On November 18, 2025, the Natural and Non-prescription Health Products Directorate (NNHPD) introduced two important regulatory tools designed to bring greater clarity, predictability, and flexibility to Canada’s Natural Health Product (NHP) framework: the Monograph Combination Guide and the List of Interchangeable Terms. These tools follow a 60-day consultation period with industry and represent Health Canada’s ongoing commitment to modernizing NHP oversight and improving submission and labelling consistency.

Scope & Purpose

Both tools support NNHPD’s broader priorities—simplifying regulatory pathways, ensuring consistent risk communication, and aligning NHP practices with those used for non-prescription drugs.

• The Monograph Combination Guide provides clear expectations on when a product combining multiple monographs can proceed via a Class II pathway versus when it must be filed as a Class III submission.
• The List of Interchangeable Terms offers a standardized set of acceptable synonyms for NHP and non-prescription drug labels, enabling more flexible and consumer-friendly wording while preserving regulatory intent.

Together, these updates help streamline licensing decisions, reduce ambiguity, and create more predictable outcomes for applicants.

What Has Been Introduced?

1. Monograph Combination Guide

The Monograph Combination Guide is a comprehensive resource outlining how multiple monographs may be combined within a single product. It clarifies:

• When Class II is appropriate: including for combinations that fall fully within monograph parameters and do not present conflicting conditions of use.
• When Class III is required, such as when:
  • Monographs carry contradictory or incompatible directions, contraindications, or duration-of-use statements.
  • Additive pharmacological effects (e.g., sedative, diuretic, glucose-modifying, or blood-pressure-lowering effects) exceed allowable thresholds.
  • The product includes complex combinations requiring supporting evidence.

The guide also introduces structured combination tables, detailed additive-dose calculations, and clear expectations for specific qualifiers, risk statement hierarchy, and application of the 10% sub-therapeutic criterion.

For companies developing multi-ingredient formulations, this represents a significant shift toward more transparent and science-based classification.

2. List of Interchangeable Terms

The List of Interchangeable Terms provides an exhaustive list of acceptable synonyms for use on NHP and non-prescription drug labels, allowing manufacturers to:

• Replace rigid terminology (e.g., “Ask” with “Consult,” “Apply” with “Use,” “Active ingredient” with “Medicinal ingredient”)
• Improve readability while maintaining compliance with the Natural Health Products Regulations and the Food and Drugs Act
• Adjust terminology in Product Facts Tables where permitted

These interchangeable terms support more modern, consumer-focused labelling without compromising the integrity of approved claims or regulatory requirements.

How to Be Prepared

With both tools now in effect, companies should begin integrating these frameworks into their regulatory and labelling workflows. Practical steps include:

• Reassessing product classifications: Review formulations against the Monograph Combination Guide to confirm whether future submissions qualify for Class II or require Class III evidence packages.
• Auditing current labels: Identify opportunities to adopt interchangeable terms to improve clarity and consistency.
• Reviewing risk statements and directions for use: Ensure statements from multiple monographs are harmonized according to the guide’s hierarchy and rules.
• Documenting additive effects: Prepare combination tables and provide necessary justification for ingredients with shared pharmacological actions.
• Updating internal SOPs and submission templates: Build these tools into formulation design, regulatory review, and quality documentation.

Get Expert Advice

Health Canada’s new tools mark an important advancement in the modernization of Canada’s NHP regulatory system. For many companies—especially those developing innovative or multi-ingredient formulations—interpreting and operationalizing these updates may require specialized guidance.

dicentra has supported more than 24,000 regulatory and quality projects, including NPN submissions, Class II attestations, complex Class III applications, label reviews, and compliance assessments. Our team can help evaluate your formulas under the new Monograph Combination Guide, optimize your labelling using the Interchangeable Terms list, and ensure your submissions are fully aligned with NNHPD expectations.

If you’d like to understand how these new tools may impact your products or upcoming filings, contact dicentra today.