Innovative Drug European Associates

Is Brexit putting your clinical trial at risk?

May 24, 2019 by admin

FAO: ALL UK-BASED SPONSORS OF EU CLINICAL TRIALS

If you are a UK-based sponsor with a clinical trial in the rest of the EU, Brexit could have a profound impact on the legal status of your study.

Clinical trials in the EU are governed by the Clinical Trials Directive 2001/20/EC. According to Article 19 of this Directive, the sponsor of a clinical trial or a legal representative must be established in the EU. As a UK-based sponsor you currently meet this requirement. However after Brexit, unless you have a legal presence elsewhere in the EU, you will no longer meet the requirement.

If you do not have an office or registered address in the EU, and you wish to perform clinical trials in the EU, you must have a legal representative who is established within the EU. Without a legal representative the trial will not be approved, or may be suspended, by the regulatory or ethics authorities.

The legal representative acts on your behalf to ensure compliance with your legal obligations under the Regulation and handles any request related to the conduct of a clinical trial. The representative forms a local point-of-contact for the EU regulatory authorities to address formal correspondence and where, if necessary, notice of due process can be served.

The European Commission has issued a notice to confirm that from the Brexit withdrawal date, as a sponsor established in the United Kingdom and conducting a clinical trial with sites in the EU-27, you must have a legal representative who is established in the EU.

While the withdrawal negotiations are still in progress, the European Medicines Agency (EMA) expects you to work on the assumption that the UK will leave the EU and, in order to avoid any disruption, prepare for that eventuality. National competent authorities are issuing warnings to sponsors (you may well have received one) asking them to prepare for Brexit now, or risk facing a suspension of their clinical trials after the withdrawal date.*

IDEA Regulatory is highly experienced in providing EU legal representative services to non-EU clinical trial sponsors. Setting up legal representation for a sponsor usually takes 2-4 weeks. However, we are currently offering an express service to get you Brexit-ready from our Dublin office in under 1 week.

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*Taken from: The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Web article “Consequences of “Brexit”: BfArM’s preparations.

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