Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 14A

Civil penalty relating to importing goods into Australia

             (1)  A person contravenes this subsection if:

                     (a)  the person imports therapeutic goods into Australia; and

                     (b)  the person does not have the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging).

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Civil penalty relating to supplying goods for use in Australia

             (2)  A person contravenes this subsection if:

                     (a)  the person supplies therapeutic goods for use in Australia; and

                     (b)  the person does not have the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods.

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Civil penalty relating to exporting goods from Australia

             (3)  A person contravenes this subsection if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  the person does not have the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia).

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Decisions on whether to give consent

             (4)  The Secretary must, as soon as practicable after making a decision to give a consent, cause particulars of the decision to be published in the Gazette .

             (5)  The Secretary must, within 28 days after making a decision to refuse to give a consent, notify the applicant in writing of the decision and of the reasons for the decision.