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Manufacturers Canada Pharmaceutical Industry

Bennett Jones LLP

Differences in Consumer Protection Legislation Continue to Deter National Consumer Protection Based Class Actions

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The Supreme Court of British Columbia’s recent December 2023 decision in MacKinnon v Pfizer Canada Inc. (MacKinnon) illustrates that certifying a national class action against product manufacturers based on breaches of...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

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The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Smart & Biggar

B.C. Supreme Court declines to strike Province’s class action claims to recover healthcare costs and damages related to opioid...

Smart & Biggar on

In August 2018, the Province of British Columbia (Province) commenced a class action on behalf of itself and other provincial and federal governments against approximately 50 pharmaceutical manufacturers, wholesalers, and...more

Smart & Biggar

Amendments to Food and Drug Regulations (Exports), Natural Health Products Regulations (Labelling)

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The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette: - Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...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 Consultation on Electronic Media in Prescription Drug Labelling

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On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more

Smart & Biggar

Special Access Program and Emergency Drug Release Program amendments in force

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On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

Arnall Golden Gregory LLP

A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada

On September 25, 2020, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)....more

Smart & Biggar

Canada cracks down on COVID-19 related product advertising claims

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COVID-19 has resulted in the launch of numerous new products, as well as numerous new claims about existing products. Products can be classified as drugs (including natural health products and hard surface disinfectants) or...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

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In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Issues Proposed Policies to Facilitate Importation of Prescription Drugs from Canada, Other Countries

• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more

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