Commonwealth Coat of Arms of Australia

 

PB 22 of 2025

 

National Health (Minimum Stockholding) Amendment Determination (No. 2) 2025

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

Dated 24 February 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 March 2025

National Health (Minimum Stockholding) Determination 2023

Schedule 2—Amendments commencing 1 August 2025

National Health (Minimum Stockholding) Determination 2023

 

 

 

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 2) 2025.

 (2) This instrument may also be cited as PB 22 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 March 2025.

1 March 2025

2.  Schedule 1

1 March 2025.

1 March 2025

3.  Schedule 2

1 August 2025.

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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

Amitriptyline

Tablet containing amitriptyline hydrochloride 25 mg

Oral

APXAmitriptyline

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

(b) after 31 December 2023—5 months stock by reference to usual demand

substitute:

Amitriptyline

Tablet containing amitriptyline hydrochloride 25 mg

Oral

APX-Amitriptyline

5 months stock by reference to usual demand

2  Schedule 1 (table)

Omit:

Amitriptyline

Tablet containing amitriptyline hydrochloride 50 mg

Oral

APXAmitriptyline

(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

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


substitute:

Amitriptyline

Tablet containing amitriptyline hydrochloride 50 mg

Oral

APXAmitriptyline

4.5 months stock by reference to usual demand

Amitriptyline

Tablet containing amitriptyline hydrochloride 50 mg

Oral

ENTRIP

4.5 months stock by reference to usual demand

3  Schedule 1 (table item dealing with the drug Codeine, column number 4)

Omit “Aspen Pharma Pty Ltd”, substitute “Aspen Pharmacare Australia Pty Ltd”.

4  Schedule 1 (table)

Omit:

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APXDoxycycline

(a) between 1 July 2023 and 31 December 2023—4.5 months stock by reference to usual demand

(b) after 31 December 2023—5.5 months stock by reference to usual demand

substitute:

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APXDoxycycline

5.5 months stock by reference to usual demand

5  Schedule 1 (table)

Omit:

Enalapril

Tablet containing enalapril maleate 5 mg

Oral

Acetec

(a) between 1 July 2023 and 31 December 2023—0 months stock by reference to usual demand

(b) after 31 December 2023—2 months stock by reference to usual demand

substitute:

Enalapril

Tablet containing enalapril maleate 5 mg

Oral

Acetec

2 months stock by reference to usual demand

6  Schedule 1 (table)

Omit:

Fentanyl

Transdermal patch 10.20 mg

Transdermal

Denpax

(a) between 1 July 2023 and 31 December 2023—0 months stock by reference to usual demand

(b) after 31 December 2023—2.5 months stock by reference to usual demand

substitute:

Fentanyl

Transdermal patch 10.20 mg

Transdermal

Denpax

2.5 months stock by reference to usual demand

7  Schedule 1 (table)

Omit:

Fentanyl

Transdermal patch 2.1 mg

Transdermal

APOFentanyl

(a) between 1 July 2023 and 31 December 2023—3 months stock by reference to usual demand

(b) after 31 December 2023—3.5 months stock by reference to usual demand

substitute:

Fentanyl

Transdermal patch 2.1 mg

Transdermal

APOFentanyl

3.5 months stock by reference to usual demand

8  Schedule 1 (table)

Omit:

Fentanyl

Transdermal patch 5.10 mg

Transdermal

Denpax

(a) between 1 July 2023 and 31 December 2023—0 months stock by reference to usual demand

(b) after 31 December 2023—2.5 months stock by reference to usual demand

substitute:

Fentanyl

Transdermal patch 5.10 mg

Transdermal

Denpax

2.5 months stock by reference to usual demand

9  Schedule 1 (table)

Omit:

Galantamine

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

Galantyl

(a) between 1 July 2023 and 31 December 2023—0 months stock by reference to usual demand

(b) after 31 December 2023—1.5 months stock by reference to usual demand

substitute:

Galantamine

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

Galantyl

1.5 months stock by reference to usual demand

10  Schedule 1 (table)

Omit:

Irbesartan

Tablet 150 mg

Oral

Irbesartan GH

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

Irbesartan

Tablet 300 mg

Oral

Irbesartan GH

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

11  Schedule 1 (table)

Omit:

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

APOLansoprazole ODT

(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

substitute:

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

APOLansoprazole ODT

4.5 months stock by reference to usual demand

12  Schedule 1 (table)

After:

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

insert:

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Viatris

after 31 June 2025—4 months stock by reference to usual demand of both Levetiracetam Viatris and Levetiracetam Mylan added together

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam Viatris

after 31 June 2025—4 months stock by reference to usual demand of both Levetiracetam Viatris and Levetiracetam Mylan added together

13  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

Chemists' Own Macrogol with Electrolytes

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


14  Schedule 1 (table)

Omit:

Nicorandil

Tablets 10 mg, 60

Oral

Ikotab

(a) between 1 July 2023 and 31 December 2023—0 months stock by reference to usual demand

(b) after 31 December 2023—2 months stock by reference to usual demand

substitute:

Nicorandil

Tablets 10 mg, 60

Oral

Ikotab

2 months stock by reference to usual demand

15  Schedule 1 (table)

Omit:

Nicorandil

Tablets 20 mg, 60

Oral

Ikotab

(a) between 1 July 2023 and 31 December 2023—0 months stock by reference to usual demand

(b) after 31 December 2023—2 months stock by reference to usual demand

substitute:

Nicorandil

Tablets 20 mg, 60

Oral

Ikotab

2 months stock by reference to usual demand

16  Schedule 1 (table)

Omit:

Olanzapine

Tablet 15 mg (orally disintegrating)

Oral

PRYZEX ODT

(a) between 1 July 2023 and 31 December 2023—3 months stock by reference to usual demand

(b) after 31 December 2023—3.5 months stock by reference to usual demand

substitute:

Olanzapine

Tablet 15 mg (orally disintegrating)

Oral

PRYZEX ODT

3.5 months stock by reference to usual demand

17  Schedule 1 (table)

Omit:

Olmesartan

Tablet containing olmesartan medoxomil 40 mg

Oral

OLMERTAN

(a) between 1 July 2023 and 31 December 2023—3 months stock by reference to usual demand

(b) after 31 December 2023—3.5 months stock by reference to usual demand

substitute:

Olmesartan

Tablet containing olmesartan medoxomil 40 mg

Oral

OLMERTAN

3.5 months stock by reference to usual demand

18  Schedule 1 (table)

Omit:

Pantoprazole

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

Oral

APOPantoprazole

(a) between 1 July 2023 and 31 December 2023—4.5 months stock by reference to usual demand

(b) after 31 December 2023—5.5 months stock by reference to usual demand

substitute:

Pantoprazole

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

Oral

APOPantoprazole

5.5 months stock by reference to usual demand


19  Schedule 1 (table)

Omit:

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Sozol

(a) between 1 July 2023 and 31 December 2023—4.5 months stock by reference to usual demand

(b) after 31 December 2023—5.5 months stock by reference to usual demand

substitute:

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Sozol

5.5 months stock by reference to usual demand

20  Schedule 1 (table)

Omit:

Perindopril

Tablet containing perindopril erbumine 2 mg

Oral

Indosyl Mono 2

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

(b) after 31 December 2023—5 months stock by reference to usual demand

Perindopril

Tablet containing perindopril erbumine 4 mg

Oral

Indosyl Mono 4

(a) between 1 July 2023 and 31 December 2023—4.5 months stock by reference to usual demand

(b) after 31 December 2023—5.5 months stock by reference to usual demand

Perindopril with indapamide

Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

Oral

Indosyl Combi 4/1.25

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

(b) after 31 December 2023—5 months stock by reference to usual demand

Perindopril with indapamide

Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

Oral

Perindo Combi 4/1.25

(a) between 1 July 2023 and 31 December 2023—2 months stock by reference to usual demand

(b) after 31 December 2023—2.5 months stock by reference to usual demand

21  Schedule 1 (table)

After:

Periciazine

Tablet 2.5 mg

Oral

Neulactil

6 months stock by reference to usual PBS demand

insert:

Perindopril

Tablet containing perindopril erbumine 2 mg

Oral

Indosyl Mono 2

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

Perindopril

Tablet containing perindopril erbumine 4 mg

Oral

Indosyl Mono 4

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

Perindopril

Tablet containing perindopril erbumine 8 mg

Oral

Indosyl Mono 8

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

Perindopril with indapamide

Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

Oral

Indosyl Combi 4/1.25

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

Perindopril with indapamide

Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

Oral

Perindo Combi 4/1.25

2.5 months stock by reference to usual demand

22  Schedule 1 (table)

Omit:

Pregabalin

Capsule 150 mg

Oral

Cipla Pregabalin

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

23  Schedule 1 (table)

Omit:

Ramipril

Capsule 10 mg

Oral

APXRamipril

(a) between 1 July 2023 and 31 December 2023—4.5 months stock by reference to usual demand

(b) after 31 December 2023—5.5 months stock by reference to usual demand

Ramipril

Capsule 10 mg

Oral

Prilace

(a) between 1 July 2023 and 31 December 2023—4.5 months stock by reference to usual demand

(b) after 31 December 2023—5.5 months stock by reference to usual demand

substitute:

Ramipril

Capsule 10 mg

Oral

APXRamipril

5.5 months stock by reference to usual demand

Ramipril

Capsule 10 mg

Oral

Prilace

5.5 months stock by reference to usual demand


24  Schedule 1 (table)

Omit:

Risperidone

Tablet 3 mg

Oral

APORisperidone

(a) between 1 July 2023 and 31 December 2023—3 months stock by reference to usual demand

(b) after 31 December 2023—3.5 months stock by reference to usual demand

substitute:

Risperidone

Tablet 3 mg

Oral

APORisperidone

3.5 months stock by reference to usual demand

25  Schedule 1 (table)

Omit:

Roxithromycin

Tablet 300 mg

Oral

APXRoxithromycin

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

(b) after 31 December 2023—5 months stock by reference to usual demand

substitute:

Roxithromycin

Tablet 300 mg

Oral

APXRoxithromycin

5 months stock by reference to usual demand

26  Schedule 1 (table)

Omit:

Sotalol

Tablet containing sotalol hydrochloride 160 mg

Oral

Cardol

(a) between 1 July 2023 and 31 December 2023—0 months stock by reference to usual demand

(b) after 31 December 2023—1.5 months stock by reference to usual demand

substitute:

Sotalol

Tablet containing sotalol hydrochloride 160 mg

Oral

Cardol

1.5 months stock by reference to usual demand

27  Schedule 1 (table)

Omit:

Valine with carbohydrate

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

Oral

Valine 1000

after 30 November 2024—0 months stock by reference to usual PBS demand

Valine with carbohydrate

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

Oral

Valine 50

after 30 November 2024—0 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

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

1  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

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

Application to the Ear

Ciloxan

6 months stock by reference to usual PBS demand

2  Schedule 1 (table)

After:

Methoxyflurane

Liquid for inhalation 999 mg per g, 3 ml (with inhaler)

Inhalation by mouth

Penthrox (Combination Pack)

6 months stock by reference to usual PBS demand

insert:

Metoclopramide

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

Metoclopramide HCl Medsurge

6 months stock by reference to usual demand