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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.

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Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028 Download in PDF format (640 KB, 22 pages) Organization: Health Canada Date published: June 2024 On this page Message from the Minister of Health Health product shortages in Canada What…

Regulatory cooperation: Canadian guidance on veterinary drug simultaneous reviews with the United States: Overview Overview Pre-submission Submission filing Preview process Cancellation process, contact us Crosswalk example On this page Purpose Defining a simultaneous review…

Closed consultation: Proposal to amend the list of maximum residue limits for veterinary drugs in foods - Proposed MRL 2025-1 From Health Canada Current status: Closed This consultation ran from February 5, 2025 to April 21, 2025. Health Canada sought comments on a proposal to…

Notice to stakeholders: Update on the post-market re-evaluation of medically important antimicrobials for veterinary use with unspecified or prolonged durations of use Background Antimicrobials are essential tools; they support animal and public health and contribute to a safe…

Guidance for industry: Preparation of veterinary abbreviated new drug submissions (generic drugs) - Clinical and human safety requirements: Overview Overview Regulatory requirements Clinical requirements Human safety requirements Labelling requirements Appendices On this page…

Guidance for industry: Preparation of veterinary new drug submissions and abbreviated new drug submissions (new and generic drugs) - Quality requirements: General General Drug substance Drug product Appendices On This Page G.1 Introduction G.2 Scope and application G.3 Core…

Consultation on Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs Current status: Open This consultation opened on June 10, 2025, and closes on September 8, 2025. Health Canada is proposing revisions to its Guidance Document: Information and…

Consultation: Categorization of antimicrobial drugs based on importance in human medicine Current status: Closed This consultation ran from June 18, 2025 to August 16, 2025. Health Canada's Veterinary Drugs Directorate (VDD) sought comments on proposed revisions to its…

Share your thoughts: Consultation on draft National Priority List of Pediatric Drugs From: Health Canada Current status: Closed Opened on October 21, 2024, and closed on December 20, 2024. As part of the Pediatric Drug Action Plan, Health Canada is working with stakeholders to…

Health Canada updates the guidance on expanded access clinical trials: Notice On this page Background About expanded access clinical trials Consultation process What changed in the guidance What’s next Contact us Background Health Canada has updated the guidance on expanded…

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