Commonwealth Coat of Arms of Australia

 

PB 145 of 2024

 

National Health (Minimum Stockholding) Amendment Determination (No. 12) 2024

I, Eden Simon, as delegate of the Minister for Health and Aged Care, make the following determination.

Dated 20 December 2024

Eden Simon

Acting Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health and Aged Care

 

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments commencing 1 January 2025

National Health (Minimum Stockholding) Determination 2023

Schedule 2—Amendments commencing 1 April 2025

National Health (Minimum Stockholding) Determination 2023

Schedule 3—Amendments commencing immediately after the commencement of Schedule 2 to the National Health (Minimum Stockholding) Amendment Determination (No. 10) 2024 – 1 April 2025

National Health (Minimum Stockholding) Determination 2023

Schedule 4—Amendments commencing 1 June 2025

National Health (Minimum Stockholding) Determination 2023

 

 

 

1  Name

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 12) 2024.

 (2) This instrument may also be cited as PB 145 of 2024.

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

1 January 2025.

1 January 2025

2.  Schedule 1

1 January 2025.

1 January 2025

3.  Schedule 2

1 April 2025.

1 April 2025

4.  Schedule 3

Immediately after the commencement of Schedule 2 to the National Health (Minimum Stockholding) Amendment Determination (No. 10) 2024.

1 April 2025

4.  Schedule 4

1 June 2025.

1 June 2025

 (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 99AEKC(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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1Amendments commencing 1 January 2025

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Omit:

Atenolol

Oral solution 50 mg in 10 mL, 300 mL

Oral

AtenololAFT

4 months stock by reference to usual PBS demand

substitute:

Atenolol

Oral solution 50 mg in 10 ml, 300 ml

Oral

Atenolol-AFT

(a) between 1 January 2025 and 31 May 2025—4 months stock by reference to usual PBS demand

(b) after 31 May 2025—6 months stock by reference to usual PBS demand

2  Schedule 1 (table)

Omit:

Bisoprolol

Tablet containing bisoprolol fumarate 10 mg

Oral

Cipla Bisoprolol

between 1 July 2024 and 31 December 2024—0 months stock by reference to usual demand

Bisoprolol

Tablet containing bisoprolol fumarate 2.5 mg

Oral

Cipla Bisoprolol

between 1 July 2024 and 31 December 2024—0 months stock by reference to usual demand

Bisoprolol

Tablet containing bisoprolol fumarate 5 mg

Oral

Cipla Bisoprolol

between 1 July 2024 and 31 December 2024—0 months stock by reference to usual demand

3  Schedule 1 (table)

Omit:

Cefazolin

Powder for injection 1 g (as sodium)

Injection

Cefazolin-AFT

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

substitute:

Cefazolin

Powder for injection 1 g (as sodium)

Injection

Cefazolin-AFT

300,000 packs of a pack quantity of 5

4  Schedule 1 (table)

Omit:

Celecoxib

Capsule 100 mg

Oral

NOUMED CELECOXIB

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Celecoxib

Capsule 200 mg

Oral

NOUMED CELECOXIB

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

5  Schedule 1 (table)

Omit:

Duloxetine

Capsule 30 mg (as hydrochloride)

Oral

Cymbalta

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Duloxetine

Capsule 60 mg (as hydrochloride)

Oral

Cymbalta

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

6  Schedule 1 (table)

Omit:

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Prozac 20

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

7  Schedule 1 (table)

Omit:

Hypromellose

Eye drops 3 mg per mL, 10 mL

Application to the Eye

Genteal

between 1 July 2024 and 31 December 2024—0 months stock by reference to usual demand

Hypromellose

Eye drops 3 mg per mL, 10 mL

Application to the Eye

In a Wink Moisturising

between 1 July 2024 and 31 December 2024—0 months stock by reference to usual demand

8  Schedule 1 (table)

Omit:

Lamotrigine

Tablet 100 mg

Oral

NOUMED LAMOTRIGINE

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Lamotrigine

Tablet 200 mg

Oral

NOUMED LAMOTRIGINE

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Lamotrigine

Tablet 25 mg

Oral

NOUMED LAMOTRIGINE

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Lamotrigine

Tablet 50 mg

Oral

NOUMED LAMOTRIGINE

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Lansoprazole

Capsule 30 mg

Oral

NOUMED LANSOPRAZOLE

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

9  Schedule 1 (table item dealing with the drug Methoxyflurane, column number 4)

Omit “Penthrox”, substitute “Penthrox (Combination Pack)”.

