12.—(1) Amendments in section 121 (contravention due to fault of other person) as follows.
(2) In subsection (1) (where a person is guilty of an offence due to act or default of another, the other is also guilty of the offence), for “to which this section applies constitutes an offence under this Act” substitute “of the Clinical Trials Regulations constitutes an offence under those Regulations”.
(3) In subsection (2) (defence of due diligence where contravention due to act or default of another), for “this Act in respect of a contravention of a provision to which this section applies” substitute “the Clinical Trials Regulations in respect of a contravention of a provision of those Regulations”.
(4) Omit subsection (4) (provisions to which section applies).