National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025N00848 Not in force Notifiable Instrument

Legislation content

 

PB 121 of 2025

 

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2025

I, Rebecca Richardson, as delegate of the Minister for Health and Ageing, make the following Determination.

Dated 21 October 2025    

Rebecca Richardson

Assistant Secretary
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing

Contents

1  Name...................................................1

2  Commencement............................................1

3  Authority................................................1

4  Schedules................................................1

Schedule 1—Amendments—General 2

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 2

Schedule 2—Amendments—Additional designated brands effective from 1 April 2026              3

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 3

 

 

1  Name

 (1) This instrument is the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2025.

 (2) This instrument may also be cited as PB 121 of 2025.

2  Commencement

 (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.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

 

2.  Schedule 1

The day after this instrument is registered.

 

3.  Schedule 2

1 April 2026.

1 April 2026

Note: This table relates only to the provisions of this instrument as originally made.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.

3  Authority

  This instrument is made under subsection 99ADHC(2) of the National Health Act 1953.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

Schedule 1—Amendments—General

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023

1  Section 5 (table)

Omit:

GA gel

Amino acid formula with vitamins and minerals without lysine and low in tryptophan

Sachets containing oral powder 24 g, 30 (GA gel)

Oral

2  Section 5 (table)

Omit:

Estradiol Transdermal System (Sandoz, USA)

Estradiol

Transdermal patches 1.56 mg, 8

Transdermal

3  Section 5 (table)

Omit:

Hymenoptera Yellow Jacket Venom

Insect allergen extract-yellow jacket venom

Injection set containing 550 micrograms with diluent

Injection

4  Section 5 (table)

Omit:

Kevtam 1000

Levetiracetam

Tablet 1 g

Oral

5  Section 5 (table)

Omit:

Levetiracetam Mylan

Levetiracetam

Tablet 1 g

Oral

6  Section 5 (table)

Omit:

Valprease 200

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

7  Section 5 (table)

Omit:

Valprease 500

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

 

Schedule 2—Amendments—Additional designated brands effective from 1 April 2026

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023

1  Section 5 (after table item dealing with the brand Cal-500 of the drug Calcium in the form Tablet, chewable, 500 mg (as carbonate))

Insert:

Carboplatin Accord

Carboplatin

Solution for I.V. injection 450 mg in 45 mL

Injection

2  Section 5 (after table item dealing with the brand Rosuzet Composite Pack of the drug Ezetimibe and rosuvastatin in the form Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium))

Insert:

Atozet

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Ezetast

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Ezetimibe/Atorvastatin GH 10/10

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Atozet

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

Ezetast

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

Ezetimibe/Atorvastatin GH 10/20

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

3  Section 5 (after table item dealing with the brand Ezetimibe/Atorvastatin GH 10/80 of the drug Ezetimibe with atorvastatin in the form Tablet 10 mg-80 mg)

Insert:

APO-Fentanyl

Fentanyl

Transdermal patch 12.6 mg

Transdermal

Fentanyl Sandoz

Fentanyl

Transdermal patch 12.6 mg

Transdermal

APO-Fentanyl

Fentanyl

Transdermal patch 16.8 mg

Transdermal

Fentanyl Sandoz

Fentanyl

Transdermal patch 16.8 mg

Transdermal

APO-Fentanyl

Fentanyl

Transdermal patch 2.1 mg

Transdermal

Fentanyl Sandoz

Fentanyl

Transdermal patch 2.1 mg

Transdermal

APO-Fentanyl

Fentanyl

Transdermal patch 4.2 mg

Transdermal

Fentanyl Sandoz

Fentanyl

Transdermal patch 4.2 mg

Transdermal

APO-Fentanyl

Fentanyl

Transdermal patch 8.4 mg

Transdermal

Fentanyl Sandoz

Fentanyl

Transdermal patch 8.4 mg

Transdermal


4  Section 5 (after table item dealing with the brand Flucil of the drug Flucloxacillin in the form Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL)

Insert:

