National Health (Originator Brand) Determination 2025
Summary
The Australian Department of Health has issued the National Health (Originator Brand) Determination 2025 under the National Health Act 1953. The instrument defines what constitutes an 'originator brand' for the purposes of pharmaceutical regulation and Schedule 1 lists the specific originator brands. This determination affects how medicines are classified, priced, and substituted under Australia's pharmaceutical regulatory framework.
What changed
The National Health (Originator Brand) Determination 2025 establishes the criteria and lists the brands that qualify as originator brands under the National Health Act 1953. Schedule 1 contains the enumerated originator brands. Section 6 provides the definitional framework for originator brand determination.
Pharmaceutical companies seeking originator brand status for their medicines will be directly affected, as this determination governs PBS pricing arrangements and whether generic substitution rules apply. Healthcare providers and dispensers should verify whether specific medicines are classified as originator brands, which affects prescription substitution practices. The instrument operates within the broader pharmaceutical pricing and reimbursement framework established by the National Health Act.
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Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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National Health (Originator Brand) Determination 2025
In force Administered by
- Department of Health, Disability and Ageing
This item is authorised by the following title:
- National Health Act 1953 Latest version View as made version F2026C00332 C03 01 April 2026
View document Legislative instrument Filter active Table of contents
- 1 Name
- 4 Authority
- 5 Definitions
- 6 Originator Brand
- Schedule 1–Originator Brand
- Endnotes
- Endnote 1—About the endnotes
- Endnote 2—Abbreviation key
- Endnote 3—Legislation history
- Endnote 4—Amendment history
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