10  Schedule 1 (table)

Omit:

Nortriptyline

Tablet 10 mg (as hydrochloride)

Oral

NortriTABS 10 mg

between 1 October 2024 and 31 December 2024—0 months stock by reference to usual demand

Nortriptyline

Tablet 25 mg (as hydrochloride)

Oral

NortriTABS 25 mg

between 1 October 2024 and 31 December 2024—0 months stock by reference to usual demand

11  Schedule 1 (table)

Omit:

Phenoxymethylpenicillin

Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL

Oral

Phenoxymethylpenicillin-AFT

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

12  Schedule 1 (table)

Omit:

Pregabalin

Capsule 150 mg

Oral

NOUMED PREGABALIN

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Pregabalin

Capsule 25 mg

Oral

NOUMED PREGABALIN

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Pregabalin

Capsule 300 mg

Oral

NOUMED PREGABALIN

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Pregabalin

Capsule 75 mg

Oral

NOUMED PREGABALIN

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

13  Schedule 1 (table)

Omit:

Ramipril

Tablet 1.25 mg

Oral

Tryzan Tabs 1.25

(a) between 1 July 2023 and 31 December 2023—1 month stock by reference to usual demand

(b) after 31 December 2023—3 months stock by reference to usual demand

substitute:

Ramipril

Tablet 1.25 mg

Oral

Ramipril Viatris

(a) between 1 January 2025 and 28 February 2025—3 months stock by reference to usual demand of Tryzan Tabs 1.25

(b) after 28 February 2025—3 months stock by reference to usual demand of both Ramipril Viatris and Tryzan Tabs 1.25 added together

14  Schedule 1 (table)

After:

Ramipril

Tablet 1.25 mg

Oral

Ramipril Viatris

(a) between 1 January 2025 and 28 February 2025—3 months stock by reference to usual demand of Tryzan Tabs 1.25

(b) after 28 February 2025—3 months stock by reference to usual demand of both Ramipril Viatris and Tryzan Tabs 1.25 added together

insert:

Ramipril

Tablet 10 mg

Oral

Ramipril Viatris

after 28 February 2025—6 months stock by reference to usual demand of both Ramipril Viatris and Tryzan Tabs 10 added together

Ramipril

Tablet 2.5 mg

Oral

Ramipril Viatris

after 28 February 2025—6 months stock by reference to usual demand of both Ramipril Viatris and Tryzan Tabs 2.5 added together

Ramipril

Tablet 5 mg

Oral

Ramipril Viatris

after 28 February 2025—6 months stock by reference to usual demand of both Ramipril Viatris and Tryzan Tabs 5 added together

15  Schedule 1 (table)

Omit:

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

NOUMED SERTRALINE

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

NOUMED SERTRALINE

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

16  Schedule 1 (table)

Omit:

Simvastatin

Tablet 10 mg

Oral

NOUMED SIMVASTATIN

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Simvastatin

Tablet 20 mg

Oral

NOUMED SIMVASTATIN

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

Simvastatin

Tablet 40 mg

Oral

NOUMED SIMVASTATIN

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

17  Schedule 1 (table)

Omit:

Telmisartan

Tablet 80 mg

Oral

NOUMED TELMISARTAN

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

18  Schedule 1 (table)

After:

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Tenofovir ARX

4 months stock by reference to usual demand of both Tenofovir APOTEX and Tenofovir ARX added together

insert:

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Viread

between 1 January 2025 and 31 March 2025—2 months stock by reference to usual demand

 

Schedule 2Amendments commencing 1 April 2025

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Omit:

Abacavir with lamivudine

Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg

Oral

Abacavir/Lamivudine Viatris

after 31 December 2024—4 months stock by reference to usual demand of both Abacavir/Lamivudine Viatris and Abacavir/Lamivudine Mylan added together

Acamprosate

Tablet (enteric coated) containing acamprosate calcium 333 mg

Oral

Acamprosate Viatris

after 30 July 2024—4 months stock by reference to usual demand of both Acamprosate Viatris and Acamprosate Mylan added together

2  Schedule 1 (table)

Omit:

Ceftriaxone

Powder for injection 1 g (as sodium)

