March 23, 2020 – Health Canada has issued a notice to industry on interim measures for manufacturers, domestic and importers on disinfectants, hand sanitizers, personal protective equipment (such as masks and gowns) and swabs in relation to the COVID-19 pandemic. Health Canada has expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing.
In light of the unprecedented demand and urgent need for products that can help limit the spread of COVID-19—including hand sanitizers, disinfectants and personal protective equipment (such as masks and gowns)—as well as swabs, Health Canada is facilitating access to products that may not fully meet current regulatory requirements, as an interim measure.
- Importers who currently have a Drug Establishment Licence (DEL) or Site Licence (SL) to conduct activities related to hand sanitizers and disinfectants that are covered by this measure are required to notify Health Canada in advance that they will be importing products and maintain records that will facilitate product recalls, if needed.
- Domestic companies that do not currently have a DEL or SL to conduct activities related to hand sanitizers and disinfectants covered by this measure may submit an application for expedited review to Health Canada. Authorization will be granted based on an attestation to the requirements.
Domestic companies that do not currently have a DIN or NPN for a disinfectant or hand sanitizer may submit an application for expedited review to Health Canada. - Medical Device Establishment Licence (MDEL) applications for Class I medical devices related to COVID-19 can be submitted for expedited review using the MDEL Application Form (FRM-0292) available on Health Canada’s website. The completed MDEL application form should be sent to [email protected]. Authorization will be granted based on an attestation to the requirements.
- Requests to import or manufacture medical devices that may not fully meet current regulatory requirements can be submitted to: [email protected]
In Canada, disinfectants are classified as non-prescription drugs. Hand sanitizers are classified as natural health products (NHPs) or non-prescription drugs, depending on the ingredients. Class I personal protective equipment (such as masks and gowns) and swabs are regulated as medical devices in Canada.
While these products are typically subject to regulatory requirements, such as licensing and bilingual labelling, Health Canada will allow certain products to be sold in Canada under this interim measure, including:
products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labelling, different packaging from what was authorized); and
products that are not authorized for sale in Canada but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances.
In addition, Health Canada is expediting approvals of product, as well as establishment and site licences related to these types of products.
The Department will continue to update Canadians on any further efforts to increase supplies of health products that may be used to help combat the COVID-19 pandemic. Importers who currently have a Drug Establishment Licence (DEL) or Site Licence (SL) to conduct activities related to hand sanitizers and disinfectants that are covered by this measure are required to notify Health Canada in advance that they will be importing products and maintain records that will facilitate product recalls, if needed.
Requests to import or manufacture medical devices that may not fully meet current regulatory requirements can be submitted to: [email protected]
Products already authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN) on the product label. These products are listed on Health Canada’s Drug Product Database or Licensed Natural Health Products Database.
Contact information and Related links
Public Health Agency of Canada COV
HC Guidance Document on Disinfectants
Health Canada Enquiries
Tel (613) 957-2991
1-866 225-0709
Email: [email protected]