Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 42Y

Application for order

  (1)   Within 6 years of a person (the wrongdoer ) contravening a civil penalty provision, the Secretary may apply on behalf of the Commonwealth to the Federal Court for an order that the wrongdoer pay the Commonwealth a pecuniary penalty.

Court may order wrongdoer to pay pecuniary penalty

  (2)   If the Court is satisfied that the wrongdoer has contravened a civil penalty provision, the Court may order the wrongdoer to pay to the Commonwealth for each contravention the pecuniary penalty that the Court determines is appropriate (but not more than the maximum amount specified for the provision).

Determining amount of pecuniary penalty

  (3)   In determining the pecuniary penalty, the Court must have regard to all relevant matters, including:

  (a)   the nature and extent of the contravention; and

  (b)   the nature and extent of any loss or damage suffered as a result of the contravention; and

  (c)   the circumstances in which the contravention took place; and

  (d)   whether the person has previously been found by the Court in proceedings under this Act to have engaged in any similar conduct.

Civil evidence and procedure rules apply

  (4)   The Court must apply the rules of evidence and procedure for civil matters when hearing and determining an application for an order under this section.

Note:   The standard of proof in civil proceedings is the balance of probabilities: see section   140 of the Evidence Act 1995 .

Conduct contravening more than one civil penalty provision

  (5)   If conduct constitutes a contravention of 2 or more civil penalty provisions, proceedings may be instituted under this Act against a person in relation to the contravention of any one or more of those provisions. However, the person is not liable to more than one pecuniary penalty under this section in respect of the same conduct.