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如何获取前注册人提交的不到 12 年的数据?
问题(中文)
如何获取前注册人提交的不到 12 年的数据?
Question (EN)
How to obtain data submitted less than 12 years previously from a previous registrant?
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)
该物质已注册,但相关研究提交的时间距调查时间不足 12 年。ECHA 会将先前注册人的名称和地址告知潜在注册人。如果需要涉及脊椎动物试验的信息,潜在注册人必须联系 ECHA 确定的先前注册人(和/或其他调查方)。如果需要不涉及脊椎动物试验的信息,潜在注册人可以联系这些先前注册人(和/或其他调查方)。任何涉及脊椎动物的研究都必须提出信息共享请求。但是,如果数据不涉及脊椎动物试验,潜在注册人必须向先前注册人索取数据。先前注册人和潜在注册人必须尽一切努力就所请求数据的共享及其费用达成协议。他们还必须履行实施条例 2016/9 中关于联合提交和数据共享的规定。尽一切努力的义务以及《实施条例》规定的义务适用于任何请求的信息,无论其涉及脊椎动物研究还是非脊椎动物研究。有关获取12年前提交的数据,请参阅问答102。
Answer (EN)
The substance has been registered but the relevant studies were submitted less than 12 years before the inquiry. ECHA informs the potential registrant of the names and addresses of the previous registrants.
If he needs information involving tests on vertebrate animals, the potential registrant must contact the previous registrants (and/or the other inquirers) identified by ECHA. If he needs information not involving tests on vertebrate animals, the potential registrant may contact these previous registrants (and/or the other inquirers).
A request for sharing information must be made for any studies involving vertebrate animals. However, a potential registrant has to request data from the previous registrants if that data does not involve testing on vertebrate animals. The previous registrant and the potential registrant have to make every effort to reach an agreement on the sharing of the data requested and its costs. They must also apply the obligations set out in the Implementing Regulation 2016/9 on joint submission and data sharing. The obligations to make every effort and those set out in the Implementing Regulation apply to any information requested, whether it concerns vertebrate or non-vertebrate animal studies.
See Q&A 102 for access to data submitted more than 12 years previously.