4  Pre-submission requirements

The Australian Government Department of Health provides a range of documents and services to assist applicants 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 applicants 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 need to be lodged by 11:30 pm on the specified days.

 

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