Commonwealth Consolidated Regulations Commonwealth Consolidated Regulationsmade under the
Compilation No. 11
Compilation date: 1 April 2024
Includes amendments: F2024L00380
Registered: 3 April 2024
About this compilation
This compilation
This is a compilation of the National Health (Pharmaceutical Benefits) Regulations 2017 that shows the text of the law as amended and in force on 1 April 2024 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.
Self-repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
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
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
Part 3--Safety net concession cards and pharmaceutical benefits entitlement cards
Division 1A--Value for safety net purposes
17A Value for safety net purposes
Division 1--Pharmaceutical benefits prescription record forms etc.
18 Pharmaceutical benefits prescription record forms etc.
Division 2--Issue of safety net concession cards
19 Application for safety net concession card
20 Prescribed offices
Division 3--Issue of pharmaceutical benefits entitlement card
21 Application for pharmaceutical benefits entitlement card
22 Prescribed offices
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
Part 4--Supply of pharmaceutical benefits
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 of quantity of units
Division 2--Supply by particular PBS prescribers
31 Meaning of practitioner
32 Prescriber bag supplies--practitioners on ships
33 Prescriber bag supplies--practitioners other than approved medical 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
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
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
Part 7--Price reduction, price disclosure and stockholding
Division 1--Price reduction
65A Price reductions for single brands of combination items
66 Reduction day
Division 2--Price disclosure
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
Part 8--Arrangements for the Pharmaceutical Benefits Advisory Committee
Division 1--Matters relating to the appointment of members of the Committee
86 Nominating bodies
87 Number of nominations for appointment
88 Resignation
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
Division 3--Matters relating to sub-committees
97 Remuneration for chair and members of sub-committees
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 easures No. 1) Regulations 2021
104 Transitional provision relating to the National Health (Pharmaceutical Benefits) Amendment (2024 easures No. 1) Regulations 2024
Schedule 1--Prescribed offices
1 Table of prescribed offices
Endnotes
Endnote 1--About the endnotes
Endnote 2--Abbreviation key
Endnote 3--Legislation history
Endnote 4--Amendment history
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1--About the endnotes
Endnote 2--Abbreviation key
Endnote 3--Legislation history
Endnote 4--Amendment history
Abbreviation key--Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history--Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Editorial changes
The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.
If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.
If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to the amendment history.
ad = added or inserted | o = order(s) |
am = amended | Ord = Ordinance |
amdt = amendment | orig = original |
c = clause(s) | par = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub-subparagraph(s) |
Ch = Chapter(s) | pres = present |
def = definition(s) | prev = previous |
Dict = Dictionary | (prev ... ) = previously |
disallowed = disallowed by Parliament | Pt = Part(s) |
Div = Division(s) | r = regulation(s)/rule(s) |
ed = editorial change | reloc = relocated |
exp = expires/expired or ceases/ceased to have | renum = renumbered |
effect | rep = repealed |
F = Federal Register of Legislation | rs = repealed and substituted |
gaz = gazette | s = section(s)/subsection(s) |
LA = Legislation Act 2003 | Sch = Schedule(s) |
Sdiv = Subdivision(s) | |
(md) = misdescribed amendment can be given | SLI = Select Legislative Instrument |
effect | SR = Statutory Rules |
