翻译：Julia 来自：蒲公英
原标题：来自英国的API将需要书面证明
14.06.2017
APIs from UK will need Written Confirmation
来自英国的API将需要书面证明
As indicated in Brexit: U.K. will become 'Third Country' according to EU Statement, the European Medicines Agency (EMA) and the European Commission intend to provide a series of Brexit related Questions and Answers on the consequences for the pharmaceutical industry. Now, the EMA has published a first set of Q&As.
正如英国脱欧专题中所指，根据EU声明英国将成为“第三国”，因此EMA和EC将出台一系列英国脱欧相关问答，说明其对制药行业产生的影响。现在，EMA已经发布了第一套问答。
Most of the questions and answers are drug product oriented and are also discussing the location of the establishment of a company in the context of centralised procedures. But question number six gives some information about an important aspect of API distribution: the Written Confirmation.
大部分问题是关于药品来源的，还有一些是公司在集中评审情况下其所在地问题。但第6问中给出了一些信息，说的是原料药销售比较重要的一个方面，即书面证明。
And the Agency is clear about that: "As of the date of the withdrawal of the UK from the Union, active substances manufactured in the UK will be considered imported active substances." That means APIs imported into the European Union will need to be accompanied by a Written Confirmation from the competent authority of the exporting third country (in this case the UK), pursuant to Article 46b(2) of Directive 2001/83/EC.
官方清楚地说明“自英国正式脱离欧盟之日起，在英国生产的活性物质将被认为是进口的活性物质。”这意味着进口至欧盟的API会需要有出口第三国的书面证明（在这里指英国），以符合指令2001/83/EC第46b(2)条的要求。
Generally, after the withdrawal of the UK from the European Union (EU), "medicinal products manufactured in the UK will be considered imported medicinal products". That means:
通常来说，在英国脱离欧盟之后，“在英国生产的药品将会被认为是进口药品”。这意味着：
The Marketing Authorisation Holder (MAH) must be established in the EU (or EEA states Norway, Iceland and Liechtenstein). This will be also the case for centrally authorised medicinal products.
上市许可持有人（MAH）必须是在EU境内设立的（或EEA国家挪威、冰岛和列支敦士克）。集中审评的药品也是这样。
The sponsor of an orphan medicinal product designation must be established in the EU (or EEA).
指定孤儿药的主办人必须在EU境内（或EEA境内公司）。
The Qualified Person for Pharmacovigilance (QPPV) must reside and carry out his/her tasks in a Member State of the EU/EEA. Also the Pharmacovigilance System Master (PSMF) must be located in the EU/EEA.
药物警戒授权人（QPPV）必须居住在EU/EEA成员国内，并在其境内执行其任务。药物警戒系统（PSMF）也必须在EU/EEA境内。
All production batches imported into the EU/EAA must be analysed/ controlled (again) at a site located in the EU/EEA.
所有进口至EU/EAA的生产批次必须在EU/EEA境内场所进行（重新）分析/控制。
Batch release has to be performed in the EU/EAA. As a consequence, a UK based site for batch release has to transfer this activity "to a location established in the Union (EEA) and submit the corresponding variation".
批放行必须在EU/EEA境内进行。因此，在英国执行批放行的场所必须将其活动转移“至一个EEA境内的地址，并相应地提交变更”。
