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. 

It should be read in conjunction with the document detailing the relevant deadlines that apply to achieve listing in a particular edition in the Schedule (found at PBS Calendars).

The following information must be received by the Listing Unit by the final documentation deadline. 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 Listing Unit is recommended to determine the information requirements specific to a particular listing.

• Letter of Application.
  This includes details of the timing of the listing being sought, and any other relevant information (see below).
• 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.
  • Note: For New Brands, prior to submitting an application sponsors should contact the Pharmaceutical Pricing Section in relation to the pricing of the new brand. Sponsors can also check the reference pricing groups document (found at 12.5% and 16% Price Reductions) to determine whether the 16% price reduction policy may affect their application.
  • A completed PB11a (price alteration/acceptance form) must be provided to the Pharmaceutical Pricing Section by the Final Documentation deadline.
• Current format ARTG Certificate.
  This is a copy of the current certificate for the product as issued by the Therapeutic Goods Administration (TGA).  This document may however be provided up to 15 days after the final documentation deadline.  If the current format of the ARTG Certificate is not able to be provided for example, for a product entered in the ARTG before this format of Certificate was available, contact should be made with the Listing Unit about additional information that may need to be provided to the Listing Unit.
• 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.  It does not need to be provided for a new brand.
• Primary Pack Label.
  A copy of the TGA approved label must be provided.  A copy of final artwork is acceptable. 
• Brand Equivalence Statement (applies to New Brands only).
  New brands must be listed with an equivalence indicator. In order for a brand equivalence indicator to be included in the entry for the new brand, it is the sponsor's responsibility to request a statement from the TGA indicating that it is appropriate for an equivalence indicator to be shown in the PBS Schedule, and against which other brands.  This advice must be received by the Listing Unit by the deadline.  It is suggested the statement be requested from the TGA towards the end of the evaluation process to ensure that the TGA has sufficient time to provide the advice prior to the listing deadline.  Applicants may wish to check with the Listing Unit whether the TGA statement has been received when submitting their application if it is not included in the documentation they have provided.
• Assurance of Stock Availability.
  Written assurance must be provided in the Letter of Application that sufficient stock of the product to meet anticipated demand will be available at the time of listing on the PBS.
• A signed original responsible person declaration.