Starting June 9, 2025, Class II NHP submissions will no longer be reviewed just based on the date you filed them. Health Canada is updating how it handles licensing applications by applying a new workload management approach, prioritizing submissions based on intent to sell or manufacture in Canada.
If your product doesn’t meet these criteria, or you forget to submit the right form, your application might be delayed. In this blog, we explain what the new approach means, how it affects your licensing strategy, and what steps you need to take to stay on track.
What are Class II NHPs?
Class II natural health products (NHPs) fall in the middle of Health Canada’s risk-based classification system. These products usually include ingredients with strong evidence of safety and efficacy but require more documentation than Class I products.
Unlike Class I submissions, which rely only on pre-cleared information, Class II submissions may combine monograph and non-monograph ingredients. This means applicants need to provide additional data to support their claims, though review times are typically faster than for Class III submissions.
Why Health Canada is changing how it handles Class II NHPs
Until now, Class II NHP submissions were managed on a first-come, first-served basis. But with growing submission volumes and limited resources, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) is shifting its review strategy.
From June 9 onward, only applications that show a clear intent to sell or manufacture in Canada within six months will be prioritized for review. This aligns with how Class III submissions are already being handled. For you, this means extra steps, but also more predictability if you follow them correctly.
What you need to do to stay compliant
To benefit from prioritized review, you’ll need to follow a few extra steps under Health Canada’s updated system. It’s no longer just about submitting your application and waiting your turn. Now, Health Canada is prioritizing submissions that show a clear plan to enter the Canadian market soon.
If you plan to sell or manufacture your product within six months of licensing, and you submit the correct form on time, you’ll move ahead in the queue. If not, your submission could be delayed. Here’s what you’ll need to do to stay on track:
- Confirm that your product will be sold or manufactured in Canada within six months of licensing
- Submit a Workload Management Form within seven days of receiving your acknowledgment letter from NNHPD
- Provide accurate information, including your submission number, brand name, and authorized signing official
The form you choose will depend on whether the product is being sold or only manufactured in Canada. And yes, Health Canada will deprioritize your file if you skip this step or fill it out incorrectly.
Supporting your Class II NHP submissions
Navigating licensing is already a time-consuming process. With these new changes, staying compliant is about more than just submitting the right paperwork, it’s about knowing when and how to act.
At Quality Smart Solutions, we help guide you through every stage of the NHP licensing process. We prepare your product licence application, assist with your Workload Management Form, and make sure your submission is complete, accurate, and aligned with the new criteria.
We act as your regulatory partner, so you don’t have to worry about missed deadlines or deprioritized submissions.
Key tips for staying on track with Health Canada’s new process
Here’s what to keep in mind when submitting your Class II NHP application:
- Choose the right form:
- Form 1: Products Sold in Canada – For products intended for sale (and possibly manufacturing) or
- Form 2: Manufactured in Canada – For products only being manufactured, not sold
- Submit within 7 days: Once you receive your acknowledgment letter and submission number, you have 7 calendar days to submit your form
- Verify your info: Double-check your company name, brand name, file/submission number, and signing official
- Monitor your submission status: If your form isn’t submitted or is filled out incorrectly, your submission will be reviewed later, when resources allow
- Include accurate site info: You must comply with section 22 of the NHPR by providing valid site details before your product goes to market
For additional information, you can check the full bulletin directly from Health Canada.
Frequently asked questions
Will my Class II submission be delayed if I don’t submit the form?
Yes. Without the Workload Management Form, your application will be deprioritized and only reviewed when capacity allows.
Is it still worth submitting if I’m unsure about launching in Canada within 6 months?
It’s better to wait. You can withdraw and resubmit when your product is closer to entering the market.
What if I already submitted before June 9, 2025?
Good news, applications submitted before this date don’t need a Workload Management Form and will be processed under the previous system.
What if my product is both manufactured and sold in Canada?
You can use the ‘Products Sold in Canada’ form and include both sets of information in your submission.
Ready to get licensed? Let us help
Health Canada’s updated process for Class II NHP submissions puts more pressure on applicants to meet the right requirements within a narrow timeframe. But you don’t have to manage this alone.
Our experts at Quality Smart Solutions are here to guide you through it all, from forms to filings and final approvals. Get in touch with us today or learn more about our Natural Health Product licensing and consulting services. Let’s make your path to compliance easier.
