A Local Representative is a legal or natural person residing in a specific country or region, appointed by a foreign sponsor to assume certain local regulatory obligations. This is particularly important for companies that do not have their own establishment in the country where they intend to conduct a clinical trial or market a product.
In the European Union, this role is often referred to as ‘Legal Representative’ or ‘Authorized Representative’ within the framework of the EU Clinical Trials Regulation (CTR 536/2014). The Local Representative acts as the official point of contact for national health authorities and ethics committees. They are responsible for submitting documents, receiving official correspondence, and ensuring compliance with local regulations. CROs like Mediconomics offer this service to facilitate foreign sponsors’ access to the European market.