Federal Register of Legislation - Australian Government

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Regulations as made
This instrument updates cost recovery fees for the 2022-23 financial year in relation to applications and submissions for listing on the Pharmaceutical Benefits Scheme (PBS) and National Immunisation Program (NIP) to ensure that cost recovery fees accurately reflect the cost of delivering PBS and NIP listing services.
Administered by: Health and Aged Care
Registered 25 Jul 2022
Tabling HistoryDate
Tabled HR27-Jul-2022
Tabled Senate28-Jul-2022
To be repealed 28 Oct 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022

I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated               13 July 2022

David Hurley

Governor‑General

By His Excellency’s Command

Mark Butler

Minister for Health and Aged Care

 

 

 

  

  


Contents

1  Name. 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Schedules................................................................................................................................. 1

Schedule 1—Amendments                                                                                           2

National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022          2

 


1  Name

                   This instrument is the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 August 2022.

1 August 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under the National Health Act 1953.

Note:          See section 99YBA of the National Health Act 1953.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

  

National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022

1  Subsection 7(2)

Omit “181,500”, substitute “177,830”.

2  Subsection 7(2)

Omit “430”, substitute “420”.

3  Subsection 8(4)

Omit “103,560”, substitute “101,520”.

4  Subsection 8(4)

Omit “430”, substitute “420”.

5  Subsection 12(4)

Omit “430”, substitute “420”.

6  Section 14 (table item 1)

Omit “15,700”, substitute “14,980”.

7  Section 14 (table item 2)

Omit “21,350”, substitute “20,360”.

8  Subsection 22(2) (table)

Repeal the table, substitute:

 

Fees and deposits for providing submission services

Item

Column 1

Evaluation categories of submissions

Column 2

Fee ($)

Column 3

Deposit ($)

1

Category 1

219,990

420

2

Category 2

166,850

420

3

Category 3

41,340

420

4

Category 4

32,050

420

5

Committee Secretariat category

11,210

420

6

New brand or new oral form of existing pharmaceutical item category

6,230

0

7

Standard re‑entry pathway category

164,770

420

8

Early re‑entry pathway category

39,930

420

9

Early resolution pathway category

40,070

420

10

Facilitated resolution pathway category

236,610

72,440

9  Subsection 22(2) (note 4)

Omit “430”, substitute “420”.

10  Subsection 35(6)

Omit “430”, substitute “420”.

11  Subsection 41(1) (table item 1)

Omit “142,540”, substitute “135,690”.

12  Subsection 41(1) (table item 2)

Omit “112,810”, substitute “107,480”.

13  Subsection 41(1) (table item 3)

Omit “74,680”, substitute “71,110”.

14  Subsection 41(1) (table item 4)

Omit “20,460”, substitute “19,070”.

15  Subsection 41(1) (table item 5)

Omit “12,690”, substitute “11,650”.

16  Subsection 41(2)

Omit “430”, substitute “420”.

17  Paragraph 41(3)(a)

Omit “134,200”, substitute “127,895”.

18  Paragraph 41(3)(b)

Omit “104,470”, substitute “99,685”.

19  Paragraph 41(3)(c)

Omit “66,340”, substitute “63,315”.

20  At the end of paragraph 51(2)(c)

Add “or the pricing application”.

21  Subsection 51(4)

Repeal the subsection, substitute:

             (4)  If:

                     (a)  a notification is given:

                              (i)  under subsection 50(1) or (2) after receipt of a notice of intent in relation to a proposed pricing application; or

                             (ii)  under subsection 50(3) after receipt of a pricing application; and

                     (b)  the notice of intent, or the pricing application, is withdrawn after the end of the period of 10 business days beginning on the day the notification mentioned in paragraph (a) is given; and

                     (c)  the proposed pricing application, or pricing 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); and

                     (d)  all or part of the fee for providing pricing services in response to the pricing application was paid before the withdrawal of the notice of intent or the pricing application;

the fee amount paid, except the relevant deposit referred to in subsection 41(3), must be refunded.

22  Subsection 51(5)

Omit “430”, substitute “420”.

23  Subsection 56(1) (table item 1)

Omit “5,080”, substitute “4,820”.

24  Subsection 56(1) (table item 2)

Omit “1,980”, substitute “1,950”.

25  Subsection 56(1) (table item 3)

Omit “10,410”, substitute “10,340”.

26  Subsection 56(1) (table item 4)

Omit “7,090”, substitute “6,670”.

27  Subsection 60(2)

Omit “8,340”, substitute “8,215”.

28  At the end of the Part 9

Add:

Division 2Amendments made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022

85  Application provision for the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022

             (1)  Subject to subsection (2), the amendments of this instrument made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022 apply in relation to the following:

                     (a)  if a notice of intent in relation to an application or a submission for the provision of services is not required—an application or a submission (including a remade application or submission) that is received by the Department on or after 1 August 2022;

                     (b)  in any other case—an application or a submission (including a remade application or submission) for the provision of services, for which a notice of intent is given on or after 1 August 2022.

             (2)  The amendment of subsection 35(6) of this instrument made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022 applies in relation to the withdrawal of a notice of intent in relation to a proposed submission, or a submission, if:

                     (a)  the notice of intent or the submission is given on or after 1 August 2022; and

                     (b)  the notice of intent or the submission is withdrawn on or after 1 August 2022.

             (3)  The repeal and substitution of subsection 51(4) of this instrument made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022 applies in relation to the withdrawal of a notice of intent in relation to a proposed pricing application, or a pricing application, if:

                     (a)  the notice of intent or the pricing application is given on or after 1 April 2022; and

                     (b)  the notice of intent or the pricing application is withdrawn on or after 1 April 2022.

             (4)  In this section:

services means any of the following:

                     (a)  ATAGI advice;

                     (b)  the service of the Department holding a pre‑submission meeting with a person;

                     (c)  submission services;

                     (d)  pricing services;

                     (e)  list management services.