controlling entitymeans a manufacturer’s administrative, management or supervisory body, or any legal person within the meaning of Article 5(4) of Council Framework Decision 2008/841/JHA, that may represent, take decisions on behalf of, or exercise control over the manufacturer;
independent auditormeans a recognised entity competent to assess and declare that a manufacturer’s corporate compliance programme complies with the principles, rules and procedures on the ethical conduct of business, including the relevant internal department of an NCB for a manufacturer which is legally and organisationally part of that NCB, or which is a separate legal person in cases where the NCB exercises similar control over that legal person to that which it exercises over its own departments.’;