EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATIONS UNDER SECTIONS 85, 85A and 88
NO. PB 18 OF 2005
Purpose and operation
- The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
2. The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
3. “Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. Subsection 85(2) of the Act empowers the Minister to declare the drugs and medicinal preparations to which Part VII of the Act applies, and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits.
5. Subsection 85(2A) provides that the Minister may, in a declaration under subsection 85(2), declare that a particular pharmaceutical benefit is to be a relevant pharmaceutical benefit for the purposes of section 88A, and specify the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written.
6. Subsection 85(3) provides that the Minister may determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a drug or medicinal preparation referred to in subsection 85(2). Drugs or medicinal preparations in any other form are not pharmaceutical benefits.
7. Subsection 85(4) provides that a form of a drug or medicinal preparation as determined by the Minister under subsection 85(3) may be such as to require the addition of a substance or substances to the drug or medicinal preparation so that it will be suitable for administration in a particular manner or at a particular strength.
8. Subsection 85(6) provides that the Minister may determine, in respect of a drug or medicinal preparation to which Part VII of the Act applies, a brand or brands under which the drug or medicinal preparation may be supplied under that Part VII of the Act, and where such a determination is in force in relation to a drug or medicinal preparation, Part VII of the Act does not apply in relation to the drug or medicinal preparation as marketed under any other brand.
9. Subsection 85A(1) of the Act provides that the Minister may determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a pharmaceutical benefit that is or are allowable for the purposes of this Part for prescription by persons included in a class of persons specified in the determination.
10. Subsection 85A(2) of the Act provides that the Minister may, with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit:
a) determine the maximum quantity or number of units of the pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion, either for all purposes or for particular purposes;
b) determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated, either for all purposes or for particular purposes; and
c) determine the manner of administration that may, in a prescription, be directed to be used in relation to the pharmaceutical benefit.
11. Section 88A of the Act provides that, where a pharmaceutical benefit is declared in a declaration made under subsection 85(2) of the Act to be a relevant pharmaceutical benefit for the purposes of that section, the writing of a prescription for the supply of the benefit is authorised under Part VII of the Act only in the circumstances specified in the declaration pursuant to subsection 85(2A) of the Act.
12. The determinations made under sections 85, 85A and 88 of the Act on 23 May 2005 with effect from 1 June 2005 are repealed and substituted with these determinations.
13. These determinations are remade to give effect, as from 1 August 2005, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as recommended by the Pharmaceutical Benefits Advisory Committee. Changes to the determinations are detailed in the attached summary of changes.
