National Health (Pharmaceuticals and Vaccines — Cost Recovery) Regulations 2009 (Cth)

National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009

Select Legislative Instrument No. 372, 2009

made under the

National Health Act 1953

Compilation No. 7

Compilation date: 1 July 2021

Includes amendments up to: F2021L00540

Registered: 4 August 2021

About this compilation

This compilation

This is a compilation of the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009 that shows the text of the law as amended and in force on 1 July 2021 (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 Legislation Register ( 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 series page on the Legislation 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 series page on the Legislation 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

1.1......... Name of Regulations.......................................................................... 1

1.3......... Definitions.......................................................................................... 1

Part 1A—Pre‑submission services 4

Division 1A.1—Providing ATAGI advice 4

1A.1...... Fees for providing ATAGI advice...................................................... 4

1A.2...... Partial exemption from usual ATAGI fee for simple ATAGI applications 4

1A.3...... How to make an ATAGI application................................................. 5

1A.4...... Notification (including invoicing of fees).......................................... 5

1A.5...... Withdrawal of an ATAGI application................................................ 6

1A.6...... Resending ATAGI applications......................................................... 6

Division 1A.2—Holding pre‑submission meetings 7

1A.7...... Fees for holding pre‑submission meetings......................................... 7

1A.8...... How to apply for a pre‑submission meeting...................................... 7

1A.9...... Agreeing to hold a pre‑submission meeting....................................... 7

1A.10.... Notification (including invoicing of fees).......................................... 7

1A.11.... Withdrawal of a meeting application................................................. 8

1A.12.... Resending meeting applications......................................................... 8

Part 2—Submission services 9

Division 2.1A—Preliminary 9

2.1A...... Simplified outline of this Part............................................................ 9

Division 2.1—Submissions to the Committee or Minister etc. 10

2.1......... Which submissions (also known as applications for services) are relevant? 10

2.2......... Fees for submission services............................................................ 10

2.3......... Applications in Category 1............................................................... 11

2.4......... Applications in Category 2............................................................... 12

2.5......... Applications in Category 3............................................................... 13

2.6......... Applications in Category 4............................................................... 14

2.7......... Applications in Committee Secretariat category.............................. 15

2.8......... Applications in new brand of existing pharmaceutical item category 15

2.9......... Evaluation categories of certain resent applications........................ 15

Division 2.2—Application procedure including prior notice 19

2.15....... Prior notice needed for most applications........................................ 19

2.16....... How to apply for submission services.............................................. 20

2.16A.... Economic evaluations to support applications in Category 1 or Category 2 21

2.17....... Notification (including invoicing of fees)........................................ 21

2.17A.... Declining to accept incomplete application sent to Department...... 22

2.18....... Withdrawal....................................................................................... 22

2.19....... Resending applications..................................................................... 23

Division 2.3—Validating evaluation categories and assessing applications 24

2.20....... Validating an application’s evaluation category.............................. 24

2.21....... Assessing applications...................................................................... 24

Part 3—Pricing services 26

Division 3.1—Preliminary 26

3.1......... Simplified outline of this Part.......................................................... 26

Division 3.2—Fees and associated applications 27

3.2......... Applications for pricing services...................................................... 27

3.3......... Fees for providing pricing services.................................................. 27

3.4......... Pricing Pathway A applications....................................................... 28

3.5......... Pricing Pathway B applications........................................................ 28

3.6......... Pricing Pathway C applications........................................................ 28

3.7......... When pricing terms are substantially similar to those appropriate for the new drugs 29

3.8......... Pricing Pathway D applications....................................................... 30

3.9......... Pricing Secretariat applications........................................................ 31

Division 3.3—Application procedure including prior notice 32

3.10....... Prior notice of pricing applications needed...................................... 32

3.11....... How to apply for pricing services.................................................... 33

3.12....... Notification (including invoicing of fees)........................................ 33

3.13....... Withdrawal....................................................................................... 35

Division 3.4—Validating categories of pricing applications 36

3.14....... Validating a pricing application’s category...................................... 36

Division 3.5—Cessation of pricing services 6 months after pricing application is sent 37

3.15....... Cessation of pricing services 6 months after pricing application is sent 37

3.16....... Refund if deed not made within 6 months after pricing application is made 37

Part 3A—List management services 38

3A.1...... Fees for providing list management services................................... 38

3A.2...... How to apply for list management services..................................... 39

3A.3...... Notification (including invoicing of fees)........................................ 39

3A.4...... Withdrawal of a list management application.................................. 40

3A.5...... Partial refund if replacement for expired deed not made................. 40

Part 4—Fees: common rules and independent review fee 41

4.1......... Payment of fees................................................................................ 41

4.2......... Delay in paying a fee........................................................................ 41

4.3......... Independent review fee.................................................................... 42

Part 5—Exemptions and waivers 43

5.1......... Exemptions....................................................................................... 43

5.2......... Waiver of fees.................................................................................. 45

Part 6—Review of decisions 47

6.1A...... Reviewable decisions....................................................................... 47

6.1......... Notice of review rights..................................................................... 47

6.2......... Internal review.................................................................................. 47

6.3......... Internal review—Secretary............................................................... 49

6.4......... Notice of fee adjustment................................................................... 49

6.5......... Review by the Administrative Appeals Tribunal............................. 49

Part 7—Application and transitional provisions 50

Division 1—Application of these Regulations as originally made 50

7.1......... Application of these Regulations..................................................... 50

Division 2—Application and transitional provisions relating to 2019 amendments 51

7.2......... Application and transitional provisions for the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment Regulations 2019.............. 51

Division 3—Application and transitional provisions relating to amendments commencing on 1 July 2020 53

7.3......... Application of amendments of regulation 2.15................................ 53

Division 4—Application and transitional provisions relating to amendments commencing on 1 January 2021 54

7.4......... Scope of this Division...................................................................... 54

7.5......... Application of new fees.................................................................... 54

7.6......... Application of amendments of provisions about applications for pre‑submission meetings 54

7.7......... Application of amendments about procedure for making applications under Part 2 54

7.8......... Application of amendments about procedure for making pricing applications 54

7.9......... Cessation of pricing services 6 months after pricing application sent 55

7.10....... Application of amendment about time for payment of fees............. 55

7.11....... Application of provisions about including reasons for fee exemptions in applications or prior notices............................................................................................... 55

7.12....... Application of provisions about requests for waiver of fees............ 55

7.13....... Application of provisions about internal review.............................. 55

Division 5—Application provisions relating to amendments commencing on 1 July 2021 56

7.14....... Application provision for the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2021.............................. 56

Schedule 1—Applications 57

Part 1—Vaccines 57

Part 2—Pharmaceuticals 58

Part 3—Existing pharmaceutical items 60

Endnotes61

Endnote 1—About the endnotes 61

Endnote 2—Abbreviation key 62

Endnote 3—Legislation history 63

Endnote 4—Amendment history 64

Endnote 5—Editorial changes 69

Part 1—Preliminary

1.1 Name of Regulations

These Regulations are the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009.

1.3 Definitions

Note: A number of expressions used in this instrument are defined in the Act, including the following:

(a) designated vaccine;

(b) Secretary;

In these Regulations:

Act means the National Health Act 1953.

amount includes a nil amount.

ATAGI means the Commonwealth acting through the Australian Technical Advisory Group on Immunisation.

ATAGI advice has the meaning given by subregulation 1A.1(1).

ATAGI application means an application under Division 1A.1.

Australian Register of Therapeutic Goods has the same meaning as in the Therapeutic Goods Act 1989.

brand has the meaning given by subsection 84(1) of the Act.

Committee means the Commonwealth acting through the Pharmaceutical Benefits Advisory Committee.

cost‑effectiveness test, in relation to an application referred to in subregulation 2.1(1), means an assessment of:

(a) the extent (if any) to which the efficacy and toxicity of the therapy proposed in the application for a disease or disorder differs from the efficacy and toxicity of any alternative therapy for the disease or disorder; and

(b) the cost of the proposed therapy relative to the cost of the alternative therapy.

designated orphan drug has the same meaning as in the Therapeutic Goods Regulations 1990.

economic evaluation, for an application under Part 2 and a drug, medicinal preparation or vaccine the subject of the application (the proposed drug or vaccine), means data that is a comparative analysis of the costs and outcomes of:

(a) the therapy to be provided by the proposed drug or vaccine; and

(b) any other therapy that the applicant nominates as an alternative therapy to the proposed drug or vaccine.

evaluation category means any of the following categories that Division 2.1 indicates an application is in:

(a) Category 1;

(b) Category 2;

(d) Category 4;

(e) Committee Secretariat category;

(f) new brand of existing pharmaceutical item category;

(g) standard re‑entry pathway category;

(h) early re‑entry pathway category;

(i) early resolution pathway category;

(j) facilitated resolution pathway category.

high added therapeutic value: a drug, medicinal preparation or vaccine has high added therapeutic value if the drug, preparation or vaccine:

(a) addresses a high and urgent unmet clinical need; and

(b) is expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapy.

listed brand has the meaning given by subsection 84(1) of the Act.

listed drug has the meaning given by subsection 84(1) of the Act.

list management application means an application under Part 3A.

list management services means services provided as described in regulation 3A.1.

medicinal food means food that is a therapeutic good within the meaning of paragraphs (a) and (b) of the definition of therapeutic goods in section 3 of the Therapeutic Goods Act 1989.

meeting application means an application under Division 1A.2.

MSAC means the body known as the Medical Services Advisory Committee.

notification, for an application, means a notification given under:

(a) for an ATAGI application—regulation 1A.4; or

(b) for a meeting application—subregulation 1A.10(2) or (3); or

(c) for an application under Part 2—whichever one of subregulations 2.17(1), (3) and (4) is relevant to the application or prior notice of the application; or

(d) for a pricing application—whichever one of subregulations 3.12(1), (3) and (4) is relevant to the application or prior notice of the application; or

(g) for a list management application—regulation 3A.3.

Part 2 submission means a submission referred to in subregulation 2.1(1).

pharmaceutical item has the meaning given by section 84AB of the Act.

pricing application means an application under Part 3.

pricing services means services provided as described in subregulation 3.2(1).

submission due day has the meaning given by subregulation 2.16(3).

submission services means services provided as described in regulation 2.2.

Therapeutic Goods Administration means the part of the Department known as the Therapeutic Goods Administration.

usual ATAGI fee has the meaning given by subregulation 1A.1(2).

Part 1A—Pre‑submission services

Division 1A.1—Providing ATAGI advice

1A.1 Fees for providing ATAGI advice

(1) A person may make an application (the ATAGI application) for the provision of advice (the ATAGI advice) by ATAGI to the person for the person to include in a proposed Part 2 submission to the Committee that the Committee recommend to the Minister that the Minister exercise a power under section 9B of the Act.

(2) For the purposes of section 99YBA of the Act, the fee (the usual ATAGI fee) prescribed for providing the ATAGI advice to the person is $181,500.

1A.2 Partial exemption from usual ATAGI fee for simple ATAGI applications

Person may be partially exempt from usual ATAGI fee

(1) The Secretary may, in writing and on request, decide whether or not to partially exempt a person from the usual ATAGI fee.

Note 1: A decision not to partially exempt a person is reviewable (see regulation 6.1A).

Note 2: Regardless of this regulation, in some circumstances the person will be fully exempt from the usual ATAGI fee (see regulation 5.1).

(2) The Secretary must decide under subregulation (1) to partially exempt the person if:

(a) the person’s ATAGI application is only proposing:

(i) that a new brand of vaccine be determined under subsection 9B(2) of the Act as a designated vaccine; and

(ii) that the proposed determination is to specify the vaccine by reference to characteristics (other than brand) that are the same as or similar to those specified for another vaccine that is already a designated vaccine; or

(b) the person’s ATAGI application is only proposing:

(i) to vary the circumstances specified in a determination under subsection 9B(2) of the Act in which a designated vaccine may be provided; and

(ii) that the variation is to extend the vaccine’s eligible patient population to a new group of patients who are no more vulnerable to a poor outcome from either the relevant disease or the vaccine; or

(c) the Secretary is satisfied that providing the ATAGI advice to the person will not involve the degree of data analysis and consideration that would justify payment of the entire usual ATAGI fee.

For the purposes of paragraph (a), brand has the same meaning as in section 9B of the Act.

Note: For examples of the characteristics referred to in subparagraph (a)(ii), see subsection 9B(3) of the Act.

Fee payable if a person is partially exempt

(3) If a person is partially exempt under subregulation (1), the fee for providing the ATAGI advice to the person is reduced. The reduced fee is $103,560.

ATAGI application must indicate if partial exemption is requested

(4) A person who wants the Secretary to make a decision under subregulation (1) must request this in the person’s ATAGI application, and include reasons in the ATAGI application why the Secretary should do so.

(5) The Secretary may, by written notice given to the applicant, seek further information from the applicant in relation to the applicant’s request.

(6) Giving such a notice seeking further information pauses the period of 15 business days mentioned in subregulation 1A.4(1) for the ATAGI application until the further information is given in accordance with the notice.

1A.3 How to make an ATAGI application

(1) An ATAGI application must:

(a) be made in writing, in the approved form, to the Secretary; and

(b) be sent to the office of the Department administering ATAGI.

Note: The address for the office administering ATAGI can be found on the Department’s website.

(2) The Secretary may, in writing, approve a form for use in making ATAGI applications.

1A.4 Notification (including invoicing of fees)

(1) Within 15 business days after the day the Department receives an ATAGI application, the Secretary must notify the applicant in writing:

(a) that the Department has received the application; and

(b) if the applicant requests a fee exemption under regulation 1A.2 or includes in the application reasons why regulation 5.1 applies to provide a fee exemption:

(i) whether the fee exemption applies; and

(ii) for a request under regulation 1A.2—of the applicant’s review rights under Part 6; and

(c) of the amount of the fee that is payable for the service of ATAGI providing advice in response to the application; and

(d) of the manner for paying that fee.

(2) The fee for the service is payable unless a fee exemption applies under regulation 5.1.

Note 1: If a fee exemption under regulation 1A.2 applies, the reduced fee referred to in paragraph (1)(c) (and subregulation 1A.2(3)) is payable.

Note 2: Part 4 deals with the payment of fees, including the time for payment (see paragraph 4.1(1)(b)).

1A.5 Withdrawal of an ATAGI application

(1) An ATAGI application may be withdrawn by written notice to the Department.

(2) If the ATAGI application is withdrawn within 10 business days after the day notice about the application is given under regulation 1A.4, the Department must refund any fee paid for the service of ATAGI providing advice in response to the application.

1A.6 Resending ATAGI applications

(1) An applicant for an ATAGI application may remake and resend the ATAGI application in the same or an amended form.

Example: An applicant responds to an ATAGI advice by amending, and resending, the ATAGI application with the aim of receiving different ATAGI advice.

(2) These Regulations apply to the resent application as if it were a new application.

Note: This means, for example, that the resent application will attract a new fee under regulation 1A.1.

Division 1A.2—Holding pre‑submission meetings

1A.7 Fees for holding pre‑submission meetings

For the purposes of section 99YBA of the Act, the following fee is prescribed for the service of the Department holding a pre‑submission meeting with a person:

(a) in response to an application (the meeting application) by the person; and

(b) in relation to the preparation of the person’s proposed Part 2 submission to the Committee that the Committee recommend to, or advise, the Minister that the Minister exercise a power mentioned in an item of Schedule 1.

Fee for providing the service of holding a pre‑submission meeting
Item	Category of pre‑submission meeting	Fee ($)
1	First meeting	15,700
2	Second or later meeting	21,350

1A.8 How to apply for a pre‑submission meeting

(1) A meeting application, and briefing papers for the meeting, must:

(a) be made in writing, in the approved form, to the Secretary; and

(b) be sent to the office of the Department arranging such meetings.

Note 1: The briefing papers could be provided with the meeting application or afterwards.

Note 2: The address for the office arranging pre‑submission meetings can be found on the Department’s website.

(2) The Secretary may, in writing, approve forms for:

(a) meeting applications; or

(b) briefing papers for pre‑submission meetings.

1A.9 Agreeing to hold a pre‑submission meeting

The Secretary may, in writing, after considering a meeting application for a pre‑submission meeting, agree or not agree to the Department holding the pre‑submission meeting with the applicant.

1A.10 Notification (including invoicing of fees)

(1) Within 10 business days after the day the Department receives a meeting application for a pre‑submission meeting, the Secretary must notify the applicant in writing:

(a) that the Department has received the application; and

(b) whether the Secretary agrees under regulation 1A.9 to the Department holding a pre‑submission meeting with the applicant.

(2) If the Secretary agrees to the Department holding a pre‑submission meeting with the applicant on a day less than 30 business days after the Secretary notifies the applicant under subregulation (1), the notice under that subregulation must also state the matters mentioned in subregulation (4).

(3) If the Secretary agrees to the Department holding a pre‑submission meeting with the applicant on a day (the meeting day) at least 30 business days after the Secretary notifies the applicant under subregulation (1), the Secretary must notify the applicant in writing of the matters mentioned in subregulation (4) not more than 20 business days before the meeting day.

(4) The matters to be included in a notice mentioned in subregulation (2) or (3) are as follows:

(a) the category of the pre‑submission meeting (see regulation 1A.7);

(b) the amount of the fee that is payable for the service of holding the pre‑submission meeting (see regulation 1A.7);

Note: Part 4 deals with the payment of fees, including the time for payment (see paragraph 4.1(1)(b)).

1A.11 Withdrawal of a meeting application

(1) A meeting application may be withdrawn by written notice to the Department.

(2) If the meeting application is withdrawn before the end of the last business day before the pre‑submission meeting applied for is to be held, the Department must refund any fee paid for the service of holding the meeting.

1A.12 Resending meeting applications

(1) An applicant for a meeting application may remake and resend the meeting application in the same or an amended form.

(2) These Regulations apply to the resent application as if it were a new application.

