5.5  Minor submissions

The HPP will guide applicants to provide the required documents, which include:

  • Main body of the submission. Minor submissions require relevant information requested in Sections 1, 2 and 4 of the PBAC Guidelines. These submissions also need to estimate the financial cost to the Australian Government of the PBAC recommending the request for the PBS and the Repatriation Pharmaceutical Benefits Scheme (RPBS) or for the NIP.
  • References. Separate electronic documents for any and all references used in the submission (optional).
  • Appendixes. Copies of any supporting material for Section 4 (optional).
  • Financial estimates workbook. Fully executable Section 4 financial estimates Microsoft Excel workbook (also known as the Utilisation and Cost Model).
  • Model.  Fully executable Section 3 model containing the specific change(s) requested by the PBAC and their consequences for the model’s results.

The following documents are not generally required for these submissions, but may be necessary in certain circumstances:

  • completed and approved Australian Digital Health Agency AMT Mapping form (in Microsoft Word)
  • a TGA bioequivalence or equivalence statement.

If the submission concerns a first new brand of a new pharmaceutical item for a drug on F2 (already on F2 or the listing would result in the drug moving to F2) the originator brand determination issues mentioned at section 5.6 will be considered.  Any comments relevant to potential determination as an originator brand should be included in the submission, or a letter of application (see section 8.5.1).

 

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