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SCHEDULE 9MODIFICATIONS OF THE ENFORCEMENT PROVISIONS OF THE ACT SUBJECT TO WHICH THOSE PROVISIONS ARE APPLIED FOR THE PURPOSES OF THESE REGULATIONS

4.  In section 109 (enforcement in Scotland), for subsections (1) to (3), substitute—

(1) It shall be the duty of the Scottish Ministers to enforce in Scotland, or to secure the enforcement in Scotland of, the provisions of the Clinical Trials Regulations..