Commonwealth Coat of Arms of Australia

 

PB 102 of 2024

 

National Health (Minimum Stockholding) Amendment Determination (No. 9) 2024

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

Dated 26 September 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 October 2024

National Health (Minimum Stockholding) Determination 2023

Schedule 2—Amendments commencing immediately after the commencement of Schedule 2 to the National Health (Minimum Stockholding) Amendment Determination (No. 4) 2024 – 1 October 2024

National Health (Minimum Stockholding) Determination 2023

Schedule 3—Amendments commencing immediately after the commencement of Schedule 3 to the National Health (Minimum Stockholding) Amendment Determination (No. 6) 2024 – 1 December 2024

National Health (Minimum Stockholding) Determination 2023

 

1  Name

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 9) 2024.

 (2) This instrument may also be cited as PB 102 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 October 2024.

1 October 2024

2.  Schedule 1

1 October 2024.

1 October 2024

3.  Schedule 2

Immediately after the commencement of Schedule 2 to the National Health (Minimum Stockholding) Amendment Determination (No. 4) 2024.

1 October 2024

4.  Schedule 3

Immediately after the commencement of Schedule 3 to the National Health (Minimum Stockholding) Amendment Determination (No. 6) 2024.

1 December 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 October 2024

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 600/300 SUN

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

2  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 Viatris

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

3  Schedule 1 (table)

After:

Acarbose

Tablet 50 mg

Oral

GLYBOSAY

2 months stock by reference to usual demand

insert:

Alendronic acid with colecalciferol

Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

Oral

Fosamax Plus 70 mg/140 mcg

between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand

Alendronic acid with colecalciferol

Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

Oral

Fosamax Plus

between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand


4  Schedule 1 (table)

Omit:

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

5  Schedule 1 (table)

Omit:

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AlphaClav Duo Forte Viatris

after 31 August 2024—6 months stock by reference to usual demand of both Alphaclav Duo Forte Viatris and AlphaClav Duo Forte added together

6  Schedule 1 (table)

After:

Amoxicillin

Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Oral

Amoxil

4 months stock by reference to usual PBS demand

insert:

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AlphaClav Duo Forte Viatris

6 months stock by reference to usual demand

7  Schedule 1 (table)

Omit:

Aripiprazole

Tablet 10 mg

Oral

Tevaripiprazole

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

8  Schedule 1 (table)

After:

Aripiprazole

Tablet 15 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Aripiprazole

Tablet 15 mg

Oral

Aripic Aripiprazole

between 1 October 2024 and 31 March 2025—0 months stock by reference to usual demand

9  Schedule 1 (table)

Omit:

Aripiprazole

Tablet 15 mg

Oral

Tevaripiprazole

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

10  Schedule 1 (table)

After:

Aripiprazole

Tablet 20 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Aripiprazole

Tablet 20 mg

Oral

Aripic Aripiprazole

between 1 October 2024 and 31 March 2025—0 months stock by reference to usual demand

11  Schedule 1 (table)

Omit:

Aripiprazole

Tablet 20 mg

Oral

Tevaripiprazole

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

12  Schedule 1 (table)

After:

Aripiprazole

Tablet 30 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Aripiprazole

Tablet 30 mg

Oral

Aripic Aripiprazole

between 1 October 2024 and 31 March 2025—0 months stock by reference to usual demand

13  Schedule 1 (table)

Omit:

Aripiprazole

Tablet 30 mg

Oral

Tevaripiprazole

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

14  Schedule 1 (table)

Omit:

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

15  Schedule 1 (table)

After:

Benzathine benzylpenicillin

Injection containing 600,000 units benzathine benzylpenicillin tetrahydrate in 1.17 mL single use pre-filled syringe

Injection

Bicillin L-A

6 months stock by reference to usual PBS demand

insert:

Bisacodyl

Tablet 5 mg

Oral

Lax-Tab

between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand

16  Schedule 1 (table)

Omit:

Carmellose

Eye drops containing carmellose sodium 10 mg per mL, 15 mL

Application to the Eye

Refresh Liquigel

4 months stock by reference to usual PBS demand

substitute:

Carmellose

Eye drops containing carmellose sodium 10 mg per mL, 15 mL

Application to the Eye

Refresh Liquigel

between 1 October 2024 and 31 January 2025—0 months stock by reference to usual PBS demand

17  Schedule 1 (table)

Omit:

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 15 mL

Application to the Eye

Refresh Tears Plus

4 months stock by reference to usual PBS demand

substitute:

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 15 mL

Application to the Eye

Refresh Tears Plus

between 1 October 2024 and 31 January 2025—0 months stock by reference to usual PBS demand


18  Schedule 1 (table)

Omit:

Carmellose with glycerin

Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL

Application to the Eye

Optive

4 months stock by reference to usual PBS demand

substitute:

Carmellose with glycerin

Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL

Application to the Eye

Optive

between 1 October 2024 and 31 January 2025—0 months stock by reference to usual PBS demand

19  Schedule 1 (table)

After:

Cefazolin

Powder for injection 2 g (as sodium)

Injection

Cephazolin Viatris

after 30 July 2024—6 months stock by reference to usual demand of both Cephazolin Viatris and Cephazolin Alphapharm added together

insert:

Cefepime

Powder for injection 1 g (as hydrochloride)

Injection

Cefepime Kabi

between 1 October 2024 and 30 November 2024—0 months stock by reference to usual demand

Cefepime

Powder for injection 2 g (as hydrochloride)

Injection

Cefepime Kabi

between 1 October 2024 and 30 November 2024—0 months stock by reference to usual demand

20  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 250 mg (as hydrochloride)

Oral

APX-Ciprofloxacin

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

Ciprofloxacin

Tablet 500 mg (as hydrochloride)

Oral

APX-Ciprofloxacin

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

Ciprofloxacin

Tablet 750 mg (as hydrochloride)

Oral

APX-Ciprofloxacin

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

21  Schedule 1 (table)

Omit:

Ciprofloxacin

Tablet 500 mg (as hydrochloride)

Oral

Cifran

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

22  Schedule 1 (table)

Omit:

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

23  Schedule 1 (table)

Omit:

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

24  Schedule 1 (table)

Omit:

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

25  Schedule 1 (table)

After:

Entecavir

Tablet 1 mg (as monohydrate)

Oral

ENTECLUDE

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

insert:

Epoprostenol

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

between 1 October 2024 and 30 November 2024—0 months stock by reference to usual demand

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

between 1 October 2024 and 30 November 2024—0 months stock by reference to usual demand

26  Schedule 1 (table)

After:

Escitalopram

Tablet 20 mg (as oxalate)

Oral

APXEscitalopram

4 months stock by reference to usual demand

insert:

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

27  Schedule 1 (table)

Omit:

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

28  Schedule 1 (table)

Omit:

Fenofibrate

Tablet 145 mg

Oral

Fenofibrate Viatris

6 months stock by reference to usual demand of both Fenofibrate Viatris and Fenofibrate Mylan added together

29  Schedule 1 (table)

Omit:

Fluorometholone

Eye drops 1 mg per mL, 5 mL

Application to the Eye

FML Liquifilm

between 1 July 2024 and 31 January 2025—0 months stock by reference to usual demand

30  Schedule 1 (table)

Omit:

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

31  Schedule 1 (table)

Omit:

Hydrocortisone

Tablet 20 mg

Oral

Hydrocortisone Viatris 20

4 months stock by reference to usual demand of both Hydrocortisone Viatris 20 and Hydrocortisone Mylan 20 added together


32  Schedule 1 (table)

After:

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

insert:

Hypromellose with carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Application to the Eye

Genteal gel

between 1 October 2024 and 30 June 2025—0 months stock by reference to usual demand

Hypromellose with carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Application to the Eye

HPMC PAA

between 1 October 2024 and 30 June 2025—0 months stock by reference to usual demand

33  Schedule 1 (table)

After:

Insect allergen extractyellow jacket venom

Injection set containing 550 micrograms with diluent

Injection

Hymenoptera Yellow Jacket Venom

6 months stock by reference to usual PBS demand

insert:

Irbesartan

Tablet 75 mg

Oral

Karvea

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

34  Schedule 1 (table)

After:

Itraconazole

Capsule 100 mg

Oral

APO-Itraconazole

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

insert:

Labetalol

Tablet containing labetalol hydrochloride 100 mg

Oral

Presolol 100

between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand


35  Schedule 1 (table)

Omit:

Lisinopril

Tablet 20 mg

Oral

Lisinopril generichealth

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

36  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:

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

Movicol

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

37  Schedule 1 (table)

Omit:

Meloxicam

Tablet 15 mg

Oral

Pharmacor Meloxicam 15

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

38  Schedule 1 (table)

Omit:

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

39  Schedule 1 (table)

Omit:

Methylprednisolone

Injection containing methylprednisolone acetate 40 mg in 1 mL

Injection

Depo-Nisolone

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


40  Schedule 1 (table)

After:

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

insert:

Nevirapine

Tablet 400 mg (extended release)

Oral

Viramune XR

between 1 October 2024 and 30 September 2025—0 months stock by reference to usual demand

41  Schedule 1 (table)

After:

Norfloxacin

Tablet 400 mg

Oral

APONorfloxacin

2.5 months stock by reference to usual demand

insert:

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

42 Schedule 1 (table)

After:

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Acpio 45

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

insert:

Pregabalin

Capsule 150 mg

Oral

Cipla Pregabalin

between 1 October 2024 and 28 February 2025—0 months stock by reference to usual demand


43  Schedule 1 (table)

Omit:

Riluzole

Oral suspension 50 mg per 10 mL, 300 mL

Oral

Teglutik

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

44  Schedule 1 (table)

Omit:

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

45  Schedule 1 (table)

Omit:

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

46  Schedule 1 (table)

Omit:

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

47  Schedule 1 (table)

Omit:

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


48  Schedule 1 (table)

Omit:

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

 


Schedule 2Amendments commencing immediately after the commencement of Schedule 2 to the National Health (Minimum Stockholding) Amendment Determination (No. 4) 2024 – 1 October 2024

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Omit:

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

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

Oral

GA gel

6 months stock by reference to usual PBS demand

substitute:

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

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

Oral

GA gel

0 months stock by reference to usual PBS demand

2  Schedule 1 (table)

After:

Irbesartan with hydrochlorothiazide

Tablet 150 mg-12.5 mg

Oral

AVSARTAN HCT 150/12.5

4 months stock by reference to usual demand

insert:

Isoleucine with carbohydrate

Sachets of oral powder 4 g containing 1 g isoleucine, 30 (Isoleucine 1000)

Oral

Isoleucine 1000

0 months stock by reference to usual PBS demand

Isoleucine with carbohydrate

Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine 50)

Oral

Isoleucine 50

0 months stock by reference to usual PBS demand

Schedule 3Amendments commencing immediately after the commencement of Schedule 3 to the National Health (Minimum Stockholding) Amendment Determination (No. 6) 2024 – 1 December 2024

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Omit:

Valine with carbohydrate

Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000)

Oral

Valine 1000

6 months stock by reference to usual PBS demand

substitute:

Valine with carbohydrate

Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000)

Oral

Valine 1000

0 months stock by reference to usual PBS demand

2  Schedule 1 (table)

Omit:

Valine with carbohydrate

Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine 50)

Oral

Valine 50

6 months stock by reference to usual PBS demand

substitute:

Valine with carbohydrate

Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine 50)

Oral

Valine 50

0 months stock by reference to usual PBS demand