Updates to 7.4 Public Summary Documents (PSD) Procedure Guidance and Appendix B within the Procedure Guidance for Listing Medicines on the PBS
Page last updated: 3 September 2021
The Department of Health has updated Section 7.4 Public Summary Documents (PSD) and Appendix B within the Procedure Guidance for Listing Medicines on the PBS (the Procedure Guidance) to clarify supporting evidence requirements for redaction requests under Criterion 2.
There has been no change to the evidence required to support redactions under this criterion. Further detail of the necessary supporting information has been clarified in Appendix B so applicants can be better prepared to provide the appropriate documents and detail in a timely way for the PSD review process.
The supporting evidence under Criterion 2 includes the following:
- Evidence of receipt of the manuscript by the identified journal
- A copy of the submitted manuscript clearly identifying the clinical data requested to be redacted in the PSD
- Evidence that the publication of data in the PSD would prevent publication in that particular journal.
Further information is available on the Appendix B webpage.
