National Health (Pharmaceutical Benefits) Amendment Regulations 2007 (No. 2)1
Select Legislative Instrument 2007 No. 225
I, PHILIP MICHAEL JEFFERY, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the National Health Act 1953.
Dated 19 July 2007
P. M. JEFFERY
Governor‑General
By His Excellency’s Command
TONY ABBOTT
1 Name of Regulations
These Regulations are the National Health (Pharmaceutical Benefits) Amendment Regulations 2007 (No. 2).
2 Commencement
These Regulations commence on 1 August 2007.
3 Amendment of National Health (Pharmaceutical Benefits) Regulations 1960
Schedule 1 amends the National Health (Pharmaceutical Benefits) Regulations 1960.
Schedule 1 Amendments
(regulation 3)
[1] Subregulation 5 (1), definition of brand
substitute
brand, for a pharmaceutical item, means a brand of the pharmaceutical item within the meaning of subsection 84 (1) of the Act.
[2] Subregulation 5 (1), after definition of dependant
insert
drug in a pharmaceutical item has the same meaning as in Part VII of the Act.
[3] Subregulation 5 (1), after definition of pharmaceutical benefit
insert
pharmaceutical item has the same meaning as in Part VII of the Act.
pharmaceutical item has a drug has the same meaning as in Part VII of the Act.
[4] Subregulation 5 (1), after definition of repatriation pharmaceutical benefit
insert
responsible person has the same meaning as in Part VII of the Act.
[5] After Part II
insert
Part IIAAA Formularies, co‑marketed brands and therapeutic groups
9AAA Drugs on F1
For subsection 84AC (5) of the Act, a listed drug is on F1 if the drug is specified in Schedule 1.
9AAB Drugs on F2
(1) For subsection 84AC (5) of the Act, a listed drug is on F2 if the drug is specified in Schedule 2.
(2) For subsection 84AD (5) of the Act, the drugs specified in Part A of Schedule 2 are drugs in Part A of F2.
(3) For subsection 84AD (5) of the Act, the drugs specified in Part T of Schedule 2 are drugs in Part T of F2.
9AAC Co‑marketed brands
For subsection 84AE (4) of the Act, the listed brands of a pharmaceutical item specified in columns 2 and 3 of an item in Schedule 3 are co‑marketed brands.
9AAD Therapeutic groups
For subsection 84AG (6) of the Act, the therapeutic groups specified in Schedule 4 are prescribed.
[6] After Part VI
insert
Part VIA Price reductions
37A Definitions for Part VIA
In this Part:
adjusted approved ex‑manufacturer price has the meaning given by subsection 99ADB (1) of the Act.
approved price to pharmacists has the meaning given by subsection 98B (3) of the Act.
first mandatory brand means:
(a) a brand of a pharmaceutical item that is the first mandatory brand of a pharmaceutical item with the same drug and manner of administration to become a mandatory brand; and
(b) any other brand of a pharmaceutical item with the same drug and manner of administration that becomes a mandatory brand on the same day.
listed, for a brand of a pharmaceutical item, means determined under subsection 85 (6) of the Act.
mandatory brand has the same meaning as in subsection 99ADD (1) of the Act.
price disclosure requirements has the meaning given by section 99ADC of the Act.
related brand has the same meaning as in subsection 99ADD (2) of the Act.
subsequent mandatory brand means a mandatory brand of a pharmaceutical item (other than the first mandatory brand) that has the same drug and manner of administration as the first mandatory brand.
volunteered brand has the same meaning as in subsection 99ADE (1) of the Act.
37B Listed brands of pharmaceutical items, reduction days and percentages
For section 99ACK of the Act, the listed brands of pharmaceutical items, the reduction days for those brands and percentages for those brands that are mentioned in Schedule 5 are prescribed.
37C Adjusted approved price to pharmacists
For subsection 99ADB (2) of the Act, the adjusted approved price to pharmacists of a brand of a pharmaceutical item is worked out as follows:
(a) if the adjusted approved ex‑manufacturer price of the brand is $930.06 or less — by multiplying the adjusted approved ex‑manufacturer price by 1.0752 and rounding the result to the nearest cent (rounding 0.5 cents upwards);
(b) in any other case — by adding $69.94 to the adjusted approved ex‑manufacturer price.
