Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme

(including consideration of vaccines for the National Immunisation Program)

Page last updated: 12 October 2016

Information within the Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme supersedes all other procedural information on the same topic that may be located elsewhere on the PBS website.

Contents

  1. Purpose
    1.1      Purpose of this document

  2. Listing process

  3. Confidentiality and transparency
    3.1      Managing and assessing confidential material
    3.2      Managing conflicts of interest
    3.3      Managing outcomes processes transparently

  4. Presubmission requirements
    4.1      Types of submissions
    4.2      Guidelines for preparing submissions
    4.3      Timeframes for the PBS
    4.4      Cost recovery
    4.5      Presubmission meetings
    4.6      Integrated codependent submissions

  5. Lodging submissions for listing medicines or vaccines
    5.1      Lodging a submission
    5.2      Submission formats
    5.3      Compliance with standard IT capability
    5.4      Major submissions
    5.5      Minor submissions
    5.6      Committee secretariat submissions
    5.7      New brand of existing pharmaceutical item submissions (not requiring PBAC consideration)
    5.8      Providing documents after lodging a submission

  6. Procedures for consideration of submissions
    6.1      PBAC subcommittees
    6.2      Evaluation of submissions
    6.3      Management of parallel process submissions
    6.4      Input of the sponsor into the PBAC consideration
    6.5      Role of the Australian Technical Advisory Group on Immunisation for requests to list vaccines
    6.6      Role of the Nutritional Products Working Party
    6.7      Consumer input
    6.8      Additional clinical input
    6.9      PBAC and subcommittee members attending other meetings
    6.10    Stakeholder meetings
    6.11    Codependent submission processes

  7. Post-PBAC decision procedures for sponsors
    7.1      Notification of outcomes of PBAC
    7.2      Independent review
    7.3      PBAC Outcomes
    7.4      Public Summary Documents

  8. Procedures for a positive recommendation to list
    8.1      Price agreement
    8.2      Finalisation of the budget impact
    8.3      Restriction wording
    8.4      Preparation of additional access arrangements
    8.5      Other listing documents required
    8.6      Notification of listing on the PBS
    8.7      Listing a vaccine on the NIP

  9. Review of PBS listings
    9.1      Drug Utilisation Sub-Committee review
    9.2      Postmarket reviews
    9.3      PBAC commissioned reviews of listed medicines

 

Record of updates

Record of updates
Date Version Summary of changes
October 2016 Version 1.0 Procedure guidance released.