5.7 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration)
Page last updated: 12 February 2019
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. Information in the submission is required to assist when considering making a price agreement and listing the brand, and potentially for determining an originator brand under s99ADB of the National Health Act 1953.
The delegate considers an originator brand determination when listing a new brand of a medicine on the F2 formulary (including biologics). The initial originator brand determination for a drug generally occurs at the same time as the drug moves to the F2 formulary. New brand name variants of existing originator brands are also intended to be originator brands (see the National Health Amendment (Pharmaceutical Benefits) Bill 2015 Explanatory Memorandum). On occasion, other new listings for an existing F2 drug may also be considered by the delegate for originator determination – for example, a different new formulation or a new manner of administration. Further information about originator brand determination is available in the Fact Sheet about 2015 Price Disclosure changes. The current originator brand legislative instrument is called the National Health (Originator Brand) Determination and can be located on the Federal Register of Legislation.
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. In this event, the new brand will only be listed for the approved indications.
Include the following documentation in a submission for a new brand:
- a submission cover letter on company letterhead signed by the Responsible Person's authorised representative. The cover letter must include a signed supply assurance undertaking that sufficient stock of the product to meet demand will be available to allow for delivery to PBS dispensers (e.g. pharmacies, hospitals or other dispensers) in time for the PBS listing day
- TGA-approved Product Information
- a TGA bioequivalence statement
- any comments on potential determination of a new listing brand as an originator brand
- a completed and signed Responsible Person form, which includes the authorised representative
- a PB11a form should be provided by the final documentation deadline (refer to Section 8.1).
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 A2.6.