Legal Representative Clinical Trials
Are you a sponsor with offices outside the EEA and wish to conduct a clinical trial within the EEA? QbD Clinical is happy to act as your legal representative.
What is a Legal Representative?
In 2001, the European Medicines Agency (EMA) issued the European Clinical Trials Directive (2021/20/EC).
The directive requires that a sponsor wishing to conduct a clinical trial in the European Union must either have a registered office in the European Economic Area (EEA) or work with a legal representative with an established office in the EEA community.
This requirement applies to all clinical trials conducted to evaluate medicinal and/or pharmaceutical products, as well as medical devices.
A legal representative acts as an agent of a sponsor when legal proceedings are initiated and instituted within the EU/EEA. A legal representative is required for each clinical trial.
The legal representative does not assume any of the legal liabilities of the sponsor.
With the UK leaving the EU on January 1, 2021, for trials taking place within the EU, the UK will accept a legal representative who is based within the EEA and meets the requirements of the European Clinical Trials Directive.
If a study will only take place in the UK, sponsors will need to appoint a separate UK-based ‘legal contact’, and QbD Clinical can provide this service from our London office.
For clinical trials conducted in Switzerland, Article 2 (c) of the “Ordinance on clinical trials with therapeutic products” requires a non-resident sponsor to appoint a Swiss-based representative. QbD Clinical can provide this service from our Swiss office.
Why QbD Group?
Where QbD Clinical acts as the sponsor’s legal representative, the sponsor is not required to establish an office in the EEA during the clinical phase.
QbD Clinical will assist the sponsor in understanding the regulations, staying abreast of these requirements, addressing any questions from the European Authorities, and consulting with the sponsor in full transparency to provide a tailored solution.
Each sponsor may only appoint one legal representative per clinical trial. See above for any specific provisions when studies are conducted in the UK or Switzerland.
Upon appointing QbD Clinical as your legal representative, a Letter of Authorization will be prepared to formalize the appointment. This letter will be included in the submission process to the Competent Authorities and Ethics Committees.
Contact us for more information or to request a free, no-obligation proposal.