5.6 Minor submissions
The electronic documents should be provided in a series of folders labelled:
- Main body of the submission. Minor submissions generally require relevant information requested in Sections 1, 2 and 4 of the PBAC Guidelines. Minor submissions need to estimate the financial cost to the Australian Government of listing the medicine on the PBS and Repatriation Pharmaceutical Benefits Scheme (RPBS) and vaccine on the NIP or PBS. Therefore, the documents provided as an attachment include the Excel spreadsheet ‘Estimates of patient use and financial cost’. Minor submissions may also need to provide information requests from Section 2 of the PBAC Guidelines. There may also be instances where a minor submission has additional information to be provided – for example, at the request of the PBAC following its previous consideration of the medicine or vaccine as a major submission.
- References. Separate electronic documents for all references used in the submission.
- Appendixes. Copies of supporting material for Section 4.
- Key documents. The following completed documents are required by the department:
- Submission cover letter on company letterhead signed by an authorised company representative. This should include an index list of all documents provided to help check that all documents are present
PB11 (‘Application to list a Drug or Medicinal Preparation as a Pharmaceutical Benefit’)
PB11b (‘Cost of Goods Information’)
PBS Service Fee Recovery Form Part B of the Application Form for Submission Services.
The following documents are not generally required for minor submissions, but may be necessary in certain circumstances:
- restriction template
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 5.7 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).