National Health Act (Pharmaceutical Benefits - Early Supply) Instrument 2009 - specification under subsection 84AAA(2) (No. PB 30 of 2009) (Cth)

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National Health Act (Pharmaceutical Benefits—Early Supply) Instrument 2009—specification under subsection 84AAA(2) (PB 30 of 2009)

made under subsection 84AAA(2) of the

National Health Act 1953

Compilation No. 50

Compilation date:    1 December 2015

Includes amendments up to:         PB 110 of 2015

Registered:             2 December 2015

About this compilation

This compilation

This is a compilation of the National Health Act (Pharmaceutical Benefits—Early Supply) Instrument 2009—specification under subsection 84AAA(2) (PB 30 of 2009) that shows the text of the law as amended and in force on 1 December 2015 (the compilation date).

This compilation was prepared on 2 December 2015.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on ComLaw ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on ComLaw for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on ComLaw for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

1............ Name of Instrument....................................................................................................... 1

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

3............ Revocation..................................................................................................................... 1

4............ Definitions..................................................................................................................... 1

5............ Specification of pharmaceutical items............................................................................ 1

6............ Circumstances relating to specification of pharmaceutical items.................................... 1

Schedule 1—Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply          3

Endnotes31

Endnote 1—About the endnotes  31

Endnote 2—Abbreviation key  32

Endnote 3—Legislation history  33

Endnote 4—Amendment history  36

1  Name of Instrument

(1)  This Instrument is the National Health Act (Pharmaceutical Benefits—Early Supply) Instrument 2009—specification under subsection 84AAA(2).

(2)  This Instrument may also be cited as “No. PB 30 of 2009”.

2  Commencement

This Instrument commences on 1 May 2009.

3  Revocation

The National Health (Pharmaceutical Benefits – early supply) Instrument 2005 is revoked.

4  Definitions

In this Instrument:

Act means the National Health Act 1953.

I.U. means international unit.

Mg means milligram.

Ml means millilitre.

5  Specification of pharmaceutical items

(1) For paragraph 84AAA(1)(b) of the Act, a pharmaceutical item in a pharmaceutical benefit is specified if:

(a)  the item is mentioned in Schedule 1; and

(b)  all the circumstances identified in section 6 as applying to the benefit exist in relation to a benefit that has the item in Schedule 1.

(2)  A pharmaceutical item in Schedule 1 is identified by the name of the listed drug, the form of the listed drug, and the manner of administration of that form of the listed drug.

6  Circumstances relating to specification of pharmaceutical items

For paragraph 5(1)(b), the circumstances are as follows:

(1)  the form of a pharmaceutical benefit that has the pharmaceutical item mentioned in the table in Schedule 1 is the same as the form of the pharmaceutical item determined under subsection 85(3) of the Act;

(2) the manner of administration of a benefit that has the item mentioned in the table is the same as the manner of administration of the item determined under subsection 85(5) of the Act;

(3) the maximum quantity or number of units mentioned in the table for a benefit that has the item is the same as the maximum quantity or number of units determined under paragraph 85A(2)(a) of the Act;

(4) the maximum number of repeats mentioned in the table for a benefit that has the item is the same as the maximum number of repeats determined under paragraph 85A(2)(b) of the Act;

(5) any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned for a benefit that has the item in the table.

Schedule 1—Pharmaceutical items and circumstances specified under subsection 84AAA(2) for purposes of early supply

