European Commission Guidance on Brexit and EU Rules in Field of Clinical Trials
On 7 May 2020, the European Commission published an updated version of its notice on the “withdrawal of the United Kingdom and EU rules in the field of clinical trials” (see, attached copy; the Revised Notice).
Initially published on 6 September 2018, the Revised Notice has been updated to reflect the UK’s withdrawal from the EU since 1 February 2020 and the effect of the Withdrawal Agreement (i.e., the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, OJ L 29, 31.1.2020, p. 7). The Withdrawal Agreement provides for a transition period ending on 31 December 2020 during which the EU and the UK will negotiate an agreement on a new partnership. During this period, EU law continues to apply in its entirety to and in the UK, subject to some limited exceptions.
The Revised Notice reminds clinical trial sponsors of the legal situation after the end of the transition period as regards (i) the supply of investigational medicinal products (IMPs); (ii) establishment requirements; and (iii) the submission of clinical trial information to the EU clinical trials database EudraCT. It stresses that clinical trial sponsors should pay particular attention to (i) ensuring that the sponsor or its legal representative is established in the EU; and (ii) adapting distribution channels to take importation requirements into account.
Furthermore, the Revised Notice clarifies the application of Article 41(1)(a) of the Withdrawal Agreement to IMPs. This Article 41(1)(a) provides that “[a]ny good that was lawfully placed on the market in the Union or the United Kingdom before the end of the transition period may be further made available on the market of the Union or of the United Kingdom and circulate between these two markets until it reaches its end-user”.
Finally, the Revised Notice explains the rules applicable to Northern Ireland after the end of the transition period.