From 1 April 2021, Applications for a New Brand of existing pharmaceutical item must be made via the HPP where no further documentation is required. Please visit the HPP website to get started.
Listing Requirements – New Item
Page last updated: 20 April 2021
This section outlines the documentation required to allow listing of new products on the PBS.
Note: All documents are to be provided as email attachments to the PBAC Secretariat by the final documentation deadline (found at PBS Calendars)
Where the correct information has been submitted as part of the PBAC approval process (including a previous PBAC meeting), it does not need to be resubmitted. Direct liaison with the PBAC Secretariat is recommended where there is uncertainty concerning the information requirements specific to a particular listing.
Documentation required
- Letter of Application.
This includes details of the timing of the listing being sought, and any other relevant information (see below). - A specific undertaking that sufficient stock of the product to meet anticipated demand will be available at the time of listing on the PBS.
- Any comments you wish to provide to the delegate when they consider making an originator brand determination under section 99ADB of the National Health Act 1953. The delegate considers an originator brand determination on the listing of a new brand or item on F2. Please note the National Health Amendment (Pharmaceutical Benefits) Bill 2015 Explanatory Memorandum which refers to new brand name variants of existing determined originator brands. On occasion other new listings for a F2 drug may also be considered by the delegate for originator determination, for example, a different new formulation or a new manner of administration. If you would like further information in relation to originator brand determination, please contact Pharmaceutical Pricing Section.
- Application to List a Drug or Medicinal Preparation as a Pharmaceutical Benefit (Form
PB11).
This is the formal application for listing on the PBS and provides details of the product proposed, including price. - A completed PB11a (Request for Approved Ex-manufacturer Price) must be provided to the Pharmaceutical Pricing Section by the Final Documentation deadline.
- Product Information.
A copy of the current TGA approved Product Information must be provided for a new item being listed on the PBS after a PBAC recommendation. - Responsible Person Declaration.
Note: the original is to be retained by the company.
