Therapeutic Goods Act 1989

The regulations may make provision for and in relation to:

exempting a person from liability to pay annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year (the current year) if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value; and

the making of an application for an exemption and requiring payment of that charge for the current year if the application is refused; and

cancelling an exemption and requiring payment of that charge for the current year.

The regulations may require applications for exemptions to be accompanied by a specified fee. A fee must not be such as to amount to taxation.

The regulations may require a person who is applying for an exemption, or who has been granted an exemption, to provide a statement:

that is prepared by an approved person; and

that specifies whether the person’s turnover of the therapeutic goods concerned for the financial year concerned is of low value.

The regulations may provide for the obtaining of additional information or documents from applicants for exemptions or persons granted exemptions.

The regulations may provide for review by the Administrative Review Tribunal of decisions of the Secretary to refuse applications for exemptions or to cancel exemptions.

Subsections (2) to (5) do not limit subsection (1).

For the purposes of this section, the regulations may specify when a person’s turnover of therapeutic goods for a financial year is of low value. The regulations may specify different rules for different therapeutic goods.

This section does not limit paragraph 63(3)(b) (about the refund, reduction or waiving of fees or charges).

In this section: