Control of Clinical Trials Act, 1987
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Offences. |
13.—(1) (a) Subject to paragraph (b), any person who contravenes (by act or omission) any provision of this Act or any regulation under this Act or of any permission to which this Act relates shall be guilty of an offence under this section. | |
(b) It shall be a good defence to a prosecution for an offence under this section relating to the administration by a person of one or more substances or preparations to show that the substances or preparations were administered for the purpose of providing emergency medical or dental treatment. | ||
(2) (a) Subject to paragraph (b), where an offence under subsection (1) is committed by a body corporate, every person who at the time of the commission of the offence was a director, manager, secretary or other officer of the body corporate shall, as well as the body corporate, be guilty of an offence under this section and shall be liable to be proceeded against and punished accordingly. | ||
(b) It shall be a good defence to a prosecution for an offence under paragraph (a) for a person to show that the offence was committed without his knowledge and that he exercised all due diligence to prevent the commission of the offence as he ought to have exercised, having regard to the nature of his position as director, manager, secretary or other officer and to all the circumstances. | ||
(3) Notwithstanding section 10 (4) of the Petty Sessions (Ireland) Act, 1851 , summary proceedings for an offence under this section may be instituted within 12 months from the date of the offence. |