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如果在准备注册档案时出现错误,该如何更正?
问题(中文)
如果在准备注册档案时出现错误,该如何更正?
Question (EN)
How can a registration dossier be corrected in case a mistake was made in the preparation of the 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)
向欧洲化学品管理局 (ECHA) 提交注册档案后,您可能会发现自己在准备过程中犯了错误。例如,如果您在档案中意外添加了错误信息(例如,某份研究摘要中包含了错误信息),并在向 ECHA 提交档案后才发现这一点,则可能存在这种情况。在这种情况下,您应立即通过 REACH-IT 系统以自发更新的方式提交修改后的档案,并在档案标题中注明自发更新的原因以及先前有效提交的参考信息(即“上次提交编号”)。此类更新无需付费,除非错误与收费要素相关,例如吨位等级的提高,或第 119(2) 条中列出的信息保密声明。某些错误可能会导致档案无法成功提交给 ECHA。这些错误可能是业务规则或完整性检查方面的缺陷。如果您提交的材料未通过其中任何一项检查,您将以 REACH-IT 中的任务形式收到失败警报,提示您修改档案。
Answer (EN)
After you have submitted your registration dossier to ECHA you may realise that you made a mistake during its preparation. This might be the case, for example, if you accidentally introduced faulty information in the dossier (e.g. incorrect information in one of the study summaries) and noticed this only after you submitted the dossier to ECHA. In this case you should without undue delay submit the amended dossier as a spontaneous dossier update via REACH-IT, indicating in the dossier header the reason(s) why you are spontaneously updating it as well as the references of the previous valid submission (i.e. the "last submission number"). Such an update would not be subject to a fee, unless the mistake is related to a chargeable element such as an increase in tonnage band, or confidentiality claims for information listed in Article 119(2).
Some mistakes may prevent a successful submission of the dossier to ECHA. These are failures in the business rules or the completeness check. If your submission fails either of these checks, you will be alerted to the failure in the form of a task in REACH-IT, which prompts you to amend the dossier.