Commonwealth Coat of Arms of Australia

 

PB 64 of 2025

 

National Health (Minimum Stockholding) Amendment Determination (No. 5) 2025

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

Dated 27 May 2025

Rebecca Richardson

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

 

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments commencing 1 June 2025

National Health (Minimum Stockholding) Determination 2023

Schedule 2—Amendments commencing 1 November 2025

National Health (Minimum Stockholding) Determination 2023

 

 

 

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 5) 2025.

 (2) This instrument may also be cited as PB 64 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 June 2025.

1 June 2025

2.  Schedule 1

1 June 2025.

1 June 2025

3.  Schedule 2

1 November 2025.

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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

After:

Aripiprazole

Tablet 30 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Arsenic

Injection concentrate containing arsenic trioxide 10 mg in 10 mL

Injection

Arsenic Trioxide-AFT

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

2  Schedule 1 (table)

Omit:

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine-Teva

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

3  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:

Bisoprolol

Tablet containing bisoprolol fumarate 10 mg

Oral

NOUMED BISOPROLOL

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

Bisoprolol

Tablet containing bisoprolol fumarate 2.5 mg

Oral

NOUMED BISOPROLOL

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

Bisoprolol

Tablet containing bisoprolol fumarate 5 mg

Oral

NOUMED BISOPROLOL

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

 


4  Schedule 1 (table)

Omit:

Ciclosporin

Capsule 100 mg

Oral

Cyclosporin Sandoz

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

5  Schedule 1 (table)

Omit:

Ciclosporin

Capsule 25 mg

Oral

Cyclosporin Sandoz

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

6  Schedule 1 (table)

Omit:

Ciclosporin

Capsule 50 mg

Oral

Cyclosporin Sandoz

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

7  Schedule 1 (table)

After:

Dosulepin

Capsule containing dosulepin hydrochloride 25 mg

Oral

Dosulepin Viatris

6 months stock by reference to usual demand

insert:

Doxorubicin

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

Injection/Intravesical

Adriamycin

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

8  Schedule 1 (table)

Omit:

Fentanyl

Transdermal patch 10.20 mg

Transdermal

Denpax

2.5 months stock by reference to usual demand

 


9  Schedule 1 (table)

After:

Felodipine

Tablet 2.5 mg (extended release)

Oral

Plendil ER

2.5 months stock by reference to usual demand

insert:

Fentanyl

Transdermal patch 1.28 mg

Transdermal

Denpax

between 1 June 2025 and 31 August 2025—0 months stock by reference to usual demand

Fentanyl

Transdermal patch 10.20 mg

Transdermal

Denpax

between 1 June 2025 and 31 August 2025—0 months stock by reference to usual demand

Fentanyl

Transdermal patch 12.6 mg

Transdermal

Durogesic 75

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

10  Schedule 1 (table)

After:

Fentanyl

Transdermal patch 12.6 mg

Transdermal

APOFentanyl

3 months stock by reference to usual demand

insert:

Fentanyl

Transdermal patch 16.8 mg

Transdermal

Durogesic 100

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

11  Schedule 1 (table)

After:

Fentanyl

Transdermal patch 2.1 mg

Transdermal

APOFentanyl

3.5 months stock by reference to usual demand

insert:

Fentanyl

Transdermal patch 2.1 mg

Transdermal

Durogesic 12

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

Fentanyl

Transdermal patch 2.55 mg

Transdermal

Denpax

between 1 June 2025 and 31 August 2025—0 months stock by reference to usual demand

 


12  Schedule 1 (table)

Omit:

Fentanyl

Transdermal patch 5.10 mg

Transdermal

Denpax

2.5 months stock by reference to usual demand

13  Schedule 1 (table)

After:

Fentanyl

Transdermal patch 4.2 mg

Transdermal

APOFentanyl

3 months stock by reference to usual demand

insert:

Fentanyl

Transdermal patch 4.2 mg

Transdermal

Durogesic 25

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

Fentanyl

Transdermal patch 5.10 mg

Transdermal

Denpax

between 1 June 2025 and 31 August 2025—0 months stock by reference to usual demand