Note: This means, for example, that the resent application will attract a new fee under regulation 1A.7.

Part 2—Submission services

Division 2.1A—Preliminary

2.1A Simplified outline of this Part

Submission services are provided in response to a person’s submission to the Committee or Minister (also known as an application for those services). The amount of the fee payable for providing the submission services depends on the evaluation category of the person’s application, which in turn depends on what the application is for. If the application is for more than one thing, the evaluation category is generally determined by the first provision of this Part about evaluation categories to apply to the application.

If the person’s application is to the Committee, the person will generally need to have given the Department prior notice at least 20 business days before the day the Committee requires applications for the relevant Committee meeting that will be considering the application. The day that the Committee requires applications will be different depending on the evaluation category of the person’s application.

This prior notice must include the evaluation category that the application is likely to be in. The person will generally be invoiced a fee for the submission services that reflects this evaluation category.

If the Secretary later decides that the application is in a different evaluation category, the person will be notified and any difference in the fee payable will be refunded or invoiced as appropriate.

Submission services will not be provided in response to the person’s application if this prior notice is not given. The only exception to this is if the Secretary is satisfied that prior notice is not required because the submission services are required to address an urgent public health need.

Division 2.1—Submissions to the Committee or Minister etc.

2.1 Which submissions (also known as applications for services) are relevant?

(1) A person may prepare a submission (the application):

(a) that includes a request that the Committee recommends to, or advises, the Minister that the Minister exercise a power mentioned in an item of Schedule 1; or

(b) for the Minister to exercise a power mentioned in an item of Part 3 of Schedule 1.

Note: For details about how to apply, see regulation 2.16.

(2) An application may include more than one request relating to the exercise of a power mentioned in an item of Part 1 or 2 of Schedule 1, but only if:

(a) each of the requests relates to the same drug, medicinal preparation or vaccine; or

(b) the application proposes therapy for a disease or disorder and each of the requests relates to the same disease or disorder that is the subject of the proposed therapy.

Note: If an application includes 2 or more requests, the evaluation category of the application depends on the request that is covered by the earliest of the following regulations of this Division (unless the application has been resent after an earlier application was unsuccessful because it did not resolve all issues that needed to be resolved).

2.2 Fees for submission services

For the purposes of section 99YBA of the Act, the following fees are prescribed:

(a) a fee for the services provided by the Committee in considering whether to make the recommendation, or give the advice, referred to in paragraph 2.1(1)(a);

(b) a fee for the services provided by the Commonwealth in assisting the Minister to consider whether to exercise the power referred to in paragraph 2.1(1)(b).

Fees and deposits for providing submission services
Item	Column 1 Evaluation category of application in response to which submission services are provided	Column 2 Fee ($)	Column 3 Deposit included in fee ($)
1	Category 1	225,120	430
2	Category 2	170,050	430
3	Category 3	43,360	430
4	Category 4	33,980	430
5	Committee Secretariat category	12,270	430
6	New brand of existing pharmaceutical item category	6,500	0
7	Standard re‑entry pathway category	167,980	430
8	Early re‑entry pathway category	42,010	430
9	Early resolution pathway category	42,160	430
10	Facilitated resolution pathway category	240,570	72,440

Note 1: The evaluation category of an application generally depends on what the application requests or is for (see the rest of this Division). However, the evaluation category of a resent application may depend on matters not resolved by the previous application.

Note 2: The following provisions of this Division are arranged so that only the first of them (in order of appearance in this Division) to apply to an application determines the evaluation category of the application (unless the application has been resent after an earlier application was unsuccessful because it did not resolve all issues that needed to be resolved).

Note 3: The deposit in column 3 of the table may be withheld from a refund of a fee paid for an application if the application, or prior notice of it, is withdrawn soon after it is sent (see regulation 2.18).

2.3 Applications in Category 1

(1) An application referred to in subregulation 2.1(1) is in Category 1 if:

(a) the application includes a request that the Committee recommends to, or advises, the Minister that the Minister exercise a power mentioned in an item of Schedule 1; and

(b) any of subregulations (2), (3), (4) and (5) of this regulation apply in relation to the request or the application.

Drug, medicinal preparation or vaccine first in class for new population or disease

(2) This subregulation applies to a request if it relates to:

(a) a drug or medicinal preparation whose intended effect is achieved by a distinct pharmacological, chemical, immunological or metabolic means that has not been considered before by the Committee; or

(b) a vaccine whose intended effect is achieved by a distinct immunological means that has not been considered before by the Committee; or

(c) a drug, medicinal preparation, or vaccine, that is for the treatment or prevention of a disease or disorder that has not been considered before by the Committee.

Drug, medicinal preparation or vaccine covered by a provisional determination

(3) This subregulation applies to a request if it relates to a drug, medicinal preparation, or vaccine, that is a medicine, within the meaning of the Therapeutic Goods Act 1989, in relation to which a provisional determination under section 22D of that Act is in force when the application including the request is received by the Department.

Codependent application relating to testing

(4) This subregulation applies to an application relating to a drug, medicinal preparation or vaccine if:

(a) determining the existence of:

(i) the proposed circumstances for writing a prescription for supply of the drug or medicinal preparation under Part VII of the Act; or

(ii) the proposed circumstances for provision of the vaccine under section 9B of the Act;

will depend on provision of a medical service using technology before administration of the drug, medicinal preparation or vaccine starts or is continued; and

(b) it is proposed that there be an item of the table, within the meaning of the Health Insurance Act 1973, for the medical service; and

(c) the application includes a request for MSAC to recommend that such an item be included in the table (as well as the request mentioned in paragraph (1)(a) for the Committee); and

(d) in considering their respective requests, both the Committee and MSAC need to do a cost‑effectiveness test (whether or not the Committee or MSAC needs to assess anything else).

Codependent application relating to administration

(5) This subregulation applies to an application relating to a drug or medicinal preparation if:

(a) administration of the drug or medicinal preparation proposed to be provided under the Act will involve the provision of a medical service; and

(b) it is proposed that there be an item of the table, within the meaning of the Health Insurance Act 1973, for the medical service; and

(c) the application includes a request for MSAC to recommend that such an item be included in the table (as well as the request mentioned in paragraph (1)(a) for the Committee); and

(d) in considering the request for the Committee, the Committee needs to do a cost‑effectiveness test (whether or not the Committee needs to assess anything else); and

(e) in considering the request for MSAC, MSAC needs to assess the cost of the therapy proposed in the application for a disease or disorder relative to the cost of any alternative therapy for the disease or disorder (whether or not MSAC needs to assess anything else).

2.4 Applications in Category 2

An application referred to in subregulation 2.1(1) is in Category 2 if:

(a) it includes a request that the Committee:

(i) recommends to, or advises, the Minister that the Minister exercise a power mentioned in item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 2.5, 2.5A or 2.10 of Schedule 1; or

(ii) advises the Minister in relation to a power mentioned in item 2.15 of Schedule 1; and

(b) in considering the request the Committee needs to do a cost‑effectiveness test; and

(c) if the request relates to a drug or medicinal preparation—the drug or preparation is not a medicinal food the patient population for which is too small for the applicant to be able to provide a meaningful economic evaluation for the application; and

(d) the application is not in Category 1.

2.5 Applications in Category 3

(1) An application referred to in subregulation 2.1(1) is in Category 3 if:

(a) subregulation (2), (3), (4) or (5) of this regulation applies to the application; and

(b) the application is not in Category 1 or Category 2.

Applications including certain requests

(2) This subregulation applies to an application if it includes a request that the Committee recommends to, or advises, the Minister that the Minister exercise a power mentioned in item 1.4, 2.4, 2.6, 2.9, 2.11, 2.15 or 2.17 of Schedule 1.

Applications involving assessment of clinical need and effectiveness

(3) This subregulation applies to an application if:

(a) it includes a request that the Committee recommends to, or advises, the Minister that the Minister exercise a power mentioned in item 1.2, 2.2 or 2.5A of Schedule 1; and

(b) in considering the request, the Committee needs to assess the applicant’s claim about the clinical need for, and clinical effectiveness of, the drug, medicinal preparation, or vaccine, to which the request relates; and

(i) propose any change to the unit price of a listed drug or designated vaccine; or

(ii) need the Committee to assess any implications arising from the request for the cost of supplying or providing the drug, medicinal preparation or vaccine.

Applications for determination of brand of medicinal preparation with somatropin

(4) This subregulation applies to an application if it:

(a) is for the Minister to exercise a power mentioned in item 3.1 of Schedule 1 in relation to a medicinal preparation including somatropin; and

(b) includes a claim about the therapeutic benefit derived from the relationship between ingredients in the preparation.

Applications relating to medicinal food

(5) This subregulation applies to an application if it includes a request relating to a drug, or medicinal preparation, that is a medicinal food the patient population for which is too small for the applicant to be able to provide a meaningful economic evaluation for the application.

2.6 Applications in Category 4

(1) An application referred to in subregulation 2.1(1) is in Category 4 if:

(a) any of subregulations (2), (3), (4), (5) and (6) of this regulation apply to the application; and

(b) the application is not in Category 1, Category 2 or Category 3.