Leucovorin Calcium (Pfizer Australia Pty Ltd)

Folinic acid

Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

Injection

5  Section 5 (after table item dealing with the brand Nitrolingual Pumpspray of the drug Glyceryl trinitrate in the form Sublingual spray (pump pack) 400 micrograms per dose, 200 doses)

Insert:

Camino Pro Complete

Glycomacropeptide and essential amino acids with vitamins and minerals

Bars 81 g, 7 (Camino Pro Complete)

Oral

PKU Glytactin RTD 15 Lite

Glycomacropeptide and essential amino acids with vitamins and minerals

Oral liquid 250 mL, 30 (PKU Glytactin RTD 15 Lite)

Oral

PKU Glytactin RTD 15

Glycomacropeptide and essential amino acids with vitamins and minerals

Oral liquid 250 mL, 30 (PKU Glytactin RTD 15)

Oral

PKU Build 10

Glycomacropeptide and essential amino acids with vitamins and minerals

Sachets containing oral powder 15 g, 30 (PKU Build 10)

Oral

PKU Build 20

Glycomacropeptide and essential amino acids with vitamins and minerals

Sachets containing oral powder 32 g, 30 (PKU Build 20)

Oral

Camino Pro Bettermilk

Glycomacropeptide and essential amino acids with vitamins and minerals

Sachets containing oral powder 40 g, 30 (Camino Pro Bettermilk)

Oral

 


6  Section 5 (after table item dealing with the brand DBL Heparin Sodium of the drug Heparin in the form Injection 5,000 units (as sodium) in 0.2 ml)

Insert:

KetoVie 3:1

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Oral liquid 250 mL, 30 (KetoVie 3:1)

Oral

KetoVie 4:1

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Oral liquid 250 mL, 30 (KetoVie 4:1)

Oral

KetoVie Peptide 4:1

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Oral liquid 250 mL, 30 (KetoVie Peptide 4:1)

Oral

7  Section 5 (after table item dealing with the brand Oxytrol of the drug Oxybutynin in the form Transdermal patches 36 mg, 8)

Insert:

Oxycodone BNM

Oxycodone

Capsule containing oxycodone hydrochloride 10 mg

Oral

OxyNorm

Oxycodone

Capsule containing oxycodone hydrochloride 10 mg

Oral

Oxycodone BNM

Oxycodone

Capsule containing oxycodone hydrochloride 20 mg

Oral

OxyNorm

Oxycodone

Capsule containing oxycodone hydrochloride 20 mg

Oral

Oxycodone BNM

Oxycodone

Capsule containing oxycodone hydrochloride 5 mg

Oral

OxyNorm

Oxycodone

Capsule containing oxycodone hydrochloride 5 mg

Oral

Pemetrexed Accord

Pemetrexed

Powder for I.V. infusion 1 g (as disodium)

Injection

Pemetrexed SUN

Pemetrexed

Powder for I.V. infusion 1 g (as disodium)

Injection

8  Section 5 (after table item dealing with the brand Lyclear of the drug Permethrin in the form Cream 50 mg per g, 30 g)

Insert:

Nardil

Phenelzine

Tablet 15 mg (as sulfate)

Oral

 


9  Section 5 (after table item dealing with the brand Phenoxymethylpenicillin-AFT of the drug Phenoxymethylpenicillin in the form Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL)

Insert:

Aspecillin VK

Phenoxymethylpenicillin

Tablet 250 mg phenoxymethylpenicillin (as potassium)

Oral

Aspecillin VK

Phenoxymethylpenicillin

Tablet 500 mg phenoxymethylpenicillin (as potassium)

Oral

10  Section 5 (after table item dealing with the brand Teglutik of the drug Riluzole in the form Oral suspension 50 mg per 10 mL, 300 mL)

Insert:

Exelon

Rivastigmine

Capsule 1.5 mg (as hydrogen tartrate)

Oral

Exelon

Rivastigmine

Capsule 3 mg (as hydrogen tartrate)

