Health Canada has been working closely with the Public Health Agency of Canada, as well as with provincial, territorial and international partners to monitor and respond to the COVID-19 Pandemic.
Health Canada will be focusing its efforts on expediting requests related to drugs, medical devices and NHPS that mitigate the risks of COVID-19, including:
- Health Canada will expedite the review and issuance of MDELs for companies requesting to manufacture, import or distribute Class I Personal Protective Equipment (gowns, masks, face shields etc.)
- Health Canada will expedite the review and issuance of MDELs for companies requesting to manufacture, import or distribute Class I Personal Protective Equipment (gowns, masks, face shields etc.)
- Health Canada is permitting the importation of some supplies that may not fully meet Canadian regulatory requirements under the Food and Drugs Act and its Regulations:
- Disinfectants or hand sanitizers that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements.
- Disinfectants or hand sanitizers that are not authorized for sale in Canada but are authorized or registered in the United States or an MRA country.
- Health Canada will expedite the review of applications for market authorization related to disinfectants or hand sanitizers.
Additional steps Health Canada is taking to support the COVID-19 pandemic
- The NERBY date of all foreign buildings with an expiry date between March 10, 2020 and June 1, 2020 is extended to July 1, 2020
- The deadline for submitting an Annual Licence Review Application is extended to July 1, 2020
- Domestic GMP inspections previously scheduled for March 2020 are postponed
- Foreign GMP inspections previously scheduled through June 2020 are postponed
- All onsite foreign and domestic MDEL inspections are postponed indefinitely