Annual Summary Report Checklist (including PSUR and PBRER)

Checklist to be completed and accompany an annual summary report which may be provided in PSUR or PBRER format:

Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER) Checklist Descriptions

Status

  • 1 Submitted to:
    • 1.1 Biologics, Radiopharmaceuticals and Genetic Therapies (PSUR-C/PBRER-C only)
    • 1.2 Therapeutic Products Directorate (PSUR-C/PBRER-C only)
    • 1.3 Marketed Health Products Directorate
  • 2 Reason for PSUR/PBRER Submission:
    • 2.1 Significant change in what is known about the risks and benefits (C.01.018(4) Notification)
    • 2.2 PSUR-C/ PBRER-C
    • 2.3 Requested Periodic
    • 2.4 Requested Ad-Hoc
    • 2.5 Voluntary List reasons (for example, new safety information):
  • 3 Status in Canada:
    • 3.1 Not Marketed
    • 3.2 Marketed (since)
  • 4 PSUR/PBRER Information:
    • 4.1 International Birth Date
    • 4.2 PSUR/PBRER #
    • 4.3 Period covered by the present PSUR/PBRER
    • 4.4 Period covered by the previous PSUR/PBRER
  • 5 Appendices (indicate if included in the submission):
    • 5.1 Reference Information
    • 5.2 Cumulative Summary Tabulation of Serious Adverse Events from Clinical trials and Interval/Cumulative Summary Tabulations from Marketed Experience
    • 5.3 Tabular Summary of Safety Signals
    • 5.4 Listing of Interventional and Non-Interventional Studies with a Primary Objective of Post-Authorization Safety Monitoring
    • 5.5 List of the Sources of Information Used to Prepare the PSUR/PBRER
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