9
Security
安全性
The files submitted should not have any password protection, encryption or other security settings; such files will not be accepted at the validation phase at EDQM. The applicant should check any electronic submission for absence of virus before sending it to EDQM.
提交的文件不应有任何形式的密码保护、加密或其它安全设置，这类文件在EDQM验证阶段将被拒收。在将文件提交EDQM前，申请人应检查文件中确保无病毒。
The EDQM guarantees the security and confidentiality of electronic and paper data from the receipt, whatever route of submission is selected from the choices above.
无论通过上述何种方式提交，自接收到申报起，EDQM保证电子提交和纸质数据的安全性和保密性。
Annexes: 附件
Annex 1: Directory structure/file naming for TSE risk applications
TSE风险申请的目录结构和文件命名（由于均为图片，此中英文版本略，请参考官网原文）
Annex 2: Recommended granularity levels
推荐的分层标题
Annex 3: eCTD structure for a CEP dossier
CEP申报资料eCTD结构（由于均为图片，此中英文版本略，请参考官网原文）
Annex 4: NeeS structure for a CEP dossier
CEP申报资料NeeS结构（由于均为图片，此中英文版本略，请参考官网原文）
Annex 5: PDF structure and granularity
PDF结构和分层标题（由于均为图片，此中英文版本略，请参考官网原文）
Annex 6: Main issues which may lead to block administratively a submission
可能会导致申报被阻止的主要问题
ANNEX 2: Recommended granularity levels
附件2：推荐分级标题
Granularity required 分级标题 Acceptability可接受性 A=accepted 接受 R=recommended 推Level 1 第一级 Level 2 第二级 Level 3 第三级 荐 NA=not accepted不接受 3.2.S.1 3.2.S.2 General Information 3.2.S.1.1 3.2.S.1.2 3.2.S.1.3 Manufacture 3.2.S.2.1 3.2.S.2.2 3.2.S.2.3 3.2.S.1.1.X 3.2.S.1.2.X 3.2.S.1.3.X A R NA R NA R NA NA R A R A A Nomenclature Structure General Properties Manufacturer(s) Description of Manufacturing Process and Process Controls Control of Materials 3.2.S.2.1.X 3.2.S.2.2.X 3.2.S.3 3.2.S.4
3.2.S.2.4 3.2.S.2.5 3.2.S.2.6 Controls of Critical Steps and Intermediates Process Evaluation Manufacturing Development Process Validation and/or 3.2.S.2.3.X 3.2.S.2.4.X 3.2.S.2.5.X 3.2.S.2.6.X 3.2.S.3.1.X 3.2.S.3.2.X Substance of Drug 3.2.S.4.1.X 3.2.S.4.2.X of Analytical 3.2.S.4.3.X 3.2.S.4.4.X 3.2.S.4.5.X R R A R A R A NA R A R A NA R A R A A R R A R A Characterisation 3.2.S.3.1 3.2.S.3.2 Elucidation of Structure and other Characteristics Impurities Control of Drug 3.2.S.4.1 3.2.S.4.2 3.2.S.4.3 3.2.S.4.4 3.2.S.4.5 Specification Substance Analytical Procedures Validation Procedure Batch Analysis Justification of Specification 3.2.S.5 3.2.S.6 3.2.S.7 Reference Standards or Materials 3.2.S.5.X System R A R A NA R Container Closure 3.2.S.6.X Stability 3.2.S.7.1 Stability Summary and Conclusions 3.2.S.7.2 3.2.S.7.3 Post-approval Stability Protocol and Stability Commitment Stability Data 3.2.S.7.1.X 3.2.S.7.2.X 3.2.S.7.3.X NA R NA R NA （译者注：其中有几个S.X级别标题被标示为NA不可接受，译者愚钝，未能理解）
ANNEX 6: Main issues which may lead to block a submission for its format
附件6：因为其格式导致申报被拒的主要问题
— eCTD
? lifecycle issues (use of an inappropriate attribute etc.)
? 生命周期问题（采用不适当的属性等）
? a non-validated eCTD (did not pass the checker)
? 未经验证的eCTD（未通过检查）
? multiple sequences (history of the CEP application) provided when submitting an eCTD for the first time
? 在首次提交时给出多个序列号（CEP提交历史）
— NeeS:
? Structure not in line with requirements and EU validation criteria for NeeS
? 结构与NeeS要求和EU验证标准不符合
? Absence of table of content with hyperlinks
? 超链接目录缺失
? Structure not in line with requirements
? 结构不符合要求
? Absence of appropriate bookmarking
? 缺乏适当的书签
? Protected PDF file
? 文件被加密保护
— Paper applications 纸质提交
? Poor quality of documents which prevents the scanning process
? 纸质粗劣，无法扫描
? A mix between modules 1, 2 and 3 (see Annex 5 for the expected documentation structure)
? 模块1、2和3混淆（见附件5，所需的文件结构）
— For all submission formats 所有提交格式
? Coming back to a previous submission format (e.g. from eCTD to NeeS or PDF)
? 回到之前的提交格式（例如从eCTD转换为NeeS或PDF）
? Format of the submission not appropriately identified in the application form
? 在申请表中标示的提交格式不恰当
? Level of granularity not respected when updating the submission
? 申报更新时与要求的分层不符合
? Updated sections mission or incomplete
? 更新部分缺失或不完整
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