Product monograph guidance documents and notices

Contact: Bureau of Policy, Science and International Programs

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• Product monograph guidance
• Notices
• Archived notices, guidances and templates

Product monograph guidance

• Draft guidance document: Product monograph (2023) [2023-09-15]
• Draft product monograph master template (2023) [2023-09-15]
• Draft Guidance Document Preparation of the PM in XML format (available upon request via email: Click here to submit an email request to no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Request for Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format' is in the subject line of the email [2023-08-15]
• Product Monograph: Guidance Document [2020-11-01]
• Product Monograph Master Template [2020-11-01]
• Frequently Asked Questions: Product Monographs [2020-11-01]

Notices

• Consultation: Draft guidance on the preparation of the product monograph in XML format [2023-08-15]
• Health Canada changes filing requirements for product monographs: Notice [2023-03-10]
• Notice: Phase II of the XML PM Project (Product Monograph in the Extensible Markup Language Format) [2021-05-28]
• Notice - Product Monograph Implementation Plans [2020-01-13]
• Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products [2013-02-21]
• 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]

Archived notices, guidances and templates

• Guidance document: Product Monograph [2016-12-09]
  • Product Monograph Template - Standard [2016-12-09]
  • Product Monograph Template - Notice of Compliance with Conditions [2016-12-09]
  • Product Monograph Template - Subsequent Entry Product (except for Schedule C and D products) [2016-12-09]
  • Product Monograph Template - Schedule C [2016-12-09]
  • Product Monograph Template - Schedule D [2019-06-04]
  • Product Monograph Template - Schedule - Biosimilar Biologic Drug [2019-06-04]
• Notice to Stakeholders: Release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug [2017-05-11]
• Notice - Final Release: Part I - Health Professional Information and Part II - Scientific Information of the Guidance Document - Product Monograph [2016-12-09]
• Update: Implementation of Plain Language Revisions to Part III: Patient Medication Information and Associated Templates of the Guidance Document: Product Monograph [2015-11-20]
• Notice - Final Release: Plain Language Revisions to Part III: Patient Medication Information and Associated Templates of the Guidance Document [2014-04-04]
• Health Canada Workshop on Health Product Plain Language Labelling [2011-07-21]
• Notice - Product Monograph Template Revisions: a) New Boxed Message Insert for Overdose Management Information; b) New Address for Canada Vigilance Program [2010-02-17]
• 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 [2004-10-01]
  • Appendix E - Product Monograph Template - Standard (version 2004) [2010-01-01]
  • Appendix F - Product Monograph Template - Notice of Compliance with Conditions Product Monograph (version 2004) [2004-10-01]
  • Appendix G - Product Monograph Template - Subsequent Entry Product (except for Schedule C and D products) - Revised (version 2004) [2004-10-01]
  • Appendix H - Product Monograph Template - Schedule C (version 2004) [2004-10-01]
  • Appendix I Template - Product Monograph Template - Schedule D (version 2004) [2004-10-01]