Health Canada has released an updated version of the Natural Health Products Management of Applications Policy (NHP MAP), replacing the previous guidance published in April 2019. The revised NHP MAP was released alongside updates to the Web Product Licence Application (PLA) form and the Amendment and Notification Form (ANF), reflecting changes to how Natural Health Products (NHPs) are reviewed and prioritized by the Natural and Non-prescription Health Products Directorate (NNHPD).

In short: the updated NHP MAP introduces new eligibility requirements, clearer classification rules, and more structured review processes that directly impact how and when NHP applications are assessed in Canada.

You can access the guidance documents here:

• Updated NHP MAP (2025)
• Previous NHP MAP (2019)

One of the most immediate signals that this is more than a minor update is the size of the guidance itself. The previous NHP MAP was approximately 43 pages, while the updated version exceeds 100 pages. The expansion reflects a more detailed description of the entire product licence application (PLA) lifecycle, including pre-submission engagement, application screening, regulatory assessment, and post-licensing oversight (though some of the additional length is due to formatting changes).

Because the NHP MAP governs how product licence applications are managed and reviewed by Health Canada, updates to this policy can directly affect submission eligibility, timelines, and regulatory strategy for companies seeking to market natural health products in Canada.

Scope and Purpose

The updated NHP MAP provides guidance on how Health Canada manages and reviews Product Licence Applications (PLAs) for natural health products under the Natural Health Products Regulations (NHPR).

The document outlines:

• Responsibilities of applicants and licence holders
• The submission and review process for NHP applications
• How NNHPD screens, prioritizes, and assesses submissions
• Expectations for post-licensing activities, including amendments and notifications

The policy applies to Class I, II, and III NHP applications, including new product licences, amendments to existing licences, and regulatory notifications.

However, the NHP MAP does not apply to:

• Site licence applications
• NHP clinical trial applications
• Products regulated under other frameworks such as foods, drugs, or medical devices

While the 2019 guidance focused primarily on how applications move through the review process, the updated NHP MAP expands the product lifecycle perspective, placing greater emphasis on post-licensing management and ongoing compliance.

Key Changes in the Updated NHP MAP

While many updates clarify existing processes, several changes have meaningful implications for NHP manufacturers, importers, and licence holders.

1. Market-Based Eligibility for Product Licence Applications

One of the most important updates is the introduction of explicit market-based eligibility criteria for submissions.

Health Canada now requires applicants to confirm that their product will be:

• Sold in Canada within 12 months of receiving authorization, or
• Manufactured in Canada within 12 months of receiving authorization

These questions are now embedded directly into the Web PLA form, and the system will not allow submission unless at least one of these conditions is met.

Previously, a separate Workload Management Form was used to determine eligibility under a six-month timeframe. The updated approach:

• Extends the eligibility window to 12 months
• Integrates the eligibility check directly into the application form
• Eliminates the need for a separate workload management form

For industry, this signals that NNHPD is prioritizing submissions tied to active Canadian market activity or benefit to Canadian manufacturing, rather than speculative or dormant applications.

2. Prioritization of Amendments and Notifications

The updated NHP MAP extends this market-focused approach to post-licensing submissions.

Amendments and notifications will now be prioritized for products that:

• Are already sold or manufactured in Canada, or
• Will be sold or manufactured within 12 months of the amended authorization

Health Canada also encourages companies to discontinue licences for products that are no longer sold or intended for the Canadian market.

For companies managing large product portfolios, this reinforces the importance of maintaining an active and accurate inventory of product licences.

3. Expanded Guidance on Application Classification

The revised NHP MAP provides more detail on how NHP applications are classified and assessed.

Updates include:

• Clearer distinctions between application types and application classes
• Expanded guidance on Class I, II, and III applications
• Additional detail on the use of monographs and compendial references
• More explanation of when combination products may require Class III review

The document also clarifies expectations related to:

• Non-medicinal ingredients
• Specifications and quality requirements
• Storage conditions
• Situations where certain monograph conditions may be omitted

For companies developing new products, these expanded explanations provide a clearer framework for determining the appropriate submission pathway.

