Commonwealth Coat of Arms of Australia

 

PB 75 of 2024

 

National Health (Minimum Stockholding) Amendment Determination (No. 6) 2024

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

Dated 25 June 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 July 2024

National Health (Minimum Stockholding) Determination 2023

Schedule 2—Amendments commencing 1 October 2024

National Health (Minimum Stockholding) Determination 2023

Schedule 3—Amendments commencing 1 December 2024

National Health (Minimum Stockholding) Determination 2023

1  Name

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 6) 2024.

 (2) This instrument may also be cited as PB 75 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 July 2024.

1 July 2024

2.  Schedule 1

1 July 2024.

1 July 2024

3.  Schedule 2

1 October 2024.

1 October 2024

4.  Schedule 3

1 December 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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 July 2024

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Omit:

Aripiprazole

Tablet 10 mg

Oral

Aripic Aripiprazole

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

2  Schedule 1 (table)

Omit:

Atorvastatin

Tablet 10 mg (as calcium)

Oral

Atorvastatin GH

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

Atorvastatin

Tablet 40 mg (as calcium)

Oral

Atorvastatin GH

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

3  Schedule 1 (table)

After:

Atomoxetine

Capsule 80 mg (as hydrochloride)

Oral

APOAtomoxetine

3 months stock by reference to usual demand

insert:

Atorvastatin

Tablet 10 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

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

Atorvastatin

Tablet 20 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

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

Atorvastatin

Tablet 40 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

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

Atorvastatin

Tablet 80 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

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

4  Schedule 1 (table)

Omit:

Candesartan

Tablet containing candesartan cilexetil 16 mg

Oral

NOUMED CANDESARTAN

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

Candesartan

Tablet containing candesartan cilexetil 32 mg

Oral

NOUMED CANDESARTAN

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

Candesartan

Tablet containing candesartan cilexetil 4 mg

Oral

NOUMED CANDESARTAN

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

Candesartan

Tablet containing candesartan cilexetil 8 mg

Oral

NOUMED CANDESARTAN

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

Capecitabine

Tablet 150 mg

Oral

Capecitabine-DRLA

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

5  Schedule 1 (table)

After:

Calcium

Tablet, chewable, 500 mg (as carbonate)

Oral

Cal500

6 months stock by reference to usual PBS demand

insert:

Candesartan

Tablet containing candesartan cilexetil 16 mg

Oral

Blooms the Chemist Candesartan

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

Candesartan

Tablet containing candesartan cilexetil 32 mg

Oral

Blooms the Chemist Candesartan

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

Candesartan

Tablet containing candesartan cilexetil 4 mg

Oral

Blooms the Chemist Candesartan

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

Candesartan

Tablet containing candesartan cilexetil 8 mg

Oral

Blooms the Chemist Candesartan

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

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

Oral

Blooms the Chemist Candesartan HCTZ 32/12.5

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

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

Oral

Blooms the Chemist Candesartan HCTZ 32/25

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

Capecitabine

Tablet 500 mg

Oral

Capecitabine-DRLA

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

6  Schedule 1 (table)

Omit:

Cefepime

Powder for injection 1 g (as hydrochloride)

Injection

Omegapharm Pty Ltd

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

Cefepime

Powder for injection 2 g (as hydrochloride)

Injection

Omegapharm Pty Ltd

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

7  Schedule 1 (table)

Omit:

Clindamycin

Capsule 150 mg (as hydrochloride)

Oral

Clindamycin BNM

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

8  Schedule 1 (table)

After:

Clonazepam

Oral liquid 2.5 mg per mL, 10 mL

Oral

Rivotril

6 months stock by reference to usual PBS demand

insert:

Clopidogrel

Tablet 75 mg (as besilate)

Oral

BTC Clopidogrel

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


9  Schedule 1 (table)

After:

Enalapril

Tablet containing enalapril maleate 5 mg

Oral

Malean

4 months stock by reference to usual demand

insert:

Entecavir

Tablet 0.5 mg (as monohydrate)

Oral

Entecavir Mylan

after 30 September 2024— 4 months stock by reference to usual demand of both Entecavir Viatris and Entecavir Mylan added together

10  Schedule 1 (table)

After:

Escitalopram

Tablet 10 mg (as oxalate)

Oral

APXEscitalopram

4 months stock by reference to usual demand

insert:

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Blooms the Chemist Escitalopram

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

11  Schedule 1 (table)

After:

Escitalopram

Tablet 20 mg (as oxalate)

Oral

APXEscitalopram

4 months stock by reference to usual demand

insert:

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Blooms the Chemist Escitalopram

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

Ezetimibe

Tablet 10 mg

Oral

Blooms The Chemist Ezetimibe

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

12  Schedule 1 (table)

After:

Felodipine

Tablet 2.5 mg (extended release)

Oral

Plendil ER

2.5 months stock by reference to usual demand

insert:

Fenofibrate

Tablet 145 mg

Oral

Blooms the Chemist Fenofibrate

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

13  Schedule 1 (table)

Omit:

Fluorometholone

Eye drops 1 mg per mL, 5 mL

Application to the Eye

FML Liquifilm

2 months stock by reference to usual PBS demand

substitute:

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

14  Schedule 1 (table)

After:

Fluorometholone

Eye drops containing fluorometholone acetate 1 mg per mL, 5 mL

Application to the Eye

Flarex

between 1 February 2024 and 31 July 2024—0 months stock by reference to usual PBS demand

insert:

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

BTC Fluoxetine

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

15  Schedule 1 (table)

After:

Galantamine

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

Gamine XR

3 months stock by reference to usual demand

insert:

Glimepiride

Tablet 1 mg

Oral

Amaryl

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

16  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:

Granisetron

Concentrated injection 3 mg (as hydrochloride) in 3 mL

Injection

Granisetron Kabi

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

17  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 150 mg

Oral

Blooms the Chemist Irbesartan

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

Irbesartan

Tablet 75 mg

Oral

Avapro

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

Irbesartan

Tablet 75 mg

Oral

Blooms the Chemist Irbesartan

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

Irbesartan with hydrochlorothiazide

Tablet 150 mg-12.5 mg

Oral

AVSARTAN HCT 150/12.5

4 months stock by reference to usual demand

18  Schedule 1 (table)

After:

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the Eye

APOLatanoprost/Timolol 0.05/5

2.5 months stock by reference to usual demand

insert:

Leflunomide

Tablet 10 mg

Oral

Arabloc

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

Lercanidipine

Tablet containing lercanidipine hydrochloride 10 mg

Oral

BTC Lercanidipine

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

Lercanidipine

Tablet containing lercanidipine hydrochloride 20 mg

Oral

BTC Lercanidipine

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


19  Schedule 1 (table)

After:

Meloxicam

Tablet 7.5 mg

Oral

MELOBIC

4 months stock by reference to usual demand

insert:

Metformin

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

Blooms the Chemist Metformin XR 1000

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

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

Blooms the Chemist Metformin XR 500

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

20  Schedule 1 (table)

Omit:

Morphine

Tablet containing morphine sulfate pentahydrate 30 mg

Oral

Anamorph

3 months stock by reference to usual demand

21  Schedule 1 (table)

After:

Norfloxacin

Tablet 400 mg

Oral

APONorfloxacin

2.5 months stock by reference to usual demand

insert:

Olanzapine

Tablet 10 mg

Oral

NOUMED OLANZAPINE

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

22  Schedule 1 (table)

After:

Olanzapine

Tablet 15 mg (orally disintegrating)

Oral

Zypine ODT

(a) between 1 February 2024 and 30 September 2024—4 months stock by reference to usual demand of the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 15 mg, Oral;

(b) between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand of both the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 15 mg, Oral and the brand Zypine ODT of the pharmaceutical item Olanzapine, Tablet 15 mg (orally disintegrating), Oral, added together.

insert:

Olanzapine

Tablet 2.5 mg

Oral

NOUMED OLANZAPINE

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

23  Schedule 1 (table)

After:

Olanzapine

Tablet 20 mg (orally disintegrating)

Oral

Zypine ODT

(a) between 1 February 2024 and 30 September 2024—4 months stock by reference to usual demand of the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 20 mg, Oral;

(b) between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand of both the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 20 mg, Oral and the brand Zypine ODT of the pharmaceutical item Olanzapine, Tablet 20 mg (orally disintegrating), Oral, added together

insert:

Olanzapine

Tablet 5 mg

Oral

NOUMED OLANZAPINE

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

24  Schedule 1 (table)

After:

Olanzapine

Tablet 5 mg (orally disintegrating)

Oral

Zypine ODT

(a) between 1 February 2024 and 30 September 2024—4 months stock by reference to usual demand of the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 5 mg, Oral;

(b) between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand of both the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 5 mg, Oral and the brand Zypine ODT of the pharmaceutical item Olanzapine, Tablet 5 mg (orally disintegrating), Oral, added together

insert:

