Commonwealth Coat of Arms of Australia

 

PB 83 of 2024

 

National Health (Minimum Stockholding) Amendment Determination (No. 7) 2024

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

Dated 30 July 2024

Nikolai Tsyganov

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 August 2024

National Health (Minimum Stockholding) Determination 2023

1  Name

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 7) 2024.

 (2) This instrument may also be cited as PB 83 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 August 2024.

1 August 2024

2.  Schedule 1

1 August 2024.

1 August 2024

 (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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 August 2024

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Before:

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.

insert:

Abacavir with lamivudine

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

Oral

ABACAVIR/LAMIVUDINE 600/300 SUN

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

2  Schedule 1 (table)

After:

Amitriptyline

Tablet containing amitriptyline hydrochloride 50 mg

Oral

ENTRIP

(a) between 1 July 2023 and 31 December 2023—4 months stock by reference to usual demand

(b) after 31 December 2023—4.5 months stock by reference to usual demand

insert:

Amlodipine

Tablet 10 mg (as besilate)

Oral

BTC Amlodipine

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

Amlodipine

Tablet 5 mg (as besilate)

Oral

BTC Amlodipine

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

Amoxicillin

Capsule 500 mg (as trihydrate)

Oral

NOUMED AMOXICILLIN

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

3  Schedule 1 (table)

After:

Aripiprazole

Tablet 10 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Aripiprazole

Tablet 10 mg

Oral

Tevaripiprazole

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

4  Schedule 1 (table)

After:

Aripiprazole

Tablet 15 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Aripiprazole

Tablet 15 mg

Oral

Tevaripiprazole

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

5  Schedule 1 (table)

After:

Aripiprazole

Tablet 20 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Aripiprazole

Tablet 20 mg

Oral

Tevaripiprazole

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

6  Schedule 1 (table)

After:

Aripiprazole

Tablet 30 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Aripiprazole

Tablet 30 mg

Oral

Tevaripiprazole

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

7  Schedule 1 (table)

After:

Atorvastatin

Tablet 40 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

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

insert:

Atorvastatin

Tablet 80 mg (as calcium)

Oral

Atorvastatin GH

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

8  Schedule 1 (table)

After:

Azithromycin

Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL

Oral

Zithromax

4 months stock by reference to usual PBS demand

insert:

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

Azithromycin Viatris

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

9  Schedule 1 (table)

Omit:

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Bosentan Cipla

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

10  Schedule 1 (table)

Omit:

Cefazolin

Powder for injection 500 mg (as sodium)

Injection

Cefazolin-AFT

between 1 May 2024 and 30 July 2024—0 months stock by reference to usual demand

11  Schedule 1 (table)

After:

Ciclosporin

Oral liquid 100 mg per mL, 50 mL

Oral

Neoral

4 months stock by reference to usual PBS demand

insert:

Ciprofloxacin

Tablet 500 mg (as hydrochloride)

Oral

Cifran

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

12  Schedule 1 (table)

After:

Codeine

Tablet containing codeine phosphate hemihydrate 30 mg

Oral

Aspen Pharma Pty Ltd

4 months stock by reference to usual PBS demand

insert:

Cyproterone

Tablet containing cyproterone acetate 100 mg

Oral

Pharmacor Cyproterone 100

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

Cyproterone

Tablet containing cyproterone acetate 50 mg

Oral

Pharmacor Cyproterone 50

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

13  Schedule 1 (table)

After:

Dolutegravir with abacavir and lamivudine

Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg

Oral

Triumeq

6 months stock by reference to usual PBS demand

insert:

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

NOUMED DONEPEZIL

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

NOUMED DONEPEZIL

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

14  Schedule 1 (table)

After:

Enalapril

Tablet containing enalapril maleate 20 mg

Oral

APOEnalapril

3 months stock by reference to usual demand

insert:

Enalapril

Tablet containing enalapril maleate 20 mg

Oral

Enalapril generichealth

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

15  Schedule 1 (table)

After:

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Blooms the Chemist Escitalopram

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

insert:

Esomeprazole

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

Oral

NOUMED ESOMEPRAZOLE

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

Esomeprazole

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

Oral

NOUMED ESOMEPRAZOLE

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

16  Schedule 1 (table)

Omit:

Ezetimibe

Tablet 10 mg

Oral

Blooms The Chemist Ezetimibe

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

17  Schedule 1 (table)

Omit:

Fluorometholone

Eye drops containing fluorometholone acetate 1 mg per mL, 5 mL

Application to the Eye

Flarex

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


18  Schedule 1 (table)

After:

Furosemide

Oral solution 10 mg per mL, 30 mL

Oral

Lasix

4 months stock by reference to usual PBS demand

insert:

Gabapentin

Capsule 300 mg

Oral

Gabapentin generichealth

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

Gabapentin

Capsule 400 mg

Oral

Gabapentin generichealth

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

19  Schedule 1 (table)

Omit:

Ipratropium

Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30

Inhalation

Aeron 250

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

Ipratropium

Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30

Inhalation

Aeron 500

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

20  Schedule 1 (table)

After:

Lercanidipine

Tablet containing lercanidipine hydrochloride 20 mg

Oral

BTC Lercanidipine

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

insert:

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

APO-Levetiracetam

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Keppra

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Kerron

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Levetiracetam GH

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Levetiracetam-AFT

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

APO-Levetiracetam

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

Keppra

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

Kevtam 1000

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

Levactam

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

Levetiracetam GH

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Mylan

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

Levetiracetam SZ

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Viatris

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

Levi 1000

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Levetiracetam

Tablet 1 g

Oral

NOUMED LEVETIRACETAM

between 1 August 2024 and 31 January 2025—4 months stock by reference to usual demand.

Lisinopril

Tablet 20 mg

Oral

Lisinopril generichealth

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

21  Schedule 1 (table)

After:

Lithium

Tablet containing lithium carbonate 450 mg (slow release)

Oral

Quilonum SR

6 months stock by reference to usual PBS demand

insert:

Meloxicam

Tablet 15 mg

Oral

Pharmacor Meloxicam 15

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

22  Schedule 1 (table)

After:

Meloxicam

Tablet 7.5 mg

Oral

MELOBIC

4 months stock by reference to usual demand

insert:

Meloxicam

Tablet 7.5 mg

Oral

Pharmacor Meloxicam 7.5

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand


23  Schedule 1 (table)

Omit:

Metformin

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

Blooms the Chemist Metformin XR 1000

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

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

Blooms the Chemist Metformin XR 500

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

24  Schedule 1 (table)

Omit:

Mitozantrone

Injection 25 mg (as hydrochloride) in 12.5 mL

Injection

Onkotrone

between 1 May 2024 and 30 July 2024—0 months stock by reference to usual demand

25  Schedule 1 (table)

Omit:

Mycophenolic acid

Capsule containing mycophenolate mofetil 250 mg

Oral

CellCept

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

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

CellCept

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

26  Schedule 1 (table)

Omit:

Pregabalin

Capsule 25 mg

Oral

Cipla Pregabalin

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

Pregabalin

Capsule 300 mg

Oral

Cipla Pregabalin

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

27  Schedule 1 (table)

Omit:

Pregabalin

Capsule 75 mg

Oral

Cipla Pregabalin

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

28  Schedule 1 (table)

After:

Risperidone

Tablet 3 mg

Oral

Rispa

3 months stock by reference to usual demand

insert:

Rizatriptan

Tablet (orally disintegrating) 10 mg (as benzoate)

Oral

APO-Rizatriptan

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

Rizatriptan

Tablet (orally disintegrating) 10 mg (as benzoate)

Oral

Rizatriptan ODT GH

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

29  Schedule 1 (table)

After:

Temazepam

Tablet 10 mg

Oral

APOTemazepam

2.5 months stock by reference to usual demand

insert:

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Viread

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

30  Schedule 1 (table)

After:

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

insert:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg

Oral

Tenofovir EMT GH

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

31  Schedule 1 (table)

Omit:

Tobramycin

Injection 80 mg (as sulfate) in 2 mL (without preservative)

Injection

Pfizer Australia Pty Ltd

between 1 April 2024 and 30 September 2024—4 months stock by reference to usual demand

substitute:

Tobramycin

Injection 80 mg (as sulfate) in 2 mL (without preservative)

Injection

Pfizer Australia Pty Ltd

2 months stock by reference to usual demand

32  Schedule 1 (table)

After:

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

insert:

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

Valaciclovir generichealth

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

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

Valacor 500

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand

33  Schedule 1 (table)

Omit:

Valganciclovir

Tablet 450 mg (as hydrochloride)

Oral

VALGANCICLOVIR HETERO

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


34  Schedule 1 (table)

After:

Voriconazole

Powder for oral suspension 40 mg per mL, 70 mL

Oral

Vfend

4 months stock by reference to usual PBS demand

insert:

Zoledronic acid

Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

Injection

Zoledronic Acid SUN

between 1 August 2024 and 30 September 2024—0 months stock by reference to usual demand