Commonwealth Coat of Arms of Australia

 

PB 103 of 2023

 

National Health (Minimum Stockholding) Amendment Determination (No. 1) 2023

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

Dated 28 September 2023

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

National Health (Minimum Stockholding) Determination 2023

1  Name

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 1) 2023.

 (2) This instrument may also be cited as PB 103 of 2023.

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.  The whole of this instrument

1 October 2023.

1 October 2023

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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

National Health (Minimum Stockholding) Determination 2023

1  After subsection 5(2)

Add:

(3)  For the purposes of this section, a brand of pharmaceutical item to which section 99ADHC and therefore 99AEKA of the Act applies, but to which section 99ADD of the Act does not apply, is treated as if data collection periods applied to the brand, and as if the start day for the first data collection period for the brand was the day on which that brand was first determined under subsection 85(6) of the Act.

2  Schedule 1

After:

Acarbose

Tablet 50 mg

Oral

GLYBOSAY

2 months stock by reference to usual demand

insert:

Alendronic acid with colecalciferol

Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

Oral

Alendronate Plus D3 Sandoz

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

3  Schedule 1

After:

Alendronic acid with colecalciferol

Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

Oral

Fosamax Plus 70 mg/140 mcg

between 1 July 2023 and 31 December 2023—1.5 months stock by reference to usual demand

 

insert:

Alendronic acid with colecalciferol

Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

Oral

Alendronate Plus D3 Sandoz

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand


4  Schedule 1

After:

Amisulpride

Oral solution 100 mg per mL, 60 mL

Oral

Solian Solution

4 months stock by reference to usual PBS demand

insert:

Amisulpride

Tablet 100 mg

Oral

Amisulpride 100 Winthrop

Between 1 October 2023 and 31 January 2024—0 months stock by reference to usual demand

Amisulpride

Tablet 400 mg

Oral

Amisulpride 400 Winthrop

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

5  Schedule 1

After:

Atomoxetine

Capsule 80 mg (as hydrochloride)

Oral

APO-Atomoxetine

3 months stock by reference to usual demand

insert:

Atorvastatin

Tablet 20 mg (as calcium)

Oral

Atorvastatin GH

Between 1 October 2023 and 29 February 2024—0 months stock by reference to usual demand

Azathioprine

Tablet 50 mg

Oral

Azathioprine GH

Between 1 October 2023 and 31 January 2024—0 months stock by reference to usual demand

6  Schedule 1

After:

Captopril

Oral solution 5 mg per mL, 95 mL

Oral

Capoten

4 months stock by reference to usual PBS demand

insert:

Carboplatin

Solution for I.V. injection 450 mg in 45 mL

Injection

DBL Carboplatin

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand


7  Schedule 1

After:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

APO-Cephalexin

between 1 July 2023 and 31 December 2023—5.5 months stock by reference to usual demand

insert:

Cefepime

Powder for injection 2 g (as hydrochloride)

Injection

Cefepime-AFT

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

8  Schedule 1

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

Clopidogrel GH

Between 1 October 2023 and 29 February 2024—0 months stock by reference to usual demand

Clopidogrel with aspirin

Tablet 75 mg (as hydrogen sulfate)-100 mg

Oral

CLOPIDOGREL/ASPIRIN AN 75/100

Between 1 October 2023 and 31 October 2023—0 months stock by reference to usual demand

9  Schedule 1

After:

Fentanyl

Transdermal patch 8.4 mg

Transdermal

APO-Fentanyl

3 months stock by reference to usual demand

insert:

Filgrastim

Injection 300 micrograms in 0.5 mL single-use pre-filled syringe

Injection

Neupogen

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

Filgrastim

Injection 300 micrograms in 1 mL

Injection

Neupogen

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

Filgrastim

Injection 480 micrograms in 0.5 mL single-use pre-filled syringe

Injection

Neupogen

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

Filgrastim

Injection 480 micrograms in 1.6 mL

Injection

Neupogen

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

10  Schedule 1

After:

Enalapril

Tablet containing enalapril maleate 5 mg

Oral

Malean

4 months stock by reference to usual demand

insert:

Entecavir

Tablet 1 mg (as monohydrate)

Oral

ENTAC

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

11  Schedule 1

After:

Fluorometholone

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

Application to the Eye

Flarex

4 months stock by reference to usual PBS demand

insert:

Fluorouracil

Injection 2500 mg in 50 mL

Injection

DBL Fluorouracil Injection BP

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

12  Schedule 1

After:

