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Interim Order No. 2 for Drugs, Medical Devices and Foods for a Special Dietary purpose in relation to COVID-19

Mar 25, 2021

Health Canada is replacing the first Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19 has been replaced by the Interim Order No. 2 respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19. The second interim order was published in Canada Gazette Part 1, vol 155 March 20, 2021. 

The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2)  extends and modifies certain measures for drugs, medical devices and foods for special dietary purposes introduced in IO No. 1. These measures continue to be necessary to help prevent and alleviate the effects of shortages that are caused or exacerbated, directly or indirectly, by COVID-19.

Under IO No. 2, the exceptional importation and sale of drugs, medical devices, and foods for a special dietary purpose will continue to be permitted to address shortages of these products that are caused or made worse, directly or indirectly, by COVID-19. Products governed by IO No. 2 may be imported into Canada, provided they were manufactured with similar high quality and manufacturing standards to those required for Canadian-approved products.

Under IO No. 1, the Minister maintained an up-to-date list of medical device shortages and an up-to-date list of specified medical devices for which shortages must be reported. These lists are being reincorporated under IO No. 2 and will continue to be maintained

IO No. 2 also formalizes a regulatory framework to permit the exceptional importation and sale of surface disinfectants (also called biocides) to address increased demand. It modifies the definition of a “biocide” that was defined in IO No. 1 so that the term refers only to disinfectants, and not hand sanitizers, which are regulated differently. The exceptional importation framework for biocides in IO No. 2 will replace Health Canada’s earlier interim policy approach for imported disinfectants. An up-to-date list of biocides eligible for exceptional importation will be maintained. Many of the biocides that were eligible for import and sale under Health Canada’s previous policy approach will continue to be permitted under IO No. 2.

IO No. 2 modifies regulatory flexibilities previously made available to regulated parties that manufacture, import, and/or sell hand sanitizers, as the domestic production capacity for these products has now stabilized. Under IO No. 1, companies were permitted to conduct activities related to drug-based hand sanitizers without a drug establishment licence (DEL). IO No. 2 reintroduces the requirement for companies to have a DEL to conduct regulated activities related to drug-based hand sanitizers. Companies wishing to continue conducting licensable activities related to drug-based hand sanitizers will have six months to apply for a DEL. After applying, companies can continue those activities until a determination is made with respect to their applications.

In addition, IO No. 2 no longer permits companies to provide Health Canada with label text in place of a label mock-up as part of an application for a drug identification number (DIN) or a new drug submission regarding a drug-based hand sanitizer. However, any application seeking market authorization for a product that is pending a decision at the time IO No. 2 comes into force will be considered under the terms of IO No. 1.

IO No. 2 also modifies Health Canada’s approach to official languages for products that arrive in Canada through exceptional importation. Under IO No. 1, guidance for industry indicated the Department’s expectation for importers to ensure that information on the safe use of the product be available in French and English. IO No. 2 makes that regulatory requirement explicit. Importers wishing to keep their products in the Canadian market will have six months to come into compliance.

Any importer who is permitted for exceptional importation and sale under IO No. 2 must notify the Minister electronically, in a format that is specified by, or acceptable to, the Minister, at least five business days before importation. These products will still be subject to some of the requirements set out in the Food and Drugs Act and its regulations, including reporting adverse drug reactions, recall requirements and mandatory problem reporting (medical devices).

IO No. 2 also continues the requirement for manufacturers and importers of medical devices considered critical during the COVID-19 pandemic to notify the Minister of shortages of those medical devices introduced in IO No. 1. The notification must happen within five business days of becoming aware of an actual or anticipated shortage. Information is to be submitted electronically in a format specified by, or acceptable to, the Minister.

More information

Exceptional import and sale of foods for a special dietary purpose

Exceptional import and sale of drugs

Exceptional import and sale of biocides

Exceptional import and sale of medical devices

Medical device shortage reporting

Explanatory note: Interim order No. 2 extends measures for drugs, medical devices and foods for a special dietary purpose

Contact:
Health Canada
Compliance Policy and Regulatory Affairs

Telephone: 343‑540‑8524
Email: hc.prsd-questionsdspr.sc@canada.ca