Civil penalty for failing to notify adverse effects etc. of goods
29AA Civil penalty for failing to notify adverse effects etc. of goods
A person contravenes this section if:
therapeutic goods are registered or listed in relation to a person; and
the person becomes aware of information of a kind mentioned in subsection (2) relating to the goods; and
the person does not give the information to the Secretary in writing as soon as he or she becomes aware of it.
Maximum civil penalty:
for an individual—3,000 penalty units; and
for a body corporate—30,000 penalty units.
The information with which subsection (1) is concerned is information of the following kinds:
information that contradicts information already given by the person under this Act;
information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;
information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as the application for registration or listing of the goods or information already given by the person under this Act suggests;
information that indicates that the quality, safety or efficacy of the goods is unacceptable.
This Act’s bill:Second reading speech
The statute text is free to read above. View subscription options to unlock the case-law research tools for each provision.