Section 1 Context
Page last updated: September 2016
In Section 1, establish the context for the submission by providing the following essential details of the medicine and its proposed use:
- the rationale for listing key components of the clinical claim (Subsection 1.1)
- the way the proposed medicine will be used (Subsection 1.2)
- the regulatory status of the proposed medicine (Subsection 1.3)
- the proposed PBS listing (Subsection 1.4).
Flowchart 1.1 summarises the information requested for Section 1 of the submission.
Flowchart 1.1 Overview of information requests for Section 1 of a submission to the PBAC