23.11.2017
Track & Trace: New Questions and Answerspublished by the EU
追踪与追溯：EU发布新问答
It was only in June this year when the EuropeanCommission published Version 7.0 of their question and answer catalogue onpractical implementation and technical aspects of serialisation requirements asper delegated act EU 2016/161. The follow-up version 8.0 was published onNovember 22, 2017, already. It includes 72 questions and answers in tenchapters, meaning that it has once more been expanded by important questionsand an additional chapter.
刚刚在今年6月，EC发布了其依据托管法案EU2016/161的序列化要求实际实施和技术方面的问答第7.0版。随后的8.0版已于2017年11年22日发布，其中包括10个章节72个问答，也就是说又一次增加了一些重大的问答和一个章节。
The changes compared to the previous version 7.0 areas follows:
相比于7.0版的变化如下：
Q&As 1.17, 1.18, 7.13, 7.14, 7.15, 8.4 and 10.1 have been added;
增加问答1.17, 1.18, 7.13, 7.14, 7.15, 8.4 和 10.1
Q&As 1.2, 2.12 and 3.3 have been revised.
修订问答1.2, 2.12 和 3.3
Amongst others, there are new detailed explanationson the requirements parallel importers have to meet as well as answers tothe question what exactly is meant by release for sale and distribution, alsoconsidering the last putting into circulation of drug products without safetyfeatures.
其中新增的平等进口商需要符合的要求的详细解释，以及放行销售确切意义的问题回答，并且考虑了没有安全特性的药品的最后流通。
Finally, known positions regarding the (non-)applicability of requirements to radiopharmaceuticals and vaccines areexplicitly addressed, as well.
最后，还清楚说明了放射药品和疫苗要求适用性与不适用性方面的已知立场。
Overall, the complexity of the policy is revealed aswell as the challenges of practical implementation and the need for answers tospecific questions.
总体来说，这显示出了政策的复杂性、实际实施的挑战以及对具体问题的答复的需要。
Version 8.0 of the Q&A for EU FMD DR regarding serialisation can be viewed here.
EU FMD DR序列化问答第8.0版本可从官网查看。
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