Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative.
I gcás nach mbeidh urraitheoir imscrúdaithe chliniciúil bunaithe san Aontas, áiritheoidh an t-urraitheoir go mbeidh duine nádúrtha nó dlítheanach bunaithe san Aontas mar a ionadaí dlíthiúil.