37D Approved ex‑manufacturer price
For subsection 99ADB (3) of the Act, the approved ex‑manufacturer price of a brand of a pharmaceutical item is worked out as follows:
(a) if the approved price to pharmacists of the brand is $970 or less — by dividing the approved price to pharmacists by 1.0752 and rounding the result to the nearest cent (rounding 0.5 cents upwards); or
(b) in any other case — by taking $69.94 from the approved price to pharmacists.
37E Weighted average disclosed price — information
(1) For subsection 99ADB (6) of the Act, this regulation deals with how information provided under the price disclosure requirements may be used with the method set out in these Regulations for determining the weighted average disclosed price of:
(a) a brand of a pharmaceutical item; and
(b) every brand of every pharmaceutical item having the same drug and manner of administration.
(2) To use the method for a brand of a pharmaceutical item (a particular brand), all the information required under the price disclosure requirements for the reporting period must have been provided about at least 1 brand (the reported brand) of a pharmaceutical item that has the same drug and manner of administration as the particular brand.
(3) To avoid doubt, the method can be used for determining the weighted average disclosed price of the particular brand, even if:
(a) the reported brand is not the particular brand; or
(b) the particular brand is the only reported brand.
(4) If the information provided by a responsible person under the price disclosure requirements for a reporting period is incomplete, the information may be disregarded in making a determination of the weighted average disclosed price of the brand or every brand of every pharmaceutical item with the same drug and manner of administration.
Note For reporting periods, see regulation 37J.
37F Weighted average disclosed price — method
(1) For subsection 99ADB (6) of the Act, this regulation sets out a method for determining the weighted average disclosed price of:
(a) a brand of a pharmaceutical item; and
(b) every brand of every pharmaceutical item having the same drug and manner of administration.
Step 1
(2) Add up the sales revenue for the brand (excluding sales to public hospitals) for each month in each quarterly reporting period corresponding to the annual reporting period (as disclosed under the price disclosure requirements), excluding the sales revenue for:
(a) for a mandatory brand or a related brand of the mandatory brand — the first month after the mandatory brand was listed; and
(b) any period before the start of the first month in the first reporting period.
(3) If the brand is a related brand of more than 1 mandatory brand, the exclusion under paragraph (2) (a) applies to only the first month after the listing of the first of the mandatory brands.
Step 2
(4) From the amount worked out under step 1 (sales revenue), take away the incentives for the brand for the annual reporting period (as disclosed under the price disclosure requirements) (incentives). This gives the net revenue for the annual reporting period.
Step 3
(5) Add up the adjusted volume of the brand sold for each month in each quarterly reporting period corresponding to the annual reporting period (as disclosed under the price disclosure requirements). The adjusted volume is the volume worked out as if the pack sizes in which the brand was sold were equivalent to the maximum quantity for dispensing in the Schedule of Pharmaceutical Benefits.
(6) If the annual reporting period is the first annual reporting period for the brand, exclude the adjusted volume sold in:
(a) for a mandatory brand or a related brand of the mandatory brand — the first month after the mandatory brand was listed; and
(b) any period before the start of the first month in the first reporting period.
(7) If the brand is a related brand of more than 1 mandatory brand, the exclusion under paragraph (6) (a) applies to only the first month after the listing of the first of the mandatory brands.
Step 4
(8) Repeat steps 1 to 3 for every brand of the pharmaceutical item.
Step 5
(9) Add up the net revenue for each brand of the pharmaceutical item (as worked out under step 2).
(10) Add up the adjusted volume of each brand sold of the pharmaceutical item (as worked out under step 3).
(11) Divide the amount worked out under subregulation (9) by the amount worked out under subregulation (10). This gives the weighted average price for the brands of the pharmaceutical item.
Step 6
(12) Take away the amount worked out under step 5 from the approved ex‑manufacturer price of the brands of the pharmaceutical item.
(13) Divide the amount worked out under subregulation (12) by the approved ex‑manufacturer price of the brands of the pharmaceutical item and express as a percentage. This gives the percentage difference between the weighted average price for the brands of the pharmaceutical item and the approved ex‑manufacturer price.
