9.3 Lodging a submission for a resubmission pathway
9.3.1 Timelines for lodgement
The following timelines apply for resubmission pathways:
Table 9.3.1 Timeframe for resubmission lodgement
|
Resubmission Pathway |
Timeframe |
|---|---|
|
Early Re-entry Pathway |
Friday week 7 of the current or next PBAC meeting cycles only |
|
Early Resolution Pathway |
Friday week 7 of the current or next PBAC meeting cycles only |
|
Facilitated Resolution Pathway |
Wednesday week 0 following the workshop of the next or following PBAC meeting cycles only* |
|
Standard Re-entry Pathway |
Wednesday week 0 of any PBAC meeting cycle |
*Please note: a submission can only be lodged after the workshop has been held (see Section 9.4). The submission can be lodged in week 17 or week 34.
9.3.2 Documents required in submission
The following requirements apply to lodging a submission via all resubmission pathways:
- Sections 5.2 Lodging a submission and 5.3 Compliance with standard IT capability.
- Early Re-entry and Early Resolution Pathway submissions will require the same documents as a Category 3 and 4 Submission as outlined in Section 5.5. Applicants are also required to include a fully executable Section 3 model containing the specific change(s) requested by the PBAC and their consequences for the model’s results.
- Facilitated Resolution Pathway submissions are expected to require the same documents as a Category 1 and 2 Submission as outlined in Section 5.4.
- For a Standard Re-entry Pathway submission, the applicant is required to provide the documents required based on the request included in the submission.
- For example, where the resubmission relates to a request for PBS listing of a new indication of a currently listed medicine, the requirements for a Category 2 submission apply (refer Section 5.4).
- Where the submission relates to a change to an existing listing that does not change the population, the requirements of a Category 3 submission apply (refer Section 5.5).
9.3.3 Confirmation of Early Re-entry or Early Resolution Pathway consideration
Once an Early Re-entry Pathway or Early Resolution Pathway submission has been lodged, the department will confirm that the submission addresses only the issues identified by the PBAC.
If the submission includes additional information than what was requested by the PBAC, applicants will be advised within 4 weeks of lodgement and will have the following options:
- continue with the submission as lodged for consideration at the intended PBAC meeting; or
- withdraw the submission and resubmit through the Standard Re-entry Pathway at the next submission due day.
If the applicant chooses to proceed, the PSD will reflect the applicant’s choice and the rationale for the PBAC’s decision.
