Therapeutic Goods Act 1989

If:

proceedings for the contravention of section 42EA (a civil penalty provision) are brought against a person; and

in the proceedings it appears to the Court that the person has, or may have, contravened that section but that:

the person has a reasonable excuse; and

having regard to all the circumstances of the case, the person ought fairly to be excused for the contravention;

If a person thinks that proceedings for the contravention of section 42EA will or may be begun against them, they may apply to the Court for relief.

On an application under subsection (2), the Court may grant relief under subsection (1) as if proceedings had been begun in the Court.

For the purposes of subsection (2) as applying for the purposes of a case tried by a judge with a jury:

a reference in that subsection to the Court is a reference to the judge; and

the relief that may be granted includes withdrawing the case in whole or in part from the jury and directing judgment to be entered for the person on such terms as to costs as the judge thinks appropriate.

This section does not apply to civil proceedings against a person for manufacturing therapeutic goods in Australia that are counterfeit (see subparagraph 42EA(a)(i)).