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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 This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded.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.

For background on coverage and capture methods, see Methods & coverage.

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Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice (PDF Version - 72 K) Notice April 30, 2010 Our file number: 10-109087-604 Health Canada is pleased to announce the release of the…

Listing of Drugs Currently Regulated as New Drugs (The New Drugs List) November 6, 2012 Notice Our file number: 12-118879-948 (PDF Version - 191 K) Contact: Policy Bureau Enquiries The Therapeutic Products Directorate (TPD) has completed an assessment to determine whether the…

ARCHIVED - Notice: Release of Revised Draft Guidance Document: Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page…

Good Label and Package Practices Guide for Prescription Drugs Download the alternative format (PDF format, 1.34 MB, 79 pages) Organization: Health Canada Published: 2019-06-21 Preamble The utmost care has been taken to ensure the accuracy of information presented in this guide.…

Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products From [Marketed Health Products Directorate, Health Products and Foods Branch and Institute for Safe Medication Practices Canada] Overview This best practices guide provides direction to…

Non-prescription Drugs: Labelling Standards - Drug Product A non-prescription drug (NPD) labelling standard outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations…

Labelling requirements for non-prescription drugs guidance document The next version of this guidance document will be updated to align with the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing ) regulatory package that was published in…

Guidance to Establish Equivalence or Relative Potency of Safety and Efficacy of a Second Entry Short-Acting Beta2-Agonist Metered Dose Inhaler (MDI) [Health Canada, 1999] (PDF Version - 76 K) Contact: BCANS Enquiries Therapeutic Products Programme Holland Cross, Tower "B" 2 nd…

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