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. As of March 5, 2025, submissions will no longer be assessed on a first-come, first-served basis. Instead, NNHPD will prioritize applications that demonstrate clear plans for sale or manufacturing in Canada within six months of approval. This change aims to streamline the regulatory process, ensuring resources are allocated to products that will directly benefit Canadian consumers.

For companies planning to bring Class III NHPs to market, understanding these new 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 has introduced this new approach to improve efficiency in evaluating Class III NHP applications and amendments.

These changes:

• Apply only to Class III submissions (not Class I or II).
• 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 for their products.

The ultimate goal is to ensure that the regulatory process supports 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 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.
• Health & Safety Considerations: If an amendment is required due to an identified risk to consumer safety, it will receive top priority.
• Manufacturing in Canada: The product will be manufactured in Canada within six months of being licensed.

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

How to Be Prepared

To ensure your Class III NHP submission remains a priority, companies must take the following steps:

1. Submit a Workload Management Form – Applicants must attest that their product will be sold or manufactured in Canada within six months. There are two forms:
   • “Sold in Canada” Form: For products to be sold (and if applicable, manufactured) in Canada.
   • “Manufactured in Canada” Form: For products that will be manufactured but not sold in Canada.
2. Meet Submission Deadlines:
   • Applications on or after March 5, 2025: Submit the form within 15 calendar days of receiving an acknowledgment letter.
   • Applications before March 5, 2025: Have until May 1, 2025 to submit the form.
3. Ensure Proper Documentation – The form must include:
   • Product brand name
   • Submission number
   • File number
4. Sign the Form Correctly – It must be signed by an Authorized Signing Official (e.g., a Senior Official or designated representative).
5. Stay Compliant – Companies must comply with section 22 of the Natural Health Products Regulations (NHPR) by keeping site information up to date.

Failure to submit the Workload Management Form on time will result in delays or de-prioritization of your application.

Get Expert Advice

Navigating regulatory changes can be complex. If you need help ensuring your 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 5, 2025, come and gone, now is the time to ensure your application is in order. Contact us today to discuss how we can help you navigate these new requirements with confidence.