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在主要档案通过完整性检查后,我们是否需要更新成员档案,以包含与我们的纳米形式相关的主要档案中的边界组成的链接?
问题(中文)
在主要档案通过完整性检查后,我们是否需要更新成员档案,以包含与我们的纳米形式相关的主要档案中的边界组成的链接?
Question (EN)
Do we need to update the member dossier after the lead dossier has passed the completeness check to include a link to the boundary composition(s) in the lead dossier that are relevant to our nanoforms?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
如果您已提交成员档案,但依赖主要档案中的附件 VII-X 信息来获取物质纳米形态的信息,ECHA 无法验证这些数据的完整性。因此,ECHA 保留在主要注册人提交此类信息时评估您档案中与附件 VII-X 要求相关的信息的完整性的权利。主要注册人提交其档案后,您必须更新您的注册,以将您的纳米形态与主要档案中的相关附件 VII-X 信息关联起来。具体操作如下:在您自己档案的 1.2 节“法人实体成分”中,使用“相关成分参考”字段,引用主要档案中相应的边界成分名称。
Answer (EN)
If you have submitted your member dossier but rely on the lead dossier for Annex VII-X information for your nanoform of the substance, ECHA could not verify the completeness of this data. Therefore, ECHA reserves the right to assess the completeness of your dossier in relation to the information on the Annex VII-X requirements, whenever this information is submitted by the lead registrant.
Once the lead registrant has submitted their dossier, you must update your registration to link your nanoforms with the relevant Annex VII-X information in the lead dossier. This is done by referring to the corresponding boundary composition name(s) of the lead dossier, in the section 1.2 Legal entity compositions of your own dossier by using the field ‘Reference to related composition(s)’.