EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATIONS UNDER SECTIONS 85, 85A and 88
NO. PB 33 OF 2006
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 amended on 19 June 2006 with effect from 20 June 2006 (No. PB 25 of 2006) are repealed and substituted with these determinations.
13. These determinations are remade to give effect, as from 1 August 2006, 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 legislative instruments for the purposes of the Legislative Instruments Act 2003.
18. These determinations were made on 26 July 2006 and commenced on 1 August 2006.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Additions
ES EBOS Group Pty Ltd
RA Ranbaxy Australia Pty Limited
Deletions
CV Ciba Vision Australia Pty Ltd
TH Richard Thompson Pty Ltd
UW United Works of Pharmaceutical and Dietetic Products, Hungary
Alteration of Manufacturer’s Name
AX From: Aventis Pasteur Pty Limited
To: Sanofi Pasteur Pty Limited
FIRST SCHEDULE – PART 1
Items Added
Alendronate Sodium with Tablet equivalent to 70 mg alendronic acid with 70
Colecalciferol micrograms colecalciferol
Bifonazole Cream 10 mg per g, 15 g
Clotrimazole Lotion 10 mg per mL, 20 mL
Ferrous Fumarate with Tablet 310 mg (equivalent to 100 mg iron)-
Folic Acid 350 micrograms
“Lophlex LQ” Oral liquid 125 mL, 30
Lumiracoxib Tablet 200 mg
Miconazole Tincture 20 mg per mL, 30 mL
Miconazole Nitrate Cream 20 mg per g, 15 g
Cream 20 mg per g, 30 g
Cream 20 mg per g, 70 g
Powder 20 mg per g, 30 g
Lotion 20 mg per mL, 30 g
Moxonidine Tablet 200 micrograms
Tablet 400 micrograms
Perindopril Arginine Tablet 2.5 mg
Tablet 5 mg
Tablet 10 mg
Thiamine Hydrochloride Tablet 100 mg
Forms Added
Epirubicin Hydrochloride Powder for injection 50 mg
Fenofibrate Tablet 48 mg
Tablet 145 mg
Fluorouracil Injection 1000 mg in 20 mL
Glucose Indicator—Blood Electrode strips, 50 (Glucocard 01 Sensor)
Ketoconazole Cream 20 mg per g, 30 g
Shampoo 10 mg per g, 100 mL
Shampoo 20 mg per g, 60 mL
Nystatin Cream 100,000 units per g, 15 g
Testosterone Undecanoate I.M. injection 1,000 mg in 4 mL
Vinorelbine Tartrate Capsule equivalent to 20 mg vinorelbine
Capsule equivalent to 30 mg vinorelbine
Brands Added
Cefaclor Monohydrate Tablet (sustained release) equivalent to 375 mg cefaclor (RA)
Cephalexin Capsule 250 mg (anhydrous) (RA)
Capsule 500 mg (anhydrous) (RA)
Cisplatin I.V. injection 100 mg in 100 mL vial (IT)
Citalopram Hydrobromide Tablet equivalent to 20 mg citalopram (RE)
Clarithromycin Tablet 250 mg (AW)
Fluorouracil Injection 500 mg in 10 mL (IT)
Glimepiride Tablet 1 mg (AF)
Tablet 2 mg (AF)
Tablet 3 mg (AF)
Tablet 4 mg (AF)
Imipramine Hydrochloride Tablet 10 mg (LN)
Tablet 25 mg (LN)
Mirtazapine Tablet 30 mg (DP)
Ondansetron Hydrochloride Tablet equivalent to 4 mg ondansetron (AW)
Dihydrate Tablet equivalent to 8 mg ondansetron (AW)
Pravastatin Sodium Tablet 10 mg (AF, CH, DP, GX, HX, RE, TW)
Tablet 20 mg (AF, CH, DP, GX, HX, RE, TW)
Tablet 40 mg (AF, CH, DP, GX, HX, RE, TW)
Quinapril Hydrochloride Tablet equivalent to 5 mg quinapril (AF)
Tablet equivalent to 10 mg quinapril (AF)
Tablet equivalent to 20 mg quinapril (AF)
Ramipril Capsule 10 mg (ML)
Ranitidine Hydrochloride Tablet equivalent to 150 mg ranitidine (RA)
Tablet equivalent to 300 mg ranitidine (RA)
Sodium Cromoglycate Eye drops 20 mg per mL, 10 mL (AE)
Vinorelbine Tartrate Solution for I.V. infusion equivalent to 10 mg vinorelbine
in 1 mL vial (IT)
Solution for I.V. infusion equivalent to 50 mg vinorelbine
in 5 mL vial (IT)
Items Deleted
Cimetidine Hydrochloride Tablet, effervescent, equivalent to 800 mg cimetidine
Hydroxypropylcellulose Ophthalmic inserts 5 mg, 60
Lodoxamide Trometamol Eye drops equivalent to 1 mg lodoxamide per mL, 10 mL
Polymyxin B Sulphate with Eye ointment 5,000 units-400 units-5 mg per g, 4 g
Bacitracin Zinc and
Neomycin Sulfate
Forms Deleted
Cytarabine Injection 500 mg in 5 mL vial
Fentanyl Transdermal patch 2.5 mg
Transdermal patch 5 mg
Transdermal patch 7.5 mg
Transdermal patch 10 mg
