Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19: Notice

Date published: March 1, 2021

Interim Order No. 2 Respecting Drugs, Medical Devices, and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 2) was signed on March 1, 2021. This interim order extends and modifies certain measures already in place to help prevent or alleviate shortages of key health products in Canada. Key products include drugs, biocides (disinfectants), medical devices and foods for a special dietary purpose. It repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 1) that the Minister of Health made on March 30, 2020.

Under Interim Order No. 2, Canada will continue to permit the importation and sale of drugs, medical devices and foods for a special dietary purpose that:

• may not fully meet Canadian regulatory requirements, but
• are manufactured according to comparable standards

Canada will also continue mandatory reporting, requiring manufacturers and importers to report shortages of specified medical devices.

Interim Order No. 2 also provides the Minister of Health with:

• new authorities to allow biocides (disinfectants) in shortage to be imported on terms similar to those currently used for drugs, medical devices, and foods for a special dietary purpose
• authorities to collect information on medical devices that may be necessary to assess a shortage from manufacturers, importers and distributors

On this page

• Why Interim Order No. 2 was introduced
• How Interim Order No. 2 will address health product shortages in Canada

Why Interim Order No. 2 was introduced

Interim Order No. 1 helped prevent and alleviate shortages of key products that emerged during the COVID-19 pandemic. Under the Food and Drugs Act, an interim order remains in effect for a maximum of 1 year after it is signed by the Minister of Health. Under this timetable, the authorities enacted by Interim Order No. 1 would have lapsed despite the ongoing risk of health product shortages related to COVID-19. Interim Order No. 2 was introduced to prevent the loss of authorities that are still needed to address shortages and increased demand during the ongoing pandemic.

Interim Order No. 2 also introduced a transition of regulatory flexibilities for drug-based hand sanitizers that are no longer needed. These include, for example, drug establishment licences and label text instead of label mock-ups for hand sanitizers.

How Interim Order No. 2 addresses health product shortages in Canada

Interim Order No. 2 allows manufacturers, importers and sellers to source certain drugs, biocides (disinfectants), medical devices and foods for a special dietary purpose that otherwise would not be available for sale to Canadians. Health Canada will continue to maintain lists of products that may be temporarily imported and sold on an exceptional basis. This will contribute to helping prevent and alleviate new and current shortages while maintaining Canada’s high quality standards for therapeutic products.

Interim Order No. 2 also allows Health Canada to continue to track shortages of specific medical devices and inform Canadians when there is a shortage or risk of shortage. Interim Order No. 2 also allows the Minister to collect information on existing and potential shortages of medical devices from manufacturers, importers or distributors. These authorities will give Health Canada improved oversight and agility when assessing and responding to current and future shortages.

Related links

• To come