We previously reported on the Ontario government’s efforts to manage the risk of drug shortages in the early days of the pandemic. Those efforts included a recommendation that pharmacies dispense no more than a 30-days’ supply of medication to patients
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Federal Courts Extend Suspension Periods to June 15

The Federal Court of Appeal (FCA) and the Federal Court (FC) have extended their Suspension Periods to June 15, 2020.
Federal Court of Appeal
On May 28, 2020, the FCA issued a Notice to the Parties…
Health Canada collaborates with international partners to address pandemic


Health Canada recently published a notice to industry detailing its collaborations with international partners during the COVID-19 pandemic. These cooperative efforts aim to ensure that Canadians’ health product needs are being met quickly and effectively during the outbreak, and that…
Health Canada amends regulations to permit distribution of OTC and NHP samples to general public


Health Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of non-prescription drugs (NPDs, or “over-the-counter” (OTC)…
“New NAFTA” to take effect July 1, 2020: USA completes domestic ratification of CUSMA
Canada, the United States, and Mexico have each completed the domestic processes necessary to bring the Canada-United States-Mexico Agreement (CUSMA, also known as USMCA or New NAFTA) into effect. CUSMA will come into force on July 1, 2020,…
Bill C-4: New CUSMA Implementation Act Introduced
On January 29, 2020, the Government introduced Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). The Bill, sponsored by Deputy Prime Minister Freeland, was read for the first time the same day.
As we reported, the…
Ontario implements regulatory changes to streamline drug formulary listing and reduce government payments to pharmacies


The Ontario Ministry of Health and Long-Term Care (the Ministry) has amended Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act (DIDFA). The new Regulations are…
Health Canada consulting on the contents of the Generic Submissions Under Review List
On January 7, 2019, Health Canada opened a consultation on whether to include the names of sponsor companies on the generic submissions under review list (GSUR) for Abbreviated New Drug Submissions (ANDSs). This type of information…
Pharma in Brief – Federal Court dismisses application for a prohibition order regarding prasugrel hydrochloride under the old PM(NOC) Regulations


The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected…
Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application

The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic…