2019 novel coronavirus-Wuhan: EPA confirms triggering of emerging viral pathogen policy
US EPA has confirmed that the 2019 novel coronavirus-Wuhan (also 2019-nCoV) has met the conditions outlined in EPA’s Emerging Viral Pathogens guidance and has triggered the emerging viral pathogen policy.
Under this guidance, registrants with products that have existing qualified label claims against Emerging Viral Pathogens may make statements through technical literature, websites, social media sites, and other consumer service information. In order to make these off-label statements registrants’ approved labels must have the claims identified in EPA’s Emerging Viral Pathogens Guidance Document.
Labels without existing approval for Emerging Viral Pathogen claims must submit a label amendment to request the addition of EVP claims and provide supporting information. The full required supporting information can also be found in EPA’s Emerging Viral Pathogens Guidance Document.
TSG can help
If your product qualifies and has approved Emerging Viral Pathogen claims, get in touch via the form below to discuss how TSG can advise on how you can communicate with your customers and the public regarding this outbreak in compliance with EPA’s guidance. If your product label does not currently meet the EPA requirements for an Emerging Viral Pathogen claim, TSG can also assist you in updating your product’s label if necessary.
TSG’s regulatory consultants Abigail Wacek, Casey Pehrson, Lisa Amadio and Megan Priest are experienced in emerging viral pathogens and can help answer any questions you may have.
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With offices throughout the US and Europe, we can help you with navigating the complex, global regulatory environment.