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ARTICLE · 25 JUNE 2020

Revised Draft Guidelines Operationalizing The Patented Medicines Regulations: Notable Changes

Generally, the revised Guidelines add complexity to the price review process for new patented medicines.

CanadaFood, Drugs, Healthcare, Life Sciences

See our article here regarding the final October 2020 Guidelines. 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. The definition of "Gap medicines" and compliance timelines were updated following a consultation (see article here), as were compliance timelines for Grandfathered and Gap medicines (see article here). A consultation is underway regarding a further update to the definition of Gap medicine, and other changes (see article here).


As previously reported, on June 19, 2020, the PMPRB released its much-anticipated revised draft Guidelines operationalizing the amended Patented Medicines Regulations, with comments due by July 20,2020. The backgrounder that contextualizes its revisions to the draft Guidelines was released on June 22, 2020.

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The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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