4 Presubmission requirements
The Australian Government Department of Health provides a range of documents and services to assist sponsors and other organisations who wish to prepare and submit a submission to the PBAC for:
- listing a new medicine on the PBS or vaccine on the NIP
- listing a new form and strength (pharmaceutical item) of an existing medicine on the PBS or vaccine on the NIP
- requesting a new indication or a change in a component of the listing of a PBS-listed medicine or a NIP-listed vaccine
- consideration of any other matter.
This section also provides information for sponsors who want to prepare a submission to list a new brand of medicine on the PBS that does not require consideration by the PBAC.
The timeframes provided in Section 4.1 are relative to the PBAC meeting at which the
submission is considered by the PBAC, or during the period before PBS listing dates
where the submission is managed by the department. The actual calendar dates each
year are published on the PBS website.
Submissions generally need to be lodged by 4 pm on the specified days.
Sponsors who need to lodge later than 4 pm should notify the department ahead of time (refer to contact details in Appendix A).