Document ID: chunk:federal_register_of_legislation:C2024C00632:section:19a:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 19A (pt 2/3)
Character Range: 146398–149125

that could act as a substitute for the goods do not exist; and
 (b) an application under section 23 has been made for registration of the goods; and
 (ba) the application has passed preliminary assessment; and
 (c) the goods are of a kind:
 (i) included in Schedule 10 to the Therapeutic Goods Regulations 1990; or
 (ii) specified by the Secretary in a determination under subsection (4); and
 (d) the approval is necessary in the interests of public health.
 (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.
 (3) The Secretary may make written determinations specifying foreign countries for the