Injection

Ceftriaxone Viatris

after 31 May 2024—6 months stock by reference to usual demand of both Ceftriaxone Viatris and Ceftriaxone  Alphapharm added together

substitute:

Ceftriaxone

Powder for injection 1 g (as sodium)

Injection

Ceftriaxone Viatris

6 months stock by reference to usual demand

3  Schedule 1 (table)

Omit:

Dosulepin

Capsule containing dosulepin hydrochloride 25 mg

Oral

Dosulepin Viatris

after 31 May 2024—6 months stock by reference to usual demand of both Dosulepin Viatris and Dosulepin Mylan added together

substitute:

Dosulepin

Capsule containing dosulepin hydrochloride 25 mg

Oral

Dosulepin Viatris

6 months stock by reference to usual demand

4  Schedule 1 (table)

Omit:

Entecavir

Tablet 0.5 mg (as monohydrate)

Oral

Entecavir Viatris

after 30 September 2024—4 months stock by reference to usual demand of both Entecavir Viatris and Entecavir Mylan added together

5  Schedule 1 (table)

Omit:

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

after 31 December 2024—4 months stock by reference to usual demand of both Esomeprazole Viatris and Esomeprazole Mylan added together

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

after 31 December 2024—4 months stock by reference to usual demand of both Esomeprazole Viatris and Esomeprazole Mylan added together

6  Schedule 1 (table)

Omit:

Nevirapine

Tablet 200 mg

Oral

Nevirapine Viatris

after 30 November 2024— 4 months stock by reference to usual demand of both Nevirapine Viatris and Nevirapine Alphapharm added together

7  Schedule 1 (table)

Omit:

Oxycodone

Tablet containing oxycodone hydrochloride 5 mg

Oral

Oxycodone Viatris

after 28 February 2024—6 months stock by reference to usual demand of both Oxycodone Viatris and Oxycodone Mylan added together

substitute:

Oxycodone

Tablet containing oxycodone hydrochloride 5 mg

Oral

Oxycodone Viatris

6 months stock by reference to usual demand

8  Schedule 1 (table)

Omit:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg

Oral

Tenofovir Disoproxil Emtricitabine Viatris 300/200

after 30 April 2024—4 months stock by reference to usual demand of both Tenofovir Disoproxil Emtricitabine Viatris 300/200 and Tenofovir Disoproxil Emtricitabine Mylan 300/200 added together

9  Schedule 1 (table)

Omit:

Tobramycin

Injection 80 mg in 2 mL

Injection

Tobramycin Viatris

4 months stock by reference to usual demand of both Tobramycin Viatris and Tobramycin Mylan added together

10  Schedule 1 (table)

Omit:

Trimethoprim

Tablet 300 mg

Oral

Trimethoprim Viatris

after 30 April 2024—6 months stock by reference to usual demand of both Trimethoprim Viatris and Trimethoprim Mylan added together

substitute:

Trimethoprim

Tablet 300 mg

Oral

Trimethoprim Viatris

6 months stock by reference to usual demand

 

 

 


Schedule 3Amendments commencing immediately after the commencement of Schedule 2 to the National Health (Minimum Stockholding) Amendment Determination (No. 10) 2024 – 1 April 2025

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Omit:

Atropine

Injection containing atropine sulfate monohydrate 600 micrograms in 1 mL

Injection

Atropine Injection (Pfizer)

6 months stock by reference to usual PBS demand

substitute:

Atropine

Injection containing atropine sulfate monohydrate 600 micrograms in 1 mL

Injection

Atropine Injection (Bridgewest)

(a) between 1 April 2025 and 30 September 2025—6 months stock by reference to usual PBS demand of Atropine Injection (Pfizer)

(b) between 1 October 2025 and 31 March 2026—6 months stock by reference to usual PBS demand of both Atropine Injection (Pfizer) and Atropine Injection (Bridgewest) added together

(c) after 31 March 2026—6 months stock by reference to usual PBS demand

 


Schedule 4Amendments commencing 1 June 2025

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

After:

Escitalopram

Tablet 20 mg (as oxalate)

Oral

APXEscitalopram

4 months stock by reference to usual demand

insert:

Estradiol and estradiol with norethisterone

Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate

Transdermal

Estalis sequi 50/140

6 months stock by reference to usual PBS demand

Estradiol with norethisterone

Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8

Transdermal

Estalis continuous 50/140

6 months stock by reference to usual PBS demand