Step 7
(14) Repeat steps 1 to 6 for every pharmaceutical item having the same drug and manner of administration.
Step 8
(15) Work out the weighted average percentage difference (to 2 decimal places) for every brand of every pharmaceutical item having the same drug and manner of administration in the following way:
(a) for each pharmaceutical item — multiply the percentage worked out in step 6 by:
(i) the PBS volume of the pharmaceutical item, as recorded by the Department; and
(ii) the approved ex‑manufacturer price for the brands of the pharmaceutical item;
(b) for each pharmaceutical item — multiply the PBS volume of the pharmaceutical item by the approved ex‑manufacturer price for the brands of the pharmaceutical item;
(c) add up the amounts worked out for each pharmaceutical item under paragraph (a);
(d) divide the amount resulting from the addition under paragraph (c) by the sum of the amounts worked out under paragraph (b).
Step 9
(16) If the percentage calculated at step 8 is 10% or more, the weighted average disclosed price for every brand of every pharmaceutical item having the same drug and manner of administration is the approved ex‑manufacturer price for the brands reduced by that percentage.
Note If the percentage is less than 10%, there will be no price reduction.
37G Price disclosure requirements — content of information for quarterly reporting periods
(1) For paragraph 99ADC (1) (a) of the Act, the information to be provided for the supply of a brand of a pharmaceutical item for a quarterly reporting period (as mentioned in subregulation 37J (3)) is:
(a) the name of the responsible person; and
(b) the name of the drug in the pharmaceutical item; and
(c) the brand name; and
(d) the strength of the drug; and
(e) the form of the drug; and
(f) the number or quantity of units in a pack (for example, the number of tablets per pack); and
(g) the manner of administration of the drug; and
(h) the period to which the information relates; and
(i) for each month to which the information relates:
(i) the sales revenue for the brand excluding sales to public hospitals (expressed in Australian dollars, excluding GST and rounded to the nearest whole dollar, rounding 50 cents upwards); and
(ii) the volume of the brand sold, based on the number of packs sold.
(2) The information must relate to the period from the start of the quarterly reporting period to the end of the quarterly reporting period.
(3) However, for the first quarterly reporting period, the information must relate to the period:
(a) from:
(i) the day of listing; or
(ii) if the brand is a related brand — the day of listing of the mandatory brand for which it is a related brand; or
(iii) if the brand is a volunteered brand — the first day of the month following the election to comply with the price disclosure requirements; and
(b) to the end of the quarterly reporting period.
37H Price disclosure requirements — content of information for annual reporting periods
(1) For paragraph 99ADC (1) (a) of the Act, the information to be provided in relation to the supply of a brand of a pharmaceutical item for an annual reporting period (as mentioned in subregulation 37J (4)) is:
(a) the name of the responsible person; and
(b) the name of the drug in the pharmaceutical item; and
(c) the brand name; and
(d) the strength of the drug; and
(e) the form of the drug; and
(f) the number or quantity of units in a pack (for example, the number of tablets per pack); and
(g) the manner of administration; and
(h) the period to which the information relates; and
(i) the kind of incentives (if any) given in relation to the brand for the annual reporting period; and
(j) the value of the incentives given in relation to the brand for the annual reporting period (expressed in Australian dollars, excluding GST and rounded to the nearest whole dollar).
Note The form issued by the Department for responsible persons to provide the information may include a list of different kinds of incentives (for example, rebates or cash backs) and the responsible person would fill in the values for the kind of incentives for which information is being provided.
(2) For this regulation, incentives include (but are not limited to) anything given as an incentive to take supply of the brand, whether given:
(a) before the supply of the brand, but on condition of taking supply; or
(b) at the time of the supply of the brand; or
(c) at a later date; or
(d) over a period of time; or
(e) directly in relation to the brand; or
(f) indirectly in relation to the brand (for example, in relation to a group of brands or other products).
(3) If an incentive is given over a period of time or indirectly in relation to a brand, the value of the incentive in relation to the brand for the annual reporting period is the value apportioned to the brand for that reporting period.
Note No methodology is prescribed for apportioning the value of incentives in relation to a brand for a period. However, the methodology used by a responsible person should be reasonable and documented.
(4) The information must relate to the period from the start of the annual reporting period to the end of the annual reporting period.
