1.1 Purpose of this document
This procedure guidance is an accompanying document to the PBAC Guidelines. This document explains the processes that the department has put in place to:
- provide support for organisations seeking to prepare submissions
- provide information on the types and structure of submissions and additional documents required
- provide an explanation of evaluation procedures for medicines and vaccines and management of materials
- list the procedures that the Government requires to list a medicine or medicinal product on the PBS
- explain how the products on the PBS are reviewed once listing on the PBS is completed.
This document is maintained by the department. The document is routinely revised in response to changes to the processes involved in consideration and listing of medicines on the PBS and vaccines on the NIP.
Any comments or questions of a general nature about the topics included in the guidance, accuracy of the content or other matters should be forwarded to the department (refer to Appendix A).