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中级联合提交的成员注册人如何将其注册从中级更改为正式注册,或将正式注册添加到其当前档案中?
问题(中文)
中级联合提交的成员注册人如何将其注册从中级更改为正式注册,或将正式注册添加到其当前档案中?
Question (EN)
How can a member registrant of an intermediate joint submission change their registration from intermediate to full or add a full registration to their current dossier?
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)
同一物质的注册人无论其用途如何(例如中间体和非中间体),均须联合注册该物质。然而,由于适用于中间体(在严格控制的条件下使用)的信息要求较低,中间体的注册人出于实际原因可以选择与非中间体(完整)的注册人共同提交联合申报,或仅就中间体用途提交一份平行的联合申报。在更改成员注册之前,请参考以下流程图:请注意,由于以下注册:i) 完整申报、ii) 运输中间体和 iii) 现场中间体均被视为单独注册并需单独付费,因此此更新可能会触发发票。数据共享谈判:除了适用的管理费用外,联合申报的所有成员(包括牵头成员)均须承担其所需数据的费用。如果只有一个成员需要额外研究,则该成员需独自支付该数据的费用。因此,如果注册人计划提交完整的退出档案,他们只需分担与联合提交的管理费用相关的费用。
Answer (EN)
Registrants of the same substance are required to register the substance jointly regardless of the use (e.g. intermediate and non-intermediate). However, due to the reduced information requirements applicable to intermediates (used under strictly controlled conditions), registrants of intermediates may choose for practical reasons to either form a joint submission together with the registrants of non-intermediate (full) or to form one parallel joint submission for intermediate use only.Before changing the member registration, please consider the following flowchart:Please note that since registrations for: i) full, ii) transported intermediate and iii) an on-site intermediate are each considered as a separate registration and have separate fees, this update may trigger an invoice.Data sharing negotiations In addition to the applicable administrative expenses, all members of a joint submission (including the lead) have to contribute to the costs of the data they need. If only one member needs additional studies, they alone will need to pay for the cost of that data. Consequently, if a registrant is planning to submit a full opt-out dossier, they are only required to share the costs related to the administration expenses of the joint submission.