我的成分不在先导注册档案报告的边界成分范围内。我该怎么办？

我的成分不在先导注册档案报告的边界成分范围内。我该怎么办？

My composition falls outside the boundary composition reported in the lead registration dossier. What should I do?

如果您的成分超出了现有联合提交的边界成分范围，您首先需要联系现有注册人，与其讨论联合注册中报告的附件 VII-XI 数据是否足以适用于您的物质。如果双方一致认为数据充分，则牵头注册人需要更新牵头档案中报告的边界成分记录，以扩大其范围。这意味着更新边界成分以涵盖您的成分和现有注册人的成分。所有各方都需要确保所应用的标准透明，并且所收集/生成的相关附件 VII-XI 数据明显涵盖所有商定的成分。

Where your composition is outside the boundary composition of an existing joint submission, the first step would be for you to contact the existing registrant(s) and discuss with him whether the Annex VII-XI data reported in the joint registration would be sufficient as to apply to your substance. Where it is agreed that the data is sufficient, it would then be necessary for the lead registrant to update the boundary composition record reported in the lead dossier to expand its scope. This would mean updating the boundary composition to cover the compositions of both your composition and that of the existing registrants. All parties would need to ensure that the criteria applied are transparent and that the relevant Annex VII-XI data collected/generated demonstrably covers all agreed compositions.