Document ID: chunk:federal_register_of_legislation:C2024C00632:section:31:p4
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 31 (pt 4/5)
Character Range: 368011–370622

in Australia, any imports into Australia or any exports from Australia of the goods contravene those conditions;
 (h) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.
 (2A) If a notice is given under subsection (2) to a person covered by paragraph (2)(ac), then paragraphs (2)(a) to (h) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were listed.
 (3) An approval of a form may require or permit information to be given in accordance with specified software requirements:
 (a) on a specified kind of data processing device; or
 (b) by way of a specified kind of electronic transmission.
 (4) A person commits an offence if:
 (a) either:
 (i) the person is given a notice under subsection (1) and the person is covered by paragraph (1)(ab) or (ac); or
 (ii) the person is given a notice under subsection (2) and the person is covered by paragraph (2)(ab) or (ac); and
 (b) the person fails to comply with the notice.
Penalty: 500 penalty units.
 (4A) Subsection (4) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (4A). See subsection 13.3(3) of the Criminal Code.
 (4B) A person commits an offence if:
 (a) either:
 (i) the person is given a notice under subsection (1) and the person is covered by paragraph (1)(ab) or (ac); or
 (ii) the person is given a notice under subsection (2) and the person is covered by paragraph (2)(ab) or (ac); and
 (b) the person fails to comply with the notice.
Penalty: 100 penalty units.
 (5) An offence against subsection (4B) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
 (5AA) Subsection (4B) does not apply if the person has a reasonable excuse.
Note: A defendant bears an evidential burden in relation to the matter in subsection (5AA): see subsection 13.3(3) of the Criminal Code.
 (5A) A person commits an offence if:
 (a) the person is given a notice under this section in relation to therapeutic goods; and
 (b) the person gives information or a document in compliance or purported compliance with the notice; and
 (c) the information or document is false or misleading in a material particular; and
 (d) either:
 (i) the use of the therapeutic goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or
 (ii) the use of the therapeutic goods, if the therapeutic goods were used, would result in,