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从收到信函到更新档案的时间很短(大约一个半月)。这段时间太短,我们无法理解该物质被选中的原因(尤其是来自外部来源的物质)、审阅完整的档案,并与专家和共同注册人确定更新事宜,尤其是在涉及多种物质的情况下。信函和更新截止日期之间的时间间隔可以延长吗?
问题(中文)
从收到信函到更新档案的时间很短(大约一个半月)。这段时间太短,我们无法理解该物质被选中的原因(尤其是来自外部来源的物质)、审阅完整的档案,并与专家和共同注册人确定更新事宜,尤其是在涉及多种物质的情况下。信函和更新截止日期之间的时间间隔可以延长吗?
Question (EN)
The time between receiving the letter and the date to update the dossier is quite short (ca. 1 and a half months). This time is too short to understand why the substance has been selected (especially if it comes from external sources), review the full dossier and define the update to do with experts and co-registrants, particularly if more than one substance is implicated. Can the period between the letter and update deadline be increased?
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)
ECHA 了解收到信函与 MSCA 开始手动筛选工作之间的时间间隔很短。ECHA 每月向 MSCA 提供一份报告,其中包含入围物质提交的所有更新信息。因此,如果某种物质被选中进行手动筛选,MSCA 将被告知卷宗更新情况,以防这些更新无法在手动筛选工作开始前提交。请注意,如果该物质因此次手动验证而进入进一步的监管流程,那么手动筛选期间未考虑的卷宗更新将非常有价值。很遗憾,我们无法在 1 月之前发送信函,因为这是最终确定入围名单的时间。
Answer (EN)
ECHA is aware of the short time between the receipt of the letters and the start of the manual screening work by the MSCAs
On a monthly basis, ECHA provides the MSCAs with a report with all the updates submitted for the shortlisted substances. Therefore, if a substance is selected for manual screening, MSCAs will be informed about dossier updates, in case these updates cannot be submitted before the start of the manual screening work.
Please note that dossier updates not considered during the manual screening will be valuable if the substance is selected for further regulatory processes as a result of this manual verification. Unfortunately, we cannot send the letters earlier than January because this is when the shortlist is finalised.