【脱欧的后果】来自英国的API将需要书面确认

毒手药王邓智先

APIs from UK will need Written Confirmation

来自英国的API将需要书面确认

如Brexit所示：根据欧盟声明，英国将成为“第三国”，欧洲药物管理局（EMA）和欧盟委员会打算为制药行业提供一系列与Brexit相关的问题解答。现在，EMA已经发布了第一套问答。

大多数问题和答案都是以药品为导向，也在集中程序的背景下讨论建立公司的地点。但问题六提供了有关API分发的一个重要方面的一些信息：书面确认。

原子能机构明确表示：“截至英国撤出联盟之日，英国生产的活性物质将被视为进口活性物质。”这意味着根据指令2001/83 / EC第46b（2）条，进口到欧盟的API将需要附有出口第三国主管当局（在这种情况下是英国）的书面确认。

一般来说，英国从欧盟撤出后，英国制造的药用产品将被视为进口药品。这意味着：

营销授权持有人（MAH）必须在欧盟（或欧洲经济区州挪威，冰岛和列支敦士登）成立。中央授权的药用产品也是如此。

孤儿药品名称的发起人必须在欧盟（或欧洲经济区）中确定。

药物警戒合格人员（QPPV）必须在欧盟/欧洲经济区成员国居住并执行其任务。药物警戒系统师（PSMF）也必须位于欧盟/欧洲经济区。

欧盟/欧洲经济区的所有生产批次必须在欧盟/欧洲经济区的一个地点进行再分析/控制。

必须在EU / EAA中执行批发。因此，英国的批量发布网站必须将此活动“转移到联盟（EEA）建立的位置并提交相应的变更”。
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.

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.

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.

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:

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.

The sponsor of an orphan medicinal product designation must be established in the EU (or EEA).

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.

All production batches imported into the EU/EAA must be analysed/ controlled (again) at a site located in the EU/EEA.

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".

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