NNHPD has introduced two new regulatory tools designed to simplify the natural health product submission process and give you more flexibility when preparing labels. Moreover, these updates were created to improve clarity in submission pathways and support modern, consistent labelling practices across the industry.
If you work with NHPs or non-prescription drugs, you will want to understand these changes before preparing your next application. The tools were released on November 18, 2025, following a 60-day consultation with industry stakeholders.
Because these tools will directly influence how you classify your products and prepare your labels, it is important that you know how to use them. Keep reading to learn what the tools include and how they may change your compliance approach.
What Are the New NNHPD Regulatory Tools
The Natural and Non-prescription Health Products Directorate (NNHPD) has published two resources:
- Monograph Combination Guide
- List of Interchangeable Terms
These tools advance NNHPD’s goal of offering clearer pathways for submissions and more flexible options for compliant labelling. You can find the official Health Canada NNHPD bulletin here.
Why These NNHPD Tools Matter
The updates aim to improve transparency when choosing between Class II and Class III submissions. They also support more flexible and consistent wording on labels, which helps you align your product communication with Health Canada’s expectations.
In addition, the tools help harmonize approaches between natural health products and non-prescription drugs so you can apply consistent standards across your portfolio.
Furthermore, these updates reduce uncertainty during application preparation because expectations are clearer and easier to interpret. As a result, they streamline decision making for regulatory teams and help you plan your submission strategy with greater confidence.
Understanding the Monograph Combination Guide
The new Monograph Combination Guide helps you determine whether your product should be submitted as a Class II or Class III NHP application. Although many companies rely on monographs to streamline approvals, combining multiple monographs can sometimes lead to questions about eligibility. This guide:
- outlines when you may attest to more than one monograph explains situations where combined monographs still qualify as Class II
- identifies when complexity or risk requires a Class III application
- provides best practices to prepare stronger submissions
- works together with the NHP Management of Applications Policy
This tool supports consistency by helping you interpret NNHPD expectations the same way the reviewers do. As a result, you are less likely to choose the wrong submission class or face reclassification later in the process.
Understanding the List of Interchangeable Terms
The List of Interchangeable Terms supports flexibility in labelling for both NHPs and non prescription drugs. Because labels must stay consistent with the terms authorized by Health Canada, companies sometimes struggle to find wording that is both compliant and consumer friendly. This new list:
- defines acceptable alternate terms that carry the same meaning
- adapts wording principles from U.S. over the counter drug labelling standards
- supports modernization of NHP and NPD labelling
- allows for clear communication while still respecting official terms of authorization
- complements current Health Canada labelling guidance
If you are updating labels or preparing new ones, this list can help you avoid unnecessary revisions while giving you more flexibility in how you present information to consumers.
How and When to Use These NNHPD Tools
Both tools are now active and available. However, before you file an NHP application, you should consult the Monograph Combination Guide to verify whether your formulation qualifies for Class II or requires a Class III pathway. NNHPD may still request more information or evaluate risk based on the full formulation, so early review is helpful.
The List of Interchangeable Terms can be used at your discretion when preparing labels. While it offers more flexibility, all terms must still align with the approved authorization. These tools work best when used together with your existing regulatory strategy, especially if you are preparing products for market entry or updating older submissions.
Key Takeaways
- NNHPD has released two new regulatory tools that support clearer submissions and more flexible labelling.
- The Monograph Combination Guide helps you confirm whether your product belongs in Class II or Class III.
- The List of Interchangeable Terms provides approved alternate label wording to increase clarity and consistency.
- Both tools enhance predictability and reduce regulatory uncertainty.
- Using these resources early in your process can help you avoid delays and prepare stronger, more compliant submissions.
Frequently Asked Questions
Is the Monograph Combination Guide mandatory for all submissions?
No, it is not mandatory, but skipping it can lead to incorrect classification. Using the guide early can prevent rework and strengthen your application.
Does the List of Interchangeable Terms replace Health Canada’s existing labelling rules?
No, it does not replace existing rules. It supports labelling flexibility while still requiring full compliance with authorized terms.
Do these tools reduce the need for Class III submissions?
Not always. Some formulations will still require Class III review. However, the guide may expand eligibility for Class II submissions when multiple monographs apply.
Can interchangeable terms be used for any NHP?
Not in every situation. You must still confirm that the alternate term matches the meaning approved in your product’s market authorization.
Will these tools make the submission process faster?
Yes, in many cases. Clearer guidance often reduces uncertainty, which helps you prepare stronger submissions and avoid reclassification.
Conclusion
These new NNHPD tools provide clearer pathways for submissions and more flexible options for compliant labelling. If you want support interpreting the Monograph Combination Guide, reviewing interchangeable terms, or preparing a full submission package, our regulatory team can help you move forward with confidence.
To learn more about NHP licensing pathways, explore our NHP licensing services. If you need direct support with submissions or labelling, you can reach our team through the Quality Smart Solutions contact page.
