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Drugs and Health Products
Revision of the Product Monograph
- Health Canada Workshop on Health Product Plain Language Labelling [2011-07-21]
- Draft Guidance Document - Product Monograph - Part III: Consumer Information [2011-07-21]
- Notice - Submissions Seeking Changes to the Product Monograph Sections: (a) Clinical Trial Adverse Drug Reactions (3.5.2 - 3.5.3) and; (b) Post-Market Adverse Drug Reactions (3.5.5) [2010-12-06]
- Notice - Product Monograph Template Revisions: a) New Boxed Message Insert for Overdose Management Information; b) New Address for Canada Vigilance Program
[2010-02-17] - Frequently Asked Questions: Product Monographs Posted to the Health Canada Website [2008-02-05]
- Record of Decisions - April 11, 2007, Consumer Information Meeting [2007-07-19 ]
- Notice: Transparency - Release of Product Monographs Directly to Requesters [2006-05-29]
- Notice: Revised Implementation Procedures for Product Monograph Guidance [2006-05-29]
- Guidance for Industry:Product Monograph [2004-06-14]
- Appendix E - Product Monograph Template - Standard [2010-02-17]
- Appendix F - Product Monograph Template - Notice of Compliance with Conditions Product Monograph
- Appendix G - Product Monograph Template - Subsequent Entry Product (except for Schedule C and D products)- Revised
- Appendix H - Product Monograph Template - Schedule C
- Appendix I - Product Monograph Template - Schedule D
- Executive Summary - Health Canada Consumer Information Study Report to Health Canada [2001-10-12]
