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

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 (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 Name of Regulations

1.3 Definitions

Part 1A—Pre‑submission services

Division 1A.1—Providing ATAGI advice

1A.1 Fees for providing ATAGI advice

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

1A.3 How to make an ATAGI application

1A.4 Notification (including invoicing of fees)

1A.5 Withdrawal of an ATAGI application

1A.6 Resending ATAGI applications

Division 1A.2—Holding pre‑submission meetings

1A.7 Fees for holding pre‑submission meetings

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

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

1A.10 Notification (including invoicing of fees)

1A.11 Withdrawal of a meeting application

1A.12 Resending meeting applications

Part 2—Submission services

Division 2.1A—Preliminary

2.1A Simplified outline of this Part

Division 2.1—Submissions to the Committee or Minister etc.

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

2.2 Fees for submission services

2.3 Applications in Category 1

2.4 Applications in Category 2

2.5 Applications in Category 3

2.6 Applications in Category 4

2.7 Applications in Committee Secretariat category

2.8 Applications in new brand of existing pharmaceutical item category

2.9 Evaluation categories of certain resent applications

Division 2.2—Application procedure including prior notice

2.15 Prior notice needed for most applications

2.16 How to apply for submission services

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

2.17 Notification (including invoicing of fees)

2.17A Declining to accept incomplete application sent to Department

2.18 Withdrawal

2.19 Resending applications

Division 2.3—Validating evaluation categories and assessing applications

2.20 Validating an application’s evaluation category

2.21 Assessing applications

Part 3—Pricing services

Division 3.1—Preliminary

3.1 Simplified outline of this Part

Division 3.2—Fees and associated applications

3.2 Applications for pricing services

3.3 Fees for providing pricing services

3.4 Pricing Pathway A applications

3.5 Pricing Pathway B applications

3.6 Pricing Pathway C applications

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

3.8 Pricing Pathway D applications

3.9 Pricing Secretariat applications

Division 3.3—Application procedure including prior notice

3.10 Prior notice of pricing applications needed

3.11 How to apply for pricing services

3.12 Notification (including invoicing of fees)

3.13 Withdrawal

Division 3.4—Validating categories of pricing applications

3.14 Validating a pricing application’s category

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

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

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

Part 3A—List management services

3A.1 Fees for providing list management services

3A.2 How to apply for list management services

3A.3 Notification (including invoicing of fees)

3A.4 Withdrawal of a list management application

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

Part 4—Fees: common rules and independent review fee

4.1 Payment of fees

4.2 Delay in paying a fee

4.3 Independent review fee

Part 5—Exemptions and waivers

5.1 Exemptions

5.2 Waiver of fees

Part 6—Review of decisions

6.1A Reviewable decisions

6.1 Notice of review rights

6.2 Internal review

6.3 Internal review—Secretary

6.4 Notice of fee adjustment

6.5 Review by the Administrative Appeals Tribunal

Part 7—Application and transitional provisions

Division 1—Application of these Regulations as originally made

7.1 Application of these Regulations

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

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

7.3 Application of amendments of regulation 2.15

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

7.4 Scope of this Division

7.5 Application of new fees

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

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

7.8 Application of amendments about procedure for making pricing applications

7.9 Cessation of pricing services 6 months after pricing application sent

7.10 Application of amendment about time for payment of fees

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

7.12 Application of provisions about requests for waiver of fees

7.13 Application of provisions about internal review

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

Schedule 1—Applications

Part 1—Vaccines

Part 2—Pharmaceuticals

Part 3—Existing pharmaceutical items

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Editorial changes

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;

(c) vaccine.

  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;

 (c) Category 3;

 (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.

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);

 (c) the manner for paying that fee.

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

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).

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

 (c) the application does not:

 (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

 (c) be sent to:

 (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

 (c) be sent, on or before the application’s submission due day (if any), to:

 (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

 (c) of the manner for paying that fee.

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

 (c) if the request was for waiver and the fee is not waived—of the applicant’s review rights under Part 6; 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

 (c) 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.

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;

 (c) the application is withdrawn within 10 business days after the day that notification is given;

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

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.

 (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

 (c) the fee relating to Pricing Pathway C category includes a deposit of $66,340.

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

 (c) the pricing application is not in the Pricing Pathway A category.

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

 (c) the pricing application is not in the Pricing Pathway A category.

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.

3.7  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

 (c) those terms include an existing subsidisation cap that cannot be shared with the new drugs; 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.