Ibuprofen Tablet 400 mg (Max. Qty 100)
Idarubicin Hydrochloride Powder for I.V. injection 5 mg in single dose vial
Powder for I.V. injection 10 mg in single dose vial
“Ketonex-1” Oral powder 400 g
“Ketonex-2” Oral powder 400 g
Leuprorelin Acetate I.M. injection (modified release), set containing 1 vial
powder for injection 7.5 mg, 1 ampoule diluent
2 mL and 1 syringe with 2 needles
I.M. injection (modified release), set containing 1 vial
powder for injection 22.5 mg, 1 ampoule diluent
2 mL and 1 syringe with 2 needles
I.M. injection (modified release), set containing 1 vial
powder for injection 30 mg, 1 ampoule diluent
2 mL and 1 syringe with 2 needles
Naloxone Hydrochloride Injection 400 micrograms in 1 mL disposable injection set
Oestradiol Transdermal patches 2 mg, 8 (Dermestril 25)
Transdermal patches 4 mg, 8 (Dermestril 50)
Transdermal patches 8 mg, 8 (Dermestril 100)
Oestriol Tablet 1 mg
“Phenex-1” Oral powder 400 g
Vinblastine Sulfate Powder for injection 10 mg
Brands Deleted
Amitriptyline Hydrochloride Tablet 25 mg (MK)
Amoxycillin Trihydrate with Powder for oral suspension equivalent to 125 mg
Water - Purified BP amoxycillin per 5 mL, 100 mL (SI)
Powder for oral suspension equivalent to 250 mg
amoxycillin per 5 mL, 100 mL (CS)
Cimetidine Tablet 800 mg (GK)
Flucloxacillin Magnesium with Powder for oral suspension equivalent to 125 mg
Water – Purified BP flucloxacillin per 5 mL, 100mL (CS)
Imipramine Hydrochloride Tablet 25 mg (UW)
Ipratropium Bromide Nebuliser solution 250 micrograms (anhydrous) in 1 mL
single dose units, 30 (MX)
Nebuliser solution 500 micrograms (anhydrous) in 1 mL
single dose units, 30 (MX)
Alteration of Form and Max. Quantity
Ibuprofen From: Tablets 400 mg, 20 (Max. Qty 1)
To: Tablet 400 mg (Max. Qty 30)
Alteration of Manufacturer’s Code
From To
Carbomer 980 Ocular lubricating gel 2 mg per g, 10 g CV NM
Hypromellose Eye drops 3 mg per mL, 15 mL CV NM
Hypromellose with Ocular lubricating gel 3mg-2mg per g, 10 g CV NM
Carbomer 980
Insect Allergen Extract— Injection set containing 550 micrograms vial TH ES
Honey Bee Venom with 9 mL vial solvent and 3 vials diluent 1.8 mL
Insect Allergen Extract— Injection set containing 550 micrograms vial TH ES
Paper Wasp Venom with 9 mL vial solvent and 3 vials diluent 1.8 mL
Insect Allergen Extract— Injection set containing 550 micrograms vial TH ES
Yellow Jacket Venom with 9 mL vial solvent and 3 vials diluent 1.8 mL
Potassium Chloride Tablet 600 mg (sustained release) SZ NM
FIRST SCHEDULE – PART 2
Items Added
Fentanyl Transdermal patch 2.1 mg
Transdermal patch 4.2 mg
Transdermal patch 8.4 mg
Transdermal patch 12.6 mg
Transdermal patch 16.8 mg
Ibuprofen Tablet 400mg
Forms Added
Adalimumab Injection 40 mg in 0.8 mL pre-filled syringe
Etanercept Injection set containing 4 vials powder for injection 25 mg
and 4 pre-filled syringes solvent 1 mL (additional purpose for the
treatment of severe active psoriatic arthritis)
Injection set containing 4 vials powder for injection 25 mg
and 4 pre-filled syringes solvent 1 mL (Diff. Max. Rpts)
(additional purpose for the treatment of severe active psoriatic arthritis)
Injection set containing 4 vials powder for injection 25 mg
and 4 pre-filled syringes solvent 1 mL (additional purpose for the
treatment of psoriasis)
Injection set containing 4 vials powder for injection 50 mg
and 4 pre-filled syringes solvent 1 mL (additional purpose for the
treatment of psoriasis)
Ramipril Tablet 1.25 mg
Tablet 2.5 mg
Tablet 5 mg
Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10
capsules 10 mg
Brands Added
Aciclovir Tablet 200 mg (RA)
Ondansetron Hydrochloride Tablet equivalent to 4 mg ondansetron (AW)
Dihydrate Tablet equivalent to 8 mg ondansetron (AW)
Ramipril Capsule 10 mg (ML)
Items Deleted
Cimetidine Hydrochloride Tablet, effervescent, equivalent to 800 mg cimetidine
Alteration of Purpose
Adrenaline I.M. injection 150 micrograms in 0.3 mL single dose syringe
auto-injector
I.M. injection 300 micrograms in 0.3 mL single dose syringe