Consultations
14. The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
15. The determinations give effect to recommendations made by the PBAC. PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
16. Details of the determinations are set out in the Attachment.
17. The determinations are a legislative instruments for the purposes of the Legislative Instruments Act 2003.
18. These determinations were made on 26 July 2005 and commenced on 1 August 2005.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Additions
AH Altana Pharma Pty Ltd
CX Contact Lens Centre Australia Ltd
PK Pharmatel Fresenius Kabi Pty Ltd
FIRST SCHEDULE – PART 1
Items Added
Balsalazide Sodium Capsule 750 mg
Bivalirudin Trifluoroacetate Powder for I.V. injection equivalent to 250 mg bivalirudin, vial
Brimonidine Tartrate with Eye drops 2 mg brimonidine tartrate with timolol maleate
Timolol Maleate equivalent to 5 mg timolol per mL, 5 mL
Ciclesonide Pressurised inhalation 80 micrograms per dose, 120 doses
(CFC-free formulation)
Pressurised inhalation 160 micrograms per dose, 120 doses
(CFC-free formulation)
Everolimus Tablet 0.25 mg
Tablet 0.5 mg
Tablet 0.75 mg
Methylphenidate Tablet 10 mg
Hydrochloride
“PKU Express Liquid” Oral liquid 130 mL, 30
Polygeline I.V. infusion 17.5 g per 500 mL with electrolytes, 500 mL
Quinagolide Hydrochloride Tablet equivalent to 75 micrograms quinagolide
Forms Added
Carmellose Sodium Eye drops 2.5 mg per mL, single dose units
0.6 mL, 24
Ocular lubricating gel 10 mg per mL,
single dose units 0.6 mL, 28
Doxorubicin Hydrochloride Solution for I.V. injection or intravesical administration
100 mg in 50 mL single dose vial
Solution for I.V. injection or intravesical administration
200 mg in 100 mL single dose vial
Epirubicin Hydrochloride Solution for injection 100 mg in 50 mL
Escitalopram Oxalate Oral solution equivalent to 10 mg escitalopram per mL, 28 mL
Follitropin Beta Solution for injection 200 I.U. in 0.5 mL single use vial
Glucose Indicator—Blood Electrode strips, 50 (TrueTrack)
Metformin Hydrochloride Tablet 250 mg-1.25 mg
with Glibenclamide
Methotrexate Solution concentrate for I.V. infusion 500 mg in 5 mL vial
Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
Solution concentrate for I.V. infusion 5000 mg in 50 mL vial
Methylprednisolone Powder for injection equivalent to 1 g methylprednisolone
Sodium Sucinate with diluent
Metoprolol Succinate Pack containing 15 tablets 23.75 mg (controlled release),
15 tablets 47.5 mg (controlled release) and 15 tablets
95 mg (controlled release)
Oxaliplatin Solution concentrate for I.V. infusion 50 mg in 10 mL vial
Solution concentrate for I.V. infusion 100 mg in 20 mL vial
Polyvinyl Alcohol Eye drops 14 mg per mL, 15 mL
(contains sodium chlorite/hydrogen peroxide as preservative)
Eye drops 30 mg per mL, 15 mL
(contains sodium chlorite/hydrogen peroxide as preservative)
Pravastatin Sodium Tablet 80 mg
Sirolimus Tablet 2 mg
Testosterone Transdermal gel 50 mg in 5 g sachet, 30
Tramadol Hydrochloride Oral drops 100 mg per mL, 10 mL
Brands Added
Calcitriol Capsule 0.25 microgram (DP)
Citalopram Hydrobromide Tablet equivalent to 40 mg citalopram (HX)
Codeine Phosphate with Tablet 30 mg-500 mg (AF)
Paracetamol
Doxorubicin Hydrochloride Solution for I.V. injection or intravesical administration
10 mg in 5 mL single dose vial (IT)
Solution for I.V. injection or intravesical administration
50 mg in 25 mL single dose vial (IT)
Fluvoxamine Maleate Tablet 50 mg (HX)
Tablet 100 mg (HX)
Ipratropium Bromide Nebuliser solution 250 micrograms (anhydrous) in 1 mL