Circumstances in the above subregulations are not exhaustive

 (5) This regulation does not set out the only circumstances in which the pricing terms in an existing deed will be, or will not be, substantially similar to those appropriate for the new drugs.

3.8  Pricing Pathway D applications

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

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

 (b) the pricing application does not seek 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

 (c) the pricing application is not in the Pricing Pathway A category.

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

 (a) notes that the person’s Part 2 submission to the Committee covering the new drugs included one or more of the following claims about the new drugs and an alternative therapy:

 (i) a claim that the effectiveness of specified doses of the new drugs is equivalent to specified doses of the alternative therapy;

 (ii) a claim that the new drugs will provide similar health benefits to those provided by the alternative therapy;

 (iii) a claim that the new drugs may be supplied at the same or a lower price per treatment, or price per unit, as that for the alternative therapy; and

 (b) notes that the claims are consistent with the Committee’s recommendation or advice to the Minister responding to that submission; and

 (c) suggests a price based on the claims.

 (3) This subregulation applies to the pricing application if:

 (a) the pricing application notes that the person’s Part 2 submission to the Committee covering the new drugs:

 (i) claimed that the use of the new drugs provides a significant improvement in the efficacy or reduction in toxicity compared to any alternative therapy; and

 (ii) requested for the new drugs a higher price per treatment, or price per unit, than that for an alternative therapy; and

 (b) the pricing application requests for the new drugs a higher price per treatment, or price per unit, than that for:

 (i) the alternative therapy referred to in subparagraph (a)(ii); or

 (ii) another alternative therapy if, as part of the Committee’s recommendation or advice (the Committee’s response) responding to that submission, the Committee finds that the other therapy is clinically comparable to the new drugs; and

 (c) the claim in paragraph (a) and the requests in paragraphs (a) and (b) are consistent with the Committee’s response.

 (4) This subregulation applies to the pricing application if:

 (a) the pricing application notes that the person’s Part 2 submission to the Committee covering the new drugs included a request for a review of the existing price for a listed drug; and

 (b) the resulting price requested in the pricing application is consistent with the Committee’s recommendation or advice to the Minister responding to that submission.

 (5) This subregulation applies to the pricing application if:

 (a) the pricing application notes that the person’s Part 2 submission to the Committee covering the new drugs included both of the following claims about the new drugs and an alternative therapy:

 (i) a claim that the new drugs will provide similar health benefits to those provided by the alternative therapy;

 (ii) a claim that the new drugs may be supplied at the same or a lower price per treatment, or price per unit, as that for the alternative therapy; and

 (b) the claims are consistent with the Committee’s recommendation or advice to the Minister responding to that submission.

3.9  Pricing Secretariat applications

  A person’s pricing application is in the Pricing Secretariat category if it is not in the Pricing Pathway A, B, C or D category.

Division 3.3—Application procedure including prior notice

3.10  Prior notice of pricing applications needed

Prior notice required

 (1) A person proposing to make and send a pricing application:

 (a) must give the Department prior notice of the pricing application in accordance with subregulation (5); and

 (b) must do so at least 5 business days before the day the person sends the proposed pricing application to the Department.

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

Note 2: The pricing application will need to be sent to the Department within 30 business days after this prior notice is given (see paragraph 3.11(1)(d)).

Exception if an urgent public health need

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

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

Note: A decision that providing the pricing 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) The provision of pricing services in response to a pricing application will be delayed if prior notice of the pricing application:

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

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

The pricing services will not begin to be provided until at least 5 business days after the day the pricing application is sent to the Department.

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 pricing application is to be in a particular category; and

 (c) be sent to the office of the Department arranging pricing services.

Note: The address for the office arranging pricing services 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 a pricing application.

3.11  How to apply for pricing services

 (1) A pricing application must:

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

 (b) if prior notice of the pricing application is not given as described in paragraph 3.10(1)(a)—state, with reasons, why the pricing application is to be in a particular category; and

 (c) be sent to the office of the Department arranging pricing services; and

 (d) if prior notice of the pricing application is given as described in paragraph 3.10(1)(a)—be sent to that office of the Department within 30 business days after the day the prior notice is so given.

Note: The address for the office arranging pricing services can be found on the Department’s website.

 (2) If:

 (a) prior notice of a proposed pricing application is given as described in paragraph 3.10(1)(a); but

 (b) the proposed pricing application is not sent as required under paragraph (1)(d) of this regulation;

the Department must refund any fee paid for providing pricing services in response to the proposed pricing application except for the deposit referred to in subregulation 3.3(2).

