The Natural and Non-prescription Health Products Directorate (NNHPD) has changed the review process for Class III Natural Health Product (NHP) applications. Due to a growing backlog and higher submission volume, Health Canada will now prioritize applications for products sold or manufactured in Canada within six months of licensing.
Starting March 5, 2025, NNHPD will no longer review Class III applications based only on their submission date. Instead, priority will go to products that support the Canadian market. If you plan to bring an NHP to Canada, now is the time to act. Learn how these changes affect your application and how to stay ahead.
Why is this changing?
In recent years, NNHPD has received a surge in Class III NHP applications. These applications require the most resources and time to review. The high volume has exceeded the directorate’s capacity, causing delays in meeting the 210-day service standard.
Previously, applications were reviewed on a first-come, first-served basis. However, Health Canada found that some submissions were for products not intended for sale or manufacturing in Canada. These applications slowed down the process. The new system prioritizes applications that benefit Canadian businesses and consumers, improving efficiency.
Which applications get priority?
Health Canada will prioritize Class III NHP applications that meet at least one of these criteria:
- New applications for products sold in Canada within six months of licensing.
- Amendments to authorized NHPs intended for the Canadian market within six months of revision.
- Applications or amendments for products manufactured in Canada within six months of licensing.
To qualify for prioritization, applicants must submit a Workload Management Form. Applications without this form will be deprioritized and reviewed based on resource availability.
What does this mean for businesses?
These changes will impact approval timelines and require a new approach for businesses introducing NHPs in Canada. Here’s what you should do:
- Check your product plans – Ensure your application meets the new prioritization criteria before submitting.
- Submit the Workload Management Form – Without it, your application will be reviewed later, when resources allow.
- Plan ahead – If your product won’t be sold or manufactured in Canada within six months, expect longer wait times.
- Stay updated – Follow Health Canada’s official bulletin for ongoing updates.
What should you do next?
Keeping up with Health Canada’s changing regulatory landscape requires careful attention to new requirements and evolving priorities. Quality Smart Solutions offers expert guidance on NHP licensing, regulatory compliance, and submission strategies to help businesses streamline their applications.
If you need help managing your NHP regulatory submissions, contact us today or fill out the form below to ensure your product reaches the Canadian market efficiently.
By staying proactive and adapting to these regulatory changes, businesses can avoid unnecessary delays and successfully navigate Health Canada’s workload management system for Class III NHP applications.
