Health Canada XML Product Monograph for Drug Information

Health Canada has created an initiative to adopt a structured product monograph format to increase efficiency and provide Canadians with more relevant and concise drug product information. This effort will improve the treatment experience by making drug information easier for patients and prescribers alike to interpret.

This move to XML PM affects the product monograph preparation, electronic submission and approval process for human prescription drugs marketed, sold or distributed in Canada. This transition does not have any impact on human OTC drugs, veterinary drugs, natural health products and medical food and devices.

Voluntary submissions have been accepted since 2021 with the required date of compliance expected to be published in late 2024/early 2025.

What needs to be done?

• Organizing data
• Ensuring the correct attributes
• Submitting in the correct format
• Managing and storing data
• Ability to perform an audit

Fill out the form to learn more about the Health Canada process and requirements and how Reed Tech can provide guidance and expertise.

• Health Canada pilot participant and offering guidance since 2017
• Reed Tech has supported FDA SPL since 2005

Fill out the form to learn more about Health Canada mandates and requirements.