审查报告和授权申请有什么区别？

审查报告和授权申请有什么区别？

What is difference between a Review Report and the Application for Authorisation?

审查报告用于更新授权申请 (AfA)，并必须将其发送至欧洲化学品管理局 (ECHA)。费用与 AfA 相同。审查报告的流程与 AfA 相同。审查期间相关技术和其他方面取得的进展越大，更新信息的必要性就越大。信息要素相同。换言之，审查报告应包含原始申请中提交的评估报告的更新版本（化学品安全报告、替代品分析，以及（如适用）更新的社会经济分析和替代计划）。用途描述可能也需要更新，例如，以反映更窄的范围。请参阅《实用指南》第 6 节“如何申请授权”，网址为 https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676。所有与授权申请相关的问答也适用于审查报告。

The Review Report updates the Application for Authorisation (AfA), and it must be sent to ECHA. The fee is the same as the one for an AfA. The Review Report will follow the same process as for an AfA. The greater the relevant technical and other progress during the review period, the greater the need to update the information. The information elements are the same. In other words, a Review Report should include an updated version of the assessment reports submitted in the original application (Chemical Safety Report, Analysis of Alternatives and – when relevant – an updated Socio-economic Analysis and an updated Substitution Plan). The use description may also need to be updated e.g. to reflect a more narrow scope.  See Section 6 of the Practical Guide “How to apply for an authorisation” at https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676.  All the Q&As related to Applications for Authorisation are also valid for Review Reports mutatis mutandis.