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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 This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded.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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Summary: Guidance Document - Plain Language Labelling Regulations for Prescription Drugs Good Label and Package Practices Guide for Prescription Drugs Food and Drugs Act Food and Drug Regulations From Health Canada Date adopted: 2015/04/30 Date posted: 2020/03/23 Effective date:…

Notice - Revised Implementation Procedures for Product Monograph Guidance Date: 2006-05-29 (PDF Version - 27 K) Contact: Policy Bureau Enquiries May 29, 2006 Revised Implementation Procedures for Product Monograph Guidance Our file number: 06-111777-525 The Health Products and…

Transparency - Release of Product Monographs Directly to Requesters Date: 2006-05-29 (PDF Version - 21 K) Contact: Policy Bureau Enquiries May 29, 2006 Notice Our file number: 06-111774-698 The Health Products and Food Branch (HPFB) is notifying stakeholders that an interim…

Notice - Product Monograph Template Revisions (PDF Version - 22 K) February 17, 2010 Notice Our file number: 10-100000-600 Product Monograph Template Revisions: a) New Boxed Message Insert for Overdose Management Information; b) New Address for Canada Vigilance Program The…

Health Canada Workshop on Health Product Plain Language Labelling ( PDF Version - 271 K) Summary Report February 17, 2011 This report was prepared for Health Canada by Ascentum Table of Contents 1. Introduction 2. Key Findings 2.1 Plain Language Labelling Project Question and…

Notice - Final Release: Plain Language Revisions to Part III: Patient Medication Information and Associated Templates of the Guidance Document - Product Monograph (PDF Version - 29 K) Contact: Bureau of Policy, Science and International Programs April 4 2014 Our file number:…

Submissions Seeking Changes to the Product Monograph Sections: (a) Clinical Trial Adverse Drug Reactions and; (b) Post-Market Adverse Drug Reactions (PDF Version - 22 K) Contact: Policy Bureau Enquiries December 10, 2010 Our file number: 10-126163-94 Submissions Seeking Changes…

Validation rules for Product Monographs in the Extensible Markup Language (XML) format Date: September 1, 2022 Our file number: 9999 Health Canada has updated the validation rules for Product Monographs (PMs) in the Extensible Markup Language (XML) format following a time period…

Use of a Foreign-sourced Reference Product as a Canadian Reference From Health Canada Overview This guidance document provides the criteria for using a drug marketed in a country other than Canada as a Canadian Reference Product (CRP). This applies to Abbreviated New Drug…

Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience) (PDF Version - 105 K) Published by authority of the Minister of Health Date Adopted: 2015/03/20 Effective Date: 2015/05/01 Health Products and Food Branch Our mission is to help the…

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Early release: coverage and features are still expanding.