4  Pre-submission requirements

The department provides a range of documents and services to assist applicants lodging a submission to the PBAC for:

  • listing a new medicine on the PBS or new 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 4.3 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


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