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

No longer in force

Administered by

Department of Health and Aged Care

This item is authorised by the following title:

National Health Act 1953

Superseded version

View latest version

F2010C00809

01 December 2010 - 30 June 2011

Table of contents

1.1 Name of Regulations [see Note 1]
1.2 Commencement
1.3 Definitions
2.1 Scope of applications
2.2 Categories of applications
2.3 Major — applications to list
2.4 Major — health advantage test
2.5 Applications excluded from major category
2.6 Requirements for major applications
2.7 Minor — applications to change listings
2.8 Minor — clinical need and effectiveness test
2.9 Minor — exceptions to new brand of existing pharmaceutical item category
2.10 Minor — applications that are resubmissions
2.11 Minor — medicinal foods
2.12 Applications that are Committee Secretariat
2.13 Committee Secretariat — exceptions to new brand of existing pharmaceutical item category
2.14 Applications that are new brand of existing pharmaceutical item
2.15 Matters requiring consideration
2.16 How to apply
2.17 Notification
2.18 Assessment of applications
2.19 Withdrawal of application
2.20 Resubmission of applications
3.1 Applications to which this Part applies
3.2 Pricing categories
3.3 Complex pricing category
3.4 Simple pricing category
3.5 Pricing Secretariat pricing category
3.6 Claims of cost minimisation
3.7 When a pricing fee is payable
3.8 Notification
4.1 Evaluation fees
4.2 Pricing fees
4.3 Independent review fee
4.4 Payment of fees
4.5 Delay in payment of evaluation fee
4.6 Delay in payment of pricing fee
4.7 Indexation of fees
5.1 Exemptions
5.2 Waiver of fees
6.1 Notice of review rights
6.2 Internal review
6.3 Internal review — Secretary
6.4 Fee adjustment
6.5 Review by Administrative Appeals Tribunal
7.1 Application of these Regulations
- Schedule 1 Applications
- Part 1 Vaccines
- Part 2 Pharmaceuticals
- Part 3 Existing pharmaceutical items
- Schedule 2 Medicinal preparations
- Schedule 3 Evaluation fees
- Schedule 4 Pricing fees
- Notes to the STYLEREF Title National Health (Pharmaceuticals and Vaccines — Cost Recovery) Regulations 2009

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

Legislation text