAH：“誰(shuí)”負(fù)責(zé)質(zhì)量體系的實(shí)施，是注冊(cè)的負(fù)責(zé)人嗎？市場(chǎng)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)。

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(guó)的其他國(guó)家立法(例如，一些成員國(guó)有專門的”藥品廣告法”)。