The Department of Health manages and implements PBS pharmacy approval policy to improve the health outcomes of all Australians through access to medicines.
On 1 January 2019, the Department of Health assumed responsibility from the Department of Human Services for administering applications for approval to supply PBS medicines.
Please visit the Frequently Asked Questions (FAQ) web page for further details about the functions that are now the Department of Health’s responsibility and those that have remained with the Department of Human Services.
Changes to the process for hospital authorities requesting approval for private hospitals to prescribe and/or supply highly specialised drugs (HSDs)
From 1 August 2019, hospital authorities will no longer be required to seek separate approval from the Department of Health’s HSD Program when applying for approval for private hospitals to prescribe and/or supply HSDs.
The process will be integrated into the application form Application for a hospital authority to prescribe and/or supply pharmaceutical benefits and/or highly specialised drugs. This form is to be completed by hospital authorities requesting approval under sections 94 or 100 of the National Health Act 1953.
The key changes to the form are:
- Advice concerning the need for private hospitals to seek separate approval from the HSD Program has been removed.
- Question 1 on the revised form now includes an option to select a private hospital seeking to prescribe HSDs only, and the wording has been updated to clearly describe the other types of approval for which this form can be used.
- The declaration wording has been updated.
The application form is available on the Hospital Authorities page.
Delayed introduction of application fees
The Department of Health has been working towards introducing application fees from 1 July 2019 for pharmacists seeking approval to supply PBS medicines. However, as a result of the federal election on 18 May 2019, the introduction of application fees will be delayed.
An update about the timing for introducing the fees will be provided as soon as further details are available.
Preparing for access to the PBS Approved Suppliers Portal
Over the past 12 months, Health has consulted with stakeholders to develop a dedicated online portal – the PBS Approved Suppliers Portal – for lodging applications for approval to supply PBS medicines.
To ensure you are ready to submit an application through the PBS Approved Suppliers Portal when it is released within the next few months, if you have not already done so, you should take steps now to obtain an AUSkey. Instructions on how to obtain an AUSkey are available from the Australian Business Register website.
If you have already obtained and installed your AUSkey, you do not need to obtain a new one.
Further details will be provided closer to the release of the PBS Approved Suppliers Portal.
Applying via the Health Data Portal
Until the release of the PBS Approved Suppliers Portal, all applications for approval to supply PBS medicines and change of detail requests must be lodged via the Health Data Portal using an AUSkey.
Pharmacists’ representatives may still act on behalf of applicant pharmacists submitting an application for PBS pharmacy approvals.
Specific information on how to apply to become a PBS approved supplier and the relevant forms are available for Pharmacists, Hospital Authorities, and Medical Practitioners.
Please visit the Frequently Asked Questions (FAQ) web page for further details on how to apply using the Health Data Portal.
Contact the Department of Health
For enquires about PBS approval application or the Health Data Portal, please email email@example.com or you can leave a message by contacting PBS Approved Suppliers on (02) 6289 2419.
For AUSkey enquires please phone the help desk on 1300 287 539 and select option 2 from the menu.
Contact the Department of Human Services
The Department of Human Services will continue to oversee patient eligibility and PBS claim payments.
In order to set up PBS claiming with the Department of Human Services, download the online claiming and ABN forms below, fill out all details along with the Pharmacy Approval Number issued to you and email to the Department of Human Services at the address on each form.
The Department of Human Services cannot pay for PBS medicines supplied if you have not submitted these forms.