Elements of the listing process
Page last updated: 21 January 2020
Authorised representative
An Authorised Representative is an individual who has the legal authority to act on
behalf of the Responsible Person.
Drug Utilisation Sub Committee (DUSC)
Drug Utilisation Sub Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee
(PBAC) assesses estimates on projected usage and financial cost for medicines.
Economics Sub Committee (ESC)
The Economics Sub Committee (ESC) of the Pharmaceutical Benefits Advisory Committee
(PBAC) assesses clinical and economic evaluations of medicines submitted to the PBAC
for listing, and advises PBAC on the technical aspects of these evaluations.
Fees and charges
Cost Recovery for evaluation and listing on the Pharmaceutical Benefits Scheme (PBS)
and National Immunisation Program (NIP) - Frequently Asked Questions for Industry.
Guarantee of supply
The details and conditions of guarantee of supply requirements
Guidelines for Deeds of Agreement
Guidelines for Deeds of Agreement for the Pharmaceutical Benefits Scheme (Version
1.3).
Listing Requirements – New Item
Documentation required to allow listing of new products on the PBS.
Listing Requirements – New Brand
Documentation required to allow listing of new brands on the PBS.
Manner of Administration
Manner of Administrations that are currently in use by the PBS
PBAC guidelines
Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee
(PBAC) (Version 5.0)
Pharmaceutical Benefits Advisory Committee (PBAC)
Outcomes, agendas and Public Summary Documents from meetings of the Pharmaceutical
Benefits Advisory Committee (PBAC)
Responsible person
Definition and obligations of a Responsible Person.
Reviews
Reviews and Post-Market Reviews related to the Pharmaceutical Benefits Scheme.
