Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41MQ

Notification of adverse events etc. where application withdrawn or lapses

             (1)  If an application for inclusion of a kind of medical device in the Register is withdrawn or lapses, the Secretary may give the applicant written notice requiring the applicant: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 mentioned in subsection 41MP(2) or 41MPA(2) relating to the kind of device; and

                     (b)  if the applicant is aware of such information, to give the information to the Secretary in writing.

             (2)  Notice under subsection (1) may only be given within 10 working days after an application is withdrawn or lapses.

             (3)  A person commits an offence if the person fails to comply with the requirements of a notice under subsection (1) within 20 working 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 this section; 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.



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