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Adverse Events Industry Guidance for Compliance to 9 CFR 116.9

BACKGROUND
The Virus-Serum-Toxin Act regulations concerning records and reports, as specified in 9 CFR 116.9, require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of the veterinary biological products they produce and distribute. These records and reports will assist VS in monitoring the performance of licensed veterinary biological products over time, while also allowing VS to provide complete and accurate information to consumers regarding adverse events or other possible concerns associated with the use of these products.

GENERAL INSTRUCTIONS
A complete guide to reporting adverse events to the CVB using PV Express II

Use this link to go directly to the manufacturer's site for submitting adverse events in compliance with 9 CFR 116.9 - USDA Adverse Event Reporting

SUPPORTING DOCUMENTS
• Veterinary Services Memorandum 800.125 Preparation and Submission of Adverse Event Reports for Biological Products by Licensees and Permittees
• Guidance notes on the use of VeDDRA terminology (for licensed firms)
• Complete VeDDRA list (for licensed firms)
• Doses distributed reporting template

CONTACT CVB FOR TECHNICAL SUPPORT QUESTIONS
CVB.Pharma@usda.gov

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