Power to obtain information with respect to therapeutic goods
8 Power to obtain information with respect to therapeutic goods
The Secretary may, by notice in writing given to a person who has imported into Australia or has supplied in Australia:
therapeutic goods; or
goods in relation to which the Secretary is considering making a declaration under section 7; or
goods in relation to which the Minister is considering making a determination under subsection 7AAA(1) (goods that are therapeutic goods); or
goods in relation to which the Minister is considering making a determination under section 7AA (excluded goods);
request the person to give to an officer of the Department identified in the notice, within such reasonable period as is specified in the notice, information required by the notice concerning the composition, indications, directions for use or labelling of the goods or concerning advertising material relating to the goods.
A notice under subsection (1) may require the information to be given:
in writing; or
in accordance with specified software requirements:
on a specified kind of data processing device; or
by way of a specified kind of electronic transmission.
A person must not fail to comply with a notice given to the person under this section.
Penalty: 60 penalty units.
Subsection (2) does not apply if the person has a reasonable excuse.
The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.
An offence under subsection (2) is an offence of strict liability.
For strict liability, see section 6.1 of the Criminal Code.
This Act’s bill:Second reading speech
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