auto-injector
Efalizumab Injection set containing 4 vials powder for injection 125 mg
and 4 pre-filled syringes diluent 1.3 mL
Rituximab Solution for I.V. infusion 100 mg in 10 mL vial
Solution for I.V. infusion 500 mg in 50 mL vial
Topiramate Capsule 15 mg
Capsule 25 mg
Capsule 50 mg
SECOND SCHEDULE – PART 1
Items Added
Benzydamine Mouth and throat rinse 22.5 mg per 15 mL, 500 mL
Hydrochloride
Lactulose Solution BP 3.34 g per 5 mL, 500 mL
Macrogol 3350 with Sachets containing powder for oral solution 13.125 g-350.7 mg-
Sodium Chloride, 178.5 mg-46.6 mg, 30
Sodium Bicarbonate and
Potassium Chloride
Morphine Sulfate Tablet 10 mg
Tablet 20 mg
Tablet 200 mg (controlled release)
Form Added
Naproxen Oral suspension 125 mg per 5 mL, 474 mL
Alteration of Max Quantity
From To
Ibuprofen Tablet 400 mg 100 90
Paracetamol Tablet 665 mg (modified release) 96 192
SECOND SCHEDULE – PART 2
Items Added
Benzydamine Mouth and throat rinse 22.5 mg per 15 mL, 500 mL
Hydrochloride
Lactulose Solution BP 3.34 g per 5 mL, 500 mL
Macrogol 3350 with Sachets containing powder for oral solution 13.125 g-350.7 mg-
Sodium Chloride, 178.5 mg-46.6 mg, 30
Sodium Bicarbonate and
Potassium Chloride
Morphine Sulfate Tablet 10 mg
Tablet 20 mg
Tablet 200 mg (controlled release)
Form Added
Naproxen Oral suspension 125 mg per 5 mL, 474 mL
Alteration of Max Quantity
From To
Paracetamol Tablet 665 mg (modified release) 96 192
THIRD SCHEDULE ‑ PART 1
Brands Added
Cefaclor Monohydrate Tablet (sustained release) equivalent to 375 mg cefaclor (RA)
Cephalexin Capsule 250 mg (anhydrous) (RA)
Capsule 500 mg (anhydrous) (RA)
Forms Deleted
Ibuprofen Tablets 400 mg (Max. Qty 100)
Naloxone Hydrochloride Injection 400 micrograms in 1 mL disposable injection set
Brands Deleted
Amoxycillin Trihydrate with Powder for oral suspension equivalent to 125 mg
Water - Purified BP amoxycillin per 5 mL, 100 mL (SI)
Powder for oral suspension equivalent to 250 mg
amoxycillin per 5 mL, 100 mL (CS)
Flucloxacillin Magnesium with Powder for oral suspension equivalent to 125 mg
Water – Purified BP flucloxacillin per 5 mL, 100 mL (CS)
Alteration of Form and Max Quantity
Ibuprofen From: Tablets 400 mg, 20 (Max. Qty 1)
To: Tablet 400 mg (Max. Qty 30)
THIRD SCHEDULE ‑ PART 2
Item Added
Ibuprofen Tablet 400 mg
ATTACHMENT
Paragraph 1 provides that these determinations commence on 1 August 2006.
Paragraph 2 provides that the determinations under sections 85, 85A and 88 of the National Health Act 1953 (the Act) amended on 19 June 2006 with effect from 20 June 2006
(No. PB 25 of 2006) are repealed.
Paragraph 3 defines the following terms for the purposes of these determinations:
- “Act”;
- “base-priced drug”;
- “CFC”;
- “CFU”;
- “electronic communication”;
- “g”;
- “I.M.”;
- “I.V.”;
- “kg”;
- “L”;
- “m”;
- “Medicare Australia CEO”
- “mg”;
- “mL”;
- “mm”;
- “mmol”;
- “palliative care patient”;
- “PBS”; 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 maximum 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 Medicare Australia CEO 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 Medicare Australia CEO 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 Medicare Australia CEO 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 Medicare Australia CEO;
(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 Medicare Australia CEO by means of electronic communication (of a kind which has been approved by the Medicare Australia CEO)
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 Medicare Australia CEO signing for the authorisation on the prescription and:
(i) if the Medicare Australia CEO 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 Medicare Australia CEO 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 Medicare Australia CEO authorises a prescription orally, in accordance with subparagraph 12(b) or (c):
(a) the Medicare Australia CEO 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 Medicare Australia CEO.
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.