single dose units, 30 (AW)
Nebuliser solution 500 micrograms (anhydrous) in 1 mL
single dose units, 30 (AW)
Lamotrigine Tablet 5 mg (AW)
Tablet 25 mg (AW, DP, GX)
Tablet 50 mg (AW, DP, GX)
Tablet 100 mg (AW, DP, GX)
Tablet 200 mg (AW, DP, GX)
Paclitaxel Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial
(MX)
Simvastatin Tablet 5 mg (BF, HX)
Tablet 10 mg (BF, CH, DP, GX, HX, TW)
Tablet 20 mg (BF, CH, DP, GX, HX, TW)
Tablet 40 mg (BF, CH, DP, GX, HX, TW)
Tablet 80 mg (BF, CH, DP, GX, HX, TW)
Tramadol Hydrochloride Tablet 100 mg (sustained release) (HX)
Tablet 150 mg (sustained release) (HX)
Tablet 200 mg (sustained release) (HX)
Items Deleted
Altretamine Capsule 50 mg
Ferrous Gluconate Elixir 300 mg per 5 mL, 100 mL
Fusidic Acid Oral suspension 50 mg per mL, 90 mL
Insulin Zinc Suspension Injection (human) 100 units per mL, 10 mL vial
Insulin Zinc Suspension Injection (human) 100 units per mL, 10 mL vial
(Crystalline)
Thiamine Hydrochloride Injection 100 mg in 1 mL ampoule
Vincristine Sulfate with I.V. injection 1 mg vial (with required solvent)
any determined brand of
sterilised Water for
Injections or other solvent
Forms Deleted
Glucose Indicator—Blood Reagent strips, 50 (Accutrend Glucose)
Lignocaine Hydrochloride Injection 100 mg in 5 mL ampoule
Brands Deleted
Aciclovir Tablet 800 mg (BG)
Allopurinol Tablet 100 mg (BG)
Amoxycillin Trihydrate Capsule equivalent to 250 mg amoxycillin (BG)
Capsule equivalent to 500 mg amoxycillin (BG)
Amoxycillin Trihydrate Powder for oral suspension equivalent to 125 mg amoxycillin
with Water-Purified BP per 5 mL, 100 mL (BG)
Powder for oral suspension equivalent to 250 mg amoxycillin
per 5 mL, 100 mL (BG)
Cephalexin Capsule 500 mg (anhydrous) (BG)
Cephalexin with Granules for oral suspension 125 mg per 5 mL, 100 mL (BG)
Water-Purified BP Granules for oral suspension 250 mg per 5 mL, 100 mL (BG)
Cephazolin Sodium with Injection equivalent to 1 g cephazolin, vial (with required
any determined brand solvent) (BG)
of sterilised Water for
Injections or other solvent
Ciprofloxacin Hydrochloride Tablet equivalent to 750 mg ciprofloxacin (BG)
Flucloxacillin Sodium with Injection equivalent to 500 mg flucloxacillin, vial (with
any determined brand of required solvent) (AS)
sterilised Water for
Injections or other solvent
Frusemide Tablet 500 mg (AV)
Metformin Hydrochloride Tablet 500 mg (BG)
Metoprolol Tartrate Tablet 50 mg (BG)
Pethidine Hydrochloride Injection 50 mg in 1 mL ampoule (SI)
Ranitidine Hydrochloride Tablet equivalent to 150 mg ranitidine (BG)
Tablet equivalent to 300 mg ranitidine (BG)
Alterations of Form and Manner of Administration
Epirubicin Hydrochloride From: Solution for I.V. injection 10 mg in 5 mL single dose
vial; Injection
To: Solution for injection 10 mg in 5 mL; Injection or
intravesical administration
From: Solution for I.V. injection 20 mg in 10 mL single dose
vial; Injection
To: Solution for injection 20 mg in 10 mL; Injection or
intravesical administration
From: Solution for I.V. injection 50 mg in 25 mL single dose
vial; Injection
To: Solution for injection 50 mg in 25 mL; Injection or
intravesical administration
Alterations of form and Manufacturer’s Code
Methylprednisolone From: Injection equivalent to 40 mg methylprednisolone in
Sodium Succinate 1 mL vial (PH)
To: Powder for injection equivalent to 40 mg
methylprednisolone with diluent (PF)
Alteration of Maximum Repeats
Fluticasone Propionate Pressurised inhalation 250 micrograms From: 5
per dose, 120 doses (CFC-free formulation) To: 1
Powder for oral inhalation in breath actuated From: 5
