Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input

Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input

FDA Warning Letter

Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input

The Natural and Non-Prescription Health Products Directorate (NNHPD) invites industry stakeholders to provide feedback on Batch 4b, with consultation open for 75 days. We encourage you to support any suggestions for monograph revisions with published evidence or clear rationale.

What’s Included in Batch 4b?

  • Updated Monographs for Topical Ingredients
    • 16 single-ingredient monographs for traditional plants now represent ingredient quantities as percentages. Your input confirms whether these concentrations are reasonable and align with industry standards.
  • New Topical Analgesics/Antipruritic Monograph
    • This addition, featuring natural health product ingredients, is based on the Nonprescription Drug Topical Anaesthetic/Analgesic/Antipruritic Labelling Standard.

Access all documents in Batch 4b, including new monographs, directly here.

Step-by-Step Instructions to Submit Comments

Follow these steps to access and comment on the documents:

  1. Choose Your Language
    • Double-click the language-specific folder.
  2. Download the Monograph
    • Double-click the monograph you wish to view and click “Download” in the top right corner.
  3. Enable Editing
    • Open the document on your computer and click “Enable Editing” if prompted by a Protected View banner.
  4. Add Comments
    • Go to the “Review” tab in Word and use “New Comment” to add your input.
  5. Send Back Your Edited Document
    • Save your version with comments and email it to: nnhpd.consultation-dpsnso@hc-sc.gc.ca

Prefer Text-Based Comments?
You can also email your comments directly, clearly linking each comment to the corresponding monograph.

Deadline for Submission: January 14, 2025

We appreciate your insights and participation in shaping health product standards. Feedback must be submitted by January 14, 2025.

How Quality Smart Solutions Can Assist

Quality Smart Solutions specializes in guiding businesses through regulatory challenges like this consultation. Our experts clarify the comment submission process, ensuring your insights are aligned with regulatory expectations—partner with us to make your voice heard in compliance consultations like Batch 4b. Reach out to us by filling out the form below.

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About the author

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Andrew Parshad
Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.

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