If the main sponsor of a clinical trial with a medicinal product is not based in the European Economic Area (EEA), for example, an American or Japanese company, it is a statutory requirement to appoint a legal representative based in the EEA for the purposes of the trial.
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 (for example, for service of legal documents)
- 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 and does not therefore require insurance or indemnity to meet such liabilities, but may in some cases enter into specific contractual arrangements to undertake some or all of the statutory duties of the sponsor in relation to the trial, in which case the legal representative would also be regarded as a co-sponsor and would then require insurance or indemnity cover.
