Therapeutic Goods Act 1989

A person contravenes this subsection if:

the person imports therapeutic goods into Australia; and

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

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

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

Subsection (1) does not apply if:

the therapeutic goods are a biological; and

the person imports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

A person contravenes this subsection if:

the person supplies therapeutic goods for use in Australia; and

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

the goods do not conform with a standard applicable to the goods.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

Subsection (2) does not apply if:

the therapeutic goods are a biological; and

the person supplies the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

A person contravenes this subsection if:

the person exports therapeutic goods from Australia; and

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

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).

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

Subsection (3) does not apply if:

the therapeutic goods are a biological; and

the person exports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

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 or on the Department’s website.

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.

The Secretary is not required to consider giving an applicant a consent unless the applicant has paid the fee that is prescribed by the regulations for the processing of the applicant’s application for a consent.