Adverse Events Industry Guidance
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
View a complete guide to reporting adverse events to the CVB using PV Express II (1.09 MB)
Click the button to go directly to the manufacturer's site to submit adverse events (per 9 CFR 116.9):
Supporting Documents
Contact Us
For technical support, please email us at CVB.Pharma@usda.gov