Manner of administration of listed drugs and equivalent pharmaceutical items

(2) This subregulation applies to an application if it includes a request that the Committee recommends to, or advises, the Minister that the Minister exercise a power mentioned in item 2.5 of Schedule 1 so as to determine, or vary a determination of, the manner of administration of a form of a listed drug.

Changes to maximum quantity or number of repeats

(3) This subregulation applies to an application if it includes a request that the Committee recommends to, or advises, the Minister that the Minister exercise a power mentioned in item 2.6 of Schedule 1 so as to vary a determination of a maximum described in paragraph 85A(2)(a) or (b) of the Act.

Determinations affecting who may prescribe pharmaceutical benefits or pharmaceutical items

(4) This subregulation applies to an application if it includes a request that the Committee recommends to, or advises, the Minister that the Minister exercise a power mentioned in item 2.6A or 2.6B of Schedule 1 so as to:

(a) specify, or vary a specification of, persons who may prescribe pharmaceutical benefits or pharmaceutical items; or

(b) determine, or vary a determination of, a pharmaceutical benefit for whose supply a PBS prescriber of a kind mentioned in any of subsections 88(1), (1A), (1C), (1D) or (1E) of the Act is authorised to write a prescription.

Prescriber bag supplies

(5) This subregulation applies to an application if it includes a request that the Committee recommends to the Minister that the Minister exercise a power mentioned in item 2.8 of Schedule 1.

Exempt items

(6) This subregulation applies to an application if it includes a request that the Committee advises the Minister that the Minister exercise a power mentioned in item 2.16 of Schedule 1.

2.7 Applications in Committee Secretariat category

(1) An application referred to in subregulation 2.1(1) is in the Committee Secretariat category if:

(a) subregulation (2), (3) or (4) of this regulation applies to the application; and

(b) the application is not in Category 1, Category 2, Category 3 or Category 4.

New or varied listed drugs, medicinal preparations and designated vaccines that pose no greater risk

(2) This subregulation applies to an application if the application:

(a) includes a request that the Committee recommends to, or advises, the Minister that the Minister exercise a power mentioned in item 1.2, 2.2, 2.5 or 2.5A of Schedule 1; and

(b) demonstrates that there is no increase in risk to a patient associated with using a listed drug, medicinal preparation or designated vaccine as a result of the proposed exercise of the power.

Pharmaceutical benefits that can no longer be supplied early

(3) This subregulation applies to an application that includes a request that the Committee recommends to the Minister that the Minister exercise the power mentioned in item 2.7 of Schedule 1.

New brand of glucose indicator pharmaceutical item

(4) This subregulation applies to an application for the Minister to exercise a power mentioned in item 3.1 of Schedule 1 in relation to a medicinal preparation that is a pharmaceutical item that either includes a glucose indicator or has the form of a glucose indicator.

2.8 Applications in new brand of existing pharmaceutical item category

An application for the Minister to exercise a power mentioned in item 3.1 of Schedule 1 is in the new brand of existing pharmaceutical item category if the application is not in Category 3 or the Committee Secretariat category.

2.9 Evaluation categories of certain resent applications

(1) This regulation applies to an application (the current application) if:

(a) the current application is a remaking and resending, under regulation 2.19, of an amended form of an application (the previous application) that was the last sent before the current application; and

(b) the previous application was not in:

(i) the Committee Secretariat category; or

(ii) the new brand of existing pharmaceutical item category; and

(c) the Committee declined to take, or was of the view that the Minister should not take, the action sought by the previous application, because of issues (the outstanding issues) arising from the previous application.

(2) This regulation has effect in relation to the current application despite whichever of regulations 2.3, 2.4, 2.5, 2.6, 2.7 and 2.8 applies to it.

Standard re‑entry pathway category

(3) The current application is in the standard re‑entry pathway category if:

(a) after considering the previous application, the Committee either:

(i) considered that the outstanding issues could not be resolved easily and identified the outstanding issues in a communication to the applicant; or

(ii) made a suggestion described in paragraph (4)(a), (5)(a) or (6)(a); and

(b) either:

(i) the prior notice (given under regulation 2.15) for the current application; or

(ii) if prior notice was not required for the current application—the current application;

states that the current application is likely to be in the standard re‑entry pathway category.

Early re‑entry pathway category

(4) The current application is in the early re‑entry pathway category if:

(a) after considering the previous application, the Committee:

(i) considered that the drug, medicinal preparation, or vaccine, to which the application related does not have high added therapeutic value; and

(ii) considered that the outstanding issues could be resolved easily; and

(iii) suggested to the applicant that the applicant remake and resend the application, as an application in the early re‑entry pathway category, to resolve the outstanding issues; and

(iv) identified the outstanding issues in the suggestion; and

(b) the only material differences between the current application and the previous application are to address the outstanding issues; and

(c) the resending of the current application occurs after the suggestion and no later than the second submission due day after the suggestion for applications in the early re‑entry pathway category; and

(d) either:

(i) the prior notice (given under regulation 2.15) for the current application; or

(ii) if prior notice was not required for the current application—the current application;

states that the current application is likely to be in the early re‑entry pathway category.

Early resolution pathway category

(5) The current application is in the early resolution pathway category if:

(a) after considering the previous application, the Committee:

(i) considered that the drug, medicinal preparation, or vaccine, to which the application related has high added therapeutic value; and

(ii) considered that the outstanding issues could be resolved easily; and

(iii) suggested to the applicant that the applicant remake and resend the application, as an application in the early resolution pathway category, to resolve the outstanding issues; and

(iv) identified the outstanding issues in the suggestion; and

(b) the only material differences between the current application and the previous application are to address the outstanding issues; and

(c) the resending of the current application occurs after the suggestion and no later than the second submission due day after the suggestion for applications in the early resolution pathway category; and

(d) either:

(i) the prior notice (given under regulation 2.15) for the current application; or

(ii) if prior notice was not required for the current application—the current application;

states that the current application is likely to be in the early resolution pathway category.

Facilitated resolution pathway category

(6) The current application is in the facilitated resolution pathway category if:

(a) after considering the previous application, the Committee:

(i) considered that the drug, medicinal preparation, or vaccine, to which the application related has high added therapeutic value; and

(ii) considered that a workshop involving the applicant and one or more members of the Committee is desirable to discuss the outstanding issues; and

(iii) suggested to the applicant that the workshop be held and that the applicant later remake and resend the application, as an application in the facilitated resolution pathway category, to resolve the outstanding issues; and

(b) the workshop is held at which the outstanding issues are discussed; and

(c) the resending of the current application occurs after the workshop and no later than the second submission due day after the workshop for applications in the facilitated resolution pathway category; and

(d) either:

(i) the prior notice (given under regulation 2.15) for the current application; or

(ii) if prior notice was not required for the current application—the current application;

states that the current application is likely to be in the facilitated resolution pathway category.

Division 2.2—Application procedure including prior notice

2.15 Prior notice needed for most applications

Prior notice required

(1) A person proposing to make and send an application in an evaluation category other than the new brand of existing pharmaceutical item category must give the Department prior notice of the application:

(a) in accordance with subregulation (5); and

(b) at least:

(i) 20 business days before the submission due day for the application; or

(ii) if the application is to be in the early re‑entry pathway category or the early resolution pathway category—5 business days before the submission due day for the application; or

(iii) if the application is to be in the facilitated resolution pathway category because a workshop is to be held as described in subregulation 2.9(6)—10 business days before the workshop is to be held.

Note 1: Requiring this prior notice allows the Commonwealth to properly prepare for the provision of submission services in response to the application.

Note 2: The application will need to be sent to the Department on or before this submission due day (see paragraph 2.16(1)(c)).

Exception if an urgent public health need

(2) However, prior notice of the application is not required under subregulation (1) if the Secretary decides under subregulation (3) that providing submission services in response to the application is required to address an urgent public health need.

(3) The Secretary may, in writing, decide whether or not providing submission services in response to the application is required to address an urgent public health need.

Note: A decision that providing the submission services is not required to address an urgent public health need is reviewable (see regulation 6.1A).

Consequence if prior notice is required but not given

(4) Submission services will not be provided in response to an application if prior notice of the application:

(a) is required under subregulation (1); and

(b) is not given in accordance with that subregulation.

How to provide prior notice

(5) A prior notice under subregulation (1) must:

(a) be made in writing, in the approved form, to the Secretary; and

(b) state, with reasons, why the proposed application is likely to be in a particular evaluation category; and

(i) the office of the Department administering the Committee; or

(ii) if the prior notice is of an application for the Minister to exercise a power mentioned in item 3.1 of Schedule 1—the office of the Department administering applications about that item.

Note: The address for the office administering the Committee can be found on the Department’s website.

(6) The Secretary may, in writing, approve forms for use in giving a prior notice under subregulation (1) of an application under this Part.

