Workload Management for Class II Natural Health Product Submissions

NHP Product Licensing Bulletin No. 2, June 9, 2025, from the Natural and Non-prescription Health Products Directorate

On this page

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

At a glance

• Starting June 9, 2025, the Natural and Non-prescription Health Products Directorate's (NNHPD) workload management approach will be expanded to include Class II natural health product (NHP) submissions. NNHPD will screen and review Class II submissions based on the same prioritization criteria for Class III submissions.
• This means that NNHPD will no longer manage the applications for review based solely on their date of receipt.
• NNHPD will strive to meet the 90-calendar day service standard for Class II submissions that adhere to the prioritization criteria outlined in this bulletin based on workload volumes and available resources.

Purpose and scope

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

This bulletin provides information on the inclusion of Class II applications in NNHPD's workload management approach. These changes outlined will apply to both Class II new applications and amendments.

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

• Focus review activities on applications that will directly benefit people in Canada 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 soon.

Class II workload management criteria

NNHPD will focus its review efforts on NHPs that are to be sold on the Canadian market and/or manufactured in Canada. The workload management criteria are the same for both Class II and III applications.

NNHPD will focus its review on Class II 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 the licensed being amended, 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 Licensed Natural Health Products Database and associated site information, per section 22 of the Natural Health Products Regulations (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. New Applications must list the licensed Canadian manufacturing site information on the product licence application form. Marketed amendments for an already-licensed product must indicate the manufacturing site information on the Amendment Notification form if it has not already been provided to the NNHPD.

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 after the acknowledgement letter has been issued (with the submission number). 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 as complying with section 22 of the 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 encouraged 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 continue to meet the 90-calendar day service standard for prioritized Class II submissions subject to resource levels and submission volumes.

Implementation

The Class II workload management criteria introduced in this bulletin will take effect on June 9, 2025 on a go forward basis.

• For new applications and amendments submitted on June 9, 2025, and after, applicants will have 7 calendar days to submit their workload management form after receiving their acknowledgement letter and submission number from the NNHPD.
• Applications and amendments submitted prior to June 9, 2025, will be completed first and consequently, do not require a form to be submitted.

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.

Applicants are reminded that the Workload Management Form must be filled out correctly, without error, to ensure your application is prioritized (this is applicable to both Class II and III applications). Applicants must wait for an Acknowledgement Letter with submission number prior to submitting the Workload Management Form. Please verify the following information prior to submitting:

• Company name and code;
• Product's brand name;
• File/submission number;
• NPN (if required);
• Name of Authorized Signing Official and date signed.

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

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 Authorized Signing Official. This includes the Senior Official or an authorized designated party on file. NNHPD will notify the Authorized Signing Official of receipt of their Workload Management Form using weekly automated responses. Additionally, when you submit the form, you will see a message that the form has been submitted.

For new applications and amendments filed as of June 9,2025, the acknowledgment letter for Class II applications has been updated to remind applicants of the prioritization criteria. Additionally, the issuance letter will continue to remind applicants of their responsibilities to notify NNHPD 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 to provide predictability for prioritized NHP applications.

Contact us

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