Although the separation of the UK from the EU was formalised a year ago with the end of the transition period and the signing of the Trade and Cooperation Agreement, there is a fair amount of ongoing work related to its consequences. The situation in Northern Ireland has been fairly prominent in the media, with issues, amongst other things relating to the supply of medicines. This has resulted in threats to suspend the protocol and ongoing negotiations between the UK government and the EU for a better solution. We will be monitoring developments closely.
An arguably less dramatic aspect of Brexit, but a far more frequent area of legal advice for our clients (predominantly those based abroad) has been the impact of the UK "domestication" of EU law in the regulatory sphere. More specifically, in areas where the EU or national institutions had competence on regulatory matters across the EU, and required businesses or their authorised representatives to be established in the EU, those obligations are now replicated in the UK. The consequence for businesses from outside the UK wishing to sell regulated products in the UK (including medicines or medical devices) is that they will typically need specific UK regulatory approval and to be established in the UK, or to contract with a UK established entity.
When this needs to happen by is complicated and product specific. There are a number of deadlines that have already passed (for example from 1 January 2022, non-UK manufacturers were required to appoint a UK Responsible Person for the purposes of registering medical devices placed on the Great Britain market), and some that are yet to pass (e.g. the extended deadline for UKCA marking for many products does not apply until 1 January 2023).
One narrow issue that fairly frequently arises is what it means to be “established” in the UK. On this the position has not been clarified specifically in English law but for the moment the approach is likely to follow EU law on establishment, which is broadly that a mere post box or registered address is unlikely to be sufficient, and that the requirement is more likely to be fulfilled by way of a permanent physical presence. It remains to be seen whether there are further developments in this area, for example taking into account the increasingly flexible and virtual way people are doing business. It will also be interesting to see what happens in Northern Ireland, which is currently more closely aligned with the EU than UK wide/GB law. But for the moment following the traditional approach to "establishment" is considered prudent.
Please do not hesitate to contact us if you have queries on Brexit or the regulations.
Gustaf Duhs