Document ID: chunk:federal_register_of_legislation:C2023A00010:clause:9_2
Version: federal_register_of_legislation:C2023A00010
Segment Type: clause
Provision Reference: sch 9 cl 2
Character Range: 32795–35012

2  After subsection 19A(2)
Insert:
 (2A) The Secretary may, by notice in writing, grant an approval to a person for the importation into Australia, or the supply in Australia, of specified therapeutic goods (the subject goods) if the Secretary is satisfied:
 (a) that there are no registered goods that could act as a substitute for the subject goods; and
 (b) either:
 (i) that previously registered goods could act as a substitute for the subject goods; or
 (ii) that therapeutic goods whose registration is suspended under section 29D could act as a substitute for the subject goods; and
 (c) that the subject goods are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); and
 (d) that the subject goods are of a kind included in Schedule 10 to the Therapeutic Goods Regulations 1990; and
 (e) that the approval is necessary in the interests of public health.
 (2B) The Secretary may, by notice in writing, grant an approval to a person for the importation into Australia, or the supply in Australia, of specified therapeutic goods (the subject goods) if the Secretary is satisfied:
 (a) that there are no registered goods that could act as a substitute for the subject goods; and
 (b) either:
 (i) that previously registered goods could act as a substitute for the subject goods; or
 (ii) that therapeutic goods whose registration is suspended under section 29D could act as a substitute for the subject goods; and
 (c) that all of the following apply:
 (i) the subject goods are not registered or approved for general marketing in any of the foreign countries specified by the Secretary in a determination under subsection (3);
 (ii) the subject goods are registered or approved for general marketing in at least one foreign country that is not specified by the Secretary in a determination under subsection (3);
 (iii) the manufacturing and quality control procedures used in the manufacture of the subject goods are acceptable; and
 (d) that the subject goods are of a kind included in Schedule 10 to the Therapeutic Goods Regulations 1990; and
 (e) that the approval is necessary in the interests of public health.