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首页> 外文期刊>The regulatory affairs journal: Pharma >Product Information Danish agency takes tougher stance on translations of SPCs and patient information leaflets
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Product Information Danish agency takes tougher stance on translations of SPCs and patient information leaflets

机译：产品信息丹麦机构对SPC和患者信息手册的翻译采取更强硬的立场

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摘要

Due to an ongoing problem with the quality of translations of pharmaceutical product information from English into Danish, the Danish Medicines Agency has said that it is stepping up its guidance on the issue1'2. According to the agency, high-quality translations of summaries of product characteristics (SPCs) and patient information leaflets will smooth out the approval process. If the quality of the product information is poor, it will return the documents to the applicant for improvement3. "Poor quality" is defined as a translation with too many errors, lack of information or possible misunderstandings. In such cases, the application process will only resume once a new translation has been received.
机译：由于药品信息从英语到丹麦语的翻译质量一直存在问题，丹麦药品管理局表示正在加强有关问题的指导1'2。据该机构称，高质量的产品特征摘要（SPC）和患者信息手册的翻译将使批准过程更加顺利。如果产品信息的质量很差，它将把文件退回给申请人进行改进3。 “质量差”的定义是指错误太多，信息不足或可能引起误解的翻译。在这种情况下，只有在收到新的翻译后，申请流程才会恢复。

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