Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32co:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32CO (pt 1/3)
Character Range: 453913–456698

32CO  Approvals where substitutes for biologicals are unavailable etc.
 (1) The Secretary may, by notice in writing, grant an approval to a person for:
 (a) the importation into Australia of a specified biological; or
 (b) the importation into Australia of a specified biological and the supply in Australia of that biological;
if the Secretary is satisfied that:
 (c) therapeutic goods included in the Register that could act as a substitute for the biological are unavailable or are in short supply; and
 (d) any of the following conditions is satisfied:
 (i) the biological that is the subject of the application for approval is registered or approved for general marketing in at least one foreign country specified by the Secretary under subsection (5);
 (ii) an application that complies with section 32DA has been made for inclusion of the biological in the Register;
 (iii) an application under section 32DD has been made for inclusion of the biological in the Register, and the application has passed preliminary assessment; and
 (e) the biological is of a kind specified by the Secretary in a determination under subsection (6); and
 (f) the approval is necessary in the interests of public health.
 (1A) The Secretary may, by notice in writing, grant an approval to a person for:
 (a) the importation into Australia of a specified biological; or
 (b) the importation into Australia of a specified biological and the supply in Australia of that biological;
if the Secretary is satisfied that:
 (c) therapeutic goods included in the Register that could act as a substitute for the biological are unavailable or are in short supply; and
 (d) either:
 (i) the biological that is the subject of the application for approval is not registered or approved for general marketing in any of the foreign countries specified by the Secretary under subsection (5); or
 (ii) the biological that is the subject of the application for approval is registered or approved for general marketing in at least one foreign country specified by the Secretary under subsection (5), but is not readily available for importation into, and supply in, Australia; and
 (e) the biological is registered or approved for general marketing in a foreign country; and
 (f) the manufacturing and quality control procedures used in the manufacture of the biological are acceptable; and
 (g) the biological is of a kind specified by the Secretary in a determination under subsection (6); and
 (h) the approval is necessary in the interests of public health.
 (2) The Secretary may, by notice in writing, grant an approval to a person for:
 (a) the importation into Australia of a specified biological; or
 (b) the importation into Australia of a specified biological and the supply in Australia of that biological;