Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The Secretary may, by written notice given to the person in relation to whom a biological is included in the Register, cancel the entry of the biological from the Register if:
(a) the Secretary is satisfied that there would be an imminent risk of death, serious illness or serious injury if the biological continued to be included in the Register; or
(b) the biological ceases to be a biological or the biological becomes covered by an order under section 7 declaring goods not to be therapeutic goods; or
(c) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); or
(d) the person requests in writing the cancellation of the entry of the biological from the Register; or
(e) the biological contains substances that are prohibited imports for the purposes of the Customs Act 1901 ; or
(f) the Secretary is satisfied that a statement made in, or in connection with, the application for including the biological in the Register was false or misleading in a material particular; or
(g) the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the biological in the Register is not paid within 28 days after it becomes payable; or
(h) the person has failed to comply with a condition mentioned in subsection 32EA(1) or (3); or
(i) the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the biological and the Secretary is satisfied that the contravention is significant; or
(j) if the person is a body corporate--a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the biological and the Secretary is satisfied that the contravention is significant; or
(k) there is a breach, involving the biological, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under Part 5 - 1 or under the regulations, and the Secretary is satisfied that:
(i) the breach is significant; and
(ii) as a result of the breach, the presentation of the biological is misleading to a significant extent.
(1AA) Paragraph (1)(k) does not apply to export only biologicals.
(1A) The Secretary must, by written notice given to the person in relation to whom a biological is included in the Register, cancel the entry of the biological from the Register if the Secretary is satisfied that:
(a) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--imports into Australia, exports from Australia or supplies in Australia of the biological would contravene one or more of those prohibitions; or
(b) if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions--imports into Australia, exports from Australia or supplies in Australia of the biological would contravene one or more of those conditions.
(2) A notice under subsection (1) or (1A) is not a legislative instrument.