5.8 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration)
The PBAC does not generally consider submissions for new brands of existing pharmaceutical items that are not biosimilars (see Section 4.1.3 and 4.1.4).
The departmental delegate considers a submission to list a new brand of an existing pharmaceutical item. When listing a new brand of a medicine on the F2 formulary, the delegate may decide to determine the new brand an ‘originator brand’. Further information about originator brand determination is available in the Fact Sheet about 2015 Price Disclosure changes in the National Health Amendment (Pharmaceutical Benefits) Bill 2015 Explanatory Memorandum.
Submissions for a new brand of an existing pharmaceutical item must include a statement from the TGA to show that it is appropriate for an equivalence indicator to be shown on the PBS Schedule for the new brand and currently listed brands that can be prescribed. In some instances, the new brand may not have TGA approval for all indications of the currently listed brands. In this event, the applicant should only apply for PBS listing for the TGA approved indications and the new brand will only be listed for the approved indications. If this product is not entered in the Australian Register of Therapeutic Goods when the Department is processing this application it may not proceed to listing on the PBS.
The HPP is the approved method for lodging new brand of an existing pharmaceutical item submissions. The HPP will guide applicants on the documentation required for this submission type. Where an applicant is unable to lodge a submission via the HPP, the required documents for making a new brand of existing pharmaceutical item submission are specified in Part C of the Application Form for Submission Services. The contact details for lodging submissions for new brands of existing pharmaceutical items that do not require PBAC advice are provided at Appendix A2.8.
The contact details for all Pricing related questions and for sending the PB11a form are provided at Appendix A2.6.