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Brexit – Consequences for pharmaceuticals and medical devices

21.01.2021

Status quo: Reached agreement between EU and UK

By leaving the European Union (‘EU’), the United Kingdom has now became a third country. The partnership agreement negotiated between the EU and the United Kingdom (the ‘Brexit Agreement’) does not change this in principle. However, the Northern Ireland Protocol contained in the Brexit Agreement means that specific European law provisions for the territory of Northern Ireland remain applicable. Conclusively, Northern Ireland is still to be regarded as an EU territory with regard to these European law provisions. This would also apply in particular to health legislation.

The Brexit Agreement entered into force provisionally on 1 January 2021 and still has to be approved by the European Parliament. This article summarises what manufacturers, importers and distributors of pharmaceuticals and medical devices should now know with regard to cross-border distribution between the EU and the United Kingdom.

Consequences for pharmaceuticals and medical devices

Pharmaceuticals

Central marketing authorisations for pharmaceuticals apply only to the territory of the European Union. As the United Kingdom is no longer part of the EU, central marketing authorisations no longer apply to the UK territory (with the exception of Northern Ireland when the Northern Ireland Protocol permanently enters into force). Therefore, for distribution in the UK, pharmaceuticals with a central marketing authorisation now require an (additional) national marketing authorisation for the UK.

Furthermore, from now on, the distribution of pharmaceuticals from the UK to the EU constitutes an import. The import of pharmaceuticals requires that importing distributors have their registered office in the EU and are in possession of an import licence according to section 72(1) of the German Medicinal Products Act (Arzneimittelgesetz, AMG).

Imported pharmaceuticals for human use now also require a certificate according to section 72a(1) German Medicinal Products Act, which certifies that quality standards applicable in the United Kingdom have been met during manufacture. Furthermore, a contractual agreement between the United Kingdom as a third country and the EU is required, on the basis of which the equivalence of the quality standards with regard to the manufacture of the products concerned is recognised (‘mutual recognition agreement’ or MRA). Such an MRA is included in the Brexit Agreement.

For further information, please also see our news article series on the consequences of Brexit for the pharmaceutical industry:

Medical devices and in vitro diagnostics (IVD)

Medical devices and IVD are subject to extensive regulation in the EU, similar to pharmaceuticals. In particular, placing them on the market requires CE marking, which is preceded by the implementation of a conformity assessment procedure. With the conformity assessment procedure and the corresponding EU declaration of conformity, the manufacturer provides in summary, among other things, proof that the medical device or IVD meets the essential requirements regarding safety and performance.

The CE marking required for the EU will no longer be recognised by Great Britain (England, Scotland and Wales) after a transitional period until 30 June 2023. This means that in the future, a special conformity assessment procedure according to British law as well as an additional marking will be required for placing medical devices on the market in Great Britain. In addition, there will be an obligation to register with the British Medicines and Healthcare products Regulatory Agency (MHRA). Certificates issued by EU-recognised Notified Bodies as part of the conformity assessment procedure are also valid for the UK market until 30 June 2023. Furthermore, manufacturers from the EU must now appoint an authorised person (UK Responsible Person) who assumes responsibility for the medical device in the UK.

With regard to Northern Ireland, on the other hand, in the event of the final approval of the Brexit Agreement by the European Parliament, including the Northern Ireland Protocol, the requirement for CE marking and the application of EU regulations for medical devices and IVDs will remain in force. If a UK Notified Body has been involved in the conformity assessment process, special marking is required. Certain medical devices and IVDs also have to be registered with the MHRA

Outlook

Medical device manufacturers in particular are facing major challenges. Not only do they have to ensure the transition to the MDR and IVDR (Regulation (EU) 2017/745 and Regulation (EU) 2017/746) in the near future, which come into force on 26 May 2021 and 26 May 2022 respectively. In addition, they also need to get the implementation of the UK regulations underway in time if they want to remain active on the UK market.

Besides from this, it remains to be seen in particular with regard to the status of Northern Ireland, whether the European Parliament will approve the Brexit Agreement including the Northern Ireland Protocol. The deliberations of the individual committees on this matter began on Monday, 11 January 2021. How long this will take remains to be seen. It is not predictable how long these deliberations will take.

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