Health Canada has released Batch 4b for consultation, marking another significant step in its Natural Health Products (NHP) monograph revision process. This ongoing initiative by the Natural and Non-Prescription Health Products Directorate (NNHPD) is focused on ensuring that NHP monographs remain relevant and accurately reflect traditional uses and industry standards for these products.
The consultation for Batch 4b covers 16 single-ingredient topical and buccal monographs based on traditional plants. A noteworthy update in this batch is the shift to representing ingredient quantities as percentages, an adjustment that reflects common industry practices. The NNHPD is especially interested in feedback to confirm that these concentrations are reasonable and align with current industry use.
Also included is one new monograph for Topical Analgesics/Antipruritics, which includes NHP ingredients and is aligned with the standards established in the Nonprescription Drug Topical Anaesthetic/Analgesic/Antipruritic Labelling Standard. This new monograph is intended to guide formulation and labeling standards for products aimed at topical pain relief and itch mitigation.
The consultation period for Batch 4b is open from November 1, 2024, until January 14, 2025. Health Canada encourages stakeholders to provide comments on the proposed concentration percentages, especially regarding their alignment with traditional uses and industry practices. For any proposed revisions, please ensure that you include supporting published evidence or rationales.
Health Canada has outlined specific steps for reviewing and commenting on the monographs in Batch 4b. As the documents are restricted for editing, feedback can be added through the “Comments” function in Word:
Alternatively, comments can be sent via email with clear references to the associated monograph.
Our consultants at dicentra are ready to help you navigate these updates. We can provide tailored strategies to ensure your products meet the new requirements set forth in the revised monographs. Don’t wait—reach out to us today for guidance on staying compliant in this evolving regulatory landscape.