今年EDQM又出台了新规定，审批会更加严格，大家要小心了。

原文如下：

EDQM continues to optimise the evaluation process of CEP applications
In order to optimise the process of CEP evaluation and to ensure that the official timelines are met, EDQM has decided to apply the procedure for managing the Certification scheme described in the Resolution AP CSP (07) 1 more strictly. This means that the evaluation of new dossiers will be handled in two phases: the evaluation of the original dossier and, if necessary, a single request for additional information. Based on this information, a final decision whether a CEP can be granted will be taken, following a risk-based assessment. A second request for further additional information will only be issued in exceptional cases.

Any application that does not include sufficient information after evaluation of the applicant’s response to the deficiency letter will be definitively closed. This procedure will be implemented on 1st September 2008.

Moreover, EDQM reserves the right to terminate the procedure of evaluation of an application if the applicant does not provide the required information in the specified period of time mentioned in the deficiency letter or if the information is inadequate to complete the evaluation process.

Furthermore, EDQM will continue applying the validation policy put in place in 2007. This means that new applications will be validated at receipt only if formally complete. No application will be evaluated prior to successful validation. Any time needed to complete the application prior to successful validation will not be considered as assessment time.

In the event of any disagreement between the applicant and EDQM, the resolution foresees the possibility for the applicant to requesting a hearing.

Furthermore, at any stage of the process, the applicants can request Technical Advice.

http://www.edqm.eu/site/EDQM-continues-to-optimise-the-evaluation-process-of-CEP-applicationns-1202.html

另外，EDQM还有可能需要厂家提供杂质标准品。

Providing samples
(18/06/08) The Certification Division wishes to announce that its policy concerning Certification samples will change from 1st July 2008. Instead of providing samples for every new ‘chemical’ or ‘herbal drug/herbal drug preparation’ application for a Certificate of Suitability, a commitment to provide samples of the substance and/or its impurities when requested by the EDQM should be provided.

那些造假得到CEP证书的要小心了，哈哈。

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这也没什么，照做就是了！呼吁国内企业千万别存在侥幸心理！要扎实做好自己的工作！

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EDQM continues to optimise the evaluation process of CEP applications
edqm继续优化CEP申请评价过程

In order to optimise the process of CEP evaluation and to ensure that the official timelines are met, EDQM has decided to apply the procedure for managing the Certification scheme described in the Resolution AP CSP (07) 1 more strictly. This means that the evaluation of new dossiers will be handled in two phases: the evaluation of the original dossier and, if necessary, a single request for additional information. Based on this information, a final decision whether a CEP can be granted will be taken, following a risk-based assessment. A second request for further additional information will only be issued in exceptional cases.

为了优化CEP 评价过程，并确保正式的时间表都可以实现，EDQM已决定对在AP CSP(07)1决议中描述的治理认证计划的申请程序更加严格。这意味着评价新材料将分两个阶段处理：评价原来的档案和（如有必要的话）一个单一的请求提供补充资料。基于这些信息，按照风险评估最后决定CEP是否被同意。第二次请求作进一步的补充资料，只会发出在非凡情况下。

Any application that does not include sufficient information after evaluation of the applicant’s response to the deficiency letter will be definitively closed. This procedure will be implemented on 1st September 2008.
评估申请者对缺陷信的回复情况，假如有任何包含的信息不全面，将对其进行决定性关闭。这个程序，将于2008年9月1日实施。

Moreover, EDQM reserves the right to terminate the procedure of evaluation of an application if the applicant does not provide the required information in the specified period of time mentioned in the deficiency letter or if the information is inadequate to complete the evaluation process.
此外，假如申请者不能按照缺陷信中规定的时间提供所要求的信息，或者所提供的信息对完成评估过程是不充分的，edqm有权终止该申请的评估程序。

Furthermore, EDQM will continue applying the validation policy put in place in 2007. This means that new applications will be validated at receipt only if formally complete. No application will be evaluated prior to successful validation. Any time needed to complete the application prior to successful validation will not be considered as assessment time.
此外，edqm将继续应用2007年开始实行的确认政策。这意味着新的应用需经过验证，并且正式完成。
没有任何申请在验证成功之前会进行评估。在验证成功之前任何为完成申请而需要的时间将不被视为评估时间。

In the event of any disagreement between the applicant and EDQM, the resolution foresees the possibility for the applicant to requesting a hearing.

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