National Health (Listing of Pharmaceutical Benefits) Instrument 2024
Summary
The Australian Department of Health has issued the National Health (Listing of Pharmaceutical Benefits) Instrument 2024, which details the listing of pharmaceutical benefits under the National Health Act 1953. This instrument outlines the drugs, forms, administration, brands, and prescription requirements for pharmaceutical benefits.
What changed
The National Health (Listing of Pharmaceutical Benefits) Instrument 2024, effective March 1, 2026, establishes the framework for listing pharmaceutical benefits in Australia under the National Health Act 1953. It specifies which drugs and medicinal preparations are eligible, defines their forms and administration methods, outlines brand requirements, and details the responsibilities of persons associated with these brands. The instrument also covers schedule equivalents and prescription circumstances for both ready-prepared and extemporaneously-prepared pharmaceutical benefits.
This new instrument will require drug manufacturers and pharmaceutical companies to ensure their products and processes align with the specified listing criteria and prescription requirements. Healthcare providers will need to be aware of the updated guidelines for prescribing listed pharmaceutical benefits. Compliance with these provisions is essential for the continued listing and reimbursement of pharmaceutical benefits under the Australian national health system.
What to do next
- Review the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 for specific requirements related to pharmaceutical benefits.
- Ensure all pharmaceutical products and associated processes comply with the new listing, branding, and administration guidelines.
- Update prescribing practices to align with the conditions outlined for authorized prescribers and prescription circumstances.
Source document (simplified)
- Interactions
National Health (Listing of Pharmaceutical Benefits) Instrument 2024
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 F2026C00236 C23 01 March 2026
View document Legislative instrument Filter active Table of contents
- Volume 1
- Part 1—Preliminary
- 1 Name
- 3 Authority
- 4 Simplified outline
- 5 Definitions
- Part 2—Pharmaceutical benefits
- 6 Drugs and medicinal preparations to which Part VII of the Act applies (Act s 85(2))
- 7 Form or forms of a listed drug (Act s 85(3))
- 8 Manner of administration of a form of a listed drug (Act s 85(5))
- 9 Brand of a pharmaceutical item (Act s 85(6))
- 10 Responsible person for a brand of a pharmaceutical item (Act s 84AF(1))
- 11 Schedule equivalents of brands of pharmaceutical items (Act s 85(6A))
- Part 3—Prescription of pharmaceutical benefits
- Division 1—Authorised prescribers and prescription circumstances
- 12 Authorised prescribers (Act s 88)
- 13 Prescription of ready-prepared pharmaceutical benefits in certain circumstances (Act s 85(7))
- 14 Prescription of extemporaneously-prepared pharmaceutical benefits in certain circumstances (Act s 85(7))
- Division 2—Maximum quantities and repeats
- 15 Maximum quantity (number of units)—ready-prepared pharmaceutical benefits (Act s 85A(2)(a), (2A) and (3A))
- 16 Maximum number of repeats—ready-prepared pharmaceutical benefits (Act s 85A(2)(b), (2A) and (3A))
- 17 Maximum quantity—extemporaneously-prepared pharmaceutical benefits (Act s 85A(2)(a))
- 18 Maximum number of repeats—extemporaneously-prepared pharmaceutical benefits (Act s 85A(2)(b))
- Division 3—Authorisation of prescriptions
- 19 Authority required procedures
- Part 4—Quantities of pharmaceutical items
- 20 Pack quantity (Act s 84AK(2))
- 21 Determined quantity (Act s 84AK(3))
- Part 5—Supply of pharmaceutical benefits
- 22 Listed drugs and pharmaceutical benefits that can only be supplied under the prescriber bag provisions (Act s 85(2AA) and (7A))
- 23 Listed drugs and pharmaceutical benefits that can be supplied only under special arrangements (Act s 85(2A) and (8))
- Part 6—Application, saving and transitional provisions
- 24 Transitional provision—authorisation of prescriptions
- Schedule 1—Ready-prepared pharmaceutical benefits
- Part 1—Ready-prepared pharmaceutical benefits for prescription and supply
- 1 Matters relating to pharmaceutical benefits
- Volume 2
- Schedule 1—Ready-prepared pharmaceutical benefits
- Part 1—Ready-prepared pharmaceutical benefits for prescription and supply
- 1 Matters relating to pharmaceutical benefits
- Volume 3
- Schedule 1—Ready-prepared pharmaceutical benefits
- Part 1—Ready-prepared pharmaceutical benefits for prescription and supply
- 1 Matters relating to pharmaceutical benefits
- Volume 4
- Schedule 1—Ready-prepared pharmaceutical benefits
- Part 1—Ready-prepared pharmaceutical benefits for prescription and supply
- 1 Matters relating to pharmaceutical benefits
- Part 2—Ready-prepared pharmaceutical benefits for supply only
- 2 Matters relating to pharmaceutical benefits
- Schedule 2—Extemporaneously-prepared pharmaceutical benefits
- Part 1—Listed drugs that are or may be contained in extemporaneously-prepared pharmaceutical benefits
- 1 Listed drugs and circumstances
- Part 2—Additives that may be contained in extemporaneously-prepared pharmaceutical benefits
- 2 Additives
- Part 3—Maximum quantity and number of repeats
- 3 Maximum quantity and number of repeats
- Schedule 3—Responsible persons
- 1 Codes representing persons
- Volume 5
- Schedule 4—Circumstances, purposes, conditions and variations
- Part 1—Circumstances, purposes and conditions
- 1 Circumstances, purposes and conditions
- Volume 6
- Schedule 4—Circumstances, purposes, conditions and variations
- Part 1—Circumstances, purposes and conditions
- 1 Circumstances, purposes and conditions
- Volume 7
- Schedule 4—Circumstances, purposes, conditions and variations
- Part 1—Circumstances, purposes and conditions
- 1 Circumstances, purposes and conditions
- Volume 8
- Schedule 4—Circumstances, purposes, conditions and variations
- Part 1—Circumstances, purposes and conditions
- 1 Circumstances, purposes and conditions
- Volume 9
- Schedule 4—Circumstances, purposes, conditions and variations
- Part 1—Circumstances, purposes and conditions
- 1 Circumstances, purposes and conditions
- Part 2—Variation rules
- 2 Variation rules
- Volume 10
- Schedule 5—Schedule equivalent groups of brands of pharmaceutical items
- 1 Schedule equivalent groups of brands of pharmaceutical items
- Schedule 6—General statement for drugs for the treatment of hepatitis C
- 1 Criteria for eligibility for drugs for the treatment of chronic hepatitis C
- 2 Assessment of patient
- 3 Treatment regimens
- Endnotes
- Endnote 1—About the endnotes
- Endnote 2—Abbreviation key
- Endnote 3—Legislation history
- Endnote 4—Amendment history
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