World Health Organization (WHO) declares Monkeypox a public health emergency on July 23, 2022, Health Canada responds

Under Health Canada’s Emerging Viral Pathogens Policy (EVP), the disinfectant drugs guidance document, permits manufacturers to provide communications to the public regarding the expected efficacy of certain Broad Spectrum Viricide disinfectant drugs against Monkeypox. This includes communications through their websites, toll-free consumer information services, and similar media.

Disinfectants which have received market authorization as a Broad spectrum viricide supported by efficacy against any of the following organisms will be permitted to make indirect efficacy claims against Monkeypox:

• Adenovirus type 5
• Bovine Parvovirus
• Canine Parvovirus
• Poliovirus type 1

At this time Health Canada will not allow a disinfectant with proven efficacy against another virus in the Orthopoxvirus genus to make indirect claims against monkeypox under the EVP Policy.

Health Canada published a summary of surface disinfectants for emerging viral pathogens including a list of surface disinfectants that are likely to be effective against enveloped viruses.  Per Health Canada’s regulations, only indirect communications are permitted for Monkeypox claims meaning no direct claims against monkeypox are to be made for DIN-authorized disinfectants, as these will be considered unsubstantiated.

Need assistance with the post-authorization Division 1 change (PDC) process? TSG’s Canadian regulatory experts are happy to help. Get in touch with us: [email protected]