Pharmaceutical item Circumstances
Listed drug Form Manner of administration Maximum quantity or number of units Maximum number of repeats Other circumstances (if any) for a pharmaceutical benefit that has the item
Abatacept Injection 125 mg in 1 mL single dose pre‑filled syringe Injection 4 5
Aciclovir Tablet 200 mg Oral 90 5
Aclidinium Powder for oral inhalation in breath actuated device 322 micrograms (as bromide) per dose, 60 doses Inhalation by mouth 1 5
Aclidinium with eformoterol Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses Inhalation by mouth 1 5 1
Adalimumab Injection 20 mg in 0.4 mL pre-filled pen Injection 2 5
Injection 40 mg in 0.8 mL pre‑filled pen Injection 2 5
Injection 40 mg in 0.8 mL pre‑filled syringe Injection 2 5
Alendronic Acid Tablet 70 mg (as alendronate sodium) Oral 4 5
Alendronic acid with colecalciferol Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol Oral 4 5
Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol Oral 4 5
Alendronic acid with colecalciferol and calcium Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate) Oral 1 5
Amantadine Capsule containing amantadine hydrochloride 100 mg Oral 100 5
Amlodipine Tablet 5 mg (as besylate) Oral 30 5
Tablet 10 mg (as besylate) Oral 30 5
Amlodipine with atorvastatin Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) Oral 30 5
Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) Oral 30 5
Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) Oral 30 5
Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) Oral 30 5
Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) Oral 30 5
Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) Oral 30 5
Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) Oral 30 5
Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) Oral 30 5
Amlodipine with valsartan Tablet 5 mg (as besylate)‑80 mg Oral 28 5
Tablet 5 mg (as besylate)‑160 mg Oral 28 5
Tablet 5 mg (as besylate)‑320 mg Oral 28 5
Tablet 10 mg (as besylate)‑160 mg Oral 28 5
Tablet 10 mg (as besylate)‑320 mg Oral 28 5
Amlodipine with valsartan and hydrochlorothiazide Tablet 5 mg (as besylate)‑160 mg‑12.5 mg Oral 28 5
Tablet 5 mg (as besylate)‑160 mg‑25 mg Oral 28 5
Tablet 10 mg (as besylate)‑160 mg‑12.5 mg Oral 28 5
Tablet 10 mg (as besylate)‑160 mg‑25 mg Oral 28 5
Tablet 10 mg (as besylate)‑320 mg‑25 mg Oral 28 5
Anastrozole Tablet 1 mg Oral 30 5
Apixaban Tablet 2.5mg Oral 60 5
Tablet 5mg Oral 60 5
Aripiprazole Powder for injection 300 mg (as monohydrate) with diluent Injection 1 5
Powder for injection 400 mg (as monohydrate) with diluent Injection 1 5
Atenolol Tablet 50 mg Oral 30 5
Oral solution 50 mg in 10 mL, 300 mL Oral 1 5
Atomoxetine Capsule 10 mg (as hydrochloride) Oral 56 5
Capsule 18 mg (as hydrochloride) Oral 56 5
Capsule 25 mg (as hydrochloride) Oral 56 5
Capsule 40 mg (as hydrochloride) Oral 56 5
Capsule 60 mg (as hydrochloride) Oral 56 5
Capsule 80 mg (as hydrochloride) Oral 28 5
Capsule 100 mg (as hydrochloride) Oral 28 5
Atorvastatin Tablet 10 mg (as calcium) Oral 30 5
Tablet 10 mg (as calcium) Oral 30 11
Tablet 20 mg (as calcium) Oral 30 5
Tablet 20 mg (as calcium) Oral 30 11
Tablet 40 mg (as calcium) Oral 30 5
Tablet 40 mg (as calcium) Oral 30 11
Tablet 80 mg (as calcium) Oral 30 5
Tablet 80 mg (as calcium) Oral 30 11
Atorvastatin with ezetimibe Pack containing 30 tablets atorvastatin 10 mg (as calcium) and 30 tablets ezetimibe 10 mg Oral 1 5
Pack containing 30 tablets atorvastatin 20 mg (as calcium) and 30 tablets ezetimibe 10 mg Oral 1 5
Pack containing 30 tablets atorvastatin 40 mg (as calcium) and 30 tablets ezetimibe 10 mg Oral 1 5
Pack containing 30 tablets atorvastatin 80 mg (as calcium) and 30 tablets ezetimibe 10 mg Oral 1 5
Auranofin Capsule 3 mg Oral 60 5
Tablet 3 mg Oral 60 5
Baclofen Tablet 10 mg Oral 100 5
Tablet 25 mg Oral 100 5
Balsalazide Capsule containing balsalazide sodium 750 mg Oral 180 5
Betaine Oral powder 180 g Oral 1 5
Bicalutamide Tablet 50 mg Oral 28 5
Bisoprolol Tablet containing bisoprolol fumarate 2.5 mg Oral 28 5
Tablet containing bisoprolol fumarate 5 mg Oral 28 5
Tablet containing bisoprolol fumarate 10 mg Oral 28 5
Cabergoline Tablet 1 mg Oral 30 5
Tablet 2 mg Oral 30 5
Candesartan Tablet containing candesartan cilexetil 4 mg Oral 30 5
Tablet containing candesartan cilexetil 8 mg Oral 30 5
Tablet containing candesartan cilexetil 16 mg Oral 30 5
Tablet containing candesartan cilexetil 32 mg Oral 30 5
Candesartan with hydrochlorothiazide Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg Oral 30 5
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg Oral 30 5
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg Oral 30 5
Captopril Tablet 12.5 mg Oral 90 5
Tablet 25 mg Oral 90 5
Tablet 50 mg Oral 90 5
Carvedilol Tablet 6.25 mg Oral 60 5
Tablet 12.5 mg Oral 60 5
Tablet 25 mg Oral 60 5
Certolizumab pegol Injection 200 mg in 1 mL single use pre‑filled syringe Injection 2 5
Cimetidine Tablet 400 mg Oral 60 5
Clonidine Tablet containing clonidine hydrochloride 100 micrograms Oral 100 5
Tablet containing clonidine hydrochloride 150 micrograms Oral 100 5
Clopidogrel Tablet 75 mg Oral 28 5
Tablet 75 mg (as hydrogen sulfate) Oral 28 5
Tablet 75 mg (as besilate) Oral 28 5
Clopidogrel with aspirin Tablet 75 mg (as hydrogen sulfate)‑100 mg Oral 30 5
Dabigatran etexilate Capsule 110 mg (as mesilate) Oral 60 5
Capsule 150 mg (as mesilate) Oral 60 5
Dalteparin Injection containing dalteparin sodium 7,500 I.U. (anti‑Xa) in 0.75 mL single dose pre‑filled syringe Injection 30 5
Injection containing dalteparin sodium 10,000 I.U. (anti‑Xa) in 1 mL single dose pre‑filled syringe Injection 30 5
Injection containing dalteparin sodium 12,500 I.U. (anti‑Xa) in 0.5 mL single dose pre‑filled syringe Injection 30 5
Injection containing dalteparin sodium 15,000 I.U. (anti‑Xa) in 0.6 mL single dose pre‑filled syringe Injection 30 5
Injection containing dalteparin sodium 18,000 I.U. (anti‑Xa) in 0.72 mL single dose pre‑filled syringe Injection 30 5
Degarelix Powder for injection 80 mg (as acetate), injection set Injection 1 5
Denosumab Injection 120 mg in 1.7 mL Injection 1 5

