简译2012年7月最新CEP常见变更应用指南PA/PH/CEP (11) 76

水无痕

Guidance on frequent changes to applications for Certificates of Suitability (CEPs)
This document should be considered as an explicative note and should be read jointly with the EDQM Guideline on Revision/Renewal of Certificates of Suitability to the Monographs of the European Pharmacopoeia (PA/PH/CEP (04) 2).
该文件可视为对EDQM《CEP（欧洲药典适用性证书）修订/更新指南》(PA/PH/CEP (04) 2)的补充说明，应与其一起参照阅读。
This document is intended as a guide to applicants when compiling their documentation for notification/revision/renewal of their applications for certificates of suitability (CEPs). It has arisen from frequent issues occurring in submissions of notifications and revisions of dossiers for chemical purity, and it describes the key points to be considered.
该文件可指导CEP申请人进行通知或变更或更新文件的编写，其包括了化学合成品种通知或变更材料递交时常见问题，并描述了所需考虑的关键点。
By improving the quality of the data submitted, the time for the evaluation of the dossiers will be reduced and requests for additional information will be limited.
旨在提高递交资料的质量，缩短申报材料的评估时间和减少补充信息的要求。

杨曙光

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