Update on Health Canada’s Monograph Revision Consultation Plan: Batch 3 Released

Update on Health Canada’s Monograph Revision Consultation Plan: Batch 3 Released

May 6, 2024 By

Health Canada continues its commitment to updating and revising its monographs, releasing Batch 3 for consultation. This represents another crucial step in ensuring the accuracy and applicability of information provided to stakeholders within the natural health product industry.

Purpose and Scope

This blog aims to inform stakeholders about the launch of Batch 3 of the revised draft monographs by Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD). These monographs serve as vital references for regulating and overseeing natural health products in Canada.

Update on the Rollout

Health Canada released Batch 3 of the revised draft monographs for consultation on May 1, 2024. This batch consists of 21 updated monographs, along with one new monograph supporting the medicinal ingredient Nicotinamide mononucleotide. This derivative of vitamin B3 is often present in Class III single and multi-ingredient products. Stakeholders are urged to carefully review these documents and provide feedback to ensure accuracy and relevance.

The consultation period for Batch 3 concludes on June 14, 2024. While open, stakeholders will be able to review the updated monographs and submit their comments and suggestions for consideration.

Additionally, stakeholders should note the upcoming consultation period for Batch 4: September 1 – October 1, 2024

These consultation periods provide stakeholders with additional opportunities to contribute to the revision process and shape the final versions of the monographs.

How Can I Be Prepared?

Stay Informed: Refer to the Labelling of NHPs guidance document for essential information on compliance with new labelling requirements and added context for upcoming monograph changes.

Participate in Consultations: Actively engage in current and future consultation periods to share feedback, voice concerns, and contribute to refining revised monographs. A direct link to the monographs can be found here.

Here are the instructions Health Canada provided for commenting:

  1. Double-click on the folder in the language of your choice
  2. Double-click on the monograph you would like to view
  3. Click on Download in the top right corner
  4. Open the downloaded version on your computer
  5. The document may have a banner at the top that reads “PROTECTED VIEW”. Please click on Enable Editing
  6. Click the Review tab in Word
  7. Add any comments you have using the New Comment function
  8. Save this version with your comments and send it back to us at: nnhpd.consultation-dpsnso@hc-sc.gc.ca

Input is due by June 14, 2024.

Get Expert Advice: Our consultants are here to assist you in reviewing your products and ingredients and provide you with a tailored compliance strategy to help you be prepared for the upcoming monograph revisions. Don’t hesitate to get in touch today, and together, we can ensure your readiness for these important changes.