Health Canada Facilitating Access to Products to Help Flatten the Curve

OTTAWA – Dealing with the efforts to #flattenthecurve Health Canada has relaxed restrictions on a number of products that can assist in limiting the spread of COVID-19.

Health Canada states, “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.”

Interview with Minister of Health Patty Hajdu

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.

Information for manufacturers and importers

• 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 hc.mdel.application.leim.sc@canada.ca. 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: hc.mdel.application.leim.sc@canada.ca.

Information for consumers

• Check the table below for information on disinfectant and hand sanitizer products being supplied in Canada as a result of this interim measure.
• 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.
• If you see a disinfectant or hand sanitizer for sale that does not have a DIN or NPN on the product label and is not on the list below, please report it to Health Canada.
• Report any health product adverse events to Health Canada.
• Follow the Public Health Agency of Canada’s advice on preventing coronavirus.

Products

The following products permitted to be sold in Canada under this interim measure that may not fully meet labelling, licensing or packaging requirements (e.g., some products may be labelled in English only or may be labelled only with a foreign identifier number instead of a DIN or NPN):