EDQM颁布的关于CEP和检查的新的信息

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                      EDQM颁布的关于CEP和检查的新的信息
The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections.
EDMQ颁布了关于CEP程序及其相关检查的新的信息。
1)        Costs of inspections The EDQM has published a new document which describes the inspection costs. The EDQM document PA/PH/CEP (12) 28 1R refers to a table of fees and inspection costs. The costs for the inspection as well as for the travel will be invoiced prior to the inspection. For a three day inspection, for example, the fee is 5000,- Euro. If the facility is located in Asia a flat rate of 6000,- Euro will be charged to cover the travel costs, food and accommodation for the inspector. The travel costs are less when the facility is located in Europe (800,- Euro) and elsewhere (4500,- Euro). The CEP inspection fee table can be found here.
检查费用。EDQM颁布了新的文件来介绍检查费用。EDQM的 PA/PH/CEP (12) 28 1R文件介绍了一系列的费用和检查花费。检查和差旅费用在检查前就已经罗列清楚。一个三日的检查，例如，费用是5000欧元。如果厂址在亚洲，统一费用为6000欧元，包括了差旅费用、饮食住宿费用。如果厂址在欧洲或者其它地方，差旅费用更便宜一些，欧洲800欧元，其它地方4500欧元。可以在文件中找到费用清单。
2)        New Indian State has impact on CEP holders The Indian government created a new state on 2nd June 2014 which is called Telangana. The EDQM reminds holders of CEPs and applicants for CEPs that it is their responsibility to update their CEP applications. Many of the addresses mentioned on CEPs and in CEP applications which are currently listed as being in Andhra Pradesh are now in this new state of Telangana. The new address details, as well as an updated section 3.2.S.2.1 should be submitted to EDQM. This should be done until 31 August 2015.
新的印度州对CEP持有者产生了影响。印度政府在2014年6月2日新建立了Telangana州。EDQM提醒CEPs持有者和申请者有责任更新他们的CEP申请。许多CEPs和CEP申请上都涉及到地址，现在的Andhra Pradesh将成为新的Telangana。新的地址的细节，以及更新的3.2.S.2.1部分需要递交给EDQM。这个要在2015.08.31之前完成。

三尺之冰

值得学习，谢谢楼主了

大呆子

下载了，不过看不懂

syhorchid

谢谢分享

kc1711422001

Thanks for your share