Adding the Emerging Viral Pathogen 2019-nCoV (Coronavirus) to Your Disinfectant

 In Disinfectants & Sanitizers, Regulatory Affairs

By: Teri Dickinson, Regulatory Affairs Group Manager, email

On January 30, 2020, the World Health Organization (WHO) declared 2019-nCoV, as belonging to the Coronaviridae family and Betacoronavirus genus, similar to MERS Co-V and SARS Co-V, a public health emergency of international concern.  This lead Health Canada to invoke the claims against emerging viral pathogens policy within the disinfectant drugs guidance document.

Health Canada will permit manufacturers to provide communications to the public regarding the expected efficacy of certain Broad Spectrum Virucide disinfectant drugs against the emerging pathogen, 2019-nCoV. This includes communications through their web sites, toll-free consumer information services, and similar media.

Disinfectants which have received market authorization for the following claims will be permitted to make efficacy claims against 2019-nCoV:

  • Adenovirus type 5
  • Bovine Parovirus
  • Canine Parvovirus
  • Poliovirus type 1
  • specific claim against a Coronavirus within the Betacoronavirus genus

Note that Health Canada advises that ONLY indirect and “expected to be effective” and “likely to be effective” types of communications are permitted for 2019-nCoV, and that no direct claims against 2019-nCoV are to be made for DIN-authorized disinfectants, as these will be considered to be unsubstantiated.

Need help with the post-authorization Division 1 change (PDC) process to update your label?

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