competent authority


competent authority

(1) Any person or organisation with statutorily delegated or vested authority, capacity, or power to perform a designated function.
(2) A regulatory body authorised by a European Member State government to monitor compliance with the national statutes and regulations, and carry out duties on behalf of the government in compliance with EU law.

Competent Authority

A country’s regulatory body (e.g., the MHRA in the UK, Italian Medicine Agency, Federal Institute for Drugs and Medical Devices in Germany, etc.) that is charged with monitoring compliance with the national statutes and regulations of European Member States.