Olanzapine

Tablet 7.5 mg

Oral

NOUMED OLANZAPINE

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

25  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

BTC Perindopril

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

26  Schedule 1 (table)

After:

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

insert:

Perindopril

Tablet containing perindopril erbumine 4 mg

Oral

BTC Perindopril

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

27  Schedule 1 (table)

After:

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


insert:

Perindopril

Tablet containing perindopril erbumine 8 mg

Oral

BTC Perindopril

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

28  Schedule 1 (table)

After:

Pregabalin

Capsule 300 mg

Oral

Cipla Pregabalin

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

insert:

Pregabalin

Capsule 75 mg

Oral

Blooms the Chemist Pregabalin

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

29  Schedule 1 (table)

After:

Risperidone

Tablet 3 mg

Oral

Rispa

3 months stock by reference to usual demand

insert:

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

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

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

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

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

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

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

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


30  Schedule 1 (table)

Omit:

Roxithromycin

Tablet 150 mg

Oral

Roximycin

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

31  Schedule 1 (table)

Omit:

Roxithromycin

Tablet 300 mg

Oral

Roximycin

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

32  Schedule 1 (table)

Omit:

Salbutamol

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Inhalation by Mouth

Asmol CFC-Free with dose counter

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

Salbutamol

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Inhalation by Mouth

Zempreon CFC-Free with dose counter

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

33  Schedule 1 (table)

Omit:

Topiramate

Tablet 100 mg

Oral

NOUMED TOPIRAMATE

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

34  Schedule 1 (table)

Omit:

Topiramate

Tablet 200 mg

Oral

NOUMED TOPIRAMATE

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


35  Schedule 1 (table)

Omit:

Topiramate

Tablet 25 mg

Oral

NOUMED TOPIRAMATE

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

36  Schedule 1 (table)

Omit:

Topiramate

Tablet 50 mg

Oral

NOUMED TOPIRAMATE

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

37  Schedule 1 (table)

Omit:

Triglycerides, medium chain

Oral liquid 225 mL, 15 (K.Quik)

Oral

K.Quik

0 months stock by reference to usual PBS demand

38  Schedule 1 (table)

After:

Valproic acid

Tablet, crushable, containing sodium valproate 100 mg

Oral

Epilim

4 months stock by reference to usual PBS demand

insert:

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Blooms the Chemist Venlafaxine XR

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

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Blooms the Chemist Venlafaxine XR

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


Schedule 2Amendments commencing 1 October 2024

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Omit:

Acarbose

Tablet 100 mg

Oral

Acarbose Viatris

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

2  Schedule 1 (table)

Omit:

Dosulepin

Tablet containing dosulepin hydrochloride 75 mg

Oral

Dosulepin Viatris 75

6 months stock by reference to usual demand of both Dosulepin Viatris 75 and Dosulepin Mylan added together

3  Schedule 1 (table)

Omit:

Lamivudine with zidovudine

Tablet 150 mg-300 mg

Oral

Lamivudine/Zidovudine Viatris 150/300

after 31 May 2024—4 months stock by reference to usual demand of both Lamivudine/Zidovudine Viatris 150/300 and Lamivudine 150 mg + Zidovudine 300 mg Alphapharm added together

4  Schedule 1 (table)

Omit:

Moxonidine

Tablet 200 micrograms

Oral

Moxonidine Viatris

4 months stock by reference to usual demand of both Moxonidine Viatris and Moxonidine MYL added together

Moxonidine

Tablet 400 micrograms

Oral

Moxonidine Viatris

4 months stock by reference to usual demand of both Moxonidine Viatris and Moxonidine MYL added together


5  Schedule 1 (table)

Omit:

Paraffin with retinol palmitate

Eye ointment, compound, containing liquid paraffin, light liquid paraffin, wool fat, white soft paraffin and retinol palmitate, 5 g

Application to the Eye

VitA-POS

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

6  Schedule 1 (table)

Omit:

Valganciclovir

Tablet 450 mg (as hydrochloride)

Oral

Valganciclovir Viatris

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


Schedule 3Amendments commencing 1 December 2024

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

After:

Metronidazole

Suppositories 500 mg, 10

Rectal

Flagyl

6 months stock by reference to usual PBS demand

insert:

Mifepristone and misoprostol

Pack containing 1 tablet mifepristone 200 mg and 4 tablets misoprostol 200 micrograms

Oral

MS-2 Step

6 months stock by reference to usual PBS demand

2  Schedule 1 (table)

After:

Valganciclovir

Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL

Oral

Valcyte

4 months stock by reference to usual PBS demand

insert:

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

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