Changes to the requirements for submitting to the PBAC that take effect July 2015

Page last updated: 1 July 2015

The Department of Health has updated the way submissions are made to the Pharmaceutical Benefits Advisory Committee (PBAC) for listing medicines on the PBS. The documentation requirements have been revised and simplified.  The new requirements are as follows:

• Supply the whole submission and any accompanying calculations and models in electronic format on two clearly labelled USB storage devices. The devices must be tested to ensure that they are fully accessible; USB devices that cannot be accessed will be returned, noting that this may occur after the closing date for submissions.
• Sponsors must supply the whole submission and any accompanying calculations and models in electronic format on two clearly labelled USB storage devices (with any spreadsheet compatible with Microsoft Excel 2010, any word-processed document compatible with MS Word 2010, and any other software package consistent with Part I, Subsection 5.2). Ensure that all components of these electronic documents, spreadsheets and analyses are fully accessible (eg do not have password protection) and fully enabled to allow all document text, tables and figures to be accessed for copying and fully executable to allow all spreadsheet cells and all statistical or decision analysis input variables to be changed.

NOTE: Submissions not conforming to these requirements will be returned without comment.

Electronic copies of the submission must conform to the following Folder Structure:

Folder: Key Documents
Cover Letter (with Index)
PB11
PB11b
Executive Summary
PBS Service Fee Recovery Form
Completed and signed Responsible Person form
Restriction template (if applicable)
Complete and approved NEHTA (National E-health Transition Authority)
AMT Mapping Form (in Word format)
Product Information (draft/final)

Folder: TGA Documents:
ARTG (if applicable)
Delegates Overview
ACPM Resolution
ACPM Minutes
Clinical Evaluation Report

Folder: References:
Reference 1
Reference 2

Folder: Main Body (in word format)
Sections A-E (all in one (1) document)
Section D+E spreadsheets

Folder: Attachments
Attachment 1
Attachment 2

Folder: Appendicies
Appendix 1
Appendix 2

Folder: Other
Miscellaneous 1
Miscellaneous 2

• Submissions must be sent to the new address below

Send to:

PBS Submissions
MDP 903

23 Furzer Street
PHILLIP ACT 2606

Please note: submissions not correctly addressed as per above may not be received by the PBAC Secretariat and will be missed off the agenda.

Importantly from 8 July 2015 all documentation must be submitted as per requirements listed in the PBAC Guidelines. For the 8 July 2015 cutoff for major submissions to the November 2015 PBAC meeting, submissions that do not comply with the documentation requirements will still be accepted.  Sponsors will be notified that their submission is non-compliant. From the 4 November 2015 cutoff for major submissions to the March 2016 PBAC meeting, non-compliant submissions will not be accepted and will be returned to the sponsor.

These new requirements will significantly reduce the administrative burden for both industry and the Department.