Therapeutic Goods Act 1989

A person contravenes this section if:

the person does any of the following:

imports therapeutic goods into Australia;

exports therapeutic goods from Australia;

manufactures therapeutic goods in Australia;

supplies therapeutic goods in Australia; and

the person is the sponsor of the goods for use in humans; and

the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:

the manufacturer of the goods;

premises used in the manufacture of the goods.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

For the purposes of paragraph (1)(c):

a manufacturer is properly notified to the Secretary if:

the manufacturer was nominated, as a manufacturer of the goods, in an application for the registration or listing of the goods; or

the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the goods; and

premises are properly notified to the Secretary if:

the premises were nominated, as premises used in the manufacture of the goods, in an application for the registration or listing of the goods; or

the Secretary was subsequently informed in writing that the premises are used in the manufacture of the goods.