cep电子版纸版递交指南(中英文)cep_guidance_for_cep_applications.doc

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1、.201306PA/PH/CEP(09)1082RCEP电子提交和纸质提交指南（中英文） 官网原文下载：.edqm.eu/en/Guidance-for-electronic-and-paper-submissions-1585.html?mbID=107 新版本生效日期：2013年8月1日CertificationofSubstancesDivisionFK/CB PUBLICDOCUMENT 公开文件(LEVEL1) 第一层次Englishonly/Anglaisseulement 仅英文版PA/PH/CEP(09)108,2RStrasbourg,June2013Certi

2、ficationofsuitabilitytoMonographsoftheEuropeanPharmacopoeiaGuidanceforelectronicandpapersubmissionsForCertificatesofSuitability(CEP)applicationsCEP电子和纸质申报指南Dateofimplementation:1August2013Address:7,slleeKastner,CS30026F-67081Strasbourg(France)Telephone:33(0)388413030–Fax:33(0)388412771–: cepe

3、dqm.euInternet: .edqm.eu..Tableofcontent 目录1     Introduction 介绍2     Scopeandgeneralrequirements 围和一般要求3     Electronicsubmissionformats 电子申报格式3.1      eCTDsubmissionformateCTD申报格式3.2      NeeSsubmissionformatNeeS申报格式3.3      PDFformatPDF格式4     Submissionofpaperdossiers 纸质文件提交5     Contenta

4、ndstructureofanapplication 申报的容和结构6     Lifecyclemanagementofapplications 申报的生命周期管理6.1      Granularityandupdatedsections 章节分类和更新部分6.2      WhentosubmitabaselineModule3? 什么时候提交基准模块37     ValidationbytheEDQMEDQM验证8     Routes(orpathways)ofsubmission 递交方式（途径）9     Security 安全性 ..1           Int

5、roduction 介绍ThisdocumentisguidanceforelectronicandpapersubmissionsforCertificatesofSuitability(CEPs)applications.Informationandrequirementsdescribedinthisdocumentareintendedtofacilitatethehandlingandassessmentofsubmissionsforcertificatesofsuitability(CEPs)andtomaintaintheirlifecycleevenifthes

6、ubmissionisnotaneCTD.本文件意在指导CEP的电子和纸质申报。本文件中描述的所有信息和要求意在使用CEP申报资料处理和评审更为便捷，更利于维护其生命周期，即使该申报并不是以eCTD格式提交。 2           Scopeandgeneralrequirements 围和一般要求ThisguidanceshouldbeappliedforallsubmissionssenttoEDQMinthecontextofapplicationsforCEPs,andwhateverthesupportselected(electronicorpaper).本指南适用

7、于向EDQM递交的所有CEP申报，无论选用何种格式（电子或纸质）。CurrentlytheEDQMacceptspaperdossier,aswellas3electronicsubmissionformats:pdf,NeeS,andeCTD.Papersubmissionsarestillacceptedbutitisintendedtomoveto100%electronicsubmissioninthefuture,thereforeitisstronglyrecomme