1Short title
This is the Therapeutic Goods Law Application Act 2024.
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Bill homepageThis is the Therapeutic Goods Law Application Act 2024.
This Act comes into operation as follows —
Part 1 — on the day on which this Act receives the Royal Assent;
the rest of the Act — on a day fixed by proclamation.
In this Act —
amend includes replace;
amending Act means a Commonwealth Act that receives the Royal Assent on or after 27 November 2023 to the extent that it —
amends the Therapeutic Goods Act 1989 (Commonwealth); or
makes or amends a therapeutic legislative instrument;
applied therapeutic goods law means the provisions that apply as a law of the State because of sections 5 and 10;
Commonwealth administrative laws means the following —
the Administrative Appeals Tribunal Act 1975 (Commonwealth) (excluding Part IVA);
the Freedom of Information Act 1982 (Commonwealth);
the Ombudsman Act 1976 (Commonwealth);
the Privacy Act 1988 (Commonwealth);
the legislative instruments in force under those Acts;
Commonwealth therapeutic goods law means —
the Therapeutic Goods Act 1989 (Commonwealth); and
the legislative instruments under that Act;
local regulations means the regulations made under section 26;
therapeutic legislative instrument means a regulation or other legislative instrument for the time being in force under the Therapeutic Goods Act 1989 (Commonwealth).
If a term used in this Act is given a meaning in the Therapeutic Goods Act 1989 (Commonwealth), it has the same meaning in this Act.
This Act binds the Crown in right of Western Australia and, so far as the legislative power of the Parliament permits, the Crown in all its other capacities.
In this section —
Commonwealth therapeutic goods Act means the Therapeutic Goods Act 1989 (Commonwealth) as in force on 27 November 2023 as amended by —
a provision of a law of the Commonwealth that amends the Therapeutic Goods Act 1989 (Commonwealth) that is made before 27 November 2023 but has not come into operation on or before 27 November 2023; and
each provision that —
is in an amending Act that has effect for the purposes of this Part under section 7; and
has come into operation for the purposes of this Part under section 8.
The Commonwealth therapeutic goods Act applies as a law of the State.
The Commonwealth therapeutic goods Act applies under subsection (2) —
as modified by local regulations (if any) made for the purposes of section 15; and
as if it extended to matters in relation to which the State may make laws —
whether or not the Commonwealth may make laws in relation to those matters; and
even though the terms of the Commonwealth therapeutic goods Act provides that it applies only to specified matters with respect to which the Commonwealth may make laws.
Note for this subsection:
For paragraph (b)(ii), the Therapeutic Goods Act 1989 (Commonwealth) section 6 sets out specified matters to which that Act applies.
The provisions of the Commonwealth therapeutic goods Act that apply as a law of the State because of this section apply as a part of this Act.
An amending Act must be laid before each House of Parliament within 18 sitting days of the House after the day on which the Act receives the Royal Assent.
In this section —
disallowance period, in relation to a disallowance resolution of which notice is given in a House of Parliament, means the period of 30 sitting days of the House after the day on which the notice is given;
disallowance resolution means a resolution that an amending Act be disallowed;
notice period, in relation to an amending Act laid before a House of Parliament under section 6, means the period of 14 sitting days of the House after the day on which the amending Act is laid before it.
An amending Act has effect for the purposes of this Part if the amending Act is laid before each House of Parliament under section 6 and either —
no notice of a disallowance resolution is given in either House within the notice period; or
at least 1 notice of a disallowance resolution is given in a House within the notice period and, for each such notice, 1 of the following applies —
the notice is withdrawn or discharged within the disallowance period;
the disallowance resolution is lost in the House or not agreed to within the disallowance period.
For the purposes of this section and section 6 —
the period specified in section 6, a notice period or a disallowance period continues to run even though a House of Parliament is prorogued or dissolved or expires; and
notice of a disallowance resolution given in a House of Parliament, or a motion that an amending Act be disallowed in the House, does not lapse even though the House is prorogued or dissolved or expires.
If an amending Act has effect for the purposes of this Part under section 7(2), the Governor must declare that fact by proclamation as soon as practicable.
If a provision of the amending Act has come into operation in the Commonwealth before the proclamation is published —
the proclamation must fix a day on which the provision comes into operation for the purposes of this Part, which must be on or after the day on which the proclamation is published; and
the provision comes into operation for the purposes of this Part on that day.
If a provision of the amending Act has not come into operation in the Commonwealth before the proclamation is published, the provision comes into operation for the purposes of this Part when the provision comes into operation in the Commonwealth.
In this section —
parliamentary committee means a committee established by either or both of the Houses of Parliament.
If a Standing Order of a House of Parliament provides that on the publication of an instrument under a written law the instrument is referred to a parliamentary committee for consideration, the laying of an amending Act before the House under section 6 is taken to be publication of the amending Act for the purposes of the Standing Order.
This section does not apply if the Standing Orders of the House provide specifically for an amending Act to be considered by a parliamentary committee.
A therapeutic legislative instrument applies as a law of the State.
A therapeutic legislative instrument has effect for the purposes of its application under subsection (1) subject to —
any modifications made by local regulations for the purposes of section 15; and
to the extent the therapeutic legislative instrument is made under the Therapeutic Goods Act 1989 (Commonwealth) on or after 27 November 2023 — sections 11 and 13; and
to the extent the therapeutic legislative instrument is made by a provision of an amending Act — subsection (3).
A therapeutic legislative instrument, to the extent made by a provision of an amending Act, has effect for the purposes of its application under subsection (1) if —
the amending Act has effect for the purposes of this Part under section 7; and
the provision has come into operation for the purposes of this Part under section 8.
The provisions of a therapeutic legislative instrument that apply as a law of the State because of this section apply as subsidiary legislation for the purposes of this Act.
Note for this section:
Under section 14, the Interpretation Act 1984 does not apply to therapeutic legislative instruments that are subsidiary legislation for the purposes of this Act.
This section applies to a provision of a therapeutic legislative instrument made under the Therapeutic Goods Act 1989 (Commonwealth) if the provision is made under or for the purposes of —
a provision inserted into the Therapeutic Goods Act 1989 (Commonwealth) by a provision of an amending Act; or
a provision of the Therapeutic Goods Act 1989 (Commonwealth) as amended by a provision of an amending Act.
The provision of the therapeutic legislative instrument does not have effect for the purposes of its application under section 10(1) until the later of —
the day on which the provision of the amending Act comes into operation for the purposes of this Part under section 8; and
the day on which the provision of the therapeutic legislative instrument comes into operation in the Commonwealth.
However, if the amending Act does not have effect for the purposes of this Part under section 7, the provision of the therapeutic legislative instrument does not have effect for the purposes of its application under section 10(1).
This section applies to a therapeutic legislative instrument made under the Therapeutic Goods Act 1989 (Commonwealth) on or after 27 November 2023.
No later than 18 days after the day on which the therapeutic legislative instrument is made, 1 of the following must occur —
the therapeutic legislative instrument is published in the Gazette;
the therapeutic legislative instrument is published on the WA legislation website;
notice is published in the Gazette —
stating that the therapeutic legislative instrument is published on a website; and
stating the website on which the instrument is published.
For the purposes of subsection (2)(c), the website must be a website maintained by or on behalf of the State or the Commonwealth.
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