Tag archives: Interim Order

Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2

Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 2) if there is no longer an urgent public health need (UPHN) for those devices. The notice states that there is no longer an UPHN for thermometers and ventilators.

Background

As we reported, IO No. 2 (enacted … Continue Reading

Health Canada issues new Interim Order to prevent bulk exportation of prescription drugs from Canada

On November 27, 2020, the Minister of Health (the Minister) issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order), pursuant to s. 30.1(1) of the Food and Drugs Act.

Summary

The current Interim Order is a response to international frameworks which allow for bulk importation of drugs from Canada, which the Minister believes could cause Canadian drug shortages. For example, the US Food and Drug Administration (FDA) published a rule entitled Importation of Prescription Drugs (the US Importation Rule) which permits US pharmacists or wholesalers to bulk import certain … Continue Reading

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