device 500 micrograms per dose, 60 doses To: 1
Alteration of Manufacturer’s Code
From To
Amoxycillin Trihydrate Tablet equivalent to 500 mg ME AF
with Potassium amoxycillin-125 mg clavulanic acid
Clavulanate Tablet equivalent to 875 mg ME AF
amoxycillin-125 mg clavulanic acid
Amoxycillin Trihydrate Powder for oral suspension equivalent to ME AF
with Potassium 125 mg amoxycillin-31.25 mg clavulanic
Clavulanate and acid per 5 mL, 75 mL
Water – Purified BP Powder for oral suspension equivalent to ME AF
400 mg amoxycillin-57 mg clavulanic
acid per 5 mL, 60 mL
Nicotinic Acid Tablet 250 mg AS AL
Quinine Bisulfate Tablet 300 mg AF AS
Quinine Sulfate Tablet 300 mg AF LN
Sodium Clodronate Capsule equivalent to 400 mg AV SC
Tetrahydrate sodium clodronate
Tablet equivalent to 800 mg AV SC
sodium clodronate
FIRST SCHEDULE – PART 2
Items Added
Escitalopram Oxalate Tablet equivalent to 10 mg escitalopram
Tablet equivalent to 20 mg escitalopram
Oral solution equivalent to 10 mg escitalopram per mL, 28 mL
Levetiracetam Tablet 250 mg
Tablet 500 mg
Tablet 1 g
Pemetrexed Disodium Powder for I.V. infusion equivalent to 500 mg pemetrexed, vial
Heptahydrate
Topiramate Tablet 25 mg
Tablet 50 mg
Tablet 100 mg
Tablet 200 mg
Capsule 15 mg
Capsule 25 mg
Capsule 50 mg
Forms Added
Tramadol Hydrochloride Oral drops 100 mg per mL, 10 mL
Brands Added
Codeine Phosphate with Tablet 30 mg-500 mg (AF)
Paracetamol
Tramadol Hydrochloride Tablet 100 mg (sustained release) (HX)
Tablet 150 mg (sustained release) (HX)
Tablet 200 mg (sustained release) (HX)
Brands Deleted
Aciclovir Tablet 200 mg (BG)
Alteration of Purpose
Etanercept
THIRD SCHEDULE ‑ PART 1
Forms Added
Tramadol Hydrochloride Oral drops 100 mg per mL, 10 mL
Brands Added
Codeine Phosphate with Tablet 30 mg-500 mg (AF)
Paracetamol
Tramadol Hydrochloride Tablet 100 mg (sustained release) (HX)
Tablet 150 mg (sustained release) (HX)
Tablet 200 mg (sustained release) (HX)
Items Deleted
Lignocaine Hydrochloride Injection 100 mg in 5 mL ampoule
Brands Deleted
Amoxycillin Trihydrate Capsule equivalent to 250 mg amoxycillin (BG)
Capsule equivalent to 500 mg amoxycillin (BG)
Amoxycillin Trihydrate Powder for oral suspension equivalent to 125 mg amoxycillin
with Water-Purified BP per 5 mL, 100 mL (BG)
Powder for oral suspension equivalent to 250 mg amoxycillin
per 5 mL, 100 mL (BG)
Cephalexin Capsule 500 mg (anhydrous) (BG)
Cephalexin with Granules for oral suspension 125 mg per 5 mL, 100 mL (BG)
Water-Purified BP Granules for oral suspension 250 mg per 5 mL, 100 mL (BG)
Flucloxacillin Sodium with Injection equivalent to 500 mg flucloxacillin, vial (with
any determined brand of required solvent) (AS)
sterilised Water for
Injections or other solvent
Pethidine Hydrochloride Injection 50 mg in 1 mL ampoule (SI)
Alteration of Manufacturer’s Code
From To
Amoxycillin Trihydrate Tablet equivalent to 500 mg ME AF
with Potassium amoxycillin-125 mg clavulanic acid
Clavulanate Tablet equivalent to 875 mg ME AF
amoxycillin-125 mg clavulanic acid
Amoxycillin Trihydrate Powder for oral suspension equivalent to ME AF
with Potassium 125 mg amoxycillin-31.25 mg clavulanic
Clavulanate and acid per 5 mL, 75 mL
Water – Purified BP Powder for oral suspension equivalent to ME AF
400 mg amoxycillin-57 mg clavulanic
acid per 5 mL, 60 mL
ATTACHMENT
Paragraph 1 provides that these determinations commence on 1 August 2005.
Paragraph 2 provides that the determinations under sections 85, 85A and 88 of the National Health Act 1953 (the Act) made on 23 May 2005 with effect from 1 June 2005 are repealed.
