THERAPEUTIC GOODS ACT 1989 - SECT 32DR Criminal offences and civil penalties for failing to notify adverse effects etc. of biological where application withdrawn or lapses
THERAPEUTIC GOODS ACT 1989 - SECT 32DR
Criminal offences and civil penalties for failing to notify adverse effects etc. of biological where application withdrawn or lapses(1) If an application for inclusion of a biological in the Register is withdrawn or lapses, the Secretary may, within 14 days after the application is withdrawn or lapses, give the applicant written notice requiring the applicant:
(a) to inform the Secretary in writing whether the applicant is aware of any information of a kind to which subsection (2) applies; and
(b) if the applicant is aware of such information, to give the information to the Secretary in writing.
(2) This subsection applies to information of the following kinds:
(a) information that contradicts information already given by the person under this Act in relation to the biological (including information given about the quality, safety or efficacy of the biological);
(b) information that indicates that the use of the biological in accordance with the recommendations for its use may have an unintended harmful effect;
(c) information that indicates that the biological, when used in accordance with the recommendations for its use, may not be as effective as the application for inclusion of the biological in the Register or information already given by the person under this Act suggests.
(3) A person commits an offence if:
(a) the Secretary gives a notice to the person under subsection (1); and
(b) the person fails to comply with the notice within 30 days after the notice is given to the person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(4) A person commits an offence if:
(a) the person gives information in purported compliance with a notice under subsection (1); and
(b) the information is false or misleading in a material particular.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(5) A person contravenes this subsection if:
(a) the Secretary gives a notice to the person under subsection (1); and
(b) the person fails to comply with the notice within 30 days after the notice is given to the person.
Maximum civil penalty:
(a) for an individual--3,000 penalty units; and
(b) for a body corporate--30,000 penalty units.
(6) A person contravenes this subsection if:
(a) the person gives information in purported compliance with a notice under subsection (1); and
(b) the information is false or misleading in a material particular.
Maximum civil penalty:
(a) for an individual--3,000 penalty units; and
(b) for a body corporate--30,000 penalty units.