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(1) This instrument is the National Health (Originator Brand) Determination 2025. (2) This instrument may also be cited as PB 114 of 2025.
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Commonwealth legislation
This instrument designates which pharmaceutical brands count as “originator brands” under the National Health Act by listing them in Schedule 1. Designations apply to all brands containing the same listed drug, and can be limited by manner of administration or form (s 6). It repeals the 2015 determination and takes effect 1 October 2025 (ss 2–4). This changes how brands are classified under the Act, so sponsors, manufacturers and others regulated by the Act must follow the Schedule 1 listings and the Act’s exemption rule (note to s 6).
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Direct links to the current provisions in National Health (Originator Brand) Determination 2025.
(1) This instrument is the National Health (Originator Brand) Determination 2025. (2) This instrument may also be cited as PB 114 of 2025.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Commencement information</span></p></td></tr><tr><td style="width:25.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:52.54%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:22.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td></tr><tr><td style="width:25.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Provisions</span></p></td><td style="width:52.54%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Commencement</span></p></td><td style="width:22.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Date/Details</span></p></td></tr></thead><tbody><tr><td style="width:25.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1.</span><span> </span><span>The whole of this instrument</span></p></td><td style="width:52.54%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1</span><span> </span><span>October 2025</span></p></td><td style="width:22.04%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1</span><span> </span><span>October 2025</span></p></td></tr></tbody></table>
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
The National Health (Originator Brand) Determination 2015 (PB 100 of 2015) is repealed.
This instrument is made under subsection 99ADB(6B) of the National Health Act 1953.
Note: A number of expressions used in this instrument are defined in section 84 of the Act, including the following:
(a) brand
(b) exempt item
(c) pharmaceutical item
In this instrument:
Act means the National Health Act 1953.
(1) For subsection 99ADB(6B) of the Act, unless subsections (2) or (3) of this section apply, an originator brand specified in column 3 of an item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2 of the same item in Schedule 1. (2) Where a manner of administration is specified in column 4 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 of the same item in Schedule 1. (3) Where a form is specified in column 5 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 and the form specified in column 5 of the same item in Schedule 1.
Note: A brand of an exempt item is not an originator brand due to section 99ADA of the Act.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(1) This instrument is the National Health (Originator Brand) Determination 2025. (2) This instrument may also be cited as PB 114 of 2025.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Commencement information</span></p></td></tr><tr><td style="width:25.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:52.54%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:22.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td></tr><tr><td style="width:25.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Provisions</span></p></td><td style="width:52.54%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Commencement</span></p></td><td style="width:22.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Date/Details</span></p></td></tr></thead><tbody><tr><td style="width:25.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1.</span><span> </span><span>The whole of this instrument</span></p></td><td style="width:52.54%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1</span><span> </span><span>October 2025</span></p></td><td style="width:22.04%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1</span><span> </span><span>October 2025</span></p></td></tr></tbody></table>
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
The National Health (Originator Brand) Determination 2015 (PB 100 of 2015) is repealed.
This instrument is made under subsection 99ADB(6B) of the National Health Act 1953.
Note: A number of expressions used in this instrument are defined in section 84 of the Act, including the following:
(a) brand
(b) exempt item
(c) pharmaceutical item
In this instrument:
Act means the National Health Act 1953.
(1) For subsection 99ADB(6B) of the Act, unless subsections (2) or (3) of this section apply, an originator brand specified in column 3 of an item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2 of the same item in Schedule 1. (2) Where a manner of administration is specified in column 4 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 of the same item in Schedule 1. (3) Where a form is specified in column 5 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 and the form specified in column 5 of the same item in Schedule 1.
Note: A brand of an exempt item is not an originator brand due to section 99ADA of the Act.