Alterations to the Minister’s ability to approve PBS medicines on a case-by-case basis

Alterations to the Minister’s ability to approve PBS medicines on a case-by-case basis

05 Sep 2025

A legislative change now allows the Minister less time to make decisions on PBS medicine supply requests.

Pharmacists who want to supply PBS medicines to the community and claim reimbursement from the government must be approved under section 90 of the National Health Act 1953. If an application is rejected due to the Pharmacy Location Rules, pharmacists can ask the Minister for approval.

Previously, the approval process had two stages, with the Minister given three months for each stage.

The Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2025, recently passed by Parliament, has simplified this process:

  • The process is now one stage, giving the Minister four months to decide whether to approve or reject a request.

  • Pharmacists cannot make a new request for the same location within 12 months of a previous request.

These changes came into effect on 5 September 2025 and aim to streamline approvals while maintaining integrity in the PBS system.

Source: Australian Government, Department of Health