2.16 How to apply for submission services

Procedural requirements for applications

(1) An application under this Part must:

(a) be made in writing, in the approved form, to the Secretary; and

(b) if prior notice of the application is not required under subregulation 2.15(1)—state, with reasons, why the application is likely to be in a particular evaluation category; and

(i) for an application that is likely to be in an evaluation category because of subregulation 2.5(4) or regulation 2.8—the office of the Department administering applications about item 3.1 of Schedule 1; or

(ii) otherwise—the office of the Department administering the Committee.

Note: The addresses for the offices mentioned in paragraph (c) can be found on the Department’s website.

(2) The Secretary may, in writing, approve forms for use in making applications under this Part.

Submission due day

(3) For an application under this Part that:

(a) is for the Committee; and

(b) is likely to be in a particular evaluation category;

the submission due day is the day by which the Committee needs to have received applications in that evaluation category for the Committee to consider the application.

(4) The Secretary must ensure that the submission due days for future Committee consideration of applications are published on the Department’s website.

2.16A Economic evaluations to support applications in Category 1 or Category 2

An application in, or likely to be in, Category 1 or Category 2 must be accompanied by an economic evaluation for the application.

2.17 Notification (including invoicing of fees)

Notices relating to prior notices of applications

(1) Within 10 business days after the day the Department receives a notice under subregulation 2.15(1) from a person about a proposed application, the Secretary must notify the person in writing:

(a) that the Department has received the notice; and

(b) based on the statement in the notice about the evaluation category of the proposed application—of the amount of the fee that is payable for providing submission services in response to the proposed application; and

Note 1: The fee must be paid within a period starting when this notification is given (see paragraph 4.1(1)(b)).

Note 3: If it is later found that a fee exemption or waiver under regulation 5.1 or 5.2 applies, a refund may be payable (see subregulation 4.1(4)).

Notices relating to applications if fee exemption or waiver sought

(2) However, subregulation (1) does not apply if the notice received by the Department under subregulation 2.15(1) includes either of the following relating to the fee for providing submission services in response to the proposed application:

(a) reasons why regulation 5.1 is expected to apply to provide an exemption from the fee;

(b) a request for waiver of the fee.

In that case, subregulation (3) of this regulation applies instead.

(3) Within 15 business days after the Department receives the application to which the notice under subregulation 2.15(1) relates, the Secretary must notify the applicant in writing:

(a) that the Department has received the application; and

(b) whether the fee exemption applies, or whether the fee is waived; and

(d) if the fee exemption does not apply and the fee is not waived:

(i) of the amount of the fee that is payable for providing submission services in response to the application; and

(ii) of the manner for paying that fee.

Notices relating to applications for which prior notice is not required

(4) Within 15 business days after the day the Department receives an application referred to in subregulation 2.1(1) for which prior notice is not required under subregulation 2.15(1), the Secretary must notify the applicant in writing:

(a) that the Department has received the application; and

(b) if the application includes either reasons why regulation 5.1 applies to provide a fee exemption or a request for waiver of the fee for providing submission services in response to the proposed application:

(i) whether the fee exemption applies, or the fee is waived; and

(ii) if waiver was requested but the fee is not waived—of the applicant’s review rights under Part 6; and

(i) of the amount of the fee that is payable for providing submission services in response to the application; and

(ii) of the manner for paying that fee.

Fee specified in notification under this regulation is payable

(5) The amount of the fee (if any) specified in a notification under this regulation is payable.

Note: Part 4 deals with the payment of fees, including the time for payment (see paragraph 4.1(1)(b)).

2.17A Declining to accept incomplete application sent to Department

(1) The Secretary may decline to accept an application referred to in subregulation 2.1(1) that is sent to the Department if the application is so incomplete that it does not provide an adequate basis for:

(a) preparing a recommendation or advice requested by the application; or

(b) deciding whether to exercise a power as applied for.

(2) If the Secretary declines to accept an application:

(a) the Secretary must, within 10 business days, notify the applicant in writing of the declining of the application; and

(b) the Commonwealth may refuse to provide any submission services relating to the application; and

(c) the Department must refund any fee paid for providing submission services in response to the application except for the deposit included in the fee.

2.18 Withdrawal

Prior notices or applications may be withdrawn at any time

(1) Either of the following may be withdrawn by written notice to the Department:

(a) a notice (a prior notice) under subregulation 2.15(1) given about a proposed application;

(b) an application under this Part.

When a withdrawal will result in a refund

(2) If:

(a) a notification is given under subregulation 2.17(1) in response to prior notice of a proposed application; and

(b) the prior notice or the application is withdrawn:

(i) before the later of the end of the tenth business day after the notification is given and the end of the last business day before the submission due day for the application; or

(ii) if the proposed application is likely to be in, or the application is in, the early re‑entry pathway category, the early resolution pathway category or the facilitated resolution pathway category—within 10 business days after the notification is given;

the Department must refund any fee paid for providing submission services in response to the application except for the deposit referred to in column 3 of the table in regulation 2.2.

(2A) If:

(a) a notification is given under subregulation 2.17(3) about an application; and

(b) the application is withdrawn within 10 business days after the notification is given;

the Department must refund any fee paid for providing submission services in response to the application except for the deposit referred to in column 3 of the table in regulation 2.2.

(3) If all of the following apply:

(a) prior notice of the application is not required under subregulation 2.15(1);

(b) a notification is given under subregulation 2.17(4) about the application;

the Department must refund any fee paid for providing submission services in response to the application.

(4) Despite subregulations (2), (2A) and (3), the Department need not make a refund under any of those subregulations relating to a proposed application in the facilitated resolution pathway category if the withdrawal mentioned in that subregulation occurs after the last business day before the workshop mentioned in subregulation 2.9(6) in connection with the application.

2.19 Resending applications

An applicant for an application under this Part may remake and resend the application in the same or an amended form. These Regulations apply to the resent application as if it were a new application.

Note: This means, for example, that the resent application will attract a new fee under regulation 2.2.

Division 2.3—Validating evaluation categories and assessing applications

2.20 Validating an application’s evaluation category

(1) After having:

(a) had regard to the matters in Division 2.1; and

(b) consulted with the Chair of the Committee;

the Secretary may, in writing, determine that an application under this Part is in one of the evaluation categories mentioned in that Division.

Note: The Secretary may initiate a review of the decision to make the determination (see regulation 6.3).

(1A) To avoid doubt, the Secretary may determine under subregulation (1) that the application is in an evaluation category (the determined category) other than the category that the application, or prior notice (under subregulation 2.15(1)) of the application, states the application to be likely to be in, even if the determined category is an evaluation category described in regulation 2.9 (about evaluation categories of certain resent applications).

(2) If the evaluation category determined under subregulation (1) for the application is different from the evaluation category used to work out the fee notified to the person under regulation 2.17 (or previously under this regulation), the Secretary must notify the person in writing accordingly.

(3) A notice under subregulation (2) to the person must state:

(a) the amounts of the fees for the submission services that applied when the notification for the application was given (under regulation 2.17); and

(b) the fee amounts already paid, or refunded, (if any) for the submission services; and

(c) the fee amount that is to be refunded to, or is payable by, the person that reflects the amounts referred to in paragraphs (a) and (b); and

(d) the manner for paying any amount referred to in paragraph (c) that is payable by the person; and

(e) the applicant’s review rights under Part 6 in relation to the determination under subregulation (1).

Any fee amount notified under paragraph (c) as being payable is payable.

Note: Part 4 deals with the payment of fees, including the time for payment (see paragraph 4.1(1)(b)).

2.21 Assessing applications

(1) The Committee or the Minister may request further information from the applicant about an application under this Part.

(2) If the Committee, or the Minister, (the assessor) is unable to assess such an application without further information, the assessor may ask the Secretary to consider:

(a) making a determination under subregulation 2.20(1) about the application; or

(b) reviewing under regulation 6.3 a determination under subregulation 2.20(1), or a decision under subregulation 5.2(1), about the application.

Part 3—Pricing services

Division 3.1—Preliminary

3.1 Simplified outline of this Part

Pricing services may be sought after a meeting of the Committee that results in the Committee making a positive recommendation, or giving positive advice, as part of providing submission services under Part 2.

The pricing services will be provided in response to a person’s pricing application. The amount of the fee payable for providing the pricing services depends on the category of the person’s pricing application.

The person will need to have given the Department at least 5 business days prior notice of the pricing application.

This prior notice must include the category that the pricing application is likely to be in. The person will generally be invoiced a fee for the pricing services that reflects this category.

If the Secretary later decides that the pricing application is in a different category, the person will be notified and any difference in the fee payable will be refunded or invoiced as appropriate.

Pricing services will be delayed if this prior notice is not given. The only exception to this is if the Secretary is satisfied that prior notice is not required because the pricing services are required to address an urgent public health need.

The pricing application will need to be sent to the Department within 30 business days after this prior notice is given.

Six months after a pricing application is sent, the Commonwealth may cease to provide the pricing services applied for if the Secretary is satisfied that negotiations relevant to the pricing services have not concluded successfully and are not continuing because of the applicant. If the ceased services relate to a proposed deed, a partial refund of fees is available.