Gemfibrozil

Tablet 600 mg

Oral

Lipigem

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

insert:

Glimepiride

Tablet 3 mg

Oral

Amaryl

Between 1 October 2023 and 31 December 2023—0 months stock by reference to usual demand

Glimepiride

Tablet 4 mg

Oral

Amaryl

Between 1 October 2023 and 31 October 2023—0 months stock by reference to usual demand


13  Schedule 1

After:

Ibuprofen

Tablet 400 mg

Oral

APO-Ibuprofen 400

between 1 July 2023 and 31 December 2023—5 months stock by reference to usual demand

insert:

Imatinib

Capsule 100 mg (as mesilate)

Oral

CIPLA IMATINIB ADULT

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

14  Schedule 1

After:

Imatinib

Capsule 100 mg (as mesilate)

Oral

Imatinib GH

between 1 July 2023 and 31 August 2023—0 months stock by reference to usual demand

insert:

Imatinib

Capsule 400 mg (as mesilate)

Oral

CIPLA IMATINIB ADULT

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

15  Schedule 1

After:

Letrozole

Tablet 2.5 mg

Oral

Letrozole FBM

between 1 July 2023 and 31 August 2023—0 months stock by reference to usual demand

insert:

Levonorgestrel with ethinylestradiol

Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets

Oral

Monofeme 28

Between 1 October 2023 and 31 December 2023—0 months stock by reference to usual demand

16  Schedule 1

After:

Losartan

Tablet containing losartan potassium 25 mg

Oral

Cozavan

between 1 July 2023 and 31 August 2023—0 months stock by reference to usual demand

insert:

Macrogol 3350

Oral liquid 13.125 g in 25 mL with electrolytes, 500 mL

Oral

Movicol Liquid

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

17  Schedule 1

After:

Olanzapine

Tablet 5 mg (orally disintegrating)

Oral

APO-Olanzapine ODT

3 months stock by reference to usual demand

insert:

Olanzapine

Tablet 5 mg (orally disintegrating)

Oral

Olanzapine ODT generichealth 5

Between 1 October 2023 and 31 December 2023—0 months stock by reference to usual demand

18  Schedule 1

After:

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT Lupin

between 1 July 2023 and 31 August 2023—0 months stock by reference to usual demand

insert:

Oxaliplatin

Solution concentrate for I.V. infusion 100 mg in 20 mL

Injection

DBL Oxaliplatin Concentrate

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

19  Schedule 1

After:

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

insert:

Paracetamol

Tablet 665 mg (modified release)

Oral

CHEMISTS' OWN OSTEO RELIEF PARACETAMOL

Between 1 October 2023 and 31 October 2023—0 months stock by reference to usual demand

Pemetrexed

Powder for I.V. infusion 100 mg (as disodium)

Injection

Pemetrexed-AFT

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

Pemetrexed

Powder for I.V. infusion 500 mg (as disodium)

Injection

Pemetrexed-AFT

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

20  Schedule 1

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 4 mg

Oral

Perindopril generichealth

Between 1 October 2023 and 31 January 2024—0 months stock by reference to usual demand

Perindopril

Tablet containing perindopril erbumine 8 mg

Oral

Perindopril generichealth

Between 1 October 2023 and 31 January 2024—0 months stock by reference to usual demand

21  Schedule 1

Omit:

Ranitidine

Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL

Oral

Zantac Syrup

4 months stock by reference to usual PBS demand

substitute:

Ranitidine

Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL

Oral

Zantac Syrup

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual PBS demand

22  Schedule 1

After:

Thiamine

Tablet containing thiamine hydrochloride 100 mg

Oral

Betavit

4 months stock by reference to usual PBS demand

insert:

Tobramycin

Injection 80 mg in 2 mL

Injection

DBL Tobramycin

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

23  Schedule 1

After:

Valproic acid

Tablet, crushable, containing sodium valproate 100 mg

Oral

Epilim

4 months stock by reference to usual PBS demand

insert:

Vancomycin

Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

Injection

Vancomycin Viatris

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

Vancomycin

Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

Injection

Vancomycin Viatris

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand

24  Schedule 1

After:

Voriconazole

Powder for oral suspension 40 mg per mL, 70 mL

Oral

Vfend

4 months stock by reference to usual PBS demand

insert:

Voriconazole

Tablet 50 mg

Oral

Vfend

Between 1 October 2023 and 30 November 2023—0 months stock by reference to usual demand