5.5 Category 3 and Category 4 submissions
The HPP will guide applicants to provide the required documents, which include:
- Main body of the submission. Category 3 and Category 4 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, where applicable.
The following documents are not generally required for these submissions, but may be necessary in certain circumstances:
-
A positive TGA Delegate’s Overview if the medicine is not registered on the Australian Register of Therapeutic Goods at the time of submission lodgement
- 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 5.8 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).
