英国退出欧盟（Brexit）对QP意味着什么？

GMP News
03/08/2016

What does Brexit mean for the QP?

英国退出欧盟（Brexit）对QP意味着什么？

The decision of the United Kingdom to leave the EU has caused a high uncertainty throughout industry - and also in the pharmaceutical industry. The European QP Association has already received a number of questions on what Brexit actually means for QPs, for their memberships in the European QP Association or for issues like importation testing and certification. For that reason the EQPA leadership team has prepared some information:

英国离开欧盟的决定已经引发了各行业的高度不确定性，其中也包括制药行业。欧洲QP协会已经收到大量关于Brexit对QP，对其成欧洲QP的成员身份，对象进口检测和认证问题意味着什么的问题。为此，EQPA领导团队已经准备了一些资料。

Does the role of QP change? QP的角色会变化吗？
We do not expect any change in the role of QP neither in EU nor in UK. For the time of negotiations (2 years after starting the process) we consider that full delegation of responsibilities amongst all QPs as described in the revised Annex 16 is ensured. Dependent of the outcome and legal construction established after 2 years delegation possibilities between QPs in the UK and EU/EEA may need to be re-assessed.

我们不期望QP的角色在欧盟或在英国有任何变化。在谈判时（开始脱欧程序后2年），我们考虑所有QP职责全面履行，如修订后的附录16描述中所保证的。在2年英国和EU/EEA的QP之间代表谈判中，结果的独立性和所建立的合法机构可能需要重新评估。

As the role of the QP is already enshrined in UK law, if the UK agrees to abide by EU legislation, there should be no change of the roles or responsibilities of the QP. However, after Brexit unless there is some sort of bilateral agreement it may not be possible for UK QPs to work in Europe, and vice-versa.

由于QP的职责已经嵌入了英国法律，如果英国同意绑定EU法律的话，则不应该对QP的义务和职责进行修改。但是，在Brexit之后，除非有一些双边协议，否则英国QP可能无法在欧盟工作，反之亦然。

Does EU GMP continue to be applicable in UK? EU GMP在UK是否仍适用？
We expect that for the time of negotiations of the Brexit all EU GMP rules and regulations continue to apply across EU and UK. Dependent of the outcome and legal construction established after 2 years GMP rules and regulations in UK may start to develop independently from EU GMP. As EU and UK are members of PIC/S and PIC/S GMP guidelines are mostly identical with EU GMPs, strong alignment of rules and regulations should continue after Brexit irrespective of the outcome and legal construction. After Brexit the UK could seek to join Norway, Liechtenstein and Iceland in the European Economic Area (EEA). If this was achieved then it is envisaged that little would change from the current situation.

我们期望在Brexit谈判期间，所有EU GMP规定和法律持续在EU和UK适用。根据2年后所建立的合法机构及结果的独立程度，英国的GMP规范和法规可能会开始独立于EU GMP发展。由于EU和UK都是PIC/S的成员，PIC/S的GMP指南基本与EU GMP相同，在Brexit后，法规可能会在很大程度上持续相同。在Brexit之后，UK可能会寻求加入EEA的挪威、列支敦士克和冰岛。如果成功，则将与现在的情形不会有什么变化。

Does a potential move of EMA impact QPs? EMA是否可能有措施对QP产生影响？
EMA is legally linked to EU not to UK. EMA will continue its work independent of a potential move. Applicability of centrally registered dossiers to UK will have to be re-assessed after finalization of the negotiations.

EMA合法地与EU相关联，而不是UK。EMA将持续其工作，独立于可能行动。集中审评程序批准的注册文档对UK的适用性则在谈判结束后必须重新评估。

Does the Brexit have impact on requirements for importation testing? Brexit是否会对进口检测的要求产生影响？
We do not see any influence on the fulfilment of the requirements for importation testing for the time of negotiations if such testing is executed within EU or UK. Dependent of the outcome and legal construction established after Brexit possibilities to accept importation testing across EU and UK may need to be re-assessed. If after Brexit the UK can agree to an MRA or an ACAA with the EU, there will be no need for re-testing when product moves between the UK and the EU. Without an MRA or ACAA, the required re-testing will create significant additional work between the UK and the EU.

到谈判时为止，我们还没看到是否进口检测的要求的满足受到影响，如果此检测是在EU或UK内实施的话。根据在Brexit之后所建立的合法机构和结果，接受EU和UK的进口检测的结果的可能性可能需要重新评估。如果在Brexit之后，UK可以与EU在MRA或ACAA达成一致，则当药品在UK和EU之间移动时不需要重新检测。如果没有MRA或ACAA，则所需的重新检测会带来UK和EU之间很多额外工作。

Does the Brexit mean that additional certification by a QP has to be performed after importation? Brexit是否意味着在进口之后QP还要重新出具放行证书？
As already mentioned, we expect that for the time of negotiations of the Brexit all EU GMP rules and regulations continue to apply across EU and UK and neither re-testing nor re-certification has to be applied. Under a MRA the qualified person of the importer in the EU may be relieved of his responsibility to carry out the importation re-testing. However, actual MRAs are still requiring the EU GMP to perform a certification of the products after importation. Dependent of the outcome and legal construction established after Brexit possibilities to accept EU and UK QP certification and by that avoid unnecessary additional work with no added value to companies or patients may need to be re-assessed. It will be a challenge to industry but also to the EQPA to develop models how imports from UK to the EU and vice versa may get an exemption from re-certification and re-release procedures while maintaining safety of the products, by implementing possible safeguarding options to both protect the EU interests as well as UK.

正如已提及的，我们期望到Brexit谈判时，所有EU GMP规则和法规持续适用于EU和UK，这样就不需要重新检测，也不需要重新认证。在MRA下，EU进口商的QP可以免于其职责，不需要实施进口再检测。但是，实际的MRA还需要EU GMP在药品进口后实施认证。根据后所建立的法规机构和结果，接受EU和UK的QP认证的可能性，并通过此方法避免公司或患者不必要的额外工作可能需要再评估。制药行业和EQPA可能会面临挑战，要建立如何从UK进口到EU及从EU进口到UK的模式，可能会获得再认证和再放行程序豁免，通过实施可能的安全保障来保护EU利益和UK利益，保持药品的安全性。

Does the Brexit impact membership of UK QPs in the EQPA? Brexit是否对EQPA中UK的QP成员身份产生影响？
Even after a Brexit, full EQPA membership is possible if after Brexit the UK can agree to an MRA or an ACAA with the EU. The actual membership in the EQPA applies to you if you are either a registered (appointed or approved) QP in a EU member state, official EU member candidate or proposed candidate or you have a similar function (QP, Authorized Person or equal) in a country that has a MRA Agreement or an ACAA agreement with the EU in place (like, e.g., actually Switzerland or Israel).

即使是在Brexit之后，如果UK同意与EU签署MRA或者是ACAA，则全面的EQPA成员身份仍是可能的。实际上EQPA的成员身份适用于你，如果你是EU成员国的注册QP（任命的或批准的），正式的EU成员候选国，或者是所提议的候选国，或者你在一个与EU具有MRA协议或ACAA协议的国家（例如，瑞士或以色列）有相似的职能（QP，授权人或等同者）。

This statement was prepared by the lead-team of the EQPA Interest Group (July 2016) an is also available on the QP Association  website.

此声明由EQPA利益团（2016年7月）领导团队起草，在QP协会官网上也可以找到。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201676103739871/