GDPR

As outlined in GDPR’s Articles 3 and 27, non-EU-based companies that provide goods or services to individuals in the European Union or engage in activities involving the monitoring of EU-based data subjects (such as participants in clinical studies) are obliged to designate a privacy representative in the country where those data subjects reside. Regulatory authorities are empowered to employ a spectrum of sanctions to ensure compliance.

The privacy representative has certain requirements and responsibilities, including:

1. Privacy Proficiency: The appointed representative must possess specialized knowledge of privacy law, encompassing the GDPR and pertinent local regulations.
2. Individual or Corporate Representation: The privacy representative can either be an individual or a corporate entity. In the case of a corporate representative, it is essential to nominate a qualified professional with the requisite expertise as a point of reference.
3. Local Presence: The privacy representative must be situated in the same country as the data subjects they represent.
4. Liaison with Local Data Protection Authority: Acting as a vital conduit between the non-EU company and the local Data Protection Authority, the privacy representative facilitates communication and ensures compliance.

These measures are fundamental to ensuring compliance with GDPR and upholding the privacy rights of individuals within the European Union. Regulatory authorities are equipped with a range of sanctions to enforce these requirements.