Bone metastases

The condition must be due to castration‑resistant prostate cancer

Bone metastases

The condition must be due to breast cancer

Diltiazem Tablet containing diltiazem hydrochloride 60 mg Oral 90 5
Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg Oral 30 5
Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg Oral 30 5
Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg Oral 30 5
Dipyridamole Capsule 200 mg (sustained release) Oral 60 5
Dipyridamole with aspirin Capsule 200 mg (sustained release)25 mg Oral 60 5
Dutasteride Capsule 500 micrograms Oral 30 5
Dutasteride with Tamsulosin Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms Oral 30 5
Empagliflozin Tablet 10 mg Oral 30 5
Tablet 25 mg Oral 30 5
Enalapril Tablet containing enalapril maleate 5 mg Oral 30 5
Tablet containing enalapril maleate 10 mg Oral 30 5
Tablet containing enalapril maleate 20 mg Oral 30 5
Enalapril with Hydrochlorothiazide Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg Oral 30 5
Enzalutamide Capsule 40 mg Oral 112 2
Eplerenone Tablet 25 mg Oral 30 5
Tablet 50 mg Oral 30 5
Eprosartan Tablet 400 mg (as mesylate) Oral 56 5
Tablet 600 mg (as mesylate) Oral 28 5
Eprosartan with hydrochlorothiazide Tablet 600 mg eprosartan (as mesylate) with 12.5 mg hydrochlorothiazide Oral 28 5
Esomeprazole Capsule (enteric) 20 mg (as magnesium) Oral 30 5
Capsule (enteric) 40 mg (as magnesium) Oral 30 5
Tablet (enteric coated) 20 mg (as magnesium trihydrate) Oral 30 5
Tablet (enteric coated) 40 mg (as magnesium trihydrate) Oral 30 5
Etanercept Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL Injection 2 5
Injections 50 mg in 1 mL single use pre‑filled syringes, 4 Injection 1 5
Injection 50 mg in 1 mL single use auto‑injector, 4 Injection 1 5
Ezetimibe Tablet 10 mg Oral 30 5
Ezetemibe and rosuvastatin Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium) Oral 1 5
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium) Oral 1 5
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium) Oral 1 5
Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium) Oral 1 5
Ezetimibe with atorvastatin Tablet 10 mg-10 mg Oral 30 5
Tablet 10 mg-20 mg Oral 30 5
Tablet 10 mg-40 mg Oral 30 5
Tablet 10 mg-80 mg Oral 30 5
Ezetimibe with simvastatin Tablet 10 mg‑10 mg Oral 30 5
Tablet 10 mg‑20 mg Oral 30 5
Tablet 10 mg‑40 mg Oral 30 5
Tablet 10 mg‑80 mg Oral 30 5
Famciclovir Tablet 250 mg Oral 56 5
Tablet 500 mg Oral 56 5
Famotidine Tablet 20 mg Oral 60 5
Tablet 40 mg Oral 30 5
Febuxostat Tablet 80 mg Oral 28 5
Felodipine Tablet 2.5 mg (extended release) Oral 30 5
Tablet 5 mg (extended release) Oral 30 5
Tablet 10 mg (extended release) Oral 30 5
Fenofibrate Tablet 48 mg Oral 60 5
Tablet 48 mg Oral 60 11
Tablet 145 mg Oral 30 5
Tablet 145 mg Oral 30 11
Fludarabine Tablet containing fludarabine phosphate 10 mg Oral 20 5
Flutamide Tablet 250 mg Oral 100 5
Fluvastatin Tablet (prolonged release) 80 mg (as sodium) Oral 28 5
Tablet (prolonged release) 80 mg (as sodium) Oral 28 11
Fosinopril Tablet containing fosinopril sodium 10 mg Oral 30 5
Tablet containing fosinopril sodium 20 mg Oral 30 5
Fosinopril with hydrochlorothiazide Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg Oral 30 5
Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg Oral 30 5
Gemfibrozil Tablet 600 mg Oral 60 5
Tablet 600 mg Oral 60 11
Glyceryl trinitrate Transdermal patch 18 mg Transdermal 30 5
Transdermal patch 25 mg Transdermal 30 5
Transdermal patch 36 mg Transdermal 30 5
Transdermal patch 40 mg Transdermal 30 5
Transdermal patch 50 mg Transdermal 30 5
Transdermal patch 54 mg Transdermal 30 5
Transdermal patch 80 mg Transdermal 30 5
Transdermal patch 120 mg Transdermal 30 5
Glycopyrronium Capsule containing powder for oral inhalation 50 micrograms (as bromide) (for use in Breezhaler) Inhalation by mouth 30 5
Golimumab Injection 50 mg in 0.5 mL single use pre‑filled pen Injection 1 5
Injection 50 mg in 0.5 mL single use pre‑filled syringe Injection 1 5
Goserelin and bicalutamide Pack containing 1 subcutaneous implant containing goserelin 3.6 mg (as acetate) in pre‑filled injection syringe and 28 tablets bicalutamide 50 mg Implantation/
oral
1 5
Imatinib Tablet 100 mg (as mesylate) Oral 60 5
Tablet 400 mg (as mesylate) Oral 30 5
Indacaterol Capsule containing powder for oral inhalation 150 micrograms (as maleate) (for use in Breezhaler) Inhalation by mouth 30 5
Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler) Inhalation by mouth 30 5
Indacaterol with glycopyrronium Capsule containing powder for oral inhalation indacaterol 110 micrograms (as maleate) with glycopyrronium 50 micrograms (as bromide) (for use in Breezhaler) Inhalation by mouth 30 5
Irbesartan Tablet 75 mg Oral 30 5
Tablet 150 mg Oral 30 5
Tablet 300 mg Oral 30 5
