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

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........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 2

4  Schedules................................................................................................................................. 2

Schedule 1—Amendments  3

National Health (Minimum Stockholding) Determination 2023   3

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Note:          This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1—Amendments

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