The European Commission, along with the European Medicines Agency (EMA), released a notice to remind clinical trial sponsors to comply with the EU clinical trial rules following the Brexit transition period that is going to expire on 31 December, 2020.
As there is no possibility for further extension of Brexit transition period, the EC has released Brexit readiness notice for clinical trials. The sponsors are expected to abide by the following rules to ensure smooth operation of their ongoing clinical studies:
- They must have a qualified person established in the EU or EEA or a legal representative established in the EU
- Investigational medicinal products used in clinical trials must be imported to the EU only after the qualified person certifies the batch-release
- Sponsors of all ongoing trials must also establish a qualified person in the EU
Failing to establish a legal presence in the EU will be considered as a breach of Directive 2001/20/EC and could trigger for corrective actions by the authorities or in the worst case, the trial may get suspended. Get ready for the compliance with an expert advice/consultation. Stay informed and stay compliant.