National Health (Pharmaceuticals and Vaccines — Cost Recovery) Amendment Regulations 2010 (No. 1)1

Select Legislative Instrument 2010 No. 294

I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the National Health Act 1953.

Dated 24 November 2010

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

NICOLA ROXON

Minister for Health and Ageing

1 Name of Regulations

  These Regulations are the National Health (Pharmaceuticals and Vaccines — Cost Recovery) Amendment Regulations 2010 (No. 1).

2 Commencement

  These Regulations commence on the day on which Schedule 6 to the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2010 commences.

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

  Schedule 1 amends the National Health (Pharmaceuticals and Vaccines — Cost Recovery) Regulations 2009.

4 Transitional

  The amendments made by Schedule 1 apply to an application under Part 2 of the National Health (Pharmaceuticals and Vaccines — Cost Recovery) Regulations 2009 made on or after the commencement of these Regulations.

Schedule 1 Amendments

(regulation 3)

[1] Subparagraph 2.4 (1) (a) (i)

omit

2.12

insert

2.5A

[2] Paragraph 2.4 (2) (a)

omit

drug, special pharmaceutical product

insert

drug

[3] Subparagraph 2.7 (2) (a) (i)

omit

2.9, 2.11 or 2.14

insert

2.9 or 2.11

[4] Subregulation 2.8 (1)

omit

2.12

insert

2.5A

[5] Subparagraph 2.8 (2) (b) (i)

omit

drug, special pharmaceutical product

insert

drug

[6] Regulation 2.9

omit

or 3.2

[7] Paragraph 2.12 (1) (a)

omit

or 2.13

[8] Subregulation 2.12 (2)

omit

2.12

insert

2.5A

[9] Paragraph 2.12 (2) (a)

omit

drug, a special pharmaceutical product

insert

drug

[10] Regulation 2.13

omit

or 3.2

[11] Regulation 2.14

omit

or 3.2

[12] Paragraph 2.16 (2) (b)

omit

or 3.2

[13] Subparagraph 3.1 (b) (iii)

omit

Act; or

insert

Act.

[14] Subparagraph 3.1 (b) (iv), including the note

substitute

Note   There are no fees payable under these Regulations for price agreements and determinations being made as a result of applications in the new brand of existing pharmaceutical item evaluation category.

[15] Paragraph 3.3 (1) (b)

omit

drug, a special pharmaceutical product

insert

drug

[16] Subparagraph 3.3 (2) (a) (ii)

omit

[17] Paragraph 3.3 (3) (a)

omit

drug, a special pharmaceutical product

insert

drug

[18] Subparagraph 3.4 (b) (i)

omit

drug, special pharmaceutical product, or

insert

drug or a

[19] Paragraph 3.6 (a)

omit

drug, a special pharmaceutical product

insert

drug

[20] Subparagraph 3.8 (1) (a) (i)

omit

3.1 (b) (i), (iii) or (iv)

insert

3.1 (b) (i) or (iii)

[21] Paragraph 4.3 (1) (b)

omit

85 (2A)

insert

85 (7)

[22] Regulation 4.3, note

substitute

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

[23] Paragraph 5.1 (1) (h)

omit

85 (2AA)

insert

101 (4AAA)

[24] Paragraph 5.1 (1) (i)

omit

85 (2A)

insert

101 (4AAA)

[25] Schedule 1, items 2.1 and 2.2

after

Act

insert

and, if applicable, subsection 85 (2A) of the Act

[26] Schedule 1, items 2.3 and 2.4

omit

85 (2A)

insert

85 (7) or paragraph 85 (8) (b)

[27] Schedule 1, item 2.5

substitute

 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

[28] Schedule 1, item 2.8

after

93

insert

or 93AA

[29] Schedule 1, item 2.9

substitute

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

[30] Schedule 1, items 2.10 and 2.11

omit

special pharmaceutical product

insert

pharmaceutical benefit

[31] Schedule 1, items 2.12, 2.13 and 2.14

omit

[32] Schedule 1, after item 2.16

insert

 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

[33] Schedule 1, Part 3 heading

substitute

Part 3 Existing pharmaceutical items

[34] Schedule 1, item 3.2

omit

[35] Schedule 2, item 1

omit

or a special pharmaceutical product

1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.