Appendix 1 “Post-marketing Surveillance Information Input Report”

Date: [Date of Report]

Report Prepared By: [Your Name or Department]

Product Name: [Name of the Product or Drug Being Monitored]

Manufacturer/Company: [Name of the Manufacturer or Company]

Report ID/Number: [Unique Identifier for the Report]

1. Summary

Provide a brief summary of the post-marketing surveillance information gathered since the
last report. Include any significant findings, trends, or emerging issues.

2. Adverse Events

Detail any adverse events reported by healthcare professionals, patients, or other sources.
Include information such as:

Type of adverse event

Severity

Frequency

Outcome

Any actions taken in response

3. Product Quality

Report any issues related to product quality or manufacturing identified during surveillance
activities. Include details such as:

Defective products

Contamination

Packaging issues

Recalls or withdrawals

4. Regulatory Compliance

Outline any regulatory compliance issues or concerns identified, including:

Non-compliance with regulatory requirements

Warning letters or other regulatory actions received

Corrective actions taken or planned

5. Labeling Changes

Document any changes made to product labeling based on surveillance findings or regulatory
requirements. Include:

Date of labeling changes

Nature of changes (e.g., new warnings, precautions, contraindications)

6. Other Information

Include any other relevant information not covered in the previous sections, such as:

Market trends

Competitor activities

Client feedback

7. Recommendations

Provide recommendations based on the surveillance information gathered, including any

actions to address identified issues or mitigate risks.

8. Conclusion

Summarize the key points of the report and any overarching conclusions or implications for
the product's safety, efficacy, or regulatory compliance.

9. Attachments

Attach any supporting documents, such as adverse event reports, quality control records, or
correspondence with regulatory agencies.

Next Steps

Outline any next steps or follow-up actions to be taken based on the findings of the report.
Distribution

Specify who will receive copies of the report and any other stakeholders who should be
informed of its contents.

Acknowledgment

Include a space for acknowledgment signatures or comments from relevant stakeholders.