Commonwealth Coat of Arms of Australia

 

PB 11 of 2025

 

National Health (Minimum Stockholding) Amendment Determination (No. 1) 2025

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

Dated 29 January 2025

Rebecca Richardson

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

 

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments commencing 1 February 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

 

 

 

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 1) 2025.

 (2) This instrument may also be cited as PB 11 of 2025.

  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 February 2025.

1 February 2025

2.  Schedule 1

1 February 2025.

1 February 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

 (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.

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

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

1  Schedule 1 (table)

Omit:

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

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

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

2  Schedule 1 (table)

After:

Glucose and ketone indicatorurine

Test strips, 50 (KetoDiastix)

For External Use

KetoDiastix

4 months stock by reference to usual PBS demand

insert:

Glyceryl trinitrate

Transdermal patch 36 mg

Transdermal

Minitran 10

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

Glyceryl trinitrate

Transdermal patch 54 mg

Transdermal

Minitran 15

between 1 February 2025 and 31 December 2025—0 months stock by reference to usual demand

3  Schedule 1 (table)

Omit:

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.

4  Schedule 1 (table)

Omit:

Mirtazapine

Tablet 45 mg

Oral

NOUMED MIRTAZAPINE

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

5  Schedule 1 (table)

After:

Ondansetron

Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

Oral

Zofran syrup 50 mL

4 months stock by reference to usual PBS demand

insert:

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT Viatris

after 31 May 2025—4 months stock by reference to usual demand of both Ondansetron ODT Viatris and Ondansetron Mylan ODT added together

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron Tablets Viatris

after 31 May 2025—6 months stock by reference to usual demand of both Ondansetron Tablets Viatris and Ondansetron Mylan Tablets added together

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron Tablets Viatris

after 31 May 2025—4 months stock by reference to usual demand of both Ondansetron Tablets Viatris and Ondansetron Mylan Tablets added together

6  Schedule 1 (table)

After:

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

ARX-PIOGLITAZONE

4 months stock by reference to usual demand of both APOTEX-Pioglitazone and ARX-PIOGLITAZONE added together

insert:

Piroxicam

Dispersible tablet 20 mg

Oral

Feldene-D

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

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, 15 mL

Application to the Eye

Optix

between 1 February 2025 and 30 April 2025—0 months stock by reference to usual demand

7  Schedule 1 (table)

Omit:

Ramipril with felodipine

Tablet 2.5 mg2.5 mg (modified release)

Oral

Triasyn 2.5/2.5

4 months stock by reference to usual PBS demand

substitute:

Ramipril with felodipine

Tablet 2.5 mg-2.5 mg (modified release)

Oral

Triasyn 2.5/2.5

between 1 February 2025 and 30 September 2025—0 months stock by reference to usual PBS demand

8  Schedule 1 (table)

Omit:

Telmisartan

Tablet 40 mg

Oral

NOUMED TELMISARTAN

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

9  Schedule 1 (table)

After:

Trandolapril

Capsule 500 micrograms

Oral

Dolapril 0.5

2.5 months stock by reference to usual demand

insert:

Trastuzumab

Powder for I.V. infusion 150 mg

Injection

Kanjinti

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

10  Schedule 1 (table)

Omit:

Valproic acid

Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

Epilim Liquid

6 months stock by reference to usual PBS demand

substitute:

Valproic acid

Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

Epilim Liquid

(a) between 1 February 2025 and 31 March 2025—89,358 packs of a pack quantity of 1

(b) between 1 April 2025 and 30 September 2025—91,362 packs of a pack quantity of 1

(c) after 30 September 2025—6 months stock by reference to usual PBS demand

 

1  Schedule 1 (table)

Omit:

Clarithromycin

Powder for oral liquid 250 mg per 5 mL, 50 mL

Oral

Klacid

4 months stock by reference to usual PBS demand

substitute:

Clarithromycin

Powder for oral liquid 250 mg per 5 mL, 50 mL

Oral

Klacid

(a) between 1 April 2025 and 30 September 2025—17,180 packs of a pack quantity of 1

(b) after 30 September 2025—4 months stock by reference to usual PBS demand

2  Schedule 1 (table)

Omit:

Diazepam

Oral liquid 10 mg per 10 mL, 100 mL

Oral

Diazepam Elixir

4 months stock by reference to usual PBS demand

substitute:

Diazepam

Oral liquid 10 mg per 10 mL, 100 mL

Oral

Diazepam Elixir

(a) between 1 April 2025 and 30 September 2025—1,228 packs of a pack quantity of 1

(b) after 30 September 2025—4 months stock by reference to usual PBS demand

3  Schedule 1 (table)

After:

Oxazepam

Tablet 30 mg

Oral

Murelax

5 months stock by reference to usual demand

insert:

Oxybutynin

Transdermal patches 36 mg, 8

Transdermal

Oxytrol

6 months stock by reference to usual PBS demand

1  Schedule 1 (table)

Omit:

Glyceryl trinitrate

Sublingual spray (pump pack) 400 micrograms per dose, 200 doses

Sublingual

Nitrolingual Pumpspray

6 months stock by reference to usual PBS demand

substitute:

Glyceryl trinitrate

Sublingual spray (pump pack) 400 micrograms per dose, 200 doses

Sublingual

Nitrolingual Pumpspray

(a) between 1 April 2025 and 30 September 2025—162,432 packs of a pack quantity of 1

(b) after 30 September 2025—6 months stock by reference to usual PBS demand