(1) A person shall not in the course of making an application provide to the Ethics Committee or National Competent Authority any relevant information which is false or misleading in a material particular.
(2) Any person who —
(a) is conducting a clinical trial under an authorization;
(b) is a sponsor of a clinical trial;
(c) while acting under arrangements made with a sponsor of a clinical trial, performs the functions of that sponsor,
shall not provide to the Ethics Committee or National Competent Authority any relevant information which is false or misleading in a material particular.
(3) An applicant or person who contravenes subsection (1) or (2) commits an offence and is liable on summary conviction to a fine not exceeding $5,000 or to a term of imprisonment not exceeding 1 year or to both fine and imprisonment.
(4) In this regulation, “relevant information” means any information which is relevant to an evaluation of —
(a) the safety or scientific validity of a clinical trial; or
(b) whether, with regard to a clinical trial, the conditions and principles of good clinical practice are being satisfied or adhered to.