xmlns:atom="http://www.w3.org/2005/Atom"
3. For section 108 (enforcement in England and Wales) substitute—
“(1) It shall be the duty of the Secretary of State to enforce in England, or to secure the enforcement in England of, the provisions of the Clinical Trials Regulations.
(2) It shall be the duty of the National Assembly for Wales to enforce in Wales, or to secure the enforcement in Wales of, the provisions of the Clinical Trials Regulations”.