Documentation to be provided
For any revision the documentation should consist of:
- a cover letter
- the application form, duly filled and listing all the changes applied for
- a description of each change together with a justification
- data showing, when applicable, that the conditions have been met
- updat-e of the relevant section(s) of the dossier (presented in EU-CTD format).
- the specific documents described below for each change and supporting the change
- supportive information, including comparative data with the previous version of the dossier (in tabular format), showing the approved and the proposed section and highlighting the changes
Consequential changes should be identified and the relation between the changes should be described.
Each time batch data are needed:
- they should be in accordance with the specifications of the current Ph. Eur. monograph and when relevant with the additional requirements included in the Certificate of suitability
- the manufacturing site, the manufacturing date and the size of the batches should be specified.
- quantitative results should be presented numerically (i.e. not in general terms such as “complies”) and with the appropriate number of decimal places.
需要申报的文件
所有变更的申报文件必须包括以下内容:[注:与上一版本相比,此次修订版所列内容更为详细,可操作性更强]
- 附函
- 申请表,列出申请的变更
- 变更内容并说明变更的合理性
- 若适用的的话,表明符合条件的数据
- 更新申报文件相关的章节(按EU-CTD格式)[如此一来,以前以非CTD格式递交的文件如果要变更的话,岂不是要递交一本新的EDMF?]
- 下述各种变动所要求的具体文件
- 支持性信息,包括与原版本的对比数据(以表格格式),表明原内容及现内容,强调变更
应该识别间接的变更,并描述变更之间的关系。[漏掉了]
所有变更都需要申报批分析数据:
- 而且必须现行欧洲药典标准、以及CEP证书附加的有关要求。
- 必须说明生产场地、生产日期和生产批量。
- 应以数字形式表示定量结果(即:不得笼统表达为“合格”等),数位应合理。