EU Commission warns against complacency as the end of the Brexit transition period draws near
In July, the European Commission released a Communication ahead of the end of the Brexit transition period. The paper’s wordy, but instructive, title is: “Getting ready for changes: Communication on readiness at the end of the transition period between the European Union and the United Kingdom”.
The Withdrawal Agreement provided for a transition period to allow Member States and other stakeholders better to prepare for Brexit, allowing more time for future EU-UK relations to be agreed. This transition period expires on 1 January 2021, at which point the UK will leave the EU single market and customs union. Regardless of whether the nature of the future relationship can be agreed, this will have significant consequences for both the EU and UK, particularly in the trade of goods and services. In light of that reality, the purpose of the Commission’s Communication is to:
Highlight the main areas of inevitable change and to facilitate readiness and preparations by citizens, public administrations, businesses and all other stakeholders for these unavoidable disruptions.
From 1 January 2021 the EU and the UK will be two separate legal and regulatory spaces. Accordingly, all products traded between the two jurisdictions will need to comply with both regulatory regimes.
- EU businesses that distribute UK products will become ‘importers’ and will need to comply with obligations that attach to that designation. The specific obligations will vary according to the nature of the goods but for medical devices, this will include verification of the CE marking and preparation of the EU declaration of conformity, appropriate labelling and instructions for use and, where applicable, assignment of a Unique Device Identification number or “UDI” as required under the Medical Device Regulation.
- Certificates and authorisations issued by UK notified bodies will no longer be valid for placing products on the EU single market. However, authorisations may remain valid for some products, such as medical devices, already on the market.
- Certain economic operators (e.g. authorised representatives) established in the UK will no longer be recognised and will need to be relocated to the EU or a new operator appointed.
Life sciences industry
It remains to be seen what arrangements will be made for the life sciences industry, but currently on 1 January 2021, “the UK will exit the Union’s regulatory system for medicinal products and medical devices.” In the absence of specific agreement to the contrary, this means:
- Marketing authorisation holders will need to be established in the EU
- Testing and batch release sites will need to be located in the EU
- Qualified persons responsible for pharmacovigilance and batch release will need to be established in the EU
- EU clinical trials will need a sponsor or legal representative established in the EU
- Information and labelling will have to comply with EU requirements
- The certification of medical devices will have to be carried out by notified bodies established in the EU.
While negotiations to date have “shown little progress”, the Communication confirms that discussions have now been intensified over the summer. Notwithstanding the lack of progress, the Commission is careful to state that this Communication should not be seen to “prejudge the outcome of the ongoing negotiations between the EU and the UK”. However, one might reasonably infer from the tone of the document that the prospects of a comprehensive agreement being reached before the end of the year are slim, and the Commission therefore seeks to warn against complacency.
The advice summarised above contains nothing new in terms of the expected disruption at the expiry of the transition period, but should serve as a helpful reminder to all stakeholders on those issues to which they should already have turned their minds, or should now urgently be so doing, in order to best prepare for the forthcoming changes.
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