Periodic Safety Update Report (PSUR) Submission Form
Submit a periodic safety update report with the report period, product details, safety findings, and follow-up contact information.
Report Identification
Product Name or Product Code
*
Report Period Start Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Report Period End Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Marketing Authorization Number or Internal Reference
Submitting Organization Name
*
Safety Update Content
Summary of safety findings
*
Serious adverse events observed during the period
*
New or emerging risks
*
Benefit-risk conclusion or overall assessment
*
Submission Details
Primary Contact Name
*
Primary Contact Email Address
*
example@example.com
Submission Notes or Comments for Reviewer
Submit PSUR
Should be Empty: