Workload Management for Class III Natural Health Product Submissions

NHP Product Licensing Bulletin No. 1, March 5, 2025, from the Natural and Non-prescription Health Products Directorate

On this page

• At a glance
• Purpose and scope
• Class III prioritization criteria
• Implementation
• Contact us

At a glance

• Starting March 5, 2025, Class III natural health product (NHP) submissions will be screened and reviewed based on the prioritization criteria presented in this bulletin. This means that the Natural and Non-Prescription Health Products Directorate (NNHPD) will no longer manage the applications for review, based solely on their date of receipt.
• NNHPD will strive to meet the 210-calendar day service standard for Class III submissions that adhere to the prioritization criteria outlined in this bulletin based on workload volumes and available resources.

Purpose and scope

The NNHPD continuously strives to improve its services. This applies to both screening and evaluating NHP licence applications.

This bulletin provides information on changes to the way in which NNHPD will manage screening and review workload for Class III NHP submissions, including both new applications and amendments. These changes outlined do not currently apply to Class I and Class II applications.

NNHPD expects that these workload management criteria will enable Health Canada to:

• Focus review activities on applications that will directly benefit Canadians to ensure these products are safe, effective, and of high quality;
• Focus review on products that are to be manufactured and/or sold in Canada; and
• Incentivize companies to declare which NHPs they are manufacturing, marketing and/or selling in Canada.

For information about the submission process and requirements, refer to the NHP Management of Applications Policy (NHP MAP). NNHPD will update the NHP MAP to reflect the workload management approach for Class III applications soon.

Class III workload management criteria

Historically, NNHPD has reviewed applications on a first-come first-served basis. Given the significant increase in NHP applications, NNHPD will focus its review efforts on NHPs that are to be sold on the Canadian market and/or manufactured in Canada.

The NNHPD will focus its reviews of Class III applications that meet one of the following criteria:

1. Applications: An application for a product that is to be sold in Canada within six months of receiving authorization.
2. Amendments: Change(s) to an authorized NHP that is already sold in Canada or will be sold in Canada within six months of being licensed, regardless of the nature of the change(s)
   • If the product is authorized and already sold in Canada, the market status should be listed as "Active" in the Licenced Natural Health Products Database and associated site information (section 22, NHPR) should have been submitted to NNHPD.
   • A change driven by a risk to the health and safety of Canadians will take priority over others. The amendment and notification form includes a section to note whether the change was in response to a notice issued by NNHPD Risk Management Division.
3. An application or an amendment for a product that is or will be manufactured in Canada within six months of being licensed. These applications must list the licensed Canadian manufacturing site information on the product licence application form.

Applicants must inform NNHPD that their product will be sold or manufactured in Canada within six months of receiving a product licence by submitting a Workload Management Form. There are two Workload Management Forms that the applicant can choose from depending on which criteria they are attesting to meet (see further instructions below under Implementation). Applicants will be required to attest to notifying NNHPD when their product is sold in Canada as well complying with section 22 of the Natural Health Products Regulations (NHPR) by providing valid site information.

Submissions for which a form has not been submitted will be deprioritized for review. NNHPD will review deprioritized submissions, when it is able to do so. Applicants are welcome to withdraw deprioritized submissions and refile when they decide to bring the product to market in Canada within six months of licensing.

Through this workload management approach, NNHPD will focus its limited resources on submissions that support the health and safety of people in Canada and aim to provide predictability to companies meeting the criteria. NNHPD's intention is to return to meeting the 210-calendar day service standard for prioritized Class III submissions subject to resource levels and submission volumes.

Implementation

The Class III workload management criteria introduced in this bulletin will take effect on March 5, 2025.

The changes outlined herein do not apply to Class I and Class II applications, at this time. As such, Class I and Class II applications will continue to be processed based on their date of receipt. Should the volume of Class I and Class II applications increase beyond our capacity, NNHPD may revisit this approach.

There are two Workload Management Forms that the applicant will choose from depending on which criteria their product meets:

• Workload Management Form – Products Sold in Canada: For new applications and amendments for products that will be sold (and if applicable, manufactured) in Canada within six months of being licensed.
• Workload Management Form – Manufactured in Canada: For new applications and amendments for products that will not be sold but will be manufactured in Canada within six months of being licensed.

Each form allows for up to twenty products to be entered. Prioritization requests beyond twenty, will need to submit multiple forms.

Class III submissions that are actively being worked on will be completed. Once done, NNHPD will assign, and review applications based on attestation to meeting the criteria using the Workload Management Form and the date the application was received.

As of March 5, 2025, applicants will have to submit a Workload Management Form to have their submissions prioritized.

• For new applications and amendments submitted on March 5, 2025, and after, applicants will have 15 calendar days to submit their form after receiving their acknowledgement letter and submission number from the NNHPD.
• For applications and amendments submitted prior to March 5, 2025, applicants will have until May 1, 2025, to submit their form.

Please note, that the form requires the product's brand name, submission number and file number to be processed. If you have submitted your application prior to March 5, 2025, please wait for your acknowledgement letter to be issued with the required information to complete the form. Applicants are reminded that the provision of false or misleading information on an application constitutes a violation of the NHPR and may result in refusal of the submission or regulatory action.

The Workload Management Form must be signed by an Authorised Signing Official. This includes the Senior Official or an authorised designated party. The NNHPD will not notify applicants of receipt of their Workload Management Form. However, when you submit the form, you will receive a pop-up message that the form has been submitted.

For new submissions filed as of March 5, 2025, the acknowledgment letter for Class III applications has been updated to remind applicants of the prioritization factors. Additionally, the issuance letter will continue to remind applicants of their responsibilities to notify that their product is being sold in Canada and to provide valid site information before commencing sale as per section 22 of the NHPR.

NNHPD will monitor the implementation of this workload management initiative against the intended purpose and provide predictability for prioritized NHP applications.

Contact us

For inquiries about this bulletin, please contact us by email: nnhpd-dpsnso@hc-sc.gc.ca.