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National Health (Pharmaceutical Benefits) Regulations 2017
In force
Administered by
Department of Health and Aged Care
This item is authorised by the following title:
National Health Act 1953
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F2023C00545 (C10)
01 July 2023
-
31 March 2024
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Part 1—Preliminary
Division 1—General
1 Name
3 Authority
5 Interpretation
Division 2—Application of this instrument to electronic prescriptions and electronic orders
7 Preparing electronic prescriptions
8 Date when a prescription is written or a pharmaceutical benefit is prescribed
9 Requirement to give information in writing
10 Requirement to give a prescription
11 Approval of kinds of electronic communications
12 Approval of information technology requirements
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Part 2—Approvals under Part VII of the Act
13 Purpose of this Part
14 Application for certain approvals to be in approved form
15 Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner
16 Numbering of approvals
17 Certain requirements to be met after cancellation etc. of approval—approved pharmacists
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Part 3—Safety net concession cards and pharmaceutical benefits entitlement cards
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Division 1A—Value for safety net purposes
17A Value for safety net purposes
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Division 1—Pharmaceutical benefits prescription record forms etc.
18 Pharmaceutical benefits prescription record forms etc.
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Division 2—Issue of safety net concession cards
19 Application for safety net concession card
20 Prescribed offices
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Division 3—Issue of pharmaceutical benefits entitlement card
21 Application for pharmaceutical benefits entitlement card
22 Prescribed offices
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Division 4—Additional and replacement concession cards and entitlement cards
23 Purpose of this Division
24 Application for, and issue of, additional concession cards and entitlement cards
25 Application for, and issue of, replacement concession cards and entitlement cards
26 Refusal to issue additional or replacement cards by person other than the Secretary
27 Refusal to issue additional or replacement cards by the Secretary
28 Review of decisions
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Part 4—Supply of pharmaceutical benefits
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Division 1—General matters relating to supply
29 Meaning of practitioner
30 Variation of application of determination of maximum number of repeats or maximum number or quantity of units
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Division 2—Supply by particular PBS prescribers
31 Meaning of practitioner
32 Prescriber bag supplies—practitioners on ships
33 Prescriber bag supplies—obtaining benefits by practitioners
34 Prescriber bag supplies—supply of pharmaceutical benefits by approved pharmacists
35 Prescriber bag supplies—payment for pharmaceutical benefits
36 Pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act
37 Payment for pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act
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Part 5—Prescriptions and supply
38 Purpose of this Part
39 Writing prescriptions—general
40 Writing prescriptions—prescriptions other than medication chart prescriptions
41 Writing prescriptions—medication chart prescriptions
41A Writing prescriptions—additional requirements for all electronic prescriptions
41B Writing prescriptions—additional information that may be included in electronic prescriptions
42 Information about status of person
43 Restriction on using PBS forms
44 Supply of pharmaceutical benefit on first presentation of prescription
45 Supply of pharmaceutical benefit on basis of medication chart prescription
46 Continued dispensing supply of pharmaceutical benefit
47 Information about status of person—continued dispensing supplies and medication chart prescriptions
48 Supply of pharmaceutical benefits before surrender of written prescription
49 Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion
50 Continued dispensing supplies—repeated supply not to be supplied on one occasion
51 Repeated supplies of pharmaceutical benefits
52 Repeat authorisations
53 Deferred supply authorisations
54 Presentation of prescriptions in trading hours
55 Presentation of urgent prescriptions
56 Special charge for delivery
57 Receipt of pharmaceutical benefit
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Part 6—Other matters relating to prescriptions and supply etc.
58 Purpose of this Part
59 Keeping documents—other than for continued dispensing supplies or medication chart prescriptions
60 Keeping documents—continued dispensing supplies
61 Keeping documents—medication chart prescriptions
62 Proper stocks to be kept
63 Standards of composition and purity of pharmaceutical benefits and ingredients
64 Labelling of pharmaceutical benefits—full cost
65 Surrender of forms
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Part 7—Price reduction, price disclosure and stockholding
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Division 1—Price reduction
65A Price reductions for single brands of combination items
66 Reduction day
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Division 2—Price disclosure
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Subdivision A—Interpretation
67 Meaning of data collection period
68 Meaning of price sampling day
69 Special rules for certain listed brands
Subdivision B—Weighted average disclosed price
70 Method for determining weighted average disclosed price of listed brand of pharmaceutical item
71 Step 1—net revenue for brand
72 Step 2—adjusted volume for brand
73 Step 3—average approved ex manufacturer price for brand
73A Step 3A—adjusted net revenue for brand
74 Step 4—disclosed price for brand
75 Step 5—price percentage difference of brand
76 Step 6—repeat steps for each brand of pharmaceutical item
77 Step 7—total adjusted volume of brands of pharmaceutical item
78 Step 8—weighted average percentage difference of brands of pharmaceutical item
79 Step 9—repeat steps for each pharmaceutical item with related brands
80 Step 10—weighted average percentage difference for listed brand and all related brands
81 Step 11—weighted average disclosed price for listed brand of pharmaceutical item
82 When weighted average disclosed price is the same as the applicable approved ex manufacturer price
Subdivision C—Information that must not be taken into account
83 Information that must not be taken into account
84 Originator brands
Subdivision D—Price disclosure requirements
85 Price disclosure requirements
Subdivision E—Price reduction
85A Flow on price reductions for brands of combination items
Division 3—Stockholding requirements
85B Usual demand for a brand
85C Stockholding disclosure requirements
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Part 8—Arrangements for the Pharmaceutical Benefits Advisory Committee
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Division 1—Matters relating to the appointment of members of the Committee
86 Nominating bodies
87 Number of nominations for appointment
88 Resignation
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Division 2—Matters relating to the procedure of the Committee
89 Purpose of this Division
90 Presiding member
91 Meetings of the Committee
92 Quorum
93 Voting
94 Disclosure of pecuniary interests by members
95 Resolutions without a formal meeting
96 Reports and recommendations
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Division 3—Matters relating to sub committees
97 Remuneration for chair and members of sub committees
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Part 9—Application, savings and transitional provisions
98 Definitions
99 Things done under old regulations
102 Transitional provision relating to the National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019
103 Application provision relating to the National Health (Pharmaceutical Benefits) Amendment (2021 Measures No. 1) Regulations 2021
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Schedule 1—Prescribed offices
1 Table of prescribed offices
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Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history