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Health Canada Controlled Substances

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

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On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

Smart & Biggar

Restricted drugs now possible through the Special Access Program

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On January 5, 2022, amendments came into force amending the Food and Drug Regulations to allow practitioners to request access to restricted drugs through the Special Access Program (SAP), which was previously prohibited....more

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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

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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

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Rx IP Update - December 2017

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PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

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