This guide describes the processes undertaken by the Department of Health in considering and listing medicines and vaccines on the Pharmaceutical Benefits Scheme (PBS) and the National Immunisation Program (NIP). It provides information on processes, procedures, timelines and documents required. Information on cost recovery administrative processes is located on the PBS website and should be referred to for in conjunction with this document.
The operation of the Australian Government’s subsidy scheme for medicines (referred to as drugs and medicinal products), the PBS, is established by the National Health Act 1953 (the Act). This Act also establishes the responsibility of the statutory expert advisory committee, the Pharmaceutical Benefits Advisory Committee (PBAC) in its primary role of recommending, to the Minister for Health, which medicines and medicinal preparations should be subsidised by the Australian Government under the PBS and which vaccines under the NIP.
To make a recommendation for subsidy, the PBAC is required to consider both the comparative effectiveness and cost of each medicine, medicinal product or vaccine. The PBAC has endorsed the document called Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee (the PBAC Guidelines) to provide organisations preparing submissions to the PBAC with the information required by the PBAC. The PBAC Guidelines should be consulted by any organisation seeking to list a medicine or medicinal product on the PBS or a vaccine on the NIP. However, those Guidelines are generally not relevant to listing of a new brand of an existing pharmaceutical item, and not all matters in the PBAC Guidelines will be relevant to all submissions.