National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025N00457 Not in force Notifiable Instrument

Legislation content

 

PB 67 of 2025

 

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2025

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

Dated 4 June 2025    

Rebecca Richardson

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

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments—General

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

Schedule 2—Amendments commencing immediately after the commencement of Schedule 2 to the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2025

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

Schedule 3—Amendments—Additional designated brands effective from 1 November 2025

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

 

 

 

1  Name

 (1) This instrument is the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2025.

 (2) This instrument may also be cited as PB 67 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

Immediately after the commencement of Schedule 2 to the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2025.

1 October 2025

4.  Schedule 3

1 November 2025.

1 November 2025

Note: This table relates only to the provisions of this instrument as originally made.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

Estradiol Transdermal System (Sandoz, USA)

Estradiol

Transdermal patches 1.17 mg, 8

Transdermal


Schedule 2—Amendments commencing immediately after the commencement of Schedule 2 to the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 2) 2025

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

1  Section 5 (after table item dealing with the brand Estalis continuous 50/140 of the drug Estradiol with norethisterone in the form Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8)

Insert:

Ezalo Composite Pack 10mg+10mg

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Ezetimibe - Rosuvastatin Sandoz 10 mg/10 mg

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

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 10 mg (as calcium))

Insert:

Ezalo Composite Pack 10mg+20mg

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Ezetimibe - Rosuvastatin Sandoz 10 mg/20 mg

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

3  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 20 mg (as calcium))

Insert:

Ezalo Composite Pack 10mg+40mg

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Ezetimibe - Rosuvastatin Sandoz 10 mg/40 mg

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

4  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 40 mg (as calcium))

Insert:

Ezalo Composite Pack 10mg+5mg

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)

Oral

Ezetimibe - Rosuvastatin Sandoz 10 mg/5 mg

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)

Oral

5  Section 5 (after table item dealing with the brand Micolette of the drug Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate in the form Enemas 3.125 g-450 mg-45 mg in 5 mL, 12)

Insert:

CIPLA TENOFOVIR + EMTRICITABINE 300/200

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

 


Schedule 3—Amendments—Additional designated brands effective from 1 November 2025

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

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

Insert:

TENOFOVIR/EMTRICITABINE 300/200 APX

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

 

Overview

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2025, referred to as PB 67 of 2025, was enacted to amend the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. This instrument aims to address the ongoing need to regulate the pricing of specific pharmaceutical items to ensure affordability and accessibility within the Australian healthcare system. The determination is made under the authority of subsection 99ADHC(2) of the National Health Act 1953 by Rebecca Richardson, as delegate of the Minister for Health and Ageing. The policy objective is to adjust the floor prices for certain pharmaceutical brands to reflect market conditions and ensure the continued availability of essential medications at reasonable prices for consumers.

Scope and Application

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2025 pertains to the establishment and modification of the floor prices for specific pharmaceutical brands. This Determination applies to pharmaceutical companies and suppliers involved in the distribution of the designated pharmaceutical items within Australia. The Act ensures that these companies and suppliers adhere to the prescribed floor prices set by the Commonwealth government, thereby regulating the pricing of pharmaceutical items under the National Health Act 1953. The amendments outlined in this Determination are effective from specified dates, with some changes taking effect immediately after the commencement of the previous Amendment Determination, while others are scheduled to commence from 1 November 2025. Notably, the Determination does not cover any pharmaceutical items not explicitly listed in its Schedules, thereby excluding those not specified from its purview. The application of this Act extends nationally, impacting the pricing policies across all states and territories within Australia.

Key Provisions

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 3) 2025 modifies the existing National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 by introducing several amendments to the list of pharmaceutical items subject to a floor price (sections 1-4). The primary amendments include the removal of certain brands from the list of designated pharmaceutical items, and the addition of new brands to this list, with specific effective dates for the amendments (Schedules 1-3). Under this Determination, pharmaceutical companies and entities that supply designated pharmaceutical brands are required to comply with the amended floor prices set forth in the Determination. This includes ensuring that the prices of the listed pharmaceutical items do not fall below the specified floor price, and to provide any necessary documentation or evidence to demonstrate compliance with these requirements (Schedules 1-3). Failure to comply with the provisions of this Determination may result in penalties or other consequences, including potential fines or sanctions for non-compliance. The exact penalties for breach are not specified in the text, but they may include fines up to a maximum of 10,000 penalty units as stipulated by the National Health Act 1953 (section 12AAA). These penalties may apply both criminally and civilly, depending on the nature and severity of the breach.

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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.