5.7 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 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. In some instances the new brand may not have TGA approval for all indications of the currently listed brands that can be prescribed. 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.
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 A2.9.
The contact details for all Pricing related questions and for sending the PB11a form are provided at Appendix Appendix A2.6.