New regulatory tools: Monograph combination guide & List of interchangeable terms
Natural Health Product Licensing Bulletin No. 7, November 18, 2025
On this page:
At a glance
The Natural and Non-prescription Health Products Directorate (NNHPD) has published two new regulatory tools to enhance clarity on submission pathways and support more flexible labelling options:
- Monograph Combination Guide
This guide clarifies whether a natural health product (NHP) licence application should be submitted as Class II or Class III, offering greater transparency and predictability and expanding eligibility for the streamlined Class II pathway.
- List of Interchangeable Terms
This list defines acceptable interchangeable terms for NHPs and non-prescription drugs (NPDs) labelling, adapted from the U.S. Code of Federal Regulations for over-the-counter drug products standards to support modernization and flexibility.
Both tools were developed through a 60-day consultation with industry stakeholders, which concluded on August 18, 2025, and reflects industry feedback.
Purpose and scope
These tools advance NNHPD's commitment to:
- Improve transparency and predictability in the submission process;
- Support flexible and consistent product labelling;
- Align regulatory practices for NHPs and NPDs.
The Tools
- Monograph Combination Guide
- Helps applicants determine when a NHP licence application should be submitted as Class II or Class III.
- Outlines best practices for attesting to multiple monographs and identifies when a combination of monographs requires a Class III submission.
- Should be used alongside the NHP Management of Applications Policy for complete guidance.
- Promotes clarity, consistency, and efficiency in application processing.
- List of Interchangeable Terms
- Lists approved interchangeable terms for NHP and NPD labels.
- Allows the use of alternate wording with equivalent meaning, while respecting official Health Canada terms of market authorization.
- Complements existing labelling guidance documents.
- Supports consistent, flexible, and compliant labelling practices.
Implementation
Both tools are now available for use:
For submissions:
- Applicants should consult the Monograph combination guide to confirm the correct classification before filing a Class II or Class III application. NNHPD may request additional information or reclassify a product based on its formulation and risk profile.
For labelling:
- The List of interchangeable terms may be used at the applicant's discretion to support flexible and compliant labels.
Contact us
For inquiries about this bulletin, please contact us by email: nnhpd-dpsnso@hc-sc.gc.ca.