Document ID: chunk:federal_register_of_legislation:C2017A00047:clause:12_2
Version: federal_register_of_legislation:C2017A00047
Segment Type: clause
Provision Reference: sch 12 cl 2
Character Range: 60550–61861

2  After subsection 19A(1)
Insert:
 (1A) 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 if the Secretary is satisfied that:
 (a) registered goods that could act as a substitute for the goods are unavailable or are in short supply; and
 (b) either:
 (i) the goods that are the subject of the application are not registered or approved for general marketing in any of the foreign countries specified by the Secretary in a determination under subsection (3); or
 (ii) the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3), but are not readily available for importation into, and supply in, Australia; and
 (c) the goods are registered or approved for general marketing in a foreign country; and
 (d) the manufacturing and quality control procedures used in the manufacture of the goods are acceptable; and
 (e) the goods are of a kind:
 (i) included in Schedule 10 of the Therapeutic Goods Regulations; or
 (ii) specified by the Secretary in a determination under subsection (4); and
 (f) the approval is necessary in the interests of public health.