23.11.2017
Track & Trace: New Questions and Answerspublished by the EU
追蹤與追溯：EU發(fā)布新問答
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.
剛剛在今年6月，EC發(fā)布了其依據(jù)托管法案EU2016/161的序列化要求實際實施和技術方面的問答第7.0版。隨后的8.0版已于2017年11年22日發(fā)布，其中包括10個章節(jié)72個問答，也就是說又一次增加了一些重大的問答和一個章節(jié)。
The changes compared to the previous version 7.0 areas follows:
相比于7.0版的變化如下：
Q&As 1.17, 1.18, 7.13, 7.14, 7.15, 8.4 and 10.1 have been added;
增加問答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.
修訂問答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.
其中新增的平等進口商需要符合的要求的詳細解釋，以及放行銷售確切意義的問題回答，并且考慮了沒有安全特性的藥品的最后流通。
Finally, known positions regarding the (non-)applicability of requirements to radiopharmaceuticals and vaccines areexplicitly addressed, as well.
最后，還清楚說明了放射藥品和疫苗要求適用性與不適用性方面的已知立場。
Overall, the complexity of the policy is revealed aswell as the challenges of practical implementation and the need for answers tospecific questions.
總體來說，這顯示出了政策的復雜性、實際實施的挑戰(zhàn)以及對具體問題的答復的需要。
Version 8.0 of the Q&A for EU FMD DR regarding serialisation can be viewed here.
EU FMD DR序列化問答第8.0版本可從官網(wǎng)查看。
