PA/PH/CEP (04) 2, 6R CEP证书变更/更新要求指南（中英文3/3）-Julia翻译

巴西木

4.IV. Use of CEP in an application for another CEP 在一个CEP中引用另一个CEP

The use of certificates of suitability (CEPs) for starting materials in an application for a chemical CEP is applicable where there is a monograph of the European Pharmacopoeia for the substance identified as a starting material as the availability of such a monograph is a prerequisite to the issue of a CEP.

由于CEP只签发给EP各论中包括的物质，因此只有当起始物料同时也是EP各论所包括的原料药时才可以在CEP申报中引用另一个CEP作为其起始物料。

Submission of a CEP for a starting material used in the manufacturing process of a final substance in an application for a chemical CEP 在化学CEP申报中，原料药成品生产工艺所用的起始物料的CEP申报	Conditions 条件	Specific documentation 要求的文件	Type of change 变更分类
a) A newly introduced CEP used to describe a starting material 新增起始物料的CEP	1, 2, 3	1,2, 3	IN
b) A newly introduced CEP used to describe a starting material, when the specifications of the starting materials are changed 新增起始物料CEP，起始物料的质量标准变更	1,2	1,2,3,4	MIN
c) A revised CEP already referenced to describe a starting material, when the manufacturing sites mentioned on this CEP are unchanged 修订已引用起始物料CEP，CEP中所提到的生产场所无变更	2,3	1	AN
d) A revised CEP already referenced to describe a starting material when the manufacturing sites mentioned on this CEP are changed 修订已引用的起始物料CEP，CEP中所提到的生产场所发生变更	2,3	1,2	IN
e) A revised CEP already referenced for a starting material when the specifications on this CEP are changed 修订已引用的起始物料CEP，CEP中起始物料质量标准发生变更	2	1,3,4	MIN
f) A deletion of a CEP used to describe a starting material when multiple sources of starting material are used 有多个起始物料来源时删除已引用的起始物料CEP	4	2	IN
g) A deletion of a CEP used to describe a starting material and replacement by another source that does not have a CEP 删除已引用起始物料CEP，用另一个没有CEP的来源替代			MAJ
Conditions 条件
1.  The starting material must be the substance which is covered by the CEP being submitted. 起始物料必须是已提交的CEP所包括的物质。
2.  The CEP for the starting material must have been granted and be valid. 起始物料的CEP必须是已经颁发并在处于有效状态
3.  The specification and the route of synthesis of the starting material are identical to those already approved. 起始物料的合成路线和质量标准应与已批准的相同。
4.  At least one other source of the starting material remains in the dossier. 申报文件中至少有一个其它的起始物料来源。
Documentation 文件
1.  Copy of the current CEP for the starting material with the box of access completed appropriately. 起始物料有效CEP的复印件，其中授权部分填写正确完整
2.  The details of the manufacturing sites involved in the manufacturing process described in the CEP for the starting material should be provided in the section “3.2.S.2.1 Manufacturers” of the dossier. 在申报文件的“3.2.S.2.1 生产商”中提供起始物料CEP中所描述的生产工艺相关的生产场所的详细信息
3.  Batch analysis data (in a comparative tabular format) for at least two batches (minimum pilot scale) of the final substance. 最终原料药成品至少两个批次（最小中试规模）的批分析数据（以对照表的形式）
4.  A discussion on the impact of the change of specifications of the starting material on the quality of the final substance. 起始物料质量标准的变更对原料药成品质量的影响的讨论。

5. RENEWAL 更新

The Certificate of suitability is valid for five years from the date when the original certificate was granted. Regardless of any revisions treated in the meantime, the holder of a Certificate of suitability shall ask for its renewal six months prior to expiry date by providing an update of the Certification dossier.
CEP自签发之日起有效期为5年，不论其间是否有任何版本更新，CEP持有人需在有效期到期前6个月提交更新的CEP文件申请更新。

5. Renewal of the certificate of suitability CEP更新	Conditions 条件	Specific documentation 要求的文件	Type of change 变更分类
a)      No change has been made since the last certificate of suitability was granted 自上次CEP签发起无变更	1	1,2,3	Renewal 更新
b)      Changes are included in the request for renewal 更新申报中包括变更	1	2,3,4,5,6	Renewal 更新
Conditions 条件
1. No major changes to the content of the CEP application are introduced.   CEP申报内容无重要变更
Documentation 文件
1.   A statement that no changes that may affect the quality, safety or efficacy of the final substance have been made. 申明：无对原料药质量、安全、有效性产生影响的变更发生
2.  Certificates of analysis from at least two recent production batches. 最近至少2批分析报告
3.  Updated declarations as annexes to the application form 申报表格附件申明更新
4.  An updated dossier in CTD format and/or updated sections affected by the changes CTD格式的申报文件和/或受变更影响的更新部分
5.  List of changes introduced in the format of a comparative table 以比较表格列出的变更清单
6.  Relevant data supporting each changes as described in this guideline 根据指南要求提供的支持各变更的相应数据

6. TRANSFER OF HOLDERSHIP 持有人变更

A transfer of the holdership of a CEP (i.e. change in the name of the certificate holder that is not the same legal entity and where the change does not occur following a sale or a merger) is possible only in the following situations:

CEP持有人变更（即CEP持有人变更为不同法人主体，且变更不是由于公司出售或并购引起）仅在以下情形时可行

—       the current CEP is held by another company than the manufacturer and the manufacturer takes out the CEP in their own name.

—       现有CEP持有人不是生产商，现在将CEP转至生产商名下

OR 或

—       the current CEP holder and the proposed one belong to the same group.

—       现有CEP持有人和提议的持有人属于同一集团

Failure to meet these conditions leads to the submission of a new CEP application.

不符合上述条件的情况下，需要申请新的CEP。

Documentation: 文件

—       updated declarations as annex to the application form.

—       申请表格附件中的更新申明

—       a letter signed by both parties, i.e. the current and proposed holders, agreeing that the holdership of the CEP is passed on to the manufacturer from the date of the request OR a formal document from a relevant official body attesting that both companies belong to the same group.

—       由转让方和受让方双方签字的信件，同意CEP持有人自申请之日起变更，或由有关当局提供的一个正式申明文件说明两公司属于同一集团

yuansoul

“1. No major changes to the content of the CEP application are introduced.  CEP申报内容无重要变更”？这个意思？

yanzhengren

谢谢分享。