(1) As soon as a person in relation to whom therapeutic goods are registered or listed becomes aware of information of a kind mentioned in subsection (2) relating to the goods, the person must give the information to the Secretary in writing.
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.
(2) The information with which subsection (1) is concerned is information of the following kinds:
(a) information that contradicts information already furnished by the person under this Act;
(b) information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;
(c) 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 furnished by the person under this Act suggests;
(d) information that indicates that the quality, safety or efficacy of the goods is unacceptable.