July 2020: What’s New on EudraCT

The following update was posted on EudraCT What’s New section, on July 10, 2020:

The Joint Technical Notice to Sponsors by the European Commission, EMA and HMA was published yesterday on the European Commission health website.

It emphasizes that if a qualified person (QP) (for certifying the batch-release, so that the drug product can be imported) and the sponsor of a clinical trial or a legal representative (in case the sponsor is established in a third-country) is established in the United Kingdom, such a person and sponsor or the legal representative must be established in the EU if the clinical trial is authorized in at least one EU member state.

Sponsors of all ongoing trials need to establish a QP in the EU. Failure to do so could in the worst case result in discontinuation of trial treatment and thus jeopardise trial participants’ safety.

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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