Exceptional importation and sale of biocides in relation to COVID-19: Overview
There is an unprecedented demand and urgent need for access to biocides during the COVID-19 pandemic. On March 1, 2021, the Minister of Health signed Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. The interim order (IO) allows certain biocides that may not fully meet regulatory requirements to be imported and sold in Canada.
An interim order is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory processes. Further information on this IO can be found in the explanatory note.
Biocides that are eligible under the interim order
Biocides included on the list of biocides for exceptional importation and sale are called “designated biocides” and are eligible for the exceptional importation and sale provisions provided for in the IO. The list, which will be updated as required, is incorporated by reference in the IO and is maintained by Health Canada.
Criteria for adding a biocide to the List of Biocides for Exceptional Importation and Sale
At this time, biocides that meet of the following criteria will be considered for addition to the list of designated biocides:
- The product is appropriately registered or authorized in the U.S. (EPA registration number), MRA or PIC/S countries to be imported to Canada and was subject to pre-market oversight consistent with Health Canada's pre-market review of disinfectants.
- The product has not been rebranded or reformulated for importation. The product label reflects what is authorized and sold in the foreign jurisdiction.
- The product would be regulated in Canada as a disinfectant drug under the Food and Drug Regulations:
- disinfectants represented for use on environmental surfaces and inanimate objects or
- disinfectant-sanitizers (surface disinfectants with food contact and non-food contact surface sanitizer claims)
For descriptions of some products regulated under other frameworks that would not be eligible, please consult Appendix 1 of the 2020 guidance document on the management of disinfectant drug applications.
- The active ingredient(s) in the product are consistent with those found in our drug product database for a disinfectant drug.
- The product does not contain technical grade ethanol.
- The non-medicinal ingredients are appropriate for the product and do not affect its efficacy or safety.
- The label claims, warnings, directions for use and other statements are consistent with disinfectants approved in Canada.
- The product does not make direct or implied SARS-CoV-2 claims. The exception are products reviewed and approved by the U.S. EPA, as Health Canada has harmonized our approach with this regulator.
- The product is labelled with only well-established methods of application. It is not indicated for a method of application with limited or no market experience in Canada (for example, electrostatic spraying (ESS), use in tunnels or chambers, steam-generating devices). The exception are products for ESS method of application that have been reviewed and approved by the U.S. EPA, as we have harmonized our approach with this regulator.
- The product is not included in a kit with other products (for example, medical masks, gloves, disinfectants, hand sanitizers).
Accessibility of information to support safe use
Importers must take steps to ensure that information is accessible to Canadians that supports the safe use of the biocide. Importers are expected to ensure labelling information, including a detailed description of the designated biocide’s conditions of use, is accessible in both official languages (English and French).
Note: Other criteria may also be considered by Health Canada in adding products to the list of designated biocides.
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