(md not incorp) = misdescribed amendment | Sub-Ch = Sub-Chapter(s) |
cannot be given effect | SubPt = Subpart(s) |
mod = modified/modification | underlining = whole or part not |
No. = Number(s) | commenced or to be commenced |
Endnote 3--Legislation history
Name | Registration | Commencement | Application, saving and transitional provisions |
27 Mar 2017 (F2017L00313) | 1 Apr 2017 (s 2(1) item 1) |
| |
National Health (Pharmaceutical Benefits) Amendment (Safety Net) Regulations 2018 | 16 May 2018 (F2018L00621) | 1 June 2018 (s 2(1) item 1) | -- |
National Health (Pharmaceutical Benefits) Amendment (Electronic Prescriptions) Regulations 2019 | 16 Aug 2019 (F2019L01072) | 31 Oct 2019 (s 2(1) item 1) | -- |
National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019 | 9 Oct 2019 (F2019L01312) | 31 Oct 2019 (s 2(1) item 1) | -- |
National Health (Pharmaceutical Benefits) Amendment (Supply of Pharmaceutical Benefits Following Bankruptcy or External Administration) Regulations 2019 | 29 Nov 2019 (F2019L01530) | 5 Dec 2019 (s 2(1) item 1) | -- |
National Health (Pharmaceutical Benefits) Amendment (Seventh Community Pharmacy Agreement) Regulations 2020 | 9 July 2020 (F2020L00898) | 10 July 2020 (s 2(1) item 1) | -- |
National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2020 | 25 Aug 2020 (F2020L01055) | 26 Aug 2020 (s 2(1) item 1) | -- |
National Health (Pharmaceutical Benefits) Amendment (Electronic Prescribing) Regulations 2021 | 3 June 2021 (F2021L00687) | 4 June 2021 (s 2(1) item 1) | -- |
National Health (Pharmaceutical Benefits) Amendment (2021 Measures No. 1) Regulations 2021 | 16 Dec 2021 (F2021L01797) | Sch 1 (items 1-3): 1 July 2022 (s 2(1) item 2) | -- |
National Health (Pharmaceutical Benefits) Amendment (2024 Measures No. 1) Regulations 2024 | 28 Mar 2024 (F2024L00380) | 1 Apr 2024 (s 2(1) item 1) | -- |
Provision affected | How affected |
Part 1 |
|
Division 1 |
|
s 2..................... | rep LA s 48D |
s 4..................... | rep LA s 48C |
s 5..................... | am F2018L00621; F2019L01072; F2019L01312; F2020L00898; F2021L00687; F2024L00380 |
s 6..................... | rep F2018L00621 |
Division 2 |
|
s 9..................... | am F2019L01072 |
s 10.................... | am F2019L01072 |
Part 2 |
|
s 16.................... | am F2019L01530 |
Part 3 |
|
Division 1A |
|
Division 1A............... | ad F2018L00621 |
s 17A................... | ad F2018L00621 |
Division 1 |
|
s 18.................... | am F2018L00621 |
Division 2 |
|
s 19.................... | am F2018L00621 |
Division 3 |
|
s 21.................... | am F2018L00621 |
Part 4 |
|
Division 1 |
|
s 30.................... | am F2019L01072 |
| rs F2024L00380 |
Division 2 |
|
s 33.................... | am F2019L01072; F2024L00380 |
Part 5 |
|
s 39.................... | am F2019L01072 |
s 40.................... | am F2019L01072; F2019L01312; F2024L00380 |
s 41.................... | am F2019L01072; F2019L01312; F2021L00687; F2024L00380 |
s 41A................... | ad F2019L01072 |
s 41B................... | ad F2019L01072 |
s 45.................... | am F2021L00687 |
s 57.................... | am F2019L01072 |
| rep F2024L00380 |
Part 6 |
|
s 59.................... | am F2019L01072 |
Part 7 |
|
Part 7 heading............. | rs F2021L01797 |
Division 1 |
|
s 65A................... | ad F2021L01797 |
Division 2 |
|
Subdivision B |
|
s 73A................... | ad F2021L01797 |
s 74.................... | am F2021L01797 |
Subdivision C |
|
s 84.................... | am F2021L01797 |
Subdivision D |
|
s 85.................... | am F2021L01797 |
Subdivision E |
|
Subdivision E.............. | ad F2021L01797 |
s 85A................... | ad F2021L01797 |
Division 3 |
|
Division 3................ | ad F2021L01797 |
s 85B................... | ad F2021L01797 |
s 85C................... | ad F2021L01797 |
Part 9 |
|
s 100................... | rep 1 Apr 2019 (s 100(3)) |
s 101................... | rep 1 Apr 2019 (s 101(3)) |
s 102................... | ad F2019L01312 |
| am F2020L01055 |
s 103................... | ad F2021L01797 |
| am F2021L01797 |
s 104................... | ad F2024L00380 |
Schedule 2................ | rep LA s 48C |