myHealthbox Adds Support for Health Canada Product Monographs in XML Format

myHealthbox is proud to announce that its eLeaflet™ solution now supports Product Monographs in the Extensible Markup Language (XML) format, following Health Canada’s official specifications for the Structured Product Monograph (SPM) initiative.

This milestone expands the eLeaflet™ platform’s global interoperability, ensuring that pharmaceutical companies can easily manage and distribute compliant digital product information for the Canadian market — seamlessly integrated into their existing electronic workflows.

What Is the Structured Product Monograph (SPM)?

Health Canada’s Structured Product Monograph (SPM) initiative aims to modernize how drug product information is created, submitted, and shared.

The XML-based SPM replaces traditional PDF documents, ensuring machine-readable, interoperable data that integrates directly with healthcare and regulatory systems.

According to Health Canada’s implementation plans, the SPM in XML format will replace traditional document-based submissions, ensuring that product information is machine-readable, structured, and interoperable with health systems and digital platforms.

The new XML-based format supports automation, improves data quality, and enables direct integration with Health Canada databases and clinical information systems, ensuring that healthcare professionals and patients have access to accurate and up-to-date information.

With this update, myHealthbox aligns with Health Canada’s latest technical and regulatory requirements, providing pharmaceutical manufacturers with a ready-to-use digital leaflet solution that complies with the SPM data standard.

With this enhancement, myHealthbox eLeaflet allows companies to generate, validate, and submit Health Canada–compliant XML Product Monographs as part of their regulatory submissions.

Change in Filing Requirements

Health Canada has confirmed a change in filing requirements for new product monograph submissions. All new drug submissions (NDS), supplemental new drug submissions (SNDS), and abbreviated new drug submissions (ANDS) will now need to include the Product Monograph in XML format, validated according to Health Canada’s XML schema and controlled vocabulary specifications.

This change represents a significant evolution from the previous PDF-based submissions, facilitating a more efficient and standardized regulatory review process.

The myHealthbox eLeaflet™ platform now integrates native validation tools based on the Health Canada XML schema, ensuring that all submissions are pre-validated and compliant before being filed.

Full FHIR Type 2 (a–f) Support

The eLeaflet solution from myHealthbox now provides complete support for FHIR type 2 (a–f), as defined in the HL7 ePI implementation guide, in full alignment with Health Canada’s specifications. This includes integration with Health Canada’s controlled vocabularies, ensuring semantic consistency and data accuracy across submissions. The FHIR-based structure enables:

• Seamless interoperability with clinical systems
• Automated updates and synchronization
• Enhanced readability and accessibility for patients and healthcare providers
• A foundation for future data-driven regulatory and healthcare innovation

With this, myHealthbox delivers a comprehensive, regulatory-compliant framework for managing structured medicinal product information in Canada.

Implications for Companies Marketing Products in Canada

For pharmaceutical and healthcare product manufacturers, this new capability represents a major opportunity:

• Regulatory compliance: Meet the latest Health Canada XML-based filing requirements.
• Operational efficiency: Simplify submission workflows with automated validation and structured data handling.
• Digital transformation: Integrate product information seamlessly into digital health platforms and FHIR-based ecosystems.
• Future readiness: Position your organisation for upcoming ePI and structured data initiatives worldwide.

By adopting the myHealthbox eLeaflet™ platform, companies can ensure consistency and compliance across multiple regulatory regions — from Canada to Europe and the Middle East.

Expanding on Jordan FDA ePI Standards

This new feature builds on the eLeaflet platform’s existing support for ePI type 1 and ePI type 2 (a–b) as required by the Jordan Food and Drug Administration (JFDA).

With the addition of Health Canada’s FHIR type 2 (a–f) support, the platform now offers full global coverage for digital product information standards — allowing any company moving toward digital leaflets to deploy a single, unified solution supporting ePI and FHIR formats across jurisdictions.

Learn More

For more details about this new feature, technical specifications, or integration support, visit the eLeaflet.eu site.

The myHealthbox eLeaflet platform continues to lead the way in digital regulatory innovation, helping companies transition from paper and PDF to structured, interoperable electronic product information.