PA/PH/CEP (13) 110, 1R CEP审评程序 201702 中英

julia朱玉姣

Certification of SubstancesDepartment

FML/CB

PUBLIC DOCUMENT

(LEVEL1)

English only

PA/PH/CEP (13) 110, 1 R

Strasbourg, February 2017

Certification of suitability to the Monographs of theEuropean Pharmacopoeia

Management of Applications for new Certificates ofSuitability and Requests for

Revision or Renewal of Certificates of Suitability

CEP新申报以及CEP修订或更新管理程序

1             Introduction 概述

This document describes the process applied to managethe applications for new certificates of suitability (CEPs) and applicationsfor revisions/renewals of existing certificates of suitability.

本文件描述了适用于CEP新申报以及CEP修订或更新管理的流程。

This document should be read in conjunction with:

本文件应与以下文件一起解读：

―  RESOLUTION AP-CSP (07) 1, Certification of suitability to the monographsof the European Pharmacopoeia, which describes the procedure to grant andrevise CEPs.

―   法案AP-CSP (07) 1，CEP认证程序

―  EDQM “Guideline on Requirements on Revision/Renewal of Certificates ofSuitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 2), whichdescribes the categorisation of requests to revise CEPs and the conditions tobe fulfilled as well as the documentation to be submitted for each request forrevision.

―   EDQM“CEP修订/更新要求指南”（(PA/PH/CEP (04) 2），其中描述了CEP修订申请的分类、所需满足的条件以及各类修订申请所需提交的资料

―  EDQM “Guidance on applications for « sister files (PA/PH/CEP (09) 141),which describes the conditions to be fulfilled as well as the documentation tobe submitted for applications for new CEPs using the sister file procedure.

―   EDQM“《姐妹文件》申报指南”（PA/PH/CEP (09) 141），其中描述了使用姐妹文件程序申报新CEP所需满足的条件和所需提交的文件

2             Applications for CEPs orrevision or renewal of CEPs - excluding notifications and transfer ofholdership CEP申报、CEP修订或更新—CEP通知或持有人转让除外
2.1      Overview 概览

EDQM acknowledges reception of applications And responsesto requests for information submitted with respect to applications within 5 working days of receipt . Anofficial acknowledgement of receipt is sent, which specifies that the clock hasstarted together with the deadline for the treatment of the request.

EDQM会在收到申报资料，或收到补充信息后5个工作日内告知申报人已收到其申报资料。EDQM会发出一份正式收条，在其中写明已开始计时，并且写明申报的处理期限。

As shown in annex 1, Process Flows, once theapplication is validated for evaluation and the clock has started, theassessment of applications is handled by :

如附录1所示流程图，一旦申报资料经评估为有效，则开始计时。对申报资料的评审包括以下内容：

―  the evaluation of the original application and,

―   评审初始申报资料，以及

―  if necessary, the evaluation of additional information submitted uponrequest from the EDQM, and

―   必要时，评审EDQM所要求提交的其它信息，以及

―  if necessary, the evaluation of another, last, package of additionalinformation submitted upon a last request from the EDQM.

―   必要时，评审EDQM最后一次要求提交的另一份最后的其它信息包。

The timings allowed for the EDQM and for the applicantat the different steps in the process are included in the table in annex 2 andthese vary depending on the type of application (e.g. new application, type ofrevision etc.).

附录2的表中是审评过程中在不同阶段EDQM和申报人的计时要求，这些时长因申报类型不同而不同（例如，新申报、修订类型等）。

Where the assessment is successful and the applicationis accepted as complete, a CEP (new or revised) is granted or for somerevisions, a letter is sent to advise that the application has been acceptedand the current CEP remains valid. The type of revision has an impact onwhether the CEP is revised or not following acceptance of a revision as shownin annex 2.

如果评审通过，申报资料被接受认为是完整的，则颁发（新的或修订的）CEP，或者修订会被批准，EDQM发送一封函件告知申报人其所提交的申报已被接受，当前的CEP持续有效。附录2中列出了修订类型对于CEP是否修订的影响。

Applications lacking sufficient information afterevaluation of the applicant’s response to a second deficiency letter from EDQM aredefinitively closed and the applicant is advised by letter.

在对申报人提交的第二封缺陷信回复内容进行审核后，如果确认缺乏足够信息，则申请会被关闭，EDQM会发函通知申报人。

For new applications and sister file applications,this means the application is rejected without a CEP being granted. Forrevision applications, this means that the request for revision is rejected andthe current version of the CEP (without the requested changes) remains valid.For renewal applications this will have an impact on the validity of the existingCEP which may be suspended or withdrawn (see section 6).

如果是新申报或姐妹文件申报，这表示申报被拒，不会颁发CEP证书。对于修订申报，这表示修订申请被拒，当前CEP（不包括所申请的变更内容）保持有效。对于更新申报，这会对当前CP有效性产生影响，可能会导致搁置或撤销（参见第6部分）。

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