News & Analysis as of

Health Canada Vaccinations

Miller Canfield

CANADA: Are Mandatory COVID-19 Vaccination Policies Enforceable? Maybe, Maybe Not.

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Since the release of government-approved vaccines to help fight the COVID-19 pandemic, employers have been wrestling with how to implement vaccination policies in the workplace. For those employers who have implemented a...more

Smart & Biggar

Transition measures released for Interim Order for COVID-19 drugs

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As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more

Smart & Biggar

Health Canada – COVID-19 update highlights

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UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Smart & Biggar

Few significant changes made in final PMPRB Guidelines

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Update: On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final Guidelines. See also the PMPRB’s November 20, 2020 webinar slides here....more

Smart & Biggar

Accelerated examination of Canadian patent applications related to COVID-19 relief

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The Canadian Intellectual Property Office (CIPO) has launched a pilot program to provide accelerated examination of Canadian patent applications concerning medical technology related to COVID-19 and for which Health Canada...more

Smart & Biggar

COVID-19 developments – federal government issues request for information for alternative suppliers for certain pharmaceuticals

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The federal government has been proactive in seeking help from industry in tackling the pandemic. For example, Health Canada contacted Health Product Licence Holders to let them know specific areas where they may be able to...more

Smart & Biggar

First decision on CSPs: SHINGRIX refusal remanded to Health Canada

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The first decision considering the scope and meaning of the provisions in the Patent Act relating to Certificates of Supplementary Protection (CSPs) has now been released.  Justice Barnes of the Federal Court in...more

Smart & Biggar

From regulatory flexibility to reimbursement changes, how Canadian regulators and payers are managing the COVID-19 crisis

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UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more

Smart & Biggar

Health Canada facilitates availability of COVID-19 health products

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UPDATE: The Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 was made on March 1, 2021 (see Notice here) and repeals the Interim Order Respecting the Importation and...more

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