Paragraph 3 defines the following terms for the purposes of these determinations:
- “Act”;
- “base-priced drug”;
- “CFC”;
- “CFU”;
- “Commission”;
- “electronic communication”;
- “g”;
- “I.M.”;
- “I.V.”;
- “kg”;
- “L”;
- “m”;
- “Managing Director”;
- “mg”;
- “mL”;
- “mm”;
- “mmol”; and
- “Regulations”.
Paragraph 4 provides that, for a drug or medicinal preparation that is declared under subsection 85(2), the forms of that drug or medicinal preparation that are listed in the First and Second Schedules to these determinations are pharmaceutical benefits when prescribed by a medical practitioner.
Paragraph 4A provides that, for a drug or medicinal preparation listed in the Declaration under subsection 85(2), the forms of that drug or medicinal preparation listed in the Fourth Schedule to these determinations (which are composed of one or more of the drugs or medicinal preparations listed in Schedule 4 to that Declaration with or without the addition of one or more of the substances specified in Schedule 5 to that Declaration) are pharmaceutical benefits when prescribed by a medical practitioner.
Paragraph 5 provides that for a drug or medicinal preparation that is declared under subsection 85(2), the forms of that drug or medicinal preparation, that are listed in the Third Schedule to these determinations, are pharmaceutical benefits when prescribed by a participating dental practitioner.
Paragraph 6 provides that, for a particular pharmaceutical benefit specified in Part 2 of the First or Second Schedule to these determinations, a medical practitioner may prescribe the maximum quantity and number of repeats specified in that Part, only for the purposes specified in that Part, in relation to that particular pharmaceutical benefit.
Paragraph 7 provides that, for a particular pharmaceutical benefit specified in Part 2 of the Third Schedule to these determinations, a participating dental practitioner may prescribe the maximum quantity specified in that Part, only for the purposes specified in that Part, in relation to that particular pharmaceutical benefit.
Paragraph 8 provides that:
(a) A medical practitioner may only direct that a pharmaceutical benefit be administered according to the “Manner of Administration” specified for that pharmaceutical benefit in the First or Second Schedule to these determinations; or
(b) A participating dental practitioner may only direct that a pharmaceutical benefit be administered according to the “Manner of Administration” specified for that pharmaceutical benefit in the Third Schedule to these determinations.
Paragraph 9 provides that, in each Schedule to the determinations, the maximum quantity or number of units that may be directed to be supplied for a particular pharmaceutical benefit in one prescription, on any one occasion, is the number listed in the column headed “Maximum quantity” for that pharmaceutical benefit.
Paragraph 10 provides that the maxiumum number of times that a medical practitioner may direct a prescription for a pharmaceutical benefit to be repeated, if at all, is the quantity or number, if any, specified in that Part under the heading “Maximum number of repeats” for that pharmaceutical benefit.
Paragraph 11 provides, in relation to Part 2 of the First or Second Schedules, that:
(a) where a class of persons is specified in the column headed “Purposes”, the pharmaceutical benefit is to be supplied to a person included in that class of persons;
(b) where a disease or condition is specified in the column headed “Purposes”:
(i) if subparagraph (ii) does not apply, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition; or
(ii) if a class of persons is also specified in those purposes, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in the column headed “Purposes”, the pharmaceutical benefit is to be supplied for that purpose;
(d) where the column headed “Purposes” specifies that compliance with authority procedures (set out in subparagraph 11(d)) is required, then the medical practitioner must submit the prescription to the Managing Director for supply of the pharmaceutical benefit by:
(i) preparing and signing the prescription:
- in a form approved by the Secretary, and completed in ink in the medical practitioner’s handwriting; or
- in a form approved by the Secretary, by means of a computer; or
- in a form prepared by means of a computer and approved in writing for the purpose by the Secretary and in a format approved in writing by the Secretary; or
- by a method approved by the Secretary in writing.