Division 3.2—Fees and associated applications

3.2 Applications for pricing services

(1) A person may apply (the pricing application) for the Commonwealth to provide services (pricing services) in assisting the Minister to consider whether to exercise one or more powers under subsection 85(2), (2A) or (3), paragraph 85(7)(b) or section 85AD, 85B or 85E of the Act in relation to one or more drugs or medicinal preparations.

Note: For details about how to apply, see regulation 3.11.

(2) However, the person may only make the pricing application if the Committee has made a positive recommendation, or given positive advice, in response to a single Part 2 submission made to the Committee by the person that covers all of those drugs or medicinal preparations.

Note 1: A single submission can only cover multiple drugs or medicinal preparations in the case set out in paragraph 2.1(2)(b).

Note 2: A separate pricing application is required for a drug or medicinal preparation covered by a separate submission to the Committee. This means separate fees under regulation 3.3 are payable for providing pricing services relating to the drugs or medicinal preparations covered by separate submissions to the Committee.

3.3 Fees for providing pricing services

(1) For the purposes of section 99YBA of the Act, the following fee is prescribed for the pricing services provided by the Commonwealth in response to the pricing application.

Fees for providing pricing services
Item	Pricing services provided in response to pricing application in this category	Fee ($)
1	Pricing Pathway A category	142,540
2	Pricing Pathway B category	112,810
3	Pricing Pathway C category	74,680
4	Pricing Pathway D category	20,460
5	Pricing Secretariat category	12,690

(2) For the purposes of subregulations 3.11(2) and 3.13(2) and (2A) (about refunds excluding deposits), each of these fees includes a deposit of $430.

(3) For the purposes of subregulations 3.13(4) and 3.16(2) (about a refund excluding a deposit if a deed is not entered into):

(a) the fee relating to Pricing Pathway A category includes a deposit of $134,200; and

(b) the fee relating to Pricing Pathway B category includes a deposit of $104,470; and

3.4 Pricing Pathway A applications

A person’s pricing application is in the Pricing Pathway A category if:

(a) as part of the Committee’s recommendation or advice responding to the person’s Part 2 submission covering the drugs or medicinal preparations to which the pricing application relates, the Committee finds that:

(i) the drugs or medicinal preparations are expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapy; and

(ii) the drugs or medicinal preparations address a high and urgent unmet clinical need; and

(iii) it would be in the public interest for a pricing application relating to the drugs or medicinal preparations to be in this category; and

(b) the pricing application states that the application is to be in this category.

Note: Prior notice of the pricing application will also need to state that the pricing application is to be in this category (see subregulation 3.10(5)).

3.5 Pricing Pathway B applications

(1) A person’s pricing application is in the Pricing Pathway B category if:

(a) the pricing application seeks the entering into of a deed under section 85E of the Act for the drugs or medicinal preparations to which the pricing application relates (the new drugs); and

(b) no deed under that section is in force (between the Commonwealth and any person) that contains terms about the following (the pricing terms):

(i) reimbursing the Commonwealth;

(ii) providing the Commonwealth with information;

that are substantially similar to those appropriate for the new drugs; and

Note: Regulation 3.7 is relevant to paragraph (b).

(2) For the purposes of paragraph (1)(b), the pricing terms will be appropriate for the new drugs if they are consistent with the Committee’s recommendation or advice responding to the person’s Part 2 submission covering the new drugs.

3.6 Pricing Pathway C applications

(1) A person’s pricing application is in the Pricing Pathway C category if:

(a) the pricing application seeks the entering into of a deed under section 85E of the Act for the drugs or medicinal preparations to which the pricing application relates (the new drugs); and

(b) a deed under that section is in force (between the Commonwealth and any person) that contains terms about the following (the pricing terms):

(i) reimbursing the Commonwealth;

(ii) providing the Commonwealth with information;

that are substantially similar to those appropriate for the new drugs; and

Note: Regulation 3.7 is relevant to paragraph (b).

3.7 When pricing terms are substantially similar to those appropriate for the new drugs

(1) This regulation applies for the purposes of paragraphs 3.5(1)(b) and 3.6(1)(b).

When terms are substantially similar to those appropriate for the new drugs

(2) The pricing terms in an existing deed will be substantially similar to those appropriate for the new drugs if, under those terms, the new drugs can share an existing subsidisation cap with the drugs or medicinal preparations in the existing deed.

(3) The pricing terms in an existing deed will be substantially similar to those appropriate for the new drugs if:

(a) the Committee’s recommendation or advice responding to the person’s Part 2 submission covering the new drugs suggested that the pricing terms in the existing deed would be appropriate for the new drugs; and

(b) this suggestion relates to claims in that submission of the kind referred to in subparagraphs 3.8(2)(a)(i), (ii) and (iii).

When terms are not substantially similar to those appropriate for the new drugs

(4) Despite subregulations (2) and (3), the pricing terms in an existing deed will not be substantially similar to those appropriate for the new drugs if:

(a) those terms relate to further clinical testing, or to the collection of further clinical data on the effectiveness, of drugs or medicinal preparations; or

(b) those terms, to the extent that they reimburse the Commonwealth, include taking into account the clinical response of patients to drugs or medicinal preparations; or

(d) those terms, to the extent that they reimburse the Commonwealth, relate to Commonwealth expenditure on a therapy that involves using the new drugs in combination with any of the drugs or medicinal preparations covered by the existing deed.

(3) Failure to comply with subregulation (1) does not affect the validity of the decision.

6.2 Internal review

Initial internal review

(1) If a reviewable decision is made about a person, the person may apply in writing to the Secretary for review of the reviewable decision.

(2) The application must:

(a) be made within:

(i) 10 business days after the applicant received notice under these Regulations of the reviewable decision; or

(ii) any longer period allowed by the Secretary; and

(b) set out the reasons for making the application.

(3) A person authorised under subregulation (6) must, within 10 business days after receiving the application:

(a) review the reviewable decision; and

(b) make a decision (the initial review decision):

(i) to affirm or vary the reviewable decision; or

(ii) to revoke the reviewable decision, and make any other decision that the person thinks appropriate; and

Further internal review

(4) The applicant may, within 10 business days after receiving notice under paragraph (3)(c), request in writing to the Secretary, in accordance with the notice, that the Secretary review the initial review decision.

(5) The Secretary, or a person authorised under subregulation (6), (the further reviewer) must, within 10 business days after receiving the request:

(a) review the initial review decision and decide (the further review decision):

(i) to affirm or vary the initial review decision; or

(ii) to revoke the initial review decision, and make any other decision that the further reviewer thinks appropriate; and

(b) give written notice to the applicant of the further review decision.

Persons authorised by the Secretary

(6) For the purposes of subregulation (3) or (5), the Secretary may in writing authorise an SES employee, or acting SES employee, in the Department to act under that subregulation.

(7) However:

(a) disregard a person’s authorisation for the purposes of subregulation (3) if the person was involved in making the reviewable decision; and

(b) disregard a person’s authorisation for the purposes of subregulation (5) if the person was involved in making:

(i) the initial review decision; or

(ii) the reviewable decision from which the initial review decision was made.

Discretion to suspend any services to which the review relates

(8) While an application or request for review is being considered under this regulation, the Commonwealth may suspend any services under these Regulations to which the reviewable decision relates.

6.3 Internal review—Secretary

(1) The Secretary may, at any time, initiate a review of a reviewable decision (other than an earlier decision under subregulation (2)).

Note: The review could be initiated by a delegate of the Secretary (see subsection 6(5) of the Act).

(2) The Secretary may:

(a) affirm, vary or revoke the decision; and

(b) if the Secretary revokes the decision—make any other decision the Secretary thinks appropriate.

Note: Notice must be given of a decision under this subregulation (see subregulation 6.1(1)).

6.4 Notice of fee adjustment

If a person has underpaid or overpaid a fee as a result of a decision made under the following provisions, the Secretary must, within 20 business days after making the decision, notify the person accordingly:

(a) paragraph 6.2(3)(b) (an initial review decision);

(b) paragraph 6.2(5)(a) (a further review decision);

Note: A further payment, or a refund, will then be required (see subregulations 4.1(3) and (4)).

6.5 Review by the Administrative Appeals Tribunal

(1) Applications may be made to the Administrative Appeals Tribunal for review of a decision under paragraph 6.2(5)(a) of the further reviewer referred to in that paragraph.

(2) While such an application is being considered by the Administrative Appeals Tribunal, the Commonwealth may suspend any services under these Regulations to which the decision relates.

Part 7—Application and transitional provisions

Division 1—Application of these Regulations as originally made

7.1 Application of these Regulations

These Regulations apply to applications received by the Department after 31 December 2009.

Division 2—Application and transitional provisions relating to 2019 amendments

7.2 Application and transitional provisions for the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment Regulations 2019

(1) The amendments made by the amending instrument apply in relation to an application made under these Regulations on or after 1 July 2019, even if a related application under these Regulations was made before that day.

Example: An application under Part 3 is made on 10 July 2019 that relates to an application under Part 2 that was made in January 2019. The amendments made by the amending instrument will apply in relation to the application under Part 3.

