Notice to stakeholders – Publication of the final product monograph guidance document and master template (2024)

December 23, 2024
Reference number: 24-110062-750

This Notice is to inform stakeholders of the publication of the finalized 2024 versions of the Guidance document: Product Monograph and Product Monograph master template.

The Product Monograph Guidance and Master Template serve as resources to assist drug sponsors in developing product monographs that meet the required format and content standards. The product monograph is used by healthcare professionals and patients to optimize safe and effective use of drug products. Health Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission.

Following an external consultation in the fall of 2023, feedback was considered and incorporated to finalize both documents. The improvement of these documents will offer greater clarity and more detailed guidance for drug sponsors when developing a product monograph. It will reduce the administrative burden and minimize the need for repeated correspondence to seek clarity for both industry and regulator when preparing and reviewing a product monograph for authorization. These updated documents also reflect advancements in scientific knowledge and policies.

The submissions in scope are detailed in section 1.2 of the Guidance document: Product Monograph; however, please take note of the below information:

• Sponsors of generic drug products must submit their proposed monograph in the master template if the Canadian Reference Product (CRP) has an authorized product monograph in the master template or when requested by Health Canada.
• Sponsors of cross-licensed drug products must submit their proposed product monograph in the master template if the licensor has an authorized product monograph in the master template.

The Guidance document: Product Monograph and Product Monograph master template supersedes the following:

• Notice - Product Monograph Implementation Plans [2020-01-13]
• Guidance document: Product Monograph (2020) [2020-11-01]
• Product monograph master template [2020-11-01]
• Product monographs: Frequently asked questions [2020-11-01]
• Notice: Product Monograph guidance - Formatting for clinical trials section and administrative updates [2021-06-21]

While the updated information in these documents is effective immediately upon publication, Health Canada acknowledges that submissions may be in various stages of filing or review. In light of this, until March 31, 2025, the Department will exercise flexibility in ensuring that product monographs are aligned with the 2024 requirements for format and content. Sponsors are encouraged to update their product monographs as soon as possible, and should consult with the relevant regulatory project manager at Health Canada assigned to your file, or contact the email address below, if needed.

Contact

For any questions or inquiries related to this notice, please contact:

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
E-mail: hc.policy.bureau.enquiries.sc@canada.ca