Product monograph guidance documents and notices
Contact: Bureau of Policy, Science and International Programs
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Product monograph guidance
- Guidance Document: Product Monograph [2024-12-23]
- Product Monograph Master Template [2024-12-23]
- Frequently Asked Questions: Product Monographs [2020-11-01]
- Guidance document & samples: XML Product monograph (available upon request no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Guidance document Preparation of the XML Product Monograph' is in the subject line of the email. [2025-03-28]
- Validation rules for Product Monographs in the Extensible Markup Language (XML) format
Notices
- New filing requirements for second language product monographs and package insert mock-ups: Notice [2025-06-20]
- Notice to stakeholders – Publication of the final product monograph guidance document and master template (2024) [2024-12-23]
- Change in filing requirements for the extensible markup language product monograph (XML PM): Notice [2024-11-18]
- Updated: Notice – Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products [2020-03-23]
- 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
- 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]
- 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]