Commonwealth Coat of Arms of Australia

 

PB 93 of 2025

 

National Health (Minimum Stockholding) Amendment Determination (No. 7) 2025

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

Dated 29 July 2025

Rebecca Richardson

Assistant Secretary
PBS Listing, Pricing and 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 August 2025

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. 2) 2025 – 1 August 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. 4) 2025 – 1 October 2025

National Health (Minimum Stockholding) Determination 2023

 

 

 

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 7) 2025.

 (2) This instrument may also be cited as PB 93 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 August 2025.

1 August 2025

2.  Schedule 1

1 August 2025.

1 August 2025

3.  Schedule 2

Immediately after the commencement of Schedule 2 to the National Health (Minimum Stockholding) Amendment Determination (No. 2) 2025.

1 August 2025

4.  Schedule 3

Immediately after the commencement of Schedule 2 to the National Health (Minimum Stockholding) Amendment Determination (No. 4) 2025.

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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

Before:

Acarbose

Tablet 100 mg

Oral

GLYBOSAY

2 months stock by reference to usual demand

insert:

Abacavir with lamivudine

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

Oral

Kivexa

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

2  Schedule 1 (table)

After:

Allopurinol

Tablet 100 mg

Oral

APO-ALLOPURINOL

4 months stock by reference to usual demand of both Allopurinol APOTEX and APO-ALLOPURINOL added together

insert:

Allopurinol

Tablet 100 mg

Oral

NOUMED ALLOPURINOL

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

3  Schedule 1 (table)

After:

Amitriptyline

Tablet containing amitriptyline hydrochloride 50 mg

Oral

ENTRIP

4.5 months stock by reference to usual demand

insert:

Amlodipine

Tablet 10 mg (as besilate)

Oral

NOUMED AMLODIPINE

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


4  Schedule 1 (table)

After:

Amlodipine

Tablet 5 mg (as besilate)

Oral

APX-AMLODIPINE

6 months stock by reference to usual demand of both Amlodipine APOTEX and APX-AMLODIPINE added together

insert:

Amlodipine

Tablet 5 mg (as besilate)

Oral

NOUMED AMLODIPINE

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

Amoxicillin

Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

Oral

NOUMED AMOXICILLIN

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

5  Schedule 1 (table)

Omit:

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

6  Schedule 1 (table)

Omit:

Bivalirudin

Powder for I.V. injection 250 mg (as trifluoroacetate)

Injection

Bivalirudin APOTEX

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

7  Schedule 1 (table)

After:

Captopril

Oral solution 5 mg per mL, 95 mL

Oral

Capoten

4 months stock by reference to usual PBS demand

insert:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

NOUMED CEFALEXIN

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

8  Schedule 1 (table)

After:

Fentanyl

Transdermal patch 10.20 mg

Transdermal

Denpax

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

insert:

Fentanyl

Transdermal patch 12.375 mg

Transdermal

Fenpatch 75

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

9  Schedule 1 (table)

Omit:

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)

Omit:

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 16.8 mg

Transdermal

APOFentanyl

3 months stock by reference to usual demand

insert:

Fentanyl

Transdermal patch 2.063 mg

Transdermal

Fenpatch 12

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

12  Schedule 1 (table)

Omit:

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


13  Schedule 1 (table)

Omit:

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

14  Schedule 1 (table)

Omit:

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)

Omit:

Fluorouracil

Injection 5000 mg in 100 mL

Injection

Fluorouracil Ebewe

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

16  Schedule 1 (table)

Omit:

Glimepiride

Tablet 1 mg

Oral

Glimepiride APOTEX

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

17  Schedule 1 (table)

Omit:

Glimepiride

Tablet 2 mg

Oral

Glimepiride APOTEX

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

18  Schedule 1 (table)

Omit:

Glimepiride

Tablet 3 mg

Oral

Glimepiride APOTEX

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

19  Schedule 1 (table)

Omit:

Glimepiride

Tablet 4 mg

Oral

Glimepiride APOTEX

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

20  Schedule 1 (table)

Omit:

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

substitute:

Glyceryl trinitrate

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

Sublingual

Nitrolingual Pumpspray

(a) between 1 August 2025 and 30 September 2025—108,288 packs of a pack quantity of 1

(b) between 1 October 2025 and 31 March 2026—109,488 packs of a pack quantity of 1

(c) after 31 March 2026—4 months stock by reference to usual PBS demand

21  Schedule 1 (table)

Omit:

Granisetron

Concentrated injection 3 mg (as hydrochloride) in 3 mL

Injection

Granisetron-AFT

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

 


22  Schedule 1 (table)

Omit:

Letrozole

Tablet 2.5 mg

Oral

Letrozole APOTEX

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

23  Schedule 1 (table)

After:

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

APX-PANTOPRAZOLE

6 months stock by reference to usual demand of both Pantoprazole APOTEX and APX-PANTOPRAZOLE added together

insert:

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

NOUMED PANTOPRAZOLE

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

24  Schedule 1 (table)

After:

Risedronic acid

Tablet containing risedronate sodium 150 mg

Oral

APORisedronate

3 months stock by reference to usual demand

insert:

Risperidone

Tablet 0.5 mg

Oral

NOUMED RISPERIDONE

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

Risperidone

Tablet 1 mg

Oral

NOUMED RISPERIDONE

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

Risperidone

Tablet 2 mg

Oral

NOUMED RISPERIDONE

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

25  Schedule 1 (table)

After:

Risperidone

Tablet 3 mg

Oral

APORisperidone

3.5 months stock by reference to usual demand

insert:

Risperidone

Tablet 3 mg

Oral

NOUMED RISPERIDONE

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

26  Schedule 1 (table)

After:

Risperidone

Tablet 3 mg

Oral

Rispa

3 months stock by reference to usual demand

insert:

Risperidone

Tablet 4 mg

Oral

NOUMED RISPERIDONE

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

27  Schedule 1 (table)

Omit:

Sevelamer

Tablet containing sevelamer carbonate 800 mg

Oral

Sevelamer Apotex

4 months stock by reference to usual demand of both Sevelamer Apotex and ARX-SEVELAMER added together

 


28  Schedule 1 (table)

After:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

TENOFOVIR/EMTRICITABINE 300/200 ARX

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

insert:

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Lamisil (Novartis Pharmaceuticals Australia Pty Limited)

between 1 August 2025 and 31 January 2026—0 months stock by reference to usual demand

 

1  Schedule 1 (table)

After:

Ciprofloxacin

Ear drops 3 mg (as hydrochloride) per mL, 5 mL

Application to the Ear

Ciloxan

6 months stock by reference to usual PBS demand

insert:

Ciprofloxacin

Tablet 500 mg (as hydrochloride)

Oral

NOUMED CIPROFLOXACIN

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

Ciprofloxacin

Tablet 750 mg (as hydrochloride)

Oral

NOUMED CIPROFLOXACIN

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

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

NOUMED CITALOPRAM

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


1  Schedule 1 (table)

Omit:

Triglycerides, long chain with glucose polymer

Oral liquid 1 L, 6 (ProZero)

Oral

ProZero

6 months stock by reference to usual PBS demand

substitute:

Triglycerides, long chain with glucose polymer

Oral liquid 1 L, 6 (ProZero)

Oral

ProZero

0 months stock by reference to usual PBS demand