Document ID: chunk:federal_register_of_legislation:C2021A00008:clause:4_9k:p1
Version: federal_register_of_legislation:C2021A00008
Segment Type: clause
Provision Reference: sch 4 cl 9K (pt 1/2)
Character Range: 12374–15357

9K  Prohibition on import, export, manufacture or supply of therapeutic goods—international agreements

Prohibition on therapeutic goods themselves
 (1) If therapeutic goods are the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:
 (a) the import into Australia of the therapeutic goods;
 (b) the export from Australia of the therapeutic goods;
 (c) the manufacture in Australia of the therapeutic goods;
 (d) the supply in Australia of the therapeutic goods.
 (2) Before regulations are made prescribing an international agreement for the purposes of subsection (1), the Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of certain goods.

Prohibition on therapeutic goods containing an ingredient or component
 (3) If an ingredient or component of therapeutic goods is the subject of an international agreement prescribed for the purposes of this subsection, the regulations may prohibit one or more of the following:
 (a) the import into Australia of all or specified therapeutic goods that contain that ingredient or component;
 (b) the export from Australia of all or specified therapeutic goods that contain that ingredient or component;
 (c) the manufacture in Australia of all or specified therapeutic goods that contain that ingredient or component;
 (d) the supply in Australia of all or specified therapeutic goods that contain that ingredient or component.
 (4) Before regulations are made prescribing an international agreement for the purposes of subsection (3), the Minister must be satisfied that the agreement requires parties to the agreement to take steps to prohibit or restrict one or more of the import, export, manufacture and supply of goods containing that ingredient or component.

Nature of prohibition
 (5) A prohibition referred to in subsection (1) or (3) may be absolute or be subject to such conditions as are prescribed.

Procedural requirements for regulations containing prohibition
 (6) Regulations containing a prohibition referred to in subsection (1) or (3) must not be made unless:
 (a) the Minister causes to be published on the Department's website a notice setting out details of:
 (i) the international agreement; and
 (ii) the Minister's satisfaction mentioned in subsection (2) or (4); and
 (iii) the proposed prohibition; and
 (b) a period of 30 days has passed since the notice was published.

Commencement of regulations containing prohibition
 (7) Regulations containing a prohibition referred to in subsection (1) or (3) must not be expressed to commence on a day earlier than the day the international agreement enters into force for Australia.

Content of regulations containing prohibition
 (8) Without limiting subsection (5), regulations prescribing conditions referred to in that subsection may do one or