Post-Approval Reporting Guidances

Adverse Event Reporting

• CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)
• CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
• CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
• CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
• CVM GFI #214 (VICH GL35) - Electronic Standards for Transfer of Data

Other Post-Approval Reporting

• Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
• Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act