European Commission publishes notice to stakeholders on running clinical trials in the UK post-Brexit
On 6 September, The European Commission published a notice to stakeholders outlining the legal implications of running clinical trials in the UK after Brexit.
The Commission underlines that, beginning from the withdrawal date, the EU regulatory network on clinical trials (including Directive 2001/20/EC) will no longer apply to the UK as it will be a “third country”. Given this, the notice details three main actions businesses involved in clinical trials should perform:
- Mind the rules on the supply of investigational products from the third countries; their importation into the EU is subject to the holding of an authorisation, as well as having an EU-based qualified person to ensure that each batch has undergone the relevant quality checks, tests or analyses;
- Ensure that a sponsor or a legal representative is established in the EU-27 (this is a substantial amendment that requires notification to the appropriate authority/information of the Ethics Committee in accordance with the procedure set out in Article 10(a) of Directive 2001/20/EC; and
- Evaluate what clinical trial information (protocol-related vs. result-related) should be submitted to EudraCT, and what should be submitted to the MHRA (e.g. UK-specific trial information).