(5) However, for the first annual reporting period, the information for a brand must relate to the period from the day mentioned in the following table for the brand to the end of the annual reporting period:
Item | if the brand is … | the day is … |
1 | the first mandatory brand of a pharmaceutical item or a related brand | the start of the annual reporting period |
2 | a subsequent mandatory brand, that was listed after the start of the annual reporting period for the first mandatory brand, or a related brand of the subsequent mandatory brand | the first day of the month after listing of the subsequent mandatory brand |
3 | a subsequent mandatory brand, that was listed before the start of the annual reporting period for the first mandatory brand, or a related brand of the subsequent mandatory brand | the start of the annual reporting period |
4 | a volunteered brand for which the election to comply with the price disclosure requirements was made on or after the start of the annual reporting period for the first mandatory brand | the first day of the month after the election to comply with the price disclosure requirements |
5 | a volunteered brand for which the election to comply with the price disclosure requirements was made before the start of the annual reporting period for the first mandatory brand | the start of the annual reporting period |
37I Price disclosure requirements — manner and form
(1) For paragraph 99ADC (1) (b) of the Act, the information mentioned in regulation 37G and 37H must be provided by completing a form approved by the Secretary.
(2) The completed form must:
(a) include all the statements and information required by the form; and
(b) be signed (or authorised for electronic transmission) by a person who is authorised by the responsible person to provide the information.
37J Price disclosure requirements — times
(1) For paragraph 99ADC (1) (c) of the Act, the information mentioned in regulation 37G and 37H must be provided within 2 months after the end of each reporting period for the brand of the pharmaceutical item.
(2) The reporting periods for a brand of a pharmaceutical item are:
(a) the quarterly reporting period; and
(b) the annual reporting period.
(3) The quarterly reporting period for a brand of a pharmaceutical item is:
(a) the period of 3 months starting from the start of the reporting periods for the brand; and
(b) each successive period of 3 months in which the brand is subject to the price disclosure requirements.
(4) The annual reporting period for a brand of a pharmaceutical item is:
(a) the period of 12 months starting from the start of the reporting periods for the brand; and
(b) each successive period of 12 months in which the brand is subject to the price disclosure requirements.
(5) The start of the reporting periods for a brand of a pharmaceutical item mentioned in an item of the following table is the day mentioned in that item of the table:
Item | Brand of pharmaceutical item | Start of reporting period |
1 | The first mandatory brand or a related brand | The first of the days mentioned in subregulation (6) that occurs after the listing of the first mandatory brand (the start day for the first mandatory brand) |
2 | A subsequent mandatory brand, that is listed after the start day for the first mandatory brand, or a related brand of the subsequent mandatory brand | The same day as the start of the current reporting period for the first mandatory brand (even if that day is before the day of listing of the subsequent mandatory brand) |
3 | A subsequent mandatory brand, that is listed before the start day for the first mandatory brand, or a related brand of the subsequent mandatory brand | The start day for the first mandatory brand |
4 | A volunteered brand for which the election to comply with the price disclosure requirements was made on or after the start day for the first mandatory brand | The same day as the start of the current reporting period for the first mandatory brand (even if that day is before the day the election was made) |
5 | A volunteered brand for which the election to comply with the price disclosure requirements was made before the start day for the first mandatory brand | The start day for the first mandatory brand |
(6) For item 1 in the table in subregulation (5), the days are 1 January, 1 May and 1 September.
(7) For this regulation, a current reporting period for the first mandatory brand of a pharmaceutical item (the reference brand) which is used, under subregulation (5), to fix the reporting period of another brand of the pharmaceutical item, is:
(a) the reporting period for the reference brand that has started, but not ended, when the other brand becomes subject to price disclosure; or
(b) if the first mandatory brand has ceased to be listed — the reporting period for the reference brand that, if the reference brand had not ceased to be listed, would have started, but not ended, when the other brand becomes subject to price disclosure.
(8) A reporting period of a brand of pharmaceutical item (the reporting brand) that, under subregulation (5), was fixed by reference to the start day, or the current reporting period, for the first mandatory brand of a pharmaceutical item (the reference brand) is not affected by the following events:
(a) cessation of listing of the reference brand; or
(b) for a reporting brand that was a related brand of the reference brand — the listing of a subsequent mandatory brand of which the reporting brand is also a related brand.