Oral

Exelon

Rivastigmine

Capsule 4.5 mg (as hydrogen tartrate)

Oral

Exelon

Rivastigmine

Capsule 6 mg (as hydrogen tartrate)

Oral

11  Section 5 (after table item dealing with the brand TENOFOVIR/EMTRICITABINE 300/200 ARX of the drug Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg)

Insert:

Tenofovir/Emtricitabine Sandoz 301/200

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg

Oral

12  Section 5 (after table item dealing with the brand Timoptol of the drug Timolol in the form Eye drops 5 mg (as maleate) per mL, 5 mL)

Insert:

TOBI podhaler

Tobramycin

Capsule containing powder for oral inhalation 28 mg (for use in podhaler)

Inhalation by Mouth

13  Section 5 (after table item dealing with the brand Valproate Winthrop EC 500 of the drug Valproic acid in the form Tablet (enteric coated) containing sodium valproate 500 mg)

Insert:

Vancomycin Juno

Vancomycin

Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

Injection

 

Overview

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2025 was enacted to amend the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This determination was introduced to address the need for adjustments to the floor price of certain pharmaceutical items listed under the National Health Act 1953. The amendments aim to ensure that the pricing of these pharmaceutical items aligns with current market conditions and health policy objectives. Made under the authority of subsection 99ADHC(2) of the National Health Act 1953, this determination was issued by Rebecca Richardson, as delegate of the Minister for Health and Ageing, and is effective from the day after its registration. The primary objective of this amendment is to maintain a fair and affordable pricing structure for essential pharmaceutical items, thereby supporting the broader policy goal of ensuring accessible healthcare for all Australians.

Scope and Application

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2025 amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 to adjust the floor prices for specific pharmaceutical brands, ensuring that these medications remain affordable and accessible to consumers. This amendment applies to designated pharmaceutical brands listed in the Schedules, which include various medications ranging from oral tablets and injections to transdermal patches and powders for inhalation. The amendments made by this Determination are effective from the day after the instrument is registered, with certain changes to be implemented from 1 April 2026 as specified in Schedule 2. This legislation pertains to entities involved in the manufacture, distribution, and sale of pharmaceuticals within Australia, and it is applicable nationally, reflecting the Commonwealth's role in regulating healthcare costs and ensuring equitable access to essential medicines. The amendments exclude any brands not specified in the Schedules, and no specific exemptions or thresholds are mentioned within the text of this Determination. The application and enforcement of this Act may be further defined through subordinate instruments issued by the Department of Health, Disability and Ageing.

Key Provisions

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 4) 2025 modifies the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 by amending the list of pharmaceutical items with designated floor prices. The main operative sections of this Determination include the amendments to the list of designated brands in Schedule 1 and the addition of new designated brands effective from 1 April 2026 in Schedule 2. Specifically, Section 1 (1) names the Determination and Section 2 sets the commencement dates for different parts of the instrument. The commencement date for Sections 1 to 4 and other unspecified provisions is the day after the instrument is registered, while the amendments in Schedule 2 come into effect on 1 April 2026. This Determination imposes specific obligations on pharmaceutical manufacturers, suppliers, and distributors regarding the pricing of certain pharmaceutical items. It requires these entities to adhere to the designated floor prices for the listed brands, ensuring that the prices of these items do not fall below the specified thresholds. The obligation to comply with these pricing regulations is critical for maintaining the integrity of the national health system and ensuring that consumers have access to essential medications at affordable prices. Failure to comply with the provisions of this Determination can result in various consequences. While the Determination itself does not explicitly detail offences, penalties, or consequences for non-compliance, breaches of the National Health Act 1953, under which this Determination is made, can lead to significant penalties. For instance, under the National Health Act, entities found to be in breach of pricing regulations may face substantial fines. The exact penalties would depend on the nature and severity of the breach, but they could include financial penalties and potential legal actions to enforce compliance. Furthermore, persistent non-compliance could result in the revocation of the entity's authority to supply pharmaceutical items under the national health scheme.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.