Irbesartan with hydrochlorothiazide Tablet 150 mg‑12.5 mg Oral 30 5
Tablet 300 mg‑12.5 mg Oral 30 5
Tablet 300 mg‑25 mg Oral 30 5
Isosorbide mononitrate Tablet 60 mg (sustained release) Oral 30 5
Tablet 120 mg (sustained release) Oral 30 5
Ivabradine Tablet 5 mg Oral 56 5
Tablet 7.5 mg Oral 56 5
Labetalol Tablet containing labetalol hydrochloride 100 mg Oral 100 5
Tablet containing labetalol hydrochloride 200 mg Oral 100 5
Lansoprazole Capsule 15 mg Oral 30 5
Capsule 30 mg Oral 28 5
Tablet 15 mg (orally disintegrating) Oral 28 5
Tablet 30 mg (orally disintegrating) Oral 28 5
Leflunomide Tablet 10 mg Oral 30 5
Tablet 20 mg Oral 30 5
Lercanidipine Tablet containing lercanidipine hydrochloride 10 mg Oral 28 5
Tablet containing lercanidipine hydrochloride 20 mg Oral 28 5
Lercanidipine with enalapril Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 10 mg Oral 28 5
Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 20 mg Oral 28 5
Letrozole Tablet 2.5 mg Oral 30 5
Leuprorelin I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre‑filled dual‑chamber syringe Injection 1 5
Lisinopril Tablet 5 mg Oral 30 5
Tablet 10 mg Oral 30 5
Tablet 20 mg Oral 30 5
Losartan Tablet containing losartan potassium 25 mg Oral 30 5
Tablet containing losartan potassium 50 mg Oral 60 5
Mesalazine Sachet containing granules, 500 mg per sachet Oral 200 5
Sachet containing granules, 1 g per sachet Oral 100 5
Sachet containing granules, 1.5 g per sachet Oral 60 5
Sachet containing granules, 3 g per sachet Oral 30 5
Sachet containing prolonged release granules, 1 g per sachet Oral 120 5
Sachet containing prolonged release granules, 2 g per sachet Oral 60 5
Sachet containing prolonged release granules, 4 g per sachet Oral 30 5
Tablet 250 mg (enteric coated) Oral 100 5
Tablet 500 mg (enteric coated) Oral 200 5
Tablet 500 mg (prolonged release) Oral 200 5
Tablet 1 g (prolonged release) Oral 120 5
Tablet 1.2 g (prolonged release) Oral 60 5
Methyldopa Tablet 250 mg Oral 100 5
Metoprolol Tablet containing metoprolol tartrate 50 mg Oral 100 5
Tablet containing metoprolol tartrate 100 mg Oral 60 5
Metoprolol succinate Tablet 47.5 mg (controlled release) Oral 30 5
Tablet 95 mg (controlled release) Oral 30 5
Tablet 190 mg (controlled release) Oral 30 5
Minocycline Tablet 50 mg (as hydrochloride) Oral 60 5
Minoxidil Tablet 10 mg Oral 100 5
Modafinil Tablet 100 mg Oral 120 5
Moxonidine Tablet 200 micrograms Oral 30 5
Tablet 400 micrograms Oral 30 5
Nebivolol Tablet 1.25 mg (as hydrochloride) Oral 56 5
Tablet 5 mg (as hydrochloride) Oral 28 5
Tablet 10 mg (as hydrochloride) Oral 28 5
Nicorandil Tablets 10 mg, 60 Oral 1 5
Tablets 20 mg, 60 Oral 1 5
Nifedipine Tablet 10 mg Oral 60 5
Tablet 20 mg Oral 60 5
Tablet 20 mg (controlled release) Oral 30 5
Tablet 30 mg (controlled release) Oral 30 5
Tablet 60 mg (controlled release) Oral 30 5
Nilotinib Capsule 150 mg (as hydrochloride monohydrate) Oral 120 5
Capsule 200 mg (as hydrochloride monohydrate) Oral 120 5
Nilutamide Tablet 150 mg Oral 30 5
Nizatidine Capsule 150 mg Oral 60 5
Capsule 300 mg Oral 30 5
Oestradiol Transdermal patches 390 micrograms, 8 Transdermal 1 5
Transdermal patches 585 micrograms, 8 Transdermal 1 5
Transdermal patches 750 micrograms (as hemihydrate), 8 Transdermal 1 5
Transdermal patches 780 micrograms, 8 Transdermal 1 5
Transdermal patches 1.17 mg, 8 Transdermal 1 5
Transdermal patches 1.5 mg (as hemihydrate), 8 Transdermal 1 5
Transdermal patches 1.56 mg, 8 Transdermal 1 5
Transdermal patches 2 mg, 4 Transdermal 1 5
Transdermal patches 3 mg (as hemihydrate), 8 Transdermal 1 5
Transdermal patches 3.8 mg, 4 Transdermal 1 5
Transdermal patches 5.7 mg, 4 Transdermal 1 5
Transdermal patches 7.6 mg, 4 Transdermal 1 5
Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28 Transdermal 1 5
Oestradiol and oestradiol with dydrogesterone Pack containing 14 tablets oestradiol 1 mg and 14 tablets oestradiol 1 mg with dydrogesterone 10 mg Oral 1 5
Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg Oral 1 5
Oestradiol and oestradiol with norethisterone Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate Transdermal 1 5
Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate Transdermal 1 5
Oestradiol with dydrogesterone Tablet 1 mg-5 mg Oral 28 5
Oestradiol with norethisterone Transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 Transdermal 1 5
Transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 Transdermal 1 5
Olmesartan Tablet containing olmesartan medoxomil 20 mg Oral 30 5
Tablet containing olmesartan medoxomil 40 mg Oral 30 5
Olmesartan with amlodipine Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate) Oral 30 5
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate) Oral 30 5
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate) Oral 30 5
