2  Listing process

Page last updated: October 2016

The process for major and minor submissions to the PBAC is represented in the timeline below.

Timeline of PBAC procedures

Before PBAC meeting

  • Application to TGA and/or TGA delegate's overview/advice to ACPM and/or ACPM resolution and/or TGA registration granted

17 weeks before

  • Cut-off date for major submissions to department

11 weeks before

  • Cut-off date for minor submissions to department

7 weeks before

  • Departmental papers to sponsors

6 weeks before

  • Sponsor's pre-subcommittee response to department

5 weeks before

  • DUSC meeting

4 weeks before

  • ESC meeting

2 weeks before

  • Subcommittee papers to sponsors

1 week before

  • Sponsor's pre-PBAC response to department

PBAC meeting

After PBAC meeting

3 weeks after

  • PBAC ratified minutes to sponsor (positive recommendations)

5 weeks after

  • PBAC ratified minutes to sponsor (all other recommendations)
  • Listing procedures for PBS commence

6 weeks after

  • Publication of PBAC outcomes to departmental website

10 weeks after

  • Draft Public Summary Document to Sponsor

16 weeks after

  • Publication of Public Summary Document (positives and subsequent rejections)

18 weeks after

  • Publication of Public Summary Document (first time rejections and deferrals)

 

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