Health Canada’s ongoing efforts to update and revise its monographs continue with the release of Batch 2 for consultation. This marks another significant step in ensuring the accuracy and relevance of information provided to stakeholders within the natural health product industry.

Purpose and Scope

The purpose of this blog is to inform stakeholders about the release of Batch 2 of the revised draft monographs by Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD). These monographs serve as essential references for the regulation and oversight of natural health products in Canada.

Update on the Rollout

The NNHPD released Batch 2 of the revised draft monographs for consultation on January 31, 2024. This batch comprises 27 updated monographs, reflecting the latest scientific evidence and regulatory requirements. Stakeholders are encouraged to review these documents carefully and provide feedback to ensure accuracy and relevance.

The consultation period for Batch 2 extends for 60 days, concluding on April 1, 2024. During this time, stakeholders have the opportunity to review the updated monographs and submit their comments and suggestions for consideration.

Furthermore, stakeholders should be aware of the upcoming consultation periods for Batch 3 and Batch 4:

• Batch 3 comment period: May 1 – May 30, 2024
• Batch 4 comment period: 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

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.