Document ID: chunk:federal_register_of_legislation:C2024C00632:section:19:p4
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 19 (pt 4/4)
Character Range: 142266–143897

A person commits an offence if:
 (a) the person is subject to a requirement under subsection (7C); and
 (b) the person omits to do an act; and
 (c) the omission breaches the requirement.
Penalty: 10 penalty units.
 (7G) An offence against subsection (7F) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
 (7GA) Subsection (7F) does not apply in relation to a person and a requirement to notify a supply of therapeutic goods if a health practitioner, on behalf of the person, does the following:
 (a) notifies the supply to the Secretary within 28 days after the supply;
 (b) makes the notification in accordance with the requirements referred to in subsection (7D).
Note: A defendant bears an evidential burden in relation to the matter in subsection (7GA): see subsection 13.3(3) of the Criminal Code.
 (7H) In recommending to the Governor‑General that regulations should be made for the purposes of paragraph (7D)(b), the Minister must have regard to the principle that information should only be prescribed for the purposes of that paragraph if the information is reasonably required for the responsible scrutiny by the Secretary of the operation of the scheme embodied in subsection (7A).
 (8) The regulations may prescribe the circumstances in which an approval under paragraph (1)(a) must not be given, including but not limited to, circumstances relating to the following:
 (a)  therapeutic goods included in a specified class;
 (b) therapeutic goods when used in the treatment of a specified class of persons;
 (c) therapeutic goods when used for a particular indication.