Fentanyl

Transdermal patch 7.65 mg

Transdermal

Denpax

between 1 June 2025 and 31 August 2025—0 months stock by reference to usual demand

14  Schedule 1 (table)

After:

Fentanyl

Transdermal patch 8.4 mg

Transdermal

APOFentanyl

3 months stock by reference to usual demand

insert:

Fentanyl

Transdermal patch 8.4 mg

Transdermal

Durogesic 50

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

15  Schedule 1 (table)

After:

Fluconazole

Powder for oral suspension 50 mg in 5 mL, 35 mL

Oral

Diflucan

4 months stock by reference to usual PBS demand

insert:

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Fluoxetine APOTEX

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

16  Schedule 1 (table)

Omit:

Furosemide

Tablet 40 mg

Oral

NOUMED FUROSEMIDE

between 1 April 2025 and 31 May 2025—0 months stock by reference to usual demand

17  Schedule 1 (table)

Omit:

Iron polymaltose complex

Injection 100 mg (iron) in 2 mL

Injection

Ferrosig

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

18  Schedule 1 (table)

After:

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

insert:

Lamivudine

Tablet 150 mg

Oral

Lamivudine Viatris

after 30 September 2025—4 months stock by reference to usual demand of both Lamivudine Viatris and Lamivudine Alphapharm added together

19  Schedule 1 (table)

Omit:

Methylprednisolone

Powder for injection 1 g (as sodium succinate)

Injection

Solu-Medrol

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

20  Schedule 1 (table)

Omit:

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

Mycophenolate APOTEX

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


21  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) 4 mg

Oral

Ondansetron ODT Viatris

after 30 September 2025—6 months stock by reference to usual demand of both Ondansetron ODT Viatris and Ondansetron Mylan ODT added together

22  Schedule 1 (table)

After:

Promethazine

Injection containing promethazine hydrochloride 50 mg in 2 mL

Injection

DBL Promethazine Hydrochloride

6 months stock by reference to usual PBS demand

insert:

Propylene glycol

Eye drops 60 micrograms per mL, 10 mL

Application to the Eye

Systane Balance

4 months stock by reference to usual PBS demand

23  Schedule 1 (table)

After:

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

Parbezol

4 months stock by reference to usual demand

insert:

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

Pariet

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

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Pariet

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

24  Schedule 1 (table)

Omit:

Ramipril

Capsule 10 mg

Oral

Ramipril Winthrop

between 1 April 2025 and 31 May 2025—0 months stock by reference to usual demand

25  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 June 2025 and 30 September 2025—2 months stock by reference to usual demand

26  Schedule 1 (table)

After:

Tenofovir

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Viatris

after 31 January 2025— 4 months stock by reference to usual demand of both Tenofovir Disoproxil Viatris and Tenofovir Disoproxil Mylan added together

insert:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

CIPLA TENOFOVIR + EMTRICITABINE 300/200

between 1 June 2025 and 30 September 2025—4 months stock by reference to usual demand

27  Schedule 1 (table)

Omit:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

Tenofovir/Emtricitabine 300/200 APOTEX

3 months stock by reference to usual demand of both Tenofovir/Emtricitabine 300/200 APOTEX and TENOFOVIR/EMTRICITABINE 300/200 ARX added together

28  Schedule 1 (table)

Omit:

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

APO-Sodium Valproate

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Epilim EC

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Sodium Valproate Sandoz

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valprease 200

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valpro EC 200

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valproate Winthrop EC 200

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

APO-Sodium Valproate

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Epilim EC

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Sodium Valproate Sandoz

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valprease 500

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valpro EC 500

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

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valproate Winthrop EC 500

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


1  Schedule 1 (table)

After:

Tenofovir

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Viatris

after 31 January 2025— 4 months stock by reference to usual demand of both Tenofovir Disoproxil Viatris and Tenofovir Disoproxil Mylan added together

insert:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

TENOFOVIR/EMTRICITABINE 300/200 APX

6 months stock by reference to usual demand