Olmesartan with amlodipine and hydrochlorothiazide Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate) and hydrochlorothiazide 12.5 mg Oral 30 5
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate) and hydrochlorothiazide 12.5 mg Oral 30 5
Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate) and hydrochlorothiazide 25 mg Oral 30 5
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate ) and hydrochlorothiazide 12.5 mg Oral 30 5
Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate) and hydrochlorothiazide 25 mg Oral 30 5
Olmesartan with hydrochlorothiazide Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg Oral 30 5
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg Oral 30 5
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg Oral 30 5
Olsalazine Capsule containing olsalazine sodium 250 mg Oral 100 5
Tablet containing olsalazine sodium 500 mg Oral 100 5
Omeprazole Tablet 10 mg (as magnesium) Oral 30 5
Tablet 20 mg (as magnesium) Oral 30 5
Tablet 20 mg Oral 30 5
Capsule 20 mg Oral 30 5
Oxprenolol Tablet containing oxprenolol hydrochloride 40 mg Oral 100 5
Pantoprazole Sachet containing granules 40 mg (as sodium sesquihydrate) Oral 30 5
Tablet (enteric coated) 20 mg (as sodium sesquihydrate) Oral 30 5
Tablet (enteric coated) 40 mg (as sodium sesquihydrate) Oral 30 5
Pazopanib Tablet 200 mg (as hydrochloride) Oral 30 5
90 5
Tablet 400 mg (as hydrochloride) Oral 30 5
60 5
Perhexiline Tablet containing perhexiline maleate 100 mg Oral 100 5
Perindopril Tablet containing perindopril arginine 2.5 mg Oral 30 5
Tablet containing perindopril arginine 5 mg Oral 30 5
Tablet containing perindopril arginine 10 mg Oral 30 5
Tablet containing perindopril erbumine 2 mg Oral 30 5
Tablet containing perindopril erbumine 4 mg Oral 30 5
Tablet containing perindopril erbumine 8 mg Oral 30 5
Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral 30 5
Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral 30 5
Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral 30 5
Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral 30 5
Perindopril with indapamide Tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg Oral 30 5
Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg Oral 30 5
Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg Oral 30 5
Phenoxybenzamine Capsule containing phenoxybenzamine hydrochloride 10 mg Oral 100 5
Capsule containing 10 mg phenoxybenzamine hydrochloride Oral 100 5
Pindolol Tablet 5 mg Oral 100 5
Tablet 15 mg Oral 50 5
Ponatinib Tablet 15 mg (as hydrochloride) Oral 60 5 60
Tablet 45 mg (as hydrochloride) Oral 30 5 30
Pramipexole Tablet (extended release) containing pramipexole hydrochloride 1.5 mg Oral 30 5
Tablet (extended release) containing pramipexole hydrochloride 2.25 mg Oral 30 5
Tablet (extended release) containing pramipexole hydrochloride 3 mg Oral 30 5
Tablet (extended release) containing pramipexole hydrochloride 3.75 mg Oral 30 5
Tablet (extended release) containing pramipexole hydrochloride 4.5 mg Oral 30 5
Prasugrel Tablet 5 mg (as hydrochloride) Oral 28 5
Tablet 10 mg (as hydrochloride) Oral 28 5
Pravastatin Tablet containing pravastatin sodium 10 mg Oral 30 5
Tablet containing pravastatin sodium 10 mg Oral 30 11
Tablet containing pravastatin sodium 20 mg Oral 30 5
Tablet containing pravastatin sodium 20 mg Oral 30 11
Tablet containing pravastatin sodium 40 mg Oral 30 5
Tablet containing pravastatin sodium 40 mg Oral 30 11
Tablet containing pravastatin sodium 80 mg Oral 30 5
Tablet containing pravastatin sodium 80 mg Oral 30 11
Prazosin Tablet 1 mg (as hydrochloride) Oral 100 5
Tablet 2 mg (as hydrochloride) Oral 100 5
Tablet 5 mg (as hydrochloride) Oral 100 5
Probenecid Tablet 500 mg Oral 100 5
Propranolol Tablet containing propranolol hydrochloride 10 mg Oral 100 5
Tablet containing propranolol hydrochloride 40 mg Oral 100 5
Tablet containing propranolol hydrochloride 160 mg Oral 50 5
Quinapril Tablet 5 mg (as hydrochloride) Oral 30 5
Tablet 10 mg (as hydrochloride) Oral 30 5
Tablet 20 mg (as hydrochloride) Oral 30 5
Quinapril with hydrochlorothiazide Tablet 10 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide Oral 30 5
Tablet 20 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide Oral 30 5
Rabeprazole Tablet containing rabeprazole sodium 10 mg (enteric coated) Oral 28 5
Tablet containing rabeprazole sodium 20 mg (enteric coated) Oral 30 5
Raloxifene Tablet containing raloxifene hydrochloride 60 mg Oral 28 5
Ramipril Tablet 1.25 mg Oral 30 5
Tablet 2.5 mg Oral 30 5
Tablet 5 mg Oral 30 5
Tablet 10 mg Oral 30 5
Capsule 1.25 mg Oral 30 5
Capsule 2.5 mg Oral 30 5
Capsule 5 mg Oral 30 5
Capsule 10 mg Oral 30 5
Ramipril with felodipine Tablet 2.5 mg‑2.5 mg (modified release) Oral 30 5
Tablet 5 mg‑5 mg (modified release) Oral 30 5
Ranitidine Tablet 150 mg (as hydrochloride) Oral 60 5
