The Great Green North: A Discussion on Canada’s Environmental Regulations
On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following...more
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more
Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
Mid-year update: Health products approved in 2021 – In October 2021, Health Canada published a “Mid-year update: Health products approved in 2021”, which provides an update on the drugs, medical devices, over-the-counter...more
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more
In October 2020, the Pharmaceutical Advertising Advisory Board (PAAB) released an advisory addressing references to “no sub” or “no substitution” in advertising materials. The advisory states that advertisers are permitted to...more
In the first half of 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review the following top developments...more
An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in June 2018....more
Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
Federal Court of Appeal dismisses Teva’s levofloxacin damages appeal - On February 8, 2018, the Federal Court of Appeal issued public reasons for its decision dismissing Teva’s appeal relating to the damages and costs...more