4. More Structured Pre-Submission Engagement

The updated guidance formalizes Health Canada’s approach to pre-submission engagement.

Notable clarifications include:

• NNHPD does not issue formal product classification decisions prior to submission
• Pre-submission inquiries are limited to clarifications on guidance
• Pre-submission meetings are conducted virtually
• NNHPD may respond in writing instead of scheduling a meeting

The guidance also outlines expectations for pre-submission information packages, providing clearer direction for applicants seeking feedback.

5. More Detailed Screening and Information Request Processes

The revised NHP MAP includes expanded detail on how applications move through:

• Administrative screening
• Regulatory screening
• Scientific assessment

Health Canada has also clarified its approach to Information Request Notices (IRNs).

Key points include:

• NNHPD aims to issue one comprehensive IRN per stage
• Previously identified deficiencies will generally not be re-issued
• Unsolicited changes are not accepted outside IRN responses
• IRN response timelines typically range from 5 to 15 calendar days

These changes reinforce the importance of submitting complete and high-quality applications from the outset.

6. Expanded Post-Licensing Guidance

The updated NHP MAP devotes significantly more attention to post-licensing activities.

Expanded areas include:

• Amendments and notifications
• Correction requests
• Licence discontinuation
• Post-licensing compliance monitoring
• Post-licence issues and follow-up actions

Additional appendices provide detailed guidance on:

• Post-licence changes
• Amendment classifications
• Service standards

For licence holders, this provides a clearer roadmap for managing ongoing regulatory obligations.

Review Order for NHP Product Licence Applications

In addition to the updates introduced through the revised NHP MAP, Health Canada has clarified how product licence applications (PLAs) are assigned for review, addressing ongoing questions related to application backlogs.

Due to the high volume of submissions, applications are not always reviewed based on their original submission date.

Instead, review order is determined based on when prioritization was established, depending on whether the application was submitted before or after the December 15, 2025 system update.

Applications submitted before December 15, 2025

Review order will be based on:

• the date the Workload Management Form (WMF) was submitted; and
• where multiple applications share the same prioritization date, the original application receipt date

Applications submitted on or after December 15, 2025

Review priority is based on:

• the date the application is received by Health Canada

This reflects the transition to the updated NHP MAP eligibility framework, where attestations are now built directly into the PLA form.

For companies with applications already in the system, this means the prioritization date—not the original submission date—may determine when an application is reviewed.

How to Be Prepared

Because the updated NHP MAP and review prioritization approach are already in effect, companies should review their regulatory strategies to ensure alignment.

Key steps include:

• Confirming submissions meet the 12-month eligibility requirement
• Reviewing portfolios for inactive or dormant licences
• Reassessing Class I, II, III classification accuracy
• Strengthening submission quality controls
• Ensuring NHPID and supporting documentation are complete and accurate
• Reviewing internal processes for amendments and notifications

Even where requirements have not fundamentally changed, the updated NHP MAP provides greater clarity on how NNHPD interprets and applies regulatory expectations.

Get Expert Advice

The updated NHP MAP reflects Health Canada’s effort to streamline application management while focusing regulatory resources on products that will benefit the Canadian market.

For industry, this means greater transparency—but also higher expectations for submission quality, classification accuracy, and regulatory planning.

dicentra has completed more than 24,000 regulatory and compliance projects supporting companies in the natural health product sector. We assist clients with NPN applications, regulatory strategy, product classification, amendments, notifications, and ongoing licence maintenance.

Our team helps organizations interpret evolving Health Canada guidance and translate it into practical regulatory strategies that support successful product launches and long-term compliance.

If you would like to understand how the updated NHP MAP may affect your product pipeline or existing licences, connect with dicentra today.