Tablet 300 mg (as hydrochloride) Oral 30 5
Tablet, effervescent, 150 mg (as hydrochloride) Oral 60 5
Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL Oral 2 5
Rasagiline Tablet 1 mg (as mesilate) Oral 30 5
Riluzole Tablet 50 mg Oral 56 5
Risedronic acid Tablet 5 mg Oral 28 5
Tablet 35 mg Oral 4 5
Tablet (enteric coated) containing risedronate sodium 35mg Oral 4 5
Tablet containing risedronate sodium 150 mg Oral 1 5
Risedronic acid and calcium Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate) Oral 1 5
Risedronic acid and calcium with colecalciferol Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms Oral 1 5
Rivaroxaban Tablet 15 mg Oral 28 5
Tablet 20 mg Oral 28 5
Rosuvastatin Tablet 5 mg (as calcium) Oral 30 5
Tablet 5 mg (as calcium) Oral 30 11
Tablet 10 mg (as calcium) Oral 30 5
Tablet 10 mg (as calcium) Oral 30 11
Tablet 20 mg (as calcium) Oral 30 5
Tablet 20 mg (as calcium) Oral 30 11
Tablet 40 mg (as calcium) Oral 30 5
Tablet 40 mg (as calcium) Oral 30 11
Salcatonin Injection 100 I.U. in 1 mL ampoule Injection 15 5
Sapropterin Tablet (soluble) containing sapropterin hydrochloride 100 mg Oral 180 5
Selegiline Tablet containing selegiline hydrochloride 5 mg Oral 100 5
Sevelamer Tablet containing sevelamer hydrochloride 800 mg Oral 180 5
Simvastatin Tablet 5 mg Oral 30 5
Tablet 5 mg Oral 30 11
Tablet 10 mg Oral 30 5
Tablet 10 mg Oral 30 11
Tablet 20 mg Oral 30 5
Tablet 20 mg Oral 30 11
Tablet 40 mg Oral 30 5
Tablet 40 mg Oral 30 11
Tablet 80 mg Oral 30 5
Tablet 80 mg Oral 30 11
Spironolactone Tablet 25 mg Oral 100 5
Tablet 100 mg Oral 100 5
Strontium Sachet containing granules for oral suspension containing strontium ranelate 2 g Oral 28 5
Sulfasalazine Tablet 500 mg Oral 200 5
Tablet 500 mg Oral 200 11
Tablet 500 mg (enteric coated) Oral 200 5
Tablet 500 mg (enteric coated) Oral 200 11
Tamoxifen Tablet 10 mg (as citrate) Oral 60 5
Tablet 20 mg (as citrate) Oral 60 5
Telmisartan Tablet 40 mg Oral 28 5
Tablet 80 mg Oral 28 5
Telmisartan with amlodipine Tablet 40 mg‑5 mg (as besylate) Oral 28 5
Tablet 40 mg‑10 mg (as besylate) Oral 28 5
Tablet 80 mg‑5 mg (as besylate) Oral 28 5
Tablet 80 mg‑10 mg (as besylate) Oral 28 5
Telmisartan with hydrochlorothiazide Tablet 40 mg‑12.5 mg Oral 28 5
Tablet 80 mg‑12.5 mg Oral 28 5
Tablet 80 mg‑25 mg Oral 28 5
Temozolomide Capsule 5 mg Oral 5 5
Capsule 20 mg Oral 5 5
Capsule 100 mg Oral 5 5
Capsule 140 mg Oral 5 5
Capsule 180 mg Oral 5 5
Capsule 250 mg Oral 5 5
Teriparatide Injection 250 micrograms per mL, 2.4 mL in multi‑dose pre‑filled pen Injection 1 5
Testosterone Capsule containing testosterone undecanoate 40 mg Oral 60 5
Transdermal cream 50 mg per mL, 50 mL Transdermal 1 6
Transdermal gel 50 mg in 5 g sachet, 30 Transdermal 1 5
Transdermal patches 12.2 mg, 60 Transdermal 1 5
Transdermal patches 24.3 mg, 30 Transdermal 1 5
Transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses Transdermal 1 Pack 5
Theophylline Tablet 200 mg (sustained release) Oral 100 5
Tablet 250 mg (sustained release) Oral 100 5
Tablet 300 mg (sustained release) Oral 100 5
Ticagrelor Tablet 90 mg Oral 56 5
Tiotropium Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler) Inhalation by mouth 30 5
Tiotropium with olodaterol Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses Inhalation by mouth 1 5 1
Tofacitinib Tablet 5 mg Oral 56 5
Trandolapril Capsule 500 micrograms Oral 28 5
Capsule 1 mg Oral 28 5
Capsule 2 mg Oral 28 5
Capsule 4 mg Oral 28 5
Trandolapril with verapamil Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release) Oral 28 5
Trandolapril with verapamil hydrochloride Tablet containing trandolapril 2 mg with verapamil hydrochloride 180 mg (sustained release) Oral 28 5
Triptorelin Powder for I.M. injection (prolonged release) 3.75 mg (as embonate) with solvent, syringe and needles Injection 1 5
Umeclidinium Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses Inhalation by mouth 1 5
Umeclidinium with vilanterol Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses Inhalation by mouth 1 5
Valaciclovir Tablet 500 mg (as hydrochloride) Oral 30 5
Valsartan Tablet 80 mg Oral 28 5
Tablet 160 mg Oral 28 5
Tablet 320 mg Oral 28 5
Valsartan with hydrochlorothiazide Tablet 80 mg‑12.5 mg Oral 28 5
Tablet 160 mg‑12.5 mg Oral 28 5
Tablet 160 mg‑25 mg Oral 28 5
Tablet 320 mg‑12.5 mg Oral 28 5
Tablet 320 mg‑25 mg Oral 28 5
Verapamil Tablet containing verapamil hydrochloride 40 mg Oral 100 5
Tablet containing verapamil hydrochloride 80 mg Oral 100 5
Tablet containing verapamil hydrochloride 180 mg (sustained release) Oral 30 5
Tablet containing verapamil hydrochloride 240 mg (sustained release) Oral 30 5
Capsule containing verapamil hydrochloride 160 mg (sustained release) Oral 30 5
Capsule containing verapamil hydrochloride 240 mg (sustained release) Oral 30 5

