Technical Notice to Sponsors Regarding Continuous Compliance with the EU Legislation for Clinical Trials Following the Withdrawal of the United Kingdom from the EU

On 9 July 2020 a joint technical notice to sponsors by the European Commission, EMA and HMA was published.

The purpose of this technical notice is to remind sponsors of clinical trials conducted in the EU Member States, of the legal situation applicable after the end of the transition period on 31 December 2020, as described in the Commission Brexit readiness notice regarding Clinical Trials.

According to Article 13(2) of Directive 2001/20/EC, the qualified person has to be established in the EU/EEA. Investigational medicinal products used in clinical trials can be imported only after their batch-release has been certified by a qualified person in the EU. According to Article 19 of Directive 2001/20/EC, the sponsor of a clinical trial or a legal representative must be established in the EU.

In addition, for trials authorised in at least one Member State where the sponsor is established in a third-country and with a legal representative in the UK, the sponsor needs to establish its legal representative in the EU by the end of the transition period. At the end of the transition period, the sponsor or its legal representative has to be established in the EU for all ongoing trials. Failure to meet this requirement will be a breach of Directive 2001/20/EC and could trigger a request for corrective actions by Member State competent authorities.

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