Note: If the person still seeks the pricing services, the person will need to give prior notice again under regulation 3.10 of a new pricing application.

 (3) The Secretary may, in writing, approve forms for use in making pricing applications.

3.12  Notification (including invoicing of fees)

Notices relating to proposed pricing applications

 (1) Within 10 business days after the day the Department receives a notice as described in paragraph 3.10(1)(a) from a person about a proposed pricing 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 category of the proposed pricing application—of the amount of the fee that is payable for providing pricing services in response to the proposed pricing application; and

 (c) of the manner for paying that fee.

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 pricing applications if fee exemption or waiver sought

 (2) However, subregulation (1) does not apply if the notice received by the Department as described in paragraph 3.10(1)(a) includes either:

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

 (b) a request for waiver of;

the fee for providing pricing services in response to the proposed application. 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 described in paragraph 3.10(1)(a) 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

 (c) if the request was for waiver and the fee is not waived—of the applicant’s review rights under Part 6; 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 pricing 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 a pricing application for which prior notice is not required under subregulation 3.10(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

 (c) 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.

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)).

3.13  Withdrawal

Prior notices or pricing 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) given as described in paragraph 3.10(1)(a) about a proposed pricing application;

 (b) a pricing application.

When a withdrawal will result in a refund

 (2) If the prior notice is withdrawn within 10 business days after the day a notification is given under subregulation 3.12(1) about the prior notice, the Department must refund any fee paid for providing pricing services in response to the proposed pricing application except for the deposit referred to in subregulation 3.3(2).

 (2A) If the pricing application is withdrawn within 10 business days after the day a notification is given under subregulation 3.12(3) about the pricing application, the Department must refund any fee paid for providing pricing services in response to the pricing application except for the deposit referred to in subregulation 3.3(2).

 (3) If all of the following apply:

 (a) prior notice of the pricing application is not given as described in paragraph 3.10(1)(a);

 (b) a notification is given under subregulation 3.12(4) about the pricing application;

 (c) the pricing application is withdrawn within 10 business days after the day that notification is given;

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

 (4) If:

 (a) the prior notice or pricing application is withdrawn after the period described in whichever of subregulations (2), (2A) and (3) is relevant; and

 (b) the application or proposed application was or would have been for pricing services relating to the entering into of a deed under section 85E of the Act (whether or not other pricing services were or would have been applied for);

the Department must refund any fee paid for providing pricing services in response to the application or proposed application except for the deposit referred to in subregulation 3.3(3).

Division 3.4—Validating categories of pricing applications

3.14  Validating a pricing application’s category

 (1) After having had regard to the matters in regulations 3.4 to 3.9, the Secretary may, in writing, determine that a pricing application is in one of the categories mentioned in those regulations.

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

 (2) If the category determined under subregulation (1) for a pricing application is different from the category used to work out the fee notified to the person under regulation 3.12 (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 payable for the pricing services that relate to each of those categories; and

 (b) the fee amounts already paid, or refunded, (if any) for the pricing 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)).

 (4) For the purposes of paragraph (3)(a), the fee payable for the pricing services that relates to the new category determined under subregulation (1) is worked out as if that fee had been notified to the person during the same financial year as that in which the notification for the pricing application was given to the person.

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

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

  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:

 (a) an agreement or understanding has not been reached with the applicant in relation to the assistance for the Minister to consider whether to exercise a power to which the pricing services relate; and

 (b) negotiations relevant to the pricing services are not proceeding because of the applicant’s inaction.

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

 (1) This regulation applies if:

 (a) a pricing application applies for pricing services relating to the entering into of a deed under section 85E of the Act; and

 (b) under regulation 3.15, the Commonwealth ceases to provide the pricing services; and

 (c) when the Commonwealth ceased to provide the pricing services, the deed had not been entered into.

 (2) The Department must refund any fee paid for providing the pricing services except for the deposit referred to in subregulation 3.3(3).

Part 3A—List management services

3A.1  Fees for providing list management services

 (1) For the purposes of section 99YBA of the Act, the fee set out in an item of the following table is prescribed for the Commonwealth providing services (the list management services):

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

 (b) in assisting the Minister to consider whether to exercise a power described in the item.