(2) However, these Regulations apply with the modifications described in subregulation (3) in relation to an application made under Part 2 on or after 1 July 2019 that:

(a) is in the major evaluation category (see Subdivision 2 of Division 2.1); and

(b) is for consideration at the Committee meeting in November 2019.

Note: This means the amendments made by the amending instrument apply in relation to these particular Part 2 applications with the modifications in subregulation (3).

(3) These Regulations apply in relation to the application (the transitional application) as if:

(a) the fee in item 1 of the table in subregulation 2.2(1) did not include an amount equal to the deposit referred to in subregulation 2.2(2); and

(b) prior notice of the transitional application were not required under subregulation 2.15(1).

(4) Despite the amendments made by the amending instrument:

(a) the old Regulations (other than Part 3) continue to apply on and after 1 July 2019 in relation to an application:

(i) made under Part 2 of the old Regulations; and

(ii) for which a notice under regulation 2.17 of the old Regulations has been given before 1 July 2019;

as if those amendments had not been made; and

(b) Part 3 of the old Regulations continues to apply on and after 1 July 2019 in relation to an application:

(i) made by a person under Part 2 of the old Regulations; and

(ii) for which the Commonwealth has notified the person in writing before 1 July 2019 that the Commonwealth will begin pricing negotiations in response to a pricing offer sent by the person;

as if those amendments had not been made; and

(c) the old Regulations continue to apply on and after 1 July 2019, in relation to an application submitted under regulation 4.3 of the old Regulations before 1 July 2019, as if those amendments had not been made.

Example: A notice is sent under regulation 2.17 of the old Regulations in early 2019 about a person’s application under Part 2, and the Commonwealth notifies the person on 1 June 2019 that related pricing negotiations will begin. The old Regulations will continue to apply to anything done on and after 1 July 2019 in relation to the application or the pricing negotiations. For example:

(a) an application to waive the evaluation fee or pricing fee would be made under subregulation 5.2(1) of the old Regulations; and

(b) a notice about the Minister exercising a power relating to the pricing offer would be made under regulation 3.8 of the old Regulations.

(5) An application under Part 2 of the old Regulations ceases to have effect on 1 July 2019 unless it is covered by subregulation (4).

(6) In this regulation:

amending instrument means the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment Regulations 2019.

old Regulations means these Regulations (apart from this Part) as in force immediately before 1 July 2019.

Division 3—Application and transitional provisions relating to amendments commencing on 1 July 2020

7.3 Application of amendments of regulation 2.15

The amendments of regulation 2.15 made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to proposed applications whose submission due day is after 28 July 2020.

Division 4—Application and transitional provisions relating to amendments commencing on 1 January 2021

7.4 Scope of this Division

This Division applies to amendments of these Regulations made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (2020 Measures No. 2) Regulations 2020.

Note: The National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (2020 Measures No. 2) Regulations 2020 commenced on 1 January 2021.

7.5 Application of new fees

The amendments involving the following provisions apply in relation to applications, notification for which is given on or after 1 January 2021:

(a) regulation 1A.7;

(b) Division 2.1;

(d) paragraph 2.20(3)(a);

(e) subregulation 2.20(4);

(f) regulation 3.3;

(g) regulations 3A.1 and 3A.5.

7.6 Application of amendments of provisions about applications for pre‑submission meetings

The amendments of regulations 1A.9, 1A.10 and 1A.11 apply in relation to meeting applications sent on or after 1 January 2021.

7.7 Application of amendments about procedure for making applications under Part 2

(1) The amendments involving the following provisions apply to applications sent, or proposed to be sent, on or after 1 January 2021:

(a) regulation 2.15;

(b) regulation 2.16A;

(d) regulation 2.18;

(e) subregulations 2.19(2) and (3).

(2) Regulation 2.17A applies to applications sent on or after 1 January 2021.

7.8 Application of amendments about procedure for making pricing applications

The amendments involving the following provisions apply to pricing applications sent, or proposed to be sent, on or after 1 January 2021:

(a) subregulations 3.12(2), (3) and (4);

(b) regulation 3.13.

7.9 Cessation of pricing services 6 months after pricing application sent

Division 3.5 applies in relation to pricing applications sent on or after 1 January 2021.

7.10 Application of amendment about time for payment of fees

The amendment involving paragraph 4.1(1)(b) applies to notifications given on or after 1 January 2021.

7.11 Application of provisions about including reasons for fee exemptions in applications or prior notices

The amendment involving subregulations 5.1(6) and (7) applies to applications sent, or notices given, on or after 1 January 2021.

7.12 Application of provisions about requests for waiver of fees

The amendments involving regulation 5.2 apply to requests made on or after 1 January 2021.

7.13 Application of provisions about internal review

The amendment involving subregulation 6.2(3) applies to applications made under subregulation 6.2(1) on or after 1 January 2021.

Division 5—Application provisions relating to amendments commencing on 1 July 2021

7.14 Application provision for the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2021

The amendments of these Regulations made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2021 apply in relation to applications, notification for which is given on or after 1 July 2021.

Schedule 1—Applications

(Division 2.1)

Part 1—Vaccines

1.1 To specify a vaccine to be a designated vaccine in a determination under subsection 9B(2) of the Act

1.2 To vary the determination of a designated vaccine under subsection 9B(2) of the Act to change the way in which a vaccine has been specified

1.3 To vary the determination of a designated vaccine under subsection 9B(2) to add a new circumstance in which the vaccine may be provided

1.4 To vary the determination of a designated vaccine under subsection 9B(2) to change a circumstance in which the vaccine may be provided but not so as to add a new circumstance

Part 2—Pharmaceuticals

2.1 To declare a drug or medicinal preparation under subsection 85(2) of the Act and, if applicable, subsection 85(2A) of the Act

2.2 To vary a declaration made under subsection 85(2) of the Act and, if applicable, subsection 85(2A) of the Act

2.3 To specify circumstances, or vary an existing specification to add a new circumstance, in which a prescription for the supply of a pharmaceutical benefit may be written under subsection 85(7) or paragraph 85(8)(b) of the Act

2.4 To vary an existing specification to change the circumstances in which a prescription for the supply of a pharmaceutical benefit may be written under subsection 85(7) or paragraph 85(8)(b) of the Act but not so as to add a new circumstance

2.5 To determine, or vary a determination about:

(a) a form of a listed drug under subsection 85(3) of the Act; or

(b) the manner of administration of a form of a listed drug under subsection 85(5) of the Act

2.5A To determine, or vary a determination, that a pharmaceutical benefit (other than a pharmaceutical benefit that has a drug covered by subsection 85(2A) of the Act) can only be supplied under special arrangements under section 100 of the Act

2.6 To determine matters, or vary an existing determination of matters, for the writing of prescriptions by a specified class of persons under subsection 85A(2) of the Act

2.6A To specify, or vary the specification of, a class of persons in a determination made under subsection 85A(1) or (2) of the Act

2.6B To determine for the purposes of subsection 88(1), (1A), (1C), (1D) or (1E) of the Act a pharmaceutical benefit for whose supply a PBS prescriber mentioned in that subsection is authorised to write a prescription, or to vary such a determination

2.7 To vary the specification of a pharmaceutical item under subsection 84AAA(2) of the Act so that it no longer applies to a pharmaceutical benefit

2.8To make a determination about the supply of a pharmaceutical benefit under section 93, 93AA or 93AB of the Act

2.9 To make or vary a special arrangement under section 100 of the Act to provide for the supply of pharmaceutical benefits

2.10 To specify a circumstance in which a pharmaceutical benefit may be supplied in a special arrangement made under section 100 of the Act, or to vary an existing special arrangement to specify a new circumstance

2.11 To vary the circumstances in which a pharmaceutical benefit may be supplied in an existing special arrangement made under section 100 of the Act but not so as to add a new circumstance

2.15 To agree on a new price for a single brand of a combination item under subsection 99ACC(3) of the Act

Note: The Committee may advise the Minister about this under subsection 101(4AC) of the Act.

2.16 To determine that a pharmaceutical item is an exempt item under section 84AH of the Act

Note: The Committee may advise the Minister about this under subsection 101(4AB) of the Act.

