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SLI 2007 No. 225 Regulations as made
These Regulations amend the National Health (Pharmaceutical Benefits) Regulations 1960 to prescribe the implementation detail associated with major reforms to the Pharmaceutical Benefits Scheme which were given effect through amendments to the National Health Act 1953 that take effect on 1 August 2007.
Administered by: Health
Registered 24 Jul 2007
Tabling HistoryDate
Tabled HR07-Aug-2007
Tabled Senate07-Aug-2007
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

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
(as hydrogen sulfate)

Oral

Plavix

Clopidogrel

Tablet 75 mg
(as hydrogen sulfate)

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.