4.2 Guidelines for preparing submissions
Page last updated: October 2016
The PBAC provides guidance on methodological approaches to be used in the preparation of major submissions in the Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee. The PBAC Guidelines contain specified information requirements for fixed-dose combination products, nutritional products, vaccine products and codependent technologies.
Guidance for preparation of minor submissions uses elements of the PBAC Guidelines for major submissions. The structure of a minor submission should include appropriate or applicable elements of Sections 1 and 2 of the PBAC Guidelines. In addition, if there is any financial impact for the government, the sponsor needs to complete the applicable section of the Section 4 Workbook (Excel format) and provide this in the submitted documents.