Document ID: chunk:federal_register_of_legislation:C2010A00054:clause:1_32co:p1
Version: federal_register_of_legislation:C2010A00054
Segment Type: clause
Provision Reference: sch 1 cl 32CO (pt 1/2)
Character Range: 71261–74027

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) either:
 (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); or
 (ii) an application that complies with section 32DA or 32DD has been made for inclusion of the biological in the Register; 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.
 (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;
if the Secretary is satisfied that:
 (c) there are no therapeutic goods that are included in the Register that could act as a substitute for the biological; and
 (d) an application that complies with section 32DA or 32DD has been made for inclusion of the biological in the Register; 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.

Application for approval
 (3) An application for an approval must:
 (a) be made to the Secretary; and
 (b) be accompanied by such information relating to the biological as is required by the Secretary.

Secretary's decision
 (4) If an application for an approval is made, the Secretary must, after having considered the application, notify the applicant of the decision on the application as soon as practicable after making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision.

Determinations
 (5) The Secretary may, by legislative instrument, make a determination specifying foreign countries for the purposes of subparagraph (1)(d)(i).
 (6) The Secretary may, by legislative instrument, make a determination specifying the kinds of biologicals that can be the subject of an approval under this section.

Conditions
 (7) The Secretary may grant an approval subject to any conditions that are specified in the notice of approval.
 (8) A person commits an offence if:
 (a) the