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