(ii) submitting the prescription by telephone, giving the Managing Director the details of that prescription which has been prepared and signed in accordance with subsubparagaph (i); or
(iii) where the medical practitioner is unable to obtain authorisation from the Managing Director due to failure of telephone systems, submitting the prescription in line with subsubparagraph (ii) and according to the instructions stipulated in an emergency telephone message from the medical practitioner to the Managing Director;
(iv) by submitting the details of the prescription, which has been prepared and signed by the medical practitioner (in accordance with subsubparagraph (i)) to the Managing Director by means of electronic communication (of a kind which has been approved by the Managing Director)
Paragraph 11A provides that, if the prescription has been prepared and signed by the medical practitioner in accordance with subsubparagraph 11(d)(i), that prescription may be submitted by one of that medical practitioner’s employees.
Paragraph 12 provides that, subject to paragraph 12B, where a prescription is submitted under subparagraph 11(d), authorisation may be made:
(a) by the Managing Director signing for the authorisation on the prescription and:
(i) if the Managing Director requires that the medical practitioner must alter the prescription, by returning the prescription to the medical practitioner for alteration before the medical practitioner gives it to the patient; or
(ii) in any other case:
- by returning it to the medical practitioner; or
- by sending it to the person for whom it was prepared; or
(b) orally, at the time the Managing Director is given details of the prescription, if the prescription was submitted in accordance with subsubparagraph 14(d)(ii); or
(c) by the managing director sending the authorisation to the medical practitioner by electronic communication, if the prescription was submitted in accordance with subsubparagraph 11(d)(iv).
Paragraph 12 A provides that, if the Managing Director authorises a prescription orally, in accordance with subparagraph 12(b) or (c):
(a) the Managing Director must tell the medical practitioner, either orally or by electronic communication, the number of the authority prescription; and
(b) the medical practitioner must mark the number on the prescription and retain a copy of the prescription for 1 year from the date of authorisation.
Paragraph 12B provides that authorisation is deemed to be granted where a medical practitioner has submitted a prescription in accordance with subsubparagraph 14(d)(iii), and where the prescription has been completed in accordance with the instructions stipulated in the emergency telephone message provided by the Managing Director.
Paragraph 12C provides that where a prescription is authorised in accordance with paragraph 12, and an authorisation is also granted in accordance with subregulation 13(5) of the Regulations (increasing the maximum quantity or number of units of the pharmaceutical benefit that may, in the prescription, be directed to be supplied on any one occasion, or the maximum number of occasions on which the supply of the pharmaceutical benefit may, in the prescription, be directed to be repeated), the authorisation in accordance with paragraph 12 is taken to be for the prescription of the increased quantity, number, or occasions, as the case may be.
Paragraph 13 provides, in relation to Part 2 of the Third Schedule, that:
(a) where a class of persons is specified in the column headed “Purposes”, the pharmaceutical benefit is to be supplied to a person included in that class of persons;
(b) where a disease or condition is specified in the column headed “Purposes”:
(i) if subparagraph (ii) does not apply, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition; or
(ii) if a class of persons is also specified in those purposes, the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in the column headed “Purposes”, the pharmaceutical benefit is to be supplied for that purpose.
Paragraph 14 lists the names of the manufacturers of those brands of pharmaceutical benefits, listed under “Brand” in the First, Second or Third Schedule, to which this determination applies.
The Schedules
The First Schedule - Part 1 lists the forms (strength, type, size etc), the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner.
The First Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner.
The Second Schedule - Part 1 lists the forms (strength, type, size etc), the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner for patients receiving palliative care.
The Second Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a medical practitioner for patients receiving palliative care.
The Third Schedule - Part 1 lists the forms (strength, type, size etc), the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a participating dental practitioner.
The Third Schedule - Part 2 lists the forms (strength, type, size etc), the purposes, the manner of administration, the maximum quantity and maximum number of repeats of those drugs and medicinal preparations that are declared under subsection 85(2) of the Act to be pharmaceutical benefits when prescribed by a participating dental practitioner.
The Fourth Schedule lists the forms, maximum quantity and maximum number or repeats of extemporaneously-prepared pharmaceutical benefits, the ingredients of which are declared in Schedule 4 of the declaration under subsection 85(2) of the Act.