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Regulatory Requirements Canada Health Canada

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Federal Court of Appeal confirms generic not required to address patent submitted before ANDS filing but listed after

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On August 8, 2025, the Federal Court of Appeal (FCA) determined that the Minister of Health’s decision to list Canadian Patent No. 2,970,315 on the Patent Register eight days after it was submitted to Health Canada was...more

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Health Canada releases its Statistical Report 2024/2025 for PMNOC Regulations, data protection and CSPs

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On July 25, 2025, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food...more

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Health Canada publishes Guide to the precision regulating authorities under the Food and Drugs Act

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In March 2025,  Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow...more

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