 (2) This subregulation applies if:

 (a) either:

 (i) a price agreement under section 85AD of the Act is in force between the person and the Minister for the listed brand of the pharmaceutical item; or

 (ii) determinations under subsections 85B(2) and (3) of the Act are in force for the listed brand of the pharmaceutical item; and

 (b) since that agreement or those determinations entered into force, the Committee has not made a recommendation, or given advice, in response to a Part 2 submission made by the person in relation to:

 (i) the listed brand of the pharmaceutical item; or

 (ii) the drug in the pharmaceutical item; and

 (c) in the list management application, the person is seeking:

 (i) through the exercise of the power in subsection 85AD(1) of the Act—an increase in the approved ex‑manufacturer price of the listed brand of the pharmaceutical item; or

 (ii) the making of a determination under subsection 85B(3) of the Act, or the increase in a price earlier determined under that subsection, in relation to the listed brand of the pharmaceutical item.

3A.2  How to apply for list management services

 (1) A list management application must:

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

 (b) be sent to the office of the Department providing those services.

Note: The address for the office providing those services can be found on the Department’s website.

 (2) The Secretary may, in writing, approve forms for use in making list management applications.

3A.3  Notification (including invoicing of fees)

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

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

 (b) of the Ministerial power in Part VII of the Act to which the list management services relate; and

 (c) 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 list management services in response to the 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

 (d) of the amount of the fee that is payable for providing those services; and

 (e) of the manner for paying that fee.

 (2) The fee for the list management services is payable unless:

 (a) a fee exemption applies; or

 (b) the fee is waived in its entirety.

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

3A.4  Withdrawal of a list management application

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

 (2) If the application is withdrawn within 10 business days after the day notification for the application is given under regulation 3A.3, the Department must refund any fee paid for the provision of list management services relating to the application.

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

 (1) This regulation applies if:

 (a) a list management application by a person sought the exercise of a power, described in item 3 of the table in subregulation 3A.1(1), to enter into a deed (the replacement deed) with the person replacing an expired deed with the person entered into under subsection 85E(1) of the Act; and

 (b) the fee set out in that item is paid (in full or in part) for list management services in response to the application; and

 (c) the Department becomes aware of a decision (whether by the Minister, the person or an agreement between them) not to enter into the replacement deed.

 (2) The Department must refund $8,340 to the person.

Part 4—Fees: common rules and independent review fee

4.1  Payment of fees

 (1) A fee payable under these Regulations for services provided by the Commonwealth in response to an application must be paid:

 (a) in full to the Commonwealth; and

 (b) before the end of 28 days starting on the day that the Department gives notice under these Regulations to the applicant that the fee is payable.

 (2) However, the Secretary may agree, in writing, to accept payment by instalments.

 (3) If, because of a decision notified under these Regulations to a person, the person has paid a fee amount under these Regulations that falls short of the amount mentioned in that notice as being payable, the person must pay the Commonwealth an amount equal to the shortfall within:

 (a) 28 days after the day of that notice; or

 (b) a longer period allowed by the Secretary.

Note: The notice by the Secretary could be, for example:

(a) a notice relating to a different category determined under subregulation 2.20(1) or 3.14(1); or

(b) a notice under regulation 6.4 about an underpayment because of a replacement decision made as part of a review under Part 6.

 (4) If a person pays a fee amount under these Regulations that exceeds the amount notified by the Secretary as being payable, the Commonwealth must refund to the person an amount equal to the excess within 20 business days after the later of:

 (a) the day of that payment by the person of the fee amount; and

 (b) the day of that notice by the Secretary of the amount payable.

Note: The notice by the Secretary could be, for example:

(a) a notice relating to a different category determined under subregulation 2.20(1) or 3.14(1); or

(b) a notice under subregulation 2.17(3) or (4) of a decision under subregulation 5.2(1) to waive the fee; or

(c) a notice under regulation 6.4 about an overpayment because of a replacement decision made as part of a review under Part 6.

 (5) This regulation does not apply in relation to a fee mentioned in regulation 4.3.

4.2  Delay in paying a fee

 (1) If a fee payable under these Regulations by a person is not paid before the time the fee must be paid, the Commonwealth may do either or both of the following until the fee is paid or no longer payable:

 (a) refuse to consider any application sent (or to be sent) by the person under these Regulations;

 (b) refuse to provide any services relating to such an application.

Note 1: Paragraph (a) means, for example, that the Committee or ATAGI could refuse to consider the person’s current or future applications under these Regulations until the fee is paid or no longer payable.

Note 2: The Commonwealth could, instead of or in addition to refusing to do these things, seek to recover the unpaid fee as a debt (see subsection 99YBA(5) of the Act).

 (2) This regulation does not apply in relation to a fee mentioned in regulation 4.3.

4.3  Independent review fee

 (1) An applicant may seek an independent review of a decision by the Committee not to make a recommendation that the Minister:

 (a) declare a drug or medicinal preparation under subsection 85(2) of the Act; or

 (b) specify further circumstances, requested in an application, in which a prescription for the supply of a pharmaceutical benefit may be written under subsection 85(7) of the Act.

 (2) The application must:

 (a) be submitted in the form in which it was originally considered by the Committee; and

 (b) have been rejected by the Committee in its entirety.

 (3) For the purposes of section 99YBA of the Act, the fee prescribed for the provision by the Commonwealth of an independent review in response to an application under this regulation is the same as the fee that would be payable under Part 2 for submission services:

 (a) provided in response to an application referred to in subregulation 2.1(1) that is in the Category 2 evaluation category; and

 (b) for which a notification under that Part is given at the same time as the time the application under this regulation is submitted.

This fee for the independent review must be paid in full to the Commonwealth at the time the application under this regulation is submitted.

Note: The independent review will not commence until the fee is paid.

 (4) There is no fee for the Committee to reconsider an application following the independent review.

Note: See the Independent Review (PBS) website at http://www.independentreviewpbs.gov.au.

Part 5—Exemptions and waivers

5.1  Exemptions

Exemptions for services

 (1) No fee is payable under these Regulations for services if the application for the services relates to, or is for, any of the following matters:

 (b) a drug that is exempt from entry in the Australian Register of Therapeutic Goods because of an approval granted under section 19A of the Therapeutic Goods Act 1989;

 (c) if the Secretary considers that the supply of a drug, medicinal preparation or vaccine is necessary for the management of:

 (i) a public health event of national significance; or

 (ii) a biosecurity emergency that is declared to exist under subsection 443(1) of the Biosecurity Act 2015; or

 (iii) a human biosecurity emergency that is declared to exist under subsection 475(1) of the Biosecurity Act 2015;

 (d) to offer a price reduction;

 (e) to change the name of the responsible person;

 (f) to revoke a determination under subsection 9B(2) of the Act;

 (g) to vary a determination under subsection 9B(2) of the Act so that a vaccine ceases to be a designated vaccine;

 (h) to revoke a declaration under subsection 101(4AAA) of the Act;

 (i) to vary a declaration under subsection 101(4AAA) of the Act so that a drug or medicinal preparation ceases to be a listed drug;

 (j) to revoke an arrangement under subsection 100(2) of the Act;

 (k) to vary an arrangement under section 100 of the Act so that a drug or medicinal preparation ceases to be covered by the arrangement;

 (l) to change the pack size with no price implications under section 85AD of the Act;

 (m) to vary a declaration, determination, arrangement or other legislative instrument made under Part VII or section 9B of the Act:

 (i) at the request of Services Australia or the Therapeutic Goods Administration; or

 (ii) that is a mandated change because of a Government initiative.

Note: public health event of national significance is defined in section 3 of the National Health Security Act 2007.

 (2) Subregulation (1) does not apply in relation to:

 (a) services under Division 1A.2 (about pre‑submission meetings); or

 (b) services under regulation 4.3 (about independent reviews).

Exemption for submission services relating to designated orphan drugs

 (3) No fee is payable under these Regulations for submission services provided in response to a person’s application under Part 2 proposing a therapy involving the use of one or more drugs or medicinal preparations if:

 (a) on the day the application is sent to the Department under Part 2, subregulation (4) applies to each of those drugs or medicinal preparations; and

 (b) this subregulation has not already applied to submission services provided in response to an earlier application under Part 2 by the person proposing the same therapy involving the use of any of those drugs or medicinal preparations.

 (4) This subregulation applies to a drug or medicinal preparation (the drug) on a day if:

 (a) on that day, the drug is a designated orphan drug; or

 (b) both:

 (i) on that day, the Secretary is yet to decide whether to include the drug in the Australian Register of Therapeutic Goods in response to an application made by the person on or before that day; and

 (ii) were the drug to be so included, both of the registration fees for doing so have been or would be waived under paragraph 45(12)(c) of the Therapeutic Goods Regulations 1990 because of the drug being a designated orphan drug; or

 (c) less than 12 months before that day, the drug was included in the Australian Register of Therapeutic Goods and both of the registration fees for doing so were waived under paragraph 45(12)(c) of the Therapeutic Goods Regulations 1990 because the drug was a designated orphan drug.

 (5) For the purposes of paragraphs (4)(b) and (c), the registration fees are the fees described in paragraph 23B(2)(b) and subsection 24(1A) of the Therapeutic Goods Act 1989.

