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我根据 ECHA 合规性检查决定提交了一份卷宗,但该卷宗未通过技术完整性检查 (TCC)。我该如何处理?
问题(中文)
我根据 ECHA 合规性检查决定提交了一份卷宗,但该卷宗未通过技术完整性检查 (TCC)。我该如何处理?
Question (EN)
I submitted a dossier in response to an ECHA decision under compliance check and my dossier failed the technical completeness check (TCC). How should I proceed?
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)
如果您的档案在合规性检查截止日期之前提交,您可以遵循TCC信函中规定的截止日期。在您提交因技术完整性检查失败而请求的更新之前,ECHA将不会继续评估流程。如果您在提交更新请求时第二次未通过TCC,您的提交将被拒绝。如果此时合规性检查截止日期已过,则表示ECHA尚未收到对合规性检查决定的回复,可能会采取进一步的监管行动。因此,建议不要将提交监管请求的更新留到最后一刻。您可以通过联系表单告知ECHA您未能按时完成合规性检查:https://echa.europa.eu/contact
Answer (EN)
If your dossier is submitted before the compliance check deadline has passed, you may follow the deadline given in the TCC letter. ECHA will not continue with the Evaluation process before you have submitted the requested update for the technical completeness check failure(s).
If you fail TCC for the second time while submitting the requested update, your submission will be rejected.
If at this point the compliance check deadline has already passed, it means that ECHA has not received a response to the compliance check decision and may proceed with further regulatory actions. It is therefore advisable not to leave the submission of updates to regulatory requests to the last moment.
You can inform ECHA about not meeting the compliance check deadline via the contact form: https://echa.europa.eu/contact