Remake of the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009

Page last updated: 11 May 2022

The Department has recently remade the National Health (Pharmaceutical and Vaccines—Cost Recovery) Regulations 2009 (2009 Regulations), now titled National Health (Pharmaceutical and Vaccines—Cost Recovery) Regulations 2022.

The new Regulations commenced on 1 April 2022.

The purpose of this remake was to ensure that the Department continues to have authority to administer existing cost recovery arrangements. The new Regulations replaced the 2009 Regulations prior to automatic sunsetting which would have otherwise occurred on 1 April 2022.

The new Regulations include a range of minor clarifications to reflect contemporary regulation drafting preferences and current cost recovery practices. These changes do not alter the current policy intent of the PBS/NIP cost recovery process.

The remade Regulations can be accessed via the PBS website. The following documents have been updated to reflect references to the new Regulations:

• 2021-22 Pharmaceutical Benefits Scheme (PBS) /National Immunisation Program (NIP) Cost Recovery Implementation Statement
• PBS/NIP Cost Recovery Administrative Guidelines: Information for Applicants
• Procedure guidance for listing medicines on PBS
• PBS Forms

In addition to changes that reflect references to the new Regulations, the Procedure guidance for listing medicines on the PBS have also been updated to provide more information on procedures related to requirements for the provision of a delegate’s overview from Therapeutic Goods Administration (see section 5.5 and 6.3) and resubmission pathways (see section 9.1).

For any questions on remake of the Regulations, please contact PBSimprovements@health.gov.au.