2.17 To revoke or vary a declaration under subsection 85(2A) of the Act so that a listed drug is generally available for supply under Part VII of the Act rather than available only under special arrangements under section 100 of the Act

Part 3—Existing pharmaceutical items

3.1 To determine a brand under subsection 85(6) of the Act for a pharmaceutical item that has a listed brand

Endnotes

Endnote 1—About the endnotes

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 the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

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)
LIA = Legislative Instruments Act 2003	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

Number and year	Registration	Commencement	Application, saving and transitional provisions
372, 2009	16 Dec 2009 (F2009L04013)	1 Jan 2010 (r 1.2)
294, 2010	25 Nov 2010 (F2010L02952)	1 Dec 2010 (r 2)	r 4
120, 2011	30 June 2011 (F2011L01364)	Sch 2 (item 51): 1 July 2011 (r 2)	—

Name	Registration	Commencement	Application, saving and transitional provisions
Biosecurity (Consequential Amendments and Transitional Provisions) Regulation 2016	9 May 2016 (F2016L00717)	Sch 2 (item 25) and Sch 3: 16 June 2016 (s 2(1) item 1)	Sch 3
National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment Regulations 2019	9 Apr 2019 (F2019L00579)	1 July 2019 (s 2(1) item 1)	—
National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Vaccine Advice) Regulations 2019	28 June 2019 (F2019L00931)	1 July 2019 (s 2(1) item 1)	—
National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (2020 Measures No. 1) Regulations 2020	15 June 2020 (F2020L00714)	1 July 2020 (s 2(1) item 1)	—
National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (2020 Measures No. 2) Regulations 2020	27 Nov 2020 (F2020L01504)	1 Jan 2021 (s 2(1) item 1)	—
National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2021	4 May 2021 (F2021L00540)	1 July 2021 (s 2(1) item 1)	—

Endnote 4—Amendment history

Provision affected	How affected
Part 1
r 1.2...........................................	rep LA s 48D
r 1.3...........................................	am F2019L00579; F2019L00931; F2020L01504
Part 1A
Part 1A......................................	ad F2019L00579
Division 1A.1
r 1A.1........................................	ad F2019L00579
rs F2019L00931
am F2020L00714; F2020L01504; F2021L00540
r 1A.2........................................	ad F2019L00579
am F2019L00931; F2020L00714; F2020L01504; F2021L00540
r 1A.3........................................	ad F2019L00579
r 1A.4........................................	ad F2019L00579
am F2020L00714; F2020L01504
r 1A.5........................................	ad F2019L00579
am F2020L00714
r 1A.6........................................	ad F2019L00579
Division 1A.2
r 1A.7........................................	ad F2019L00579
am F2020L01504; F2021L00540
r 1A.8........................................	ad F2019L00579
r 1A.9........................................	ad F2019L00579
am F2020L01504
r 1A.10......................................	ad F2019L00579
am F2020L00714; F2020L01504
r 1A.11......................................	ad F2019L00579
am F2020L00714; F2020L01504
r 1A.12......................................	ad F2019L00579
Part 2
Part 2 heading.............................	rs F2019L00579
Division 2.1A
Division 2.1A.............................	ad F2019L00579
r 2.1A........................................	ad F2019L00579
am F2020L00714; F2020L01504
Division 2.1
Division 2.1 heading....................	rs F2019L00579
Subdivision 1 heading..................	rep F2020L01504
Subdivision 1..............................	rs F2019L00579
rep F2020L01504
r 2.1...........................................	rs F2019L00579
am F2020L01504
r 2.2...........................................	rs F2019L00579
am F2020L00714; F2020L01504; F2021L00540
ed C7
Subdivision 2 heading..................	rep F2020L01504
r 2.3...........................................	am F2019L00579
rs F2020L01504
r 2.4...........................................	am No 294, 2010; F2019L00579
rs F2020L01504
r 2.5...........................................	rs F2020L01504
r 2.6...........................................	rs F2020L01504
Subdivision 3 heading..................	rep F2020L01504
r 2.7...........................................	am No 294, 2010; F2019L00579
rs F2020L01504
am F2021L00540
r 2.8...........................................	am No 294, 2010; F2019L00579
rs F2020L01504
r 2.9...........................................	am No 294, 2010; F2019L00579
rs F2020L01504
r 2.10.........................................	am F2019L00579
rep F2020L01504
r 2.11.........................................	rep F2020L01504
Subdivision 4..............................	rep F2020L01504
r 2.12.........................................	am No 294, 2010; F2019L00579
rep F2020L01504
r 2.13.........................................	am No 294, 2010; F2019L00579
rep F2020L01504
r 2.14.........................................	am No 294, 2010; F2019L00579
rep F2020L01504
Subdivision 5..............................	rep F2019L00579
Division 2.2
Division 2.2................................	rs F2019L00579
r 2.15.........................................	rs F2019L00579
am F2020L00714; F2020L01504
r 2.16.........................................	am No 294, 2010
rs F2019L00579
am F2020L01504
r 2.16A......................................	ad F2020L01504
r 2.17.........................................	rs F2019L00579
am F2020L00714; F2020L01504
r 2.17A......................................	ad F2020L01504
r 2.18.........................................	rs F2019L00579
am F2020L00714; F2020L01504
r 2.19.........................................	rs F2019L00579
am F2020L01504
Division 2.3
Division 2.3................................	ad F2019L00579
r 2.20.........................................	rs F2019L00579
am F2020L01504
r 2.21.........................................	ad F2019L00579
Part 3
Part 3.........................................	rs F2019L00579
Division 3.1
r 3.1...........................................	am No 294, 2010
rs F2019L00579
am F2020L00714; F2020L01504
Division 3.2
r 3.2...........................................	rs F2019L00579
am F2020L00714
r 3.3...........................................	am No 294, 2010
rs F2019L00579
am F2020L01504; F2021L00540
r 3.4...........................................	am No 294, 2010
rs F2019L00579
r 3.5...........................................	rs F2019L00579
r 3.6...........................................	am No 294, 2010
rs F2019L00579
r 3.7...........................................	rs F2019L00579
r 3.8...........................................	am No 294, 2010
rs F2019L00579
r 3.9...........................................	ad F2019L00579
Division 3.3
r 3.10.........................................	ad F2019L00579
am F2020L00714
r 3.11.........................................	ad F2019L00579
am F2020L00714
r 3.12.........................................	ad F2019L00579
am F2020L00714; F2020L01504
r 3.13.........................................	ad F2019L00579
am F2020L00714; F2020L01504
Division 3.4
r 3.14.........................................	ad F2019L00579
am F2020L01504
Division 3.5
Division 3.5................................	ad F2020L01504
r 3.15.........................................	ad F2020L01504
r 3.16.........................................	ad F2020L01504
Part 3A
Part 3A......................................	ad F2019L00579
r 3A.1........................................	ad F2019L00579
am F2020L01504; F2021L00540
r 3A.2........................................	ad F2019L00579
r 3A.3........................................	ad F2019L00579
am F2020L00714; F2020L01504
r 3A.4........................................	ad F2019L00579
am F2020L00714; F2020L01504
r 3A.5........................................	ad F2020L01504
am F2021L00540
Part 4
Part 4 heading.............................	rs F2019L00579
r 4.1...........................................	rs F2019L00579
am F2020L00714; F2020L01504
r 4.2...........................................	rs F2019L00579
r 4.3...........................................	am No 294, 2010; F2019L00579; F2020L01504
r 4.4...........................................	rep F2019L00579
r 4.5...........................................	rep F2019L00579
r 4.6...........................................	rep F2019L00579
r 4.7...........................................	am F2019L00579
rep F2020L01504
Part 5
r 5.1...........................................	am No 294, 2010; No 120, 2011; F2016L00717; F2019L00579; F2020L01504
r 5.2...........................................	am F2019L00579; F2020L01504
ed C6
Part 6
r 6.1A........................................	ad F2019L00579
r 6.1...........................................	am F2019L00579; F2020L00714
r 6.2...........................................	rs F2019L00579
am F2020L00714; F2020L01504
r 6.3...........................................	rs F2019L00579
r 6.4...........................................	rs F2019L00579
am F2020L00714; F2020L01504
r 6.5...........................................	rs F2019L00579
Part 7
Part 7 heading.............................	rs F2019L00579
Division 1
Division 1 heading......................	ad F2020L00714
Division 2
Division 2 heading......................	ad F2020L00714
r 7.2...........................................	ad F2019L00579
Division 3
Division 3..................................	ad F2020L00714
r 7.3...........................................	ad F2020L00714
Division 4
Division 4..................................	ad F2020L01504
r 7.4...........................................	ad F2020L01504
r 7.5...........................................	ad F2020L01504
r 7.6...........................................	ad F2020L01504
r 7.7...........................................	ad F2020L01504
r 7.8...........................................	ad F2020L01504
r 7.9...........................................	ad F2020L01504
r 7.10.........................................	ad F2020L01504
r 7.11.........................................	ad F2020L01504
r 7.12.........................................	ad F2020L01504
r 7.13.........................................	ad F2020L01504
Division 5
Division 5..................................	ad F2021L00540
r 7.14.........................................	ad F2021L00540
Schedule 1
Schedule 1..................................	am No 294, 2010; F2019L00579; F2020L01504
Schedule 2..................................	am No 294, 2010
rep F2020L01504
Schedule 3..................................	rep F2019L00579
Schedule 4..................................	rep F2019L00579

Endnote 5—Editorial changes

In preparing this compilation for registration, the following kinds of editorial change(s) were made under the Legislation Act 2003.

Regulation 2.2

Kind of editorial change

Give effect to the misdescribed amendments as intended

Details of editorial change

Schedule 1 items 5 to 14 of the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2021 instruct to omit and substitute the fees in column 2 of table items 1 to 10 in subregulation 2.2(1).

Subregulation 2.2(1) does not appear. However, regulation 2.2 does appear.

This compilation was editorially changed to apply the amendments to the table in regulation 2.2 and give effect to the misdescribed amendments as intended.