Originally published March 10, 2025. Updated June 18, 2025, to reflect Health Canada’s June 9 expansion of the workload prioritization approach to include Class II submissions.

Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) has announced a major shift in how Class III Natural Health Product (NHP) submissions will be reviewed—and has now expanded this approach to include Class II submissions as well.

As of March 5, 2025, Class III submissions are no longer assessed on a first-come, first-served basis. Instead, NNHPD prioritizes applications that demonstrate clear plans for sale or manufacturing in Canada within six months of approval. As of June 9, 2025, this same workload management approach will apply to Class II submissions.

These changes aim to streamline the regulatory process by ensuring resources are directed toward products that will directly benefit Canadian consumers.

For companies planning to bring Class II or Class III NHPs to market, understanding these workload management criteria is critical. In this blog, we break down what’s changing, how it affects you, and what steps you should take to ensure your submission remains a priority.

Scope & Purpose

The NNHPD introduced this workload management approach to improve efficiency in evaluating Class III NHP applications and amendments. With this recent update, the same principles now apply to Class II submissions.

These changes:

• Apply to both Class II and Class III submissions (not Class I)
• Prioritize applications for NHPs that will be sold or manufactured in Canada
• Help allocate Health Canada’s resources to ensure timely and predictable approvals
• Encourage companies to be transparent about their market plans

The ultimate goal is to support the availability of safe, effective, and high-quality natural health products for Canadians.

What You Need to Know

Moving forward, NNHPD will only prioritize Class II and Class III applications that meet at least one of the following criteria:

• New Applications: The product will be sold in Canada within six months of receiving authorization
• Amendments: Any change to an already licensed NHP that is currently being sold or will be sold within six months
• Manufacturing in Canada: The product will be manufactured in Canada within six months of being licensed
• (Class III only): If an amendment is required due to an identified risk to consumer safety, it will receive top priority

If a submission does not meet these criteria, it will be deprioritized, meaning it will only be reviewed when resources allow. Companies may choose to withdraw and refile later when they plan to bring the product to market in Canada.

Timelines and Workload Management Form Requirements

To maintain priority status, applicants must submit a Workload Management Form confirming either a sales or manufacturing plan in Canada. The form must be submitted within a specific timeframe, depending on when the application was filed.

There are two types of Workload Management Forms:

• “Sold in Canada” Form: For products intended to be sold (and, if applicable, manufactured) in Canada
• “Manufactured in Canada” Form: For products that will be manufactured but not sold in Canada

Each form must include:

• Product brand name
• Submission number
• File number
• Signature from an Authorized Signing Official (e.g., a senior official or designated representative)

Failure to submit the form by the required deadline will result in the application being deprioritized.

Stay Compliant

Applicants are also reminded that they must remain compliant with Section 22 of the Natural Health Products Regulations (NHPR), which requires companies to keep site information up to date. Failure to do so can lead to delays in the review process.

Health Canada has posted a bulletin outlining the Class II changes and submission steps. The bulletin can be found here:
https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/natural-health-product-licensing/bulletin/class-ii-submissions.html

Get Expert Advice

Navigating regulatory changes can be complex. If you need help ensuring your Class II or Class III NHP submission meets the new workload management criteria, working with an experienced regulatory consulting firm can streamline the process and minimize delays.

At dicentra, we specialize in helping businesses achieve NHP compliance and secure regulatory approvals. As a leading regulatory consulting firm and Contract Research Organization (CRO) based in Canada, dicentra has been supporting clients for over 23 years. Our team can assist you with:

• Submission preparation and strategy
• Completing and submitting the Workload Management Form
• Ensuring compliance with NHPR requirements
• Ongoing regulatory support for amendments and market entry

With the March and June 2025 changes now in effect, now is the time to ensure your application is in order. Contact us today to discuss how we can help you navigate these requirements with confidence.