Australian Government - Department of Health and Ageing

Elements of the listing process

Here you will find more information regarding the various aspects of the listing process such as the PBAC guidelines and Responsible Person information.

Elements of the listing process

Also in this section:

The listing steps

Please note that the steps listed here apply to all submissions that are considered by the PBAC. Details of the different submission categories can be found below.
Participants in the listing system

Here you will find information regarding all of the participants in the listing system, including the PBAC and the PBPA.

Authorised representative

An Authorised Representative is an individual who has the legal authority to act on behalf of the Responsible Person.
Fees and charges

Information regarding PBS cost recovery.
Guarantee of supply

The guarantee of supply requirements apply to newly listed brands that are bioequivalent or biosimilar to an existing listed brand and have the same drug and manner of administration.
Listing Unit Requirements

This section outlines the documentation required to be submitted to the Listing Unit in order to allow listing of new products in the Schedule of Pharmaceutical Benefits to proceed.
Manner of Administration

The Manner of Administration is how the drug enters the body.
PBAC guidelines

Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) (Version 4.3)
Responsible person

The Responsible Person is the person or corporation with a registered ABN that is the supplier of a particular brand of a medicine on the PBS.

Elements of the listing process

Here you will find more information regarding the various aspects of the listing process such as the PBAC guidelines and Responsible Person information.

This page last updated 1 January 2009

The information on this page is drawn from the Pharmaceutical Benefits Schedule, effective 1 January 2009
http://pbs.gov.au Printed on 7 January, 2009

Copyright Notice

(c) The Commonwealth of Australia as presented by the Department of Health and Ageing, 2008. Kindly reproduced with the permission of the copyright holder for use as general reference material only.

Disclaimer

The Schedule provides information on the arrangements for the prescribing of pharmaceutical benefits by medical practitioners and participating dental practitioners, and the supply of pharmaceutical benefits by approved pharmacists, approved medical practitioners and approved hospital authorities. These arrangements operate under the National Health Act 1953. However, at the time of release, the relevant legislation giving authority for the changes included in this issue of the Schedule may still be subject to the usual Parliamentary scrutiny. This website is not a legal document, and, in cases of discrepancy, the legislation will be the source document for payment for the supply of pharmaceutical benefits.

Consumer fact sheet (CMI) - To the extent permitted by law, the Commonwealth of Australia will not be held responsible for the contents, nor accept any liability (whether arising out of negligence or otherwise), resulting from the use of information contained in a Consumer Fact sheet prepared by a manufacturer or other person.

The information on this document is for use as general reference material only.

The information is not intended to give or replace any legal, medical or dental advice. This document is not a legal document and does not constitute legal advice. Neither the information nor this document can be relied upon without first seeking and obtaining independent legal, medical or dental advice beforehand. To the extent permitted by law, the Commonwealth of Australia will not be held responsible, nor accept any liability (whether arising out of negligence or otherwise), for any injury, damages, costs, expenses and losses suffered or incurred by a person where such a person has relied on this document or used the information in it as legal, medical or dental advice.

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Elements of the listing process

Elements of the listing process