Commonwealth Consolidated Regulations Commonwealth Consolidated Regulationsmade under the
Compilation No. 4
Compilation date: 14 October 2024
Includes amendments: F2024L01299
About this compilation
This compilation
This is a compilation of the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Regulations 2022 that shows the text of the law as amended and in force on 14 October 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
1 Name
3 Authority
Part 2--Pre-submission services
Division 1--Preliminary
6 Simplified outline of this Part
Division 2--ATAGI advice
7 Fee for providing ATAGI advice
8 Reduced fee for ATAGI applications in simple category
9 Notice of intent required for most ATAGI applications
10 Requirements for ATAGI applications
11 Notification, including amount of fee payable
12 Withdrawal of notice of intent or ATAGI application, and refund of fee or liability for deposit
13 Remaking ATAGI applications
Division 3--Pre-submission meetings
14 Fees for holding pre-submission meetings
15 Requirements for pre-submission meeting applications
16 Agreeing to hold pre-submission meeting
17 Notification, including amount of fee payable
18 Withdrawal of pre-submission meeting application, and refund of fee
19 Remaking pre-submission meeting applications
Part 3--Submission services
Division 1--Preliminary
20 Simplified outline of this Part
Division 2--Submissions to the Committee or Minister and fees
21 Submissions to Committee or Minister in relation to exercise of certain powers
22 Fees for providing submission services
23 Submissions in Category 1
24 Submissions in Category 2
25 Submissions in Category 3
26 Submissions in Category 4
27 Submissions in Committee Secretariat category
28 Submissions in new brand or new oral form of existing pharmaceutical item category
29 Evaluation categories of certain remade submissions
Division 3--Procedure for making submissions and giving notice of intent
30 Notice of intent required for most submissions
31 Requirements for submissions
32 Economic evaluation to support submission in Category 1 or Category 2
33 Notification, including amount of fee payable
34 Secretary may refuse to accept incomplete submission
35 Withdrawal of notice of intent or submission, and refund of fee or liability for deposit
36 Remaking submission
Division 4--Determining evaluation category and assessing submissions
37 Determining evaluation category that submission is in
38 Assessing submissions
Part 4--Pricing services
Division 1--Preliminary
39 Simplified outline of this Part
Division 2--Pricing applications and fees
40 Applications for pricing services
41 Fees for providing pricing services
42 Pricing applications in Pricing Pathway A category
43 Pricing applications in Pricing Pathway B category
44 Pricing applications in Pricing Pathway C category
45 When pricing terms are substantially similar to those appropriate for the new drugs
46 Pricing applications in Pricing Pathway D category
47 Pricing applications in Pricing Secretariat category
Division 3--Procedure for making pricing applications and giving notice of intent
48 Notice of intent required for most pricing applications
49 Requirements for pricing applications
50 Notification, including amount of fee payable
51 Withdrawal of notice of intent or pricing application, and refund of fee or liability for deposit
Division 4--Determining pricing category of pricing applications
52 Determining pricing category that pricing application is in
Division 5--Cessation of pricing services 6 months after pricing application is made
53 Cessation of pricing services 6 months after pricing application is made
54 Refund if deed not made within 6 months after pricing application is made
Part 5--List management services
55 Simplified outline of this Part
56 Fees for providing list management services
57 Requirements for list management applications
58 Notification, including amount of fee payable
59 Withdrawal of list management application, and refund of fee
60 Refund of part of fee if replacement for expired deed not made
Part 6--Fees: common rules and independent review fee
61 Simplified outline of this Part
62 Payment of fees
63 Delay in paying fee
64 Independent review fee
65 Refund or remission of fees if services not provided
Part 7--Exemptions and waivers
66 Simplified outline of this Part
67 Exemptions
68 Waiver of fees for provision of ATAGI advice, submission services or pricing services
69 Waiver of fees for provision of list management services
Part 8--Review of decisions
70 Simplified outline of this Part
71 Reviewable decisions
72 Notice of review rights
73 Internal review
74 Secretary may initiate internal review
75 Notice of fee adjustment
76 Review by the Administrative Review Tribunal
Part 9--Application and transitional provisions
Division 1--Application of this instrument as originally made
77 Definitions for this Division
78 Submission or application for the provision of services received on or after commencement day
79 Prior notice of certain applications given before commencement day
80 Application for services received, but notification not given, before commencement day
81 Application for services received, and notification given, before commencement day
82 ATAGI application made, but waiver of fee not requested, before commencement day
83 Review of decisions made under the old Regulations
84 Things done under the old Regulations
Division 2--Amendments made by the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2022
85 Application provision for the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2022
Division 3--Amendments made by the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2023
86 Application provision for the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2023
Division 4--Amendments made by the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2024
87 Application provision for the National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2024
Schedule 1--Powers of the Minister under the Act
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 |
National Health (Pharmaceuticals and Vaccines--Cost Recovery) Regulations 2022 | 7 Feb 2022 (F2022L00118) | 1 Apr 2022 (s 2(1) item 1) |
|
National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2022 | 25 July 2022 (F2022L01009) | 1 Aug 2022 (s 2(1) item 1) | -- |
National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2023 | 23 June 2023 (F2023L00852) | 1 July 2023 (s 2(1) item 1) | -- |
National Health (Pharmaceuticals and Vaccines--Cost Recovery) Amendment (Fees) Regulations 2024 | 28 June 2024 (F2024L00808) | 1 July 2024 (s 2(1) item 1) | -- |
Administrative Review Tribunal Legislation Consequential Amendments (2024 Measures No. 1) Regulations 2024 | 11 Oct 2024 (F2024L01299) | Sch 7 (items 17-20): 14 Oct 2024 (s 2(1) item 1) | -- |
Provision affected | How affected |
Part 1 |
|
s 2..................... | rep LA s 48D |
s 4..................... | rep LA s 48C |
Part 2 |
|
Division 2 |
|
s 7..................... | am F2022L01009; F2023L00852; F2024L00808 |
s 8..................... | am F2022L01009; F2023L00852; F2024L00808 |
s 12.................... | am F2022L01009; F2023L00852; F2024L00808 |
Division 3 |
|
s 14.................... | am F2022L01009; F2023L00852; F2024L00808 |
Part 3 |
|
Division 2 |
|
s 22.................... | am F2022L01009; F2023L00852; F2024L00808 |
Division 3 |
|
s 35.................... | am F2022L01009; F2023L00852; F2024L00808 |
Part 4 |
|
Division 2 |
|
s 41.................... | am F2022L01009; F2023L00852; F2024L00808 |
Division 3 |
|
s 51.................... | am F2022L01009; F2023L00852; F2024L00808 |
Part 5 |
|
s 56.................... | am F2022L01009; F2023L00852; F2024L00808 |
s 60.................... | am F2022L01009; F2023L00852; F2024L00808 |
Part 8 |
|
s 70.................... | am F2024L01299 |
s 76.................... | am F2024L01299 |
Part 9 |
|
Division 1 |
|
s 83.................... | am F2024L01299 |
Division 2 |
|
Division 2................ | ad F2022L01009 |
s 85.................... | ad F2022L01009 |
Division 3 |
|
Division 3................ | ad F2023L00852 |
s 86.................... | ad F2023L00852 |
Division 4 |
|
Division 4................ | ad F2024L00808 |
s 87.................... | ad F2024L00808 |
Schedule 2................ | rep LA s 48C |