Natural Health Products Management of Applications Policy: Preparing and submitting your application

On this page

• Eligibility criteria for product licence applications
• Attestation requirements for submission
• Monograph attestation requirements by application type
• Summary report for class III applications
• Finished product specifications and attestation requirements
• Kit applications
• Site information
• Submitting your application

Eligibility criteria for product licence applications

New applications

You do not require a product licence if you do not intend to sell or manufacture your product in Canada.

NNHPD accepts