4.2 Guidelines for preparing submissions
The PBAC provides guidance on methodological approaches to be used in the preparation of submissions in the PBAC Guidelines. The PBAC Guidelines contain specified information requirements for fixed-dose combination products, vaccine products and codependent technologies.
Guidance for preparation of Category 3 and Category 4 submissions uses elements of the PBAC Guidelines, which also contain specified information requirements for nutritional products. The structure of these submissions should include appropriate or applicable elements of Sections 1, 2 and 4 of the PBAC Guidelines. In particular, the applicant needs to complete the applicable Section of the Section 4 - Utilisation and cost model workbook (Excel format) and provide this with the submitted documents.
The structure and requirements for preparing a resubmission are outlined in Section 9.