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EU Legal Rep - Clinical Trials

Med-di-dia can act as your Legal Rep for Clinical Trials in the EU

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What is an EU Legal Representative for Clinical Trials?

According to Article 74 of the CTR, if a sponsor of a Clinical Trial is not based in the EU, then they are required to appoint a representative within the EU to act as a Legal Representative.

The legal representative ensures compliance with the Sponsor’s obligations under EU CTR and notifies the sponsor immediately in the case of becoming aware of incompliance with EU CTR

The Legal Representative is accountable for the sponsor’s compliance with obligations under EU CTR and is the addressee for all communications with the sponsor provided for in the Regulation.

Under the Clinical Trials Regulation, the EU Legal Representative will include the following responsibilities:

  • Help sponsors understand the regulatory requirements;
  • Put together a customized solution to ensure compliance;
  • Stay up-to-date on and communicate EU legal requirements;
  • Assist in coordinating site inspections to comply with the International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP);
  • Prepare clinical trial authorisations and amendment submissions by working with the relevant Ethics Committees and National Competent Authorities.

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How does the Process work?

  • Only one Legal Representative may be appointed by the Sponsor for a specific protocol
  • The Legal Representative may be located in any EEA 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
  • For UK-only studies, a UK-based Legal Contact needs to be nominated

Med-Di-Dia can support your company as a Legal Rep!

Benefits of using Med-Di-Dia as your EU Legal Representative?

  • Help Sponsors understand the regulatory requirements within The European Union;
  • Put together a customized solution to ensure compliance in host countries;
  • Stay up-to-date on and communicate EU legal requirements;
  • Coordinating site inspections to comply with the International Conference of Harmonisation (ICH);

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