Introduced Expansion
On June 9, 2025, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) officially expanded its Workload Management Approach to include Class II natural health product (NHP) applications. This update changes how certain submissions will be reviewed based on urgency and commercial readiness. Specifically, the NNHPD is now prioritizing Class II applications that align with specific business and public health priorities, rather than reviewing applications solely based on the order they were received.
This change means that not all Class II submissions will be treated equally in terms of review timing. Companies that meet the new criteria and follow the updated process will benefit from a faster turnaround, while others may face delays if they do not align with the new framework or fail to submit the necessary forms.
Read our earlier blog to learn more about the Workload Management Approach.
What Products Are Eligible for the Workload Management?
The updated workload management framework applies to companies submitting Class II NHP applications or amendments after June 9, 2025. For a submission to be eligible for priority review, the product must meet at least one of three conditions:
- The application is for a product that will be sold in Canada within six months of being licensed.
- The amendment is for a product that is authorized and marketed in Canada, or is for a product that is to be sold in Canada within six months of being revised.
- The application or an amendment is for a product that is or will be manufactured in Canada within six months of being licensed.
These specific eligibility conditions were designed to ensure that regulatory resources are focused on products that have imminent commercial significance or contribute to the Canadian economy.
How and When to Submit a Workload Management Form
If your submission meets any of the priority review criteria, you are now required to submit one of the two designated Workload Management Forms (WMF for Products Sold in Canada or WMF for Products Manufactured in Canada) within seven calendar days of receiving the NNHPD acknowledgment and submission number. These forms provide the necessary information for NNHPD to validate and prioritize your submission.
Applications and amendments submitted prior to June 9, 2025, will continue to be reviewed according to their place in the existing queue. These do not require the new forms. However, all submissions made on or after June 9 must include the appropriate documentation to be considered for priority treatment. If no form is submitted, your application will be deprioritized and only reviewed as resources allow, which could result in significant delays.
More detailed guidance and submission instructions can be found on the official Health Canada website. The bulletin provides additional context and answers for companies seeking clarity on the new process: Health Canada Class II Submissions Bulletin
Why is the Workload Management Approach Important?
This shift is a strategic update that reflects Health Canada’s growing emphasis on efficient regulation, commercial relevance, and domestic production. For businesses, this offers an opportunity to accelerate product launches by aligning with public health and economic priorities. However, it also creates new administrative responsibilities and a heightened need for regulatory compliance.
Failing to submit the necessary forms or misunderstanding the new process can lead to long review times or missed market opportunities. On the other hand, businesses that adapt quickly and engage with the new guidelines will gain a competitive edge in the Canadian natural health product market.
How Can We Help?
At Source Nutraceutical Inc., we specialize in regulatory strategy and submission management for natural health products in Canada. Our regulatory experts are fully briefed on the NNHPD’s latest changes and are ready to assist you in identifying whether your submission qualifies for prioritization. We’ll guide you through the entire process, ensuring you submit the right form at the right time, and that your product remains compliant throughout.
Whether you are launching a new supplement, reformulating an existing one, or expanding manufacturing operations in Canada, our team is here to help you navigate this new regulatory landscape. Connect with us to ensure your submission stays on track and takes full advantage of the priority review process.
Submit the below form and one of our team members will reach out to schedule an introductory call:
Frequently Asked Questions
What is the Workload Management Approach?
This is Health Canada’s strategic method of allocating review resources based on the commercial readiness and national relevance of natural health product submissions, rather than reviewing all submissions on a first-come, first-served basis.
Which submissions qualify for prioritized review?
Eligible submissions include new products set for Canadian sale within six months, amendments to authorized products that will also be sold within six months, or any product that will be manufactured in Canada within the same time frame.
What happens if I don’t submit a Workload Management Form?
Applications submitted after June 9, 2025, without the required form will be deprioritized and reviewed only when resources allow. This can lead to substantial delays.
When is the deadline to submit the form?
The Workload Management Form must be submitted within seven calendar days of receiving the NNHPD’s acknowledgment of your submission and your submission number.
What is the review timeline for prioritized applications?
Health Canada aims to review prioritized Class II NHP submissions within 90 calendar days, although this may vary depending on submission volumes and resource availability.
