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ARTICLE · 02 DECEMBER 2020

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.

CanadaFood, Drugs, Healthcare, Life Sciences
Alice Tseng
Alice Tseng
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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, Overview and Final Guidance related to the amendments. As originally set out in the proposed Regulations (see here1), the final Regulations contain provisions to minimize the burden with providing access to unauthorized drugs in medical emergencies under the Special Access Program (SAP) (human drugs) and Emergency Drug Release (EDR) program (veterinary drugs). 

Key provisions in the Regulations are below:

  • The Regulations remove the requirement for physicians to provide full use, safety and efficacy data when certain requirements are met, including previous SAP/EDR  approval for the same medical emergency and if the drug is authorized for sale without terms and conditions by the European Medical Agency or US Food and Drug Administration

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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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