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history

Endnote 4—Amendment history

Endnotes about misdescribed amendments and other matters are included in a compilation only as necessary.

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

A = Act o = order(s)
ad = added or inserted Ord = Ordinance
am = amended orig = original
amdt = amendment par = paragraph(s)/subparagraph(s)
c = clause(s)     /sub‑subparagraph(s)
C[x] = Compilation No. x pres = present
Ch = Chapter(s) prev = previous
def = definition(s) (prev…) = previously
Dict = Dictionary Pt = Part(s)
disallowed = disallowed by Parliament r = regulation(s)/rule(s)
Div = Division(s) Reg = Regulation/Regulations
exp = expires/expired or ceases/ceased to have reloc = relocated
    effect renum = renumbered
F = Federal Register of Legislative Instruments rep = repealed
gaz = gazette rs = repealed and substituted
LI = Legislative Instrument s = section(s)/subsection(s)
LIA = Legislative Instruments Act 2003 Sch = Schedule(s)
(md) = misdescribed amendment can be given Sdiv = Subdivision(s)
    effect SLI = Select Legislative Instrument
(md not incorp) = misdescribed amendment SR = Statutory Rules
    cannot be given effect Sub‑Ch = Sub‑Chapter(s)
mod = modified/modification SubPt = Subpart(s)
No. = Number(s) underlining = whole or part not
    commenced or to be commenced

Endnote 3—Legislation history

Name FRLI registration Commencement Application, saving and transitional provisions
PB 30 of 2009 17 Apr 2009 (F2009L01354) 1 May 2009 (s 2)
PB 45 of 2009 28 May 2009 (F2009L02084) 1 June 2009 (s 2)
PB 59 of 2009 17 June 2009 (F2009L02368) 1 July 2009 (s 2)
PB 71 of 2009 29 July 2009 (F2009L02982) 1 Aug 2009 (s 2)
PB 84 of 2009 18 Aug 2009 (F2009L03212) 1 Sept 2009 (s 2)
PB 103 of 2009 29 Oct 2009 (F2009L04036) 1 Nov 2009 (s 2)
PB 115 of 2009 30 Nov 2009 (F2009L04346) 1 Dec 2009 (s 2)
PB 11 of 2010 25 Feb 2010 (F2010L00535) 1 Mar 2010 (s 2)
PB 28 of 2010 26 Mar 2010 (F2010L00755) 1 Apr 2010 (s 2)
PB 42 of 2010 28 Apr 2010 (F2010L01035) 1 May 2010 (s 2)
PB 53 of 2010 26 May 2010 (F2010L01437) 1 June 2010 (s 2)
PB 61 of 2010 22 June 2010 (F2010L01639) 1 July 2010 (s 2)
PB 79 of 2010 27 July 2010 (F2010L02194) 1 Aug 2010 (s 2)
PB 86 of 2010 12 Aug 2010 (F2010L02273) 1 Sept 2010 (s 2)
PB 106 of 2010 03 Nov 2010 (F2010L02895) 4 Nov 2010 (s 2(b))
PB 119 of 2010 30 Nov 2010 (F2010L03116) 1 Dec 2010 (s 2)
PB 30 of 2011 30 Mar 2011 (F2011L00529) 1 Apr 2011 (s 2)
PB 41 of 2011 26 May 2011 (F2011L00865) 1 June 2011 (s 2)
PB 55 of 2011 28 July 2011 (F2011L01548) 1 Aug 2011 (s 2)
PB 64 of 2011 31 Aug 2011 (F2011L01779) 1 Sept 2011 (s 2)
PB 73 of 2011 29 Sept 2011 (F2011L01988) 1 Oct 2011 (s 2)
PB 92 of 2011 30 Nov 2011 (F2011L02502) 1 Dec 2011 (s 2)
PB 24 of 2012 29 Mar 2012 (F2012L00710) 1 Apr 2012 (s 2)
PB 56 of 2012 25 July 2012 (F2012L01603) 1 Aug 2012 (s 2)
PB 69 of 2012 22 Aug 2012 (F2012L01737) 1 Sept 2012 (s 2)
PB 86 of 2012 26 Sept 2012 (F2012L01931) 1 Oct 2012 (s 2)
PB 104 of 2012 29 Nov 2012 (F2012L02292) 1 Dec 2012 (s 2)
PB 13 of 2013 25 Feb 2013 (F2013L00275) 1 Mar 2013 (s 2)
PB 28 of 2013 30 Apr 2013 (F2013L00705) 1 May 2013 (s 2)
PB 50 of 2013 29 July 2013 (F2013L01456) 1 Aug 2013 (s 2)
PB 60 of 2013 16 Aug 2013 (F2013L01581) 1 Sept 2013 (s 2)
PB 83 of 2013 29 Nov 2013 (F2013L02014) 1 Dec 2013 (s 2)
PB 25 of 2014 26 Mar 2014 (F2014L00355) 1 Apr 2014 (s 2)
PB 34 of 2014 11 Apr 2014 (F2014L00402) 1 May 2014 (s 2)
PB 39 of 2014 21 May 2014 (F2014L00591) 1 June 2014 (s 2)
PB 60 of 2014 31 July 2014 (F2014L01062) 1 Aug 2014 (s 2)
PB 69 of 2014 25 Aug 2014 (F2014L01123) 1 Sept 2014 (s 2)
PB 75 of 2014 26 Sept 2014 (F2014L01293) 1 Oct 2014 (s 2)
PB 84 of 2014 23 Oct 2014 (F2014L01392) 1 Nov 2014 (s 2)
PB 92 of 2014 28 Nov 2014 (F2014L01608) 1 Dec 2014 (s 2)
PB 106 of 2014 23 Dec 2014 (F2014L01799) 1 Jan 2015 (s 2)
PB 8 of 2015 15 Jan 2015 (F2015L00043) 1 Feb 2015 (s 2)
PB 17 of 2015 25 Feb 2015 (F2015L00206) 1 Mar 2015 (s 2)
PB 36 of 2015 25 Mar 2015 (F2015L00334) 1 Apr 2015 (s 2)
PB 46 of 2015 24 Apr 2015 (F2015L00593) 1 May 2015 (s 2)
PB 57 of 2015 30 June 2015
(F2015L01062)
1 July 2015 (s 2)
PB 71 of 2015 31 July 2015 (F2015L01206) 1 Aug 2015 (s 2)
PB 81 of 2015 28 Aug 2015 (F2015L01349) 1 Sept 2015 (s 2)
PB 93 of 2015 30 Sept 2015 (F2015L01540) 1 Oct 2015 (s 2)
PB 103 of 2015 28 Oct 2015 (F2015L01704) 1 Nov 2015 (s 2)
PB 110 of 2015 1 Dec 2015 (F2015L01899) 1 Dec 2015 (s 2)

Endnote 4—Amendment history

Provision affected How affected
Schedule 1
Schedule 1........................ am. PB 45, 59, 71, 84, 103 and 115 of 2009; PB 11, 28, 42, 53, 61, 79, 86, 106 and 119 of 2010; PB 30, 41, 55, 64, 73 and 92 of 2011; PB 24, 56, 69, 86 and 104 of 2012; PB 13, 28, 50, 60 and 83 of 2013; PB 25, 34, 39, 60, 69, 75, 84, 92 and 106 of 2014; PB 8, 17, 36, 46, 57, 71, 81, 93, 103 and 110 of 2015
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