Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 32DQ

Criminal offence and civil penalty for failing to notify adverse effects etc. of biological while it is included in the Register

Criminal offence

             (1)  A person commits an offence if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the person knows that particular information is information of a kind to which subsection (3) applies; and

                     (c)  the person fails to give that information to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).

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.

Civil penalty

             (2)  A person contravenes this subsection if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the person knows that particular information is information of a kind to which subsection (3) applies; and

                     (c)  the person fails to give that information to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).

Maximum civil penalty:

                     (a)  for an individual--3,000 penalty units; and

                     (b)  for a body corporate--30,000 penalty units.

Relevant information

             (3)  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.



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