Cost Recovery Fees and Charges

Cost recovery for PBS and NIP listings

The Pharmaceutical Benefits Scheme (PBS) provides timely, reliable, and affordable access to necessary medicines for Australians. The National Immunisation Program (NIP) aims to reduce the incidence of vaccine-preventable diseases and protect individuals and the Australian community.

Cost Recovery involves the Australian Government charging the non-government sector for some or all of the efficient costs of a specific government activity. That activity may include the provision of goods, services or regulation, or a combination of them.

The Cost Recovery Implementation Statement (CRIS) provides information on how the Department of Health, Disability and Ageing (the Department) implements cost recovery for:

• Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for medicines seeking to be listed on the PBS; or
• Submissions to the Australian Technical Advisory Group on Immunisation (ATAGI) for vaccines to be listed on the NIP; or
• Applicant-driven PBS listing and list management activities.

For further information about the cost recovery arrangements, please refer to:

• 2026-27 PBS/NIP Cost Recovery Implementation Statement (PDF 553KB) - (Word 199KB)
• PBS/NIP Cost Recovery Administrative Guidelines: Information for Applicants (PDF 458 KB) - (Word 341 KB)
• National Health (Pharmaceutical and Vaccines—Cost Recovery) Regulations 2022 (the Regulations)

Making an application

Use the Health Products Portal (HPP) to lodge Notice of Intents (NOIs) and applications for pre-submission services, ATAGI Advice,  PBAC consideration, PBS listing and many list management activities. Visit the Health Products Portal website for more information and user support contacts.

PBS and NIP fees and charges

The fees and charges for the period 1 July 2026 to 30 June 2027 are provided in the table below.

Please note that invoicing, withdrawal timeframes, and non-refundable deposits vary by application type under the Regulations.

Withdrawals and refunds

A NOI, submission or application may be withdrawn at any time.

The withdrawal timeframes to be eligible for a refund are outlined in the Regulations.

Applicants may be liable for the relevant fee, unless a refund or remittance is appropriate (less any applicable non-refundable deposits).

A delegate may decide to refund or remit a fee (less any applicable non-refundable deposits) where:

• the NOI, submission or application is withdrawn before any services are provided, or
• the Department is unable to provide the relevant service.

Payment terms

Payment is due within 28 days of the invoice date. Fees must be paid in full. Instalments or partial payments are only accepted in exceptional circumstances and must be agreed with the Department in advance.

The Department may pause work on your application until payment is received. The Department may also take steps to recover any outstanding amounts, as provided for under the Regulations.

International banking fees

International payments may attract banking fees. You are responsible for ensuring the Department receives the full invoice amount. Any shortfall caused by international banking fees will be invoiced to you or your Australian agent.

Fee exemptions and fee waivers

In certain circumstances, applicants may be exempt from paying cost recovery fees or may request a fee waiver where an application involves public interest and payment of the fee would make the application financially unviable.

These arrangements help ensure that cost recovery is not an inappropriate barrier to accessing the PBS.

Applicants can request a fee exemption or fee waiver when lodging an NOI for ATAGI, PBAC or pricing applications or when lodging a new brand or list management application in HPP. Please select the fee exemption or fee waiver option in the HPP and include the relevant supporting information.

The Department assess all requests on a case‑by‑case basis, based on the supporting information provided.

Important notes

• Fee exemptions and fee waivers are not automatic and must be supported by sufficient evidence.
• The Department may request further information to support the assessment.
• If a fee exemption or fee waiver is not granted, the applicant remains liable to pay the relevant fee.
• Fee exemptions and fee waivers do not apply to pre-submission and independent review services.

Fee exemptions

A fee exemption may be granted if it meets the criteria outlined in section 67 of the Regulations.

Fee exemptions are not discretionary decisions. An application may be exempt from fees if it meets the legislated criteria, including:

• a designated orphan drug, for submission services if it has not been previously considered by PBAC; or
• a drug exempt from Australian Register of Therapeutic Goods registration due to medicine shortages (section 19A of the Therapeutic Goods Act 1989); or
• a drug, medicinal preparation of vaccine necessary in the management of a public health event (under the National Health Security Act 2007), a biosecurity emergency or a human biosecurity emergency (under the Biosecurity Act 2015); or
• a price reduction; or
• changing the name of a responsible person; or
• a decrease to the existing pack quantity.

Fee waivers

A fee waiver may be granted if it meets the criteria under sections 68 and 69 of the Regulations.

Fee waivers are delegated decisions made by the Department under the legislation.

Applicants may be eligible for a fee waiver if the application involves the public interest and payment of the fee would make the application financially unviable.

Public Interest

Under the Regulations, an application may be in the public interest where:

• the product provides suitable therapy for a patient population;
• the patient population is not large enough to make the application financially viable; and
• the product is intended for use in palliative care, as paediatric medicine, or for the medical treatment of Aboriginal and Torres Strait Islander peoples.

Other public interest factors may also be considered when assessing a fee waiver request.

Applicants must provide sufficient information and supporting evidence to enable the Department to assess whether an application is in the public interest.

Financial Unviability

In addition to involving the public interest, payment of the fee must make the application financially unviable.

Applicants must provide sufficient information and supporting evidence to enable the Department to assess whether payment of the fee would make the application financially unviable, this could include:

• Estimated annual revenue from the proposed PBS listing, including how it was calculated, such as patient population, expected use and price.
• Estimated profit margins or projected profitability of the medicine for the proposed indication.
• Forecast sales volumes and financial projections.
• Any relevant development, manufacturing, regulatory, or operational costs associated with the application.

To assist applicants in preparing their financial forecast, they may use the Excel Profit Margin Calculations template (Excel, 53 KB)

Review of decisions

Decisions under Part 8 of the Regulations may be reviewed internally by the Department and, where applicable, by the Administrative Review Tribunal (ART). Applicants may request an initial or further internal review within 10 business days of receiving the relevant decision, and the Department must notify the outcome within 10 business days. A further internal review decision may be reviewed by the ART within 28 days. Services related to the decision may be suspended while an internal review or ART review is underway.

Contact the Cost Recovery Team

Email: pbscostrecovery@health.gov.au