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标题: 20160113 ECA新闻：CEP程序内更多规定：联系人变更和投诉流程 [打印本页]

作者: 淡定 时间: 2016-2-14 01:42 PM
标题: 20160113 ECA新闻：CEP程序内更多规定：联系人变更和投诉流程
20160113 ECA新闻：CEP程序内更多规定：联系人变更和投诉流程

GMP News
13/01/2016

Further Regulations within the CEP Procedure: Changes in Contact Persons and Complaints Procedure

CEP程序内更多规定：联系人变更和投诉流程

With the publication of two new guidelines, the EDQM has tackled further loopholes in the current rules with regard to the CEP procedure.

EDQM最近公布了2个新的指南，弥补CEP现行流程中的漏洞。

The public document entitled "Changes in contact details to be notified to EDQM" (PA/PH/CEP (10) 86 1R)" includes provisions on how to proceed when the data of the contact person have changed with whom the EDQM communicates within the CEP procedure or when a personnel change has taken place. In that case, the applicant or the holder of the CEP has two possibilities to update the details of the contact person:

公开文件题为“要通知EDQM的联系人变更（PA/PH/CEP(10)86 1R）包括了根据 CEP程序，当与EDMQ联系的联系人数据变更，或人员变更时如何行动的条款。在此情况下，CEP申报人或持有人有两种方式来更新其联系人信息：

Notification of the new data in the table 2.2 of the CEP application form. This option is applicable when the complete application form has to be submitted anyway, e.g. during an application for revision or renewal of an existing CEP.
在CEP申报表2.2中填写新数据通知。此方法适用于要提交完整申报表时，例如在对已有CEP进行升版或更新申请时。
Notification of the new data via the form developed for this purpose. This procedure has to be used when no full application form is required, e.g. during an ongoing procedure.
通过专门的表格将新数据通知EDQM。当没有需要提交完整申报表时就必须使用此方式，例如在流程进行期间。

The EDQM strongly recommends keeping the contact data up-to-date within the lifecycle of a CEP as the interruption of the communication flow and delays in response deadlines may lead to the closure of an ongoing procedure or to the cancellation of a CEP.

EDQM强烈建议在CEP生命周期内保持联系人数据更新，因为沟通流中断和延误回复超出期间可能会导致正在进行的程序关闭，或取消CEP。

The second document entitled "Complaints Procedure" /PA/PH/CEP (15) 19 describes how an applicant should proceed in the context of a complaint procedure with EDQM's CEP department, the "European Directorate for the Quality of Medicines & Healthcare's Certification Division" (DCEP). When the applicant or holder of a CEP would like to denounce a quality defect regarding the service of the DCEP within the CEP procedure, he or she should send a complaint in writing to the responsible contact person of the DCEP within a 3-month deadline after the service has been brought. After 2 days, the complainant will receive an acknowledgement of receipt and after 10 days a proposed solution from the EDQM. If a complaint is deemed unfounded by the EDQM, the CEP holder will receive a notification also within 10 days and the procedure will be closed.

第二份文件题为“投诉程序PA/PH/CEP(15)19”，其中描述了申报人如何向EDQM的CEP负责部门DCEP提交投诉。如果CEP申请人或持有人要告发DCEP在CEP处理过程中的服务质量缺陷，他/她应在被服务的3个月之内发送一份书面投诉给DCEP相关联系人。在2天后，投诉者会收到一份收条，10天后，EDQM会提出解决方案。如果投诉不被受理，CEP持有人也会在10天内收到通知，投诉流程关闭。

The complaints procedure has to be distinguished from a hearing. This path can also be followed in contentious cases; however it is part of the decision process within the CEP procedure and is subject to other regulations described in the document "Suspension or withdrawal of a certificate of suitability, closure of an application" (PA/PH/CEP (08) 17, R4).

投诉程序必须与听证程序相区别。当有争议时，也可以采用此方法。但是，这是CEP认证程序的决策流程的一部分，服从文件“CEP搁置或撤销，申报关闭（PA/PH/CEP(08)17,R4）”的规定。

http://zhuyujiao1972.blog.163.com/blog/static/986947272016014222683/

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