Commonwealth Coat of Arms of Australia

 

PB 32 of 2024

 

National Health (Minimum Stockholding) Amendment Determination (No. 3) 2024

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

Dated 27 March 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 immediately after the commencement of Schedule 3 to the National Health (Minimum Stockholding) Amendment Determination (No. 4) 2023

National Health (Minimum Stockholding) Determination 2023

Schedule 2—Amendments commencing 1 April 2024

National Health (Minimum Stockholding) Determination 2023

1  Name

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 3) 2024.

 (2) This instrument may also be cited as PB 32 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 April 2024.

1 April 2024

2.  Schedule 1

Immediately after the commencement of Schedule 3 to the National Health (Minimum Stockholding) Amendment Determination (No. 4) 2023.

1 April 2024

3.  Schedule 2

1 April 2024.

1 April 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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 immediately after the commencement of Schedule 3 to the National Health (Minimum Stockholding) Amendment Determination (No. 4) 2023

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Omit:

Pregabalin

Capsule 150 mg

Oral

Pregabalin Lupin

4 months stock by reference to usual demand of both Pregabalin Lupin and Pregabalin GH added together

2  Schedule 1 (table)

Omit:

Pregabalin

Capsule 75 mg

Oral

Pregabalin Lupin

4 months stock by reference to usual demand of both Pregabalin Lupin and Pregabalin GH added together

 

Schedule 2Amendments commencing 1 April 2024

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

Before:

Aripiprazole

Tablet 10 mg

Oral

APOAripiprazole

3 months stock by reference to usual demand

insert:

Anastrozole

Tablet 1 mg

Oral

Arimidex

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

2  Schedule 1 (table)

After:

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Bosentan Cipla

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

insert:

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Tracleer

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

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

Tracleer

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

3  Schedule 1 (table)

After:

Calcium

Tablet, chewable, 500 mg (as carbonate)

Oral

Cal500

after 30 November 2023—6 months stock by reference to usual PBS demand

insert:

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

4  Schedule 1 (table)

After:

Clarithromycin

Powder for oral liquid 250 mg per 5 mL, 50 mL

Oral

Klacid

4 months stock by reference to usual PBS demand

insert:

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

5  Schedule 1 (table)

Omit:

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

Fenac

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

6  Schedule 1 (table)

Omit:

Domperidone

Tablet 10 mg

Oral

Motilium

between 1 July 2023 and 31 March 2024—4 months stock by reference to usual PBS demand


7  Schedule 1 (table)

Omit:

Folinic acid

Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL

Injection

Leucovorin Calcium (Pfizer Australia Pty Ltd)

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

8  Schedule 1 (table)

Omit:

Glimepiride

Tablet 1 mg

Oral

Aylide 1

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

Glimepiride

Tablet 2 mg

Oral

Aylide 2

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

Glimepiride

Tablet 3 mg

Oral

Aylide 3

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

Glimepiride

Tablet 4 mg

Oral

Aylide 4

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

9  Schedule 1 (table)

Omit:

Hydralazine

Tablet containing hydralazine hydrochloride 25 mg

Oral

Alphapress 25

between 1 December 2023 and 31 March 2024—0 months stock by reference to usual PBS demand

10  Schedule 1 (table)

Omit:

Macrogol 3350

Powder for oral solution 510 g

Oral

OsmoLax

between 1 November 2023 and 31 March 2024—4 months stock by reference to usual demand


11  Schedule 1 (table)

After:

Methoxyflurane

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

Inhalation by mouth

Penthrox

6 months stock by reference to usual PBS demand

insert:

Methylprednisolone

Injection containing methylprednisolone acetate 40 mg in 1 mL

Injection

Depo-Nisolone

between 1 April 2024 and 30 September 2024—4 months stock by reference to usual demand

12  Schedule 1 (table)

Omit:

Methylprednisolone

Powder for injection 40 mg (as sodium succinate)

Injection

Methylpred

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

13  Schedule 1 (table)

After:

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

CellCept

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

insert:

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

Noumed Mycophenolate

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

14  Schedule 1 (table)

Omit:

Oxybutynin

Tablet containing oxybutynin hydrochloride 5 mg

Oral

Ditropan

between 1 November 2023 and 31 March 2024—4 months stock by reference to usual demand


15  Schedule 1 (table)

Before:

Pregabalin

Capsule 150 mg

Oral

LYPRALIN

between 1 November 2023 and 31 December 2023—0 months stock by reference to usual demand

insert:

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

NOUMED PIOGLITAZONE

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

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Pioglitazone Sandoz

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

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

NOUMED PIOGLITAZONE

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

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Pioglitazone Sandoz

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

16  Schedule 1 (table)

Omit:

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg3 mg per mL, 15 mL

Application to the Eye

Systane

between 1 July 2023 and 31 March 2024—4 months stock by reference to usual PBS demand

17  Schedule 1 (table)

Omit:

Pregabalin

Capsule 25 mg

Oral

Pregabalin Lupin

4 months stock by reference to usual demand of both Pregabalin Lupin and Pregabalin GH added together


18  Schedule 1 (table)

Omit:

Pregabalin

Capsule 300 mg

Oral

Pregabalin Lupin

4 months stock by reference to usual demand of both Pregabalin Lupin and Pregabalin GH added together

19  Schedule 1 (table)

Omit:

Prochlorperazine

Tablet containing prochlorperazine maleate 5 mg

Oral

Stemzine

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

20  Schedule 1 (table)

After:

Ramipril with felodipine

Tablet 2.5 mg2.5 mg (modified release)

Oral

Triasyn 2.5/2.5

4 months stock by reference to usual PBS demand

insert:

Riluzole

Oral suspension 50 mg per 10 mL, 300 mL

Oral

Teglutik

between 1 April 2024 and 30 September 2024—4 months stock by reference to usual demand

21  Schedule 1 (table)

Omit:

Risperidone

Tablet 1 mg

Oral

Risperidone generichealth

between 1 November 2023 and 31 March 2024—0 months stock by reference to usual demand

Risperidone

Tablet 2 mg

Oral

Risperidone generichealth

between 1 November 2023 and 31 March 2024—0 months stock by reference to usual demand

22  Schedule 1 (table)

Omit:

Risperidone

Tablet 3 mg

Oral

Risperidone generichealth

between 1 November 2023 and 31 March 2024—0 months stock by reference to usual demand

23  Schedule 1 (table)

After:

Risperidone

Tablet 4 mg

Oral

Risperidone generichealth

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

insert:

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

Noumed Rosuvastatin

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

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

Noumed Rosuvastatin

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

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

Noumed Rosuvastatin

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

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

Noumed Rosuvastatin

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

24  Schedule 1 (table)

Omit:

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Enemas 3.125 g450 mg45 mg in 5 mL, 12

Rectal

Micolette

between 1 November 2023 and 31 March 2024—4 months stock by reference to usual demand

25  Schedule 1 (table)

After:

Thiamine

Tablet containing thiamine hydrochloride 100 mg

Oral

Betavit

4 months stock by reference to usual PBS demand

insert:

Tobramycin

Injection 80 mg (as sulfate) in 2 mL (without preservative)

Injection

Pfizer Australia Pty Ltd

between 1 April 2024 and 30 September 2024—4 months stock by reference to usual demand

26  Schedule 1 (table)

After:

Topiramate

Tablet 100 mg

Oral

APOTopiramate

3 months stock by reference to usual demand

insert:

Topiramate

Tablet 100 mg

Oral

NOUMED TOPIRAMATE

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

27  Schedule 1 (table)

After:

Topiramate

Tablet 200 mg

Oral

APOTopiramate

3 months stock by reference to usual demand

insert:

Topiramate

Tablet 200 mg

Oral

NOUMED TOPIRAMATE

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

28  Schedule 1 (table)

After:

Topiramate

Tablet 25 mg

Oral

APOTopiramate

3 months stock by reference to usual demand

insert:

Topiramate

Tablet 25 mg

Oral

NOUMED TOPIRAMATE

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

29  Schedule 1 (table)

After:

Topiramate

Tablet 50 mg

Oral

APOTopiramate

3 months stock by reference to usual demand

insert:

Topiramate

Tablet 50 mg

Oral

NOUMED TOPIRAMATE

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


30  Schedule 1 (table)

Omit:

Tropisetron

I.V. injection 5 mg (as hydrochloride) in 5 mL

Injection

Tropisetron-AFT

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

31  Schedule 1 (table)

After:

Trimethoprim

Tablet 300 mg

Oral

Trimethoprim Viatris

after 30 April 2024—6 months stock by reference to usual demand of both Trimethoprim Viatris and Trimethoprim Mylan added together

insert:

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

NOUMED VALACICLOVIR

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

32  Schedule 1 (table)

Omit:

Vinorelbine

Solution for I.V. infusion 10 mg (as tartrate) in 1 mL

Injection

Navelbine

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

33  Schedule 1 (table)

Omit:

Voriconazole

Tablet 200 mg

Oral

Vfend

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