Including reasons for exemption in application or prior notice

 (6) An applicant for services who considers that subregulation (1) or (3) applies to provide a fee exemption for the services must include in the application the reasons why that subregulation applies to provide a fee exemption, unless the applicant has complied with subregulation (7).

 (7) A person who:

 (a) proposes to make and send an application for services in relation to which the person expects subregulation (1) or (3) of this regulation to apply to provide a fee exemption; and

 (b) is required by regulation 2.15 or 3.10 to give the Department prior notice of the application;

must include in the notice the reasons why that subregulation is expected to apply to provide a fee exemption.

5.2  Waiver of fees

Waiver of fees under Division 1A.1 or Part 2 or 3

 (1) The Secretary may, in writing and on request made in accordance with subregulation (1A), decide whether or not to waive one or more fees:

 (a) payable by a person under Division 1A.1 or Part 2 or 3; and

 (b) for services that directly or indirectly relate to a Part 2 submission.

 (1A) The request must be made:

 (a) in the person’s application under Part 2 or 3 for any of the services referred to in paragraph (1)(b); or

 (b) if, under regulation 2.15 or 3.10, prior notice of the application is required—in the prior notice.

Note: A request to waive fees payable under Division 1A.1 for ATAGI advice would need to be included in a related application for services under Part 2 or a prior notice of that application.

 (2) The Secretary must decide under subregulation (1) to waive one or more of those fees if:

 (a) the submission involves the public interest; and

 (b) payment of all of those fees would make the submission financially unviable.

 (3) Without limiting subregulation (2), the submission involves the public interest if:

 (a) it concerns a drug, medicinal preparation or vaccine that would represent suitable therapy for a patient population; and

 (b) the patient population is not large enough to make the submission financially viable; and

 (c) the drug, medicinal preparation or vaccine is to be used:

 (i) for palliative care; or

 (ii) as a paediatric medicine; or

 (iii) for medical treatment of Aboriginal or Torres Strait Islander peoples.

 (4) If:

 (a) as described in subregulation (1A), a person requests the Secretary to waive a fee for services that directly or indirectly relate to a Part 2 submission; and

 (b) the Secretary decides under subregulation (1) not to do so;

the person may not later request the Secretary to waive that fee.

Waiver of fees for list management services

 (5) The Secretary may, in writing and on request, decide whether or not to waive the fee payable by a person under Part 3A for list management services provided in response to a list management application.

 (6) The request must be included in the list management application.

 (7) The Secretary must decide under subregulation (5) to waive the fee if:

 (a) the list management application involves the public interest; and

 (b) payment of the fee would make that application financially unviable.

 (8) Subregulation (3) applies to:

 (a) subregulation (7); and

 (b) a list management application referred to in subregulation (7);

in a corresponding way to the way that subregulation (3) applies to subregulation (2) and a submission referred to in subregulation (2).

Part 6—Review of decisions

6.1A  Reviewable decisions

  This Part applies to the following decisions (reviewable decisions) of the Secretary:

 (a) a decision under subregulation 1A.2(1) not to partially exempt a person (about ATAGI applications);

 (b) a decision under subregulation 2.15(3) that providing submission services in response to an application is not required to address an urgent public health need;

 (c) a decision under subregulation 2.20(1) determining the evaluation category of an application under Part 2;

 (d) a decision under subregulation 3.10(3) that providing pricing services in response to a pricing application is not required to address an urgent public health need;

 (e) a decision under subregulation 3.14(1) determining the category of a pricing application;

 (f) a decision under subregulation 5.2(1) or (5) (about waiving fees);

 (g) a decision under subregulation 6.3(2) (about decisions made on reviews initiated by the Secretary).

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

6.1  Notice of review rights

 (1) When the Secretary makes a reviewable decision referred to in paragraph 6.1A(b), (d) or (g) about a person, the Secretary must, within 10 business days after making the decision, give the person:

 (a) written notice of the decision; and

 (b) a statement setting out particulars of the person’s review rights.

Note: Notice of these things for the other kinds of reviewable decisions is given under other provisions of these Regulations.

 (2) The notice must include particulars about how the person may respond to the notice.

 (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

 (c) give the applicant written notice of the initial review decision.

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);

 (c) subregulation 6.3(2) (a Secretary‑initiated 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;

 (c) subregulation 2.20(1A);

 (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;

 (c) subregulations 2.17(2), (3) and (4);

 (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

 2.8 To 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

Endnote 3—Legislation history

Endnote 4—Amendment history