9.5 Resubmission requirements and procedures for consideration of resubmissions
The HPP will guide applicants to provide the required resubmission documents. The PBAC will utilise the subcommittees for resubmissions as required to assist PBAC reconsideration. The role of the PBAC and PBAC subcommittees is outlined in Section 6.
|
Resubmission Pathway |
Resubmission requirements |
Resubmission evaluation |
|---|---|---|
|
Early Re-entry Pathway |
Same as for a Category 3 submission. |
Includes Submission Overview. |
|
Early Resolution Pathway |
Same as for a Category 3 submission. |
Not required due to out-of-session consideration. |
|
Facilitated Resolution Pathway |
Same as for a Category 2 submission. |
Includes submission Commentary, ESC and/or DUSC advice provided on a case-by-case basis. |
|
Standard Re-entry Pathway |
Dependent on the request in the resubmission: Same as for a Category 2 submission; OR Same as for a Category 3 submission. |
Includes submission Commentary, ESC and/or DUSC advice provided on a case-by-case basis; OR a submission Overview dependent on the request in the resubmission. |
Sections 6.2 Evaluation of Submissions, 6.4 Input of the applicant into the PBAC consideration, 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 and 6.11 Co-dependent submission processes apply as required.
Resubmissions are unlikely to be proceeding via parallel processing (refer Section 6.3). It is expected that ATAGI advice would only be required in relation to any new information provided as part of a resubmission (refer Section 6.5).
For Facilitated Resolution Pathway and certain Standard Re-entry Pathway resubmissions (dependent on the request), applicants have two opportunities to provide written input, the pre‑subcommittee response (refer to Section 6.4.1) and the pre-PBAC response (refer to Section 6.4.2), and one opportunity to present comments to the PBAC in the form of a hearing (refer to Section 6.4.3).
For Early Resolution Pathway, applicants have no opportunity to respond further due to early consideration. For Early Re-entry Pathway, applicants have one opportunity to provide written input, pre-PBAC response (refer to Section 6.4.2).