[7] Before Schedule 1
insert
Schedule 1 Drugs on F1
(regulation 9AAA)
Abacavir
Abciximab
Acamprosate
Acarbose
Acetazolamide
Acetylcysteine
Acitretin
Adalimumab
Adefovir
Adrenaline
Albendazole
Aluminium hydroxide with magnesium trisilicate and magnesium hydroxide
Amantadine
Amiloride
Amino acid formula with vitamins and minerals without lysine and low in tryptophane
Amino acid formula with vitamins and minerals without methionine
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine
Amino acid formula with vitamins and minerals without phenylalanine
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids
Amino acid formula without methionine, threonine and valine and low in isoleucine
Amino acid formula without phenylalanine
Amino acid formula without phenylalanine, tyrosine and methionine
Amino acids — synthetic, formula
Aminoglutethimide
Amitriptyline
Amphotericin
Anakinra
Anastrozole
Anecortave
Apomorphine
Apraclonidine
Aprepitant
Aripiprazole
Atazanavir
Atomoxetine
Atorvastatin
Atovaquone
Atropine
Auranofin
Aurothiomalate
Azithromycin
Balsalazide
BCG Immunotherapeutic (Bacillus Calmette‑Guerin/Connaught strain)
BCG‑Tice (Bacillus Calmette‑Guerin/Tice strain)
Beclomethasone
Benzathine penicillin
Benzhexol
Benztropine
Benzydamine
Benzylpenicillin
Bethanechol
Bicalutamide
Bifonazole
Bimatoprost
Biperiden
Bisoprolol
Bivalirudin
Bosentan
Botulinum toxin type A purified neurotoxin complex
Budesonide
Buprenorphine
Busulfan
Cabergoline
Calcipotriol
Calcium
Candesartan
Capecitabine
Carbimazole
Carbohydrate, fat, vitamins, minerals and trace elements
Carbomer 974
Carmellose
Carmustine
Cefepime
Cefuroxime
Celecoxib
Charcoal — activated
Chlorambucil
Chloramphenicol
Chlorpromazine
Chlorthalidone
Cholestyramine
Choriogonadotropin alfa
Chorionic gonadotrophin
Ciclesonide
Cidofovir
Cladribine
Clodronic acid
Clonidine
Clopidogrel
Clostridium botulinum type A toxin — haemagglutinin complex
Clotrimazole
Coal tar — prepared
Codeine
Colestipol
Copper sulfate
Cortisone
Cyclophosphamide
Cyproheptadine
Cytarabine
Dalteparin
Danazol
Dantrolene
Dapsone
Darbepoetin alfa
Dasatinib
Deferasirox
Deferiprone
Delavirdine
Desmopressin
Dexamethasone
Dexamphetamine
Didanosine
Dihydroergotamine
Diphtheria and tetanus vaccine, adsorbed
Diphtheria and tetanus vaccine, adsorbed, diluted for adult use
Dipivefrine
Dipyridamole
Disopyramide
Docetaxel
Dolasetron
Domperidone
Donepezil
Dornase alfa
Dorzolamide
Doxepin
Doxorubicin, pegylated liposomal
Drotrecogin alfa (activated)
Dydrogesterone
Efalizumab
Efavirenz
Eformoterol
Electrolyte replacement solution
Emtricitabine
Enfuvirtide
Enoxaparin
Entacapone
Entecavir
Eplerenone
Epoetin alfa
Epoetin beta
Epoprostenol
Eprosartan
Eptifibatide
Essential amino acids formula with minerals and vitamin C
Etanercept
Ethacrynic acid
Ethosuximide
Etidronic acid
Etonogestrel
Everolimus
Exemestane
Ezetimibe
Famciclovir
Fenofibrate
Fentanyl
Ferrous sulfate
Filgrastim
Fludrocortisone
Fluorometholone
Flupenthixol decanoate
Fluphenazine decanoate
Flurbiprofen
Fluticasone
Folic acid
Follitropin alfa
Follitropin beta
Fondaparinux
Fosamprenavir
Foscarnet
Fotemustine
Framycetin
Fusidic acid
Galantamine
Ganciclovir
Gefitinib
Gelatin — succinylated
Gemcitabine
Gestrinone
Glatiramer
Glucagon
Glucose
Glucose and ketone indicator — urine
Glucose indicator — blood
Glucose indicator — urine
Glycerol
Goserelin
Granisetron
Griseofulvin
Haloperidol
Haloperidol decanoate
Heparin
Hexamine
Homatropine
Hydralazine
Hydrochlorothiazide
Hydromorphone
Hydroxocobalamin
Hydroxychloroquine
Hydroxyurea
Hyoscine
Ibuprofen
Idarubicin
Ifosfamide
Iloprost
Imatinib
Imiquimod
Indinavir
Infliximab
Influenza vaccine
Insect allergen extract — honey bee venom
Insect allergen extract — paper wasp venom
Insect allergen extract — yellow jacket venom
Insulin aspart
Insulin detemir
Insulin glargine
Insulin glulisine
Insulin isophane
Insulin lispro
Insulin neutral
Interferon alfa‑2a
Interferon alfa‑2b
Interferon beta‑1a
Interferon beta‑1b
Interferon gamma‑1b
Irbesartan
Iron sucrose
Isoniazid
Itraconazole
Ivermectin
Ketoconazole
Lamivudine
Lanreotide
Latanoprost
Lenograstim
Letrozole
Leuprorelin
Levetiracetam
Levobunolol
Levodopa with benserazide
Levonorgestrel
Lignocaine
Lincomycin
Liothyronine
Lithium
Lumiracoxib
Macrogol 3350
Mefenamic acid
Megestrol
Melphalan
Mercaptopurine
Mesalazine
Mesna
Methysergide
Metoclopramide
Mexiletine
Miconazole
Milk powder — lactose free formula
Milk powder — lactose modified
Milk powder — synthetic
Milk protein and fat formula with vitamins and minerals — carbohydrate free
Mineral mixture
Minoxidil
Misoprostol
Modafinil
Montelukast
Morphine
Moxonidine
Mycophenolic acid
Nafarelin
Naloxone
Naltrexone
Nandrolone decanoate
Naratriptan
Nedocromil
Nelfinavir
Neomycin
Nevirapine
Nicorandil
Nilutamide
Nitrofurantoin
Nortriptyline
Nystatin
Octreotide
Oestriol
Oestrogens — conjugated
Ofloxacin
Olanzapine
Olmesartan
Olsalazine
Oxcarbazepine
Oxprenolol
Oxycodone
Pancreatic extract
Pancrelipase
Pegfilgrastim
Peginterferon alfa‑2a
Peginterferon alfa‑2b
Pemetrexed
Penicillamine
Pergolide
Perhexiline
Pericyazine
Permethrin
Phenelzine
Phenobarbitone
Phenoxybenzamine
Phenytoin
Pimecrolimus
Pioglitazone
Pizotifen
Pneumococcal vaccine, polyvalent
Polyethylene glycol 400 with propylene glycol
Polygeline
Primidone
Probenecid
Procaine penicillin
Progesterone
Promethazine
Propantheline
Propranolol
Propylthiouracil
Protein hydrolysate formula with medium chain triglycerides
Pyrantel
Pyridostigmine
Pyrimethamine
Quetiapine
Quinagolide
Raloxifene
Raltitrexed
Ranibizumab
Reboxetine
Reteplase
Rifabutin
Rifampicin
Riluzole
Risedronic acid
Risperidone
Ritonavir
Rituximab
Rivastigmine
Rosiglitazone
Rosuvastatin
Salcatonin
Salmeterol
Saquinavir
Sildenafil
Silver sulfadiazine with chlorhexidine
Sirolimus
Sodium acid phosphate
Sodium alginate with calcium carbonate and sodium bicarbonate
Sodium chloride
Sodium chloride compound
Sodium lactate compound
Somatropin
Sorbitol with sodium citrate and sodium lauryl sulfoacetate
Soy protein and fat formula with vitamins and minerals — carbohydrate free
Stavudine
Sterculia with frangula bark
Strontium
Sulfacetamide
Sulindac
Sulthiame
Tacrolimus
Telmisartan
Temozolomide
Tenecteplase
Tenofovir
Terbutaline
Testosterone
Tetrabenazine
Tetracosactrin
Thalidomide
Theophylline
Thiamine
Thioguanine
Thioridazine
Thiotepa
Thyrotropin alfa
Tiagabine
Tiaprofenic acid
Ticarcillin with clavulanic acid
Tiludronic acid
Tiotropium
Tipranavir
Tirofiban
Tobramycin
Topiramate
Topotecan
Toremifene
Tranexamic acid
Tranylcypromine
Trastuzumab
Travoprost
Trifluoperazine
Triglycerides, medium chain
Triglycerides, medium chain and long chain with glucose polymer
Triglycerides — medium chain, formula
Tropisetron
Ursodeoxycholic acid
Valaciclovir
Valganciclovir
Venlafaxine
Verteporfin
Vigabatrin
Vinblastine
Warfarin
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
Zidovudine
Ziprasidone
Zoledronic acid
Zolmitriptan
Zuclopenthixol decanoate
Schedule 2 Drugs on F2
(regulation 9AAB)
Part A Drugs in Part A of F2
Alendronic acid
Aluminium hydroxide with magnesium hydroxide
Amisulpride
Aspirin
Betamethasone
Betaxolol
Bisacodyl
Bleomycin
Brimonidine
Brinzolamide
Bupropion
Calcium folinate
Carbomer 980
Carboplatin
Carvedilol
Cefotaxime
Ceftriaxone
Cephalothin
Cephazolin
Cisplatin
Clindamycin
Clozapine
Colchicine
Cromoglycic acid
Cyclosporin
Desferrioxamine
Dexamethasone with framycetin and gramicidin
Digoxin
Diphenoxylate with atropine
Doxorubicin
Electrolyte replacement (oral)
Epirubicin
Escitalopram
Etoposide
Flecainide
Fluconazole
Fluorouracil
Flutamide
Fluvastatin
Fosinopril with hydrochlorothiazide
Gentamicin
Glibenclamide
Glipizide
Glyceryl trinitrate
Hydrocortisone
Hypromellose
Hypromellose with carbomer 980
Hypromellose with dextran
Imipramine
Irinotecan
Iron polymaltose complex
Isosorbide dinitrate
Isotretinoin
Ketoprofen
Labetalol
Leflunomide
Levodopa with carbidopa
Levonorgestrel with ethinyloestradiol
Loperamide
Medroxyprogesterone
Meloxicam
Methadone
Methotrexate
Methylprednisolone
Mianserin
Mitozantrone
Mometasone
Norethisterone
Norethisterone with ethinyloestradiol
Oestradiol
Ondansetron
Oxaliplatin
Oxazepam
Oxybutynin
Paclitaxel
Pamidronic acid
Paraffin
Perindopril with indapamide
Pilocarpine
Piperazine oestrone
Polyvinyl alcohol
Potassium chloride
Potassium chloride with potassium bicarbonate
Prednisone
Prochlorperazine
Quinine
Selegiline
Sucralfate
Sulfasalazine
Sumatriptan
Thyroxine
Ticlopidine
Tinidazole
Triamcinolone
Triamcinolone with neomycin, gramicidin and nystatin
Valproic acid
Vancomycin
Vincristine
Vinorelbine
Part T Drugs in Part T of F2
Aciclovir
Allopurinol
Alprazolam
Amiodarone
Amlodipine
Amoxycillin
Amoxycillin with clavulanic acid
Ampicillin
Atenolol
Azathioprine
Baclofen
Bromocriptine
Calcitriol
Captopril
Carbamazepine
Cefaclor
Cephalexin
Cimetidine
Ciprofloxacin
Citalopram
Clarithromycin
Clomiphene
Clomipramine
Clonazepam
Codeine with paracetamol
Cyproterone
Diazepam
Diclofenac
Dicloxacillin
Diltiazem
Dothiepin
Doxycycline
Enalapril
Erythromycin
Esomeprazole
Famotidine
Felodipine
Flucloxacillin
Fluoxetine
Fluvoxamine
Fosinopril
Frusemide
Gabapentin
Gemfibrozil
Gliclazide
Glimepiride
Hydrochlorothiazide with amiloride
Indapamide
Indomethacin
Ipratropium
Isosorbide mononitrate
Lactulose
Lamotrigine
Lansoprazole
Lercanidipine
Lisinopril
Metformin
Methyldopa
Methylphenidate
Metoprolol
Metronidazole
Minocycline
Mirtazapine
Moclobemide
Naproxen
Nifedipine
Nitrazepam
Nizatidine
Norfloxacin
Omeprazole
Pantoprazole
Paracetamol
Paroxetine
Perindopril
Phenoxymethylpenicillin
Pindolol
Piroxicam
Pravastatin
Prazosin
Prednisolone
Quinapril
Rabeprazole
Ramipril
Ranitidine
Roxithromycin
Salbutamol
Sertraline
Simvastatin
Sotalol
Spironolactone
Tamoxifen
Temazepam
Terbinafine
Timolol
Tramadol
Trandolapril
Trimethoprim
Trimethoprim with sulfamethoxazole
Verapamil
Schedule 3 Co‑marketed brands
(regulation 9AAC)
Column 1 | Column 2 | Column 3 | ||||||
Item | Listed brand of pharmaceutical item | Listed brand of pharmaceutical item | ||||||
| Brand | Drug | Form | Manner of administration | Brand | Drug | Form | Manner of administration |
1 | Avapro | Irbesartan | Tablet 75 mg | Oral | Karvea | Irbesartan | Tablet 75 mg | Oral |
2 | Avapro | Irbesartan | Tablet 150 mg | Oral | Karvea | Irbesartan | Tablet 150 mg | Oral |
3 | Avapro | Irbesartan | Tablet 300 mg | Oral | Karvea | Irebesartan | Tablet 300 mg | Oral |
4 | Iscover | Clopidogrel | Tablet 75 mg | Oral | Plavix | Clopidogrel | Tablet 75 mg | Oral |
Schedule 4 Therapeutic groups
(regulation 9AAD)
Item | Therapeutic group |
1 | Angiotensin converting enzyme inhibitor group (ACE inhibitor group) |
2 | Angiotensin II receptor antagonist group (ATRA group) |
3 | Dihydropyridine calcium‑channel blocker group (CCB group) |
4 | HMG Co‑A reductase inhibitor group (Statins group) |
5 | H2 receptor antagonist group (H2RA group) |
6 | Proton pump inhibitor group (PPI group) |
Schedule 5 Listed brands of pharmaceutical items, reduction days and percentages
(regulation 37B)
Item | Listed brand of pharmaceutical item
| Reduction days | Percentage | |||
| Brand | Drug | Form | Manner of administration |
|
|
1 | Nexium | Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) | Oral | 1) 1 August 2008 2) 1 August 2009 | 1) 12.5% 2) 12.5% |
Nexium | Esomeprazole | Tablet (enteric coated) 40 mg (as magnesium trihydrate) | Oral | |||
2 | Zoton | Lansoprazole | Capsule 15 mg | Oral | 1) 1 August 2008 2) 1 August 2009 3) 1 August 2010 | 1) 5% 2) 5% 3) 15% |
Zoton | Lansoprazole | Capsule 30 mg | Oral | |||
3 | Somac | Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) | Oral | 1) 1 August 2008 2) 1 August 2009 3) 1 August 2010 | 1) 5% 2) 5% 3) 15% |
Somac | Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | |||
4 | Pariet | Rabeprazole | Tablet (enteric coated) containing 10 mg rabeprazole sodium | Oral | 1) 1 August 2008 2) 1 August 2009 3) 1 August 2010 4) 1 August 2011 5) 1 August 2012 6) 1 August 2013 | 1) 4.17% 2) 4.17% 3) 4.16% 4) 4.17% 5) 4.17% 6) 4.16% |
Pariet | Rabeprazole | Tablet (enteric coated) containing 20 mg rabeprazole sodium | Oral | |||
5 | Zanidip | Lercanidipine | Tablet 10 mg | Oral | 1) 1 August 2008 2) 1 August 2009 3) 1 August 2010 | 1) 8.3% 2) 8.3% 3) 8.4% |
Zanidip | Lercanidipine | Tablet 20 mg | Oral |
[8] Schedule 1
renumber as Schedule 6
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.frli.gov.au.