EU Legal
Representation
Services

Compliance

The European Clinical Trials Directive (2021/20/EC) indicates that a Sponsor conducting a clinical trial in the European Union must either have a registered office within European Economic Area (EEA) territory, or work with a legal representative with an established office within the EEA community.

Each individual clinical trial conducted with pharmaceutical products, medicinal products, or medical devices can have only one legal representative. With an office in Amsterdam that specializes in complying with directives released by the European Medicines Agency (EMA), ARG is an ideal choice to serve as your legal representative in Europe.

Offerings

ARG will first help you to understand the legal requirements, and then put together a customized solution to ensure compliance. As a full-service CRO, ARG is noteworthy in that we combine comprehensive global solutions equivalent to the largest of our competitors, along with individualized customer service.

In terms of legal representation, our broad services include staying up-to-date on and communicating legal requirements. ARG can also assist in coordinating site inspections to comply with International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP), and prepare clinical trial authorisations and amendment submissions by working with the relevant Ethics Committees and National Competent Authorities.

Responsibilities

The Legal Representative

  • May be an individual person or a representative of a corporate entity.
  • Does not have to be a legally qualified person.
  • Should be willing to act as the agent of the Sponsor in the event of any legal proceedings instituted in the EEA.
  • Should be established and contactable at an address in the EEA.
  • Does not assume any of the legal liabilities of the Sponsor(s) for the trial by virtue of the role of legal representative.
  • Does not therefore require insurance or indemnity to meet such liabilities.

Process

  • Only one Legal Representative may be appointed by the Sponsor for a specific protocol.
  • The Legal Representative may be located in any Member State, regardless of the Member State(s) in which the protocol is conducted.
  • A Letter of Authorisation must be prepared on the Sponsor’s headed paper, which includes acknowledgement by the Legal Representative of the role.
  • The Letter of Authorisation must be included in each initial application to a Competent Authority or Ethics Committee regarding the protocol.
  • The Sponsor may appoint different Legal Representatives for different protocols.
Disclaimer

Disclaimer: Whilst due care and attention has been taken in the preparation of this information, ARG-RS does not claim it to be free of error. ARG-RS do not accept any responsibility for actions resulting from decisions based upon the information contained herein, and recommend that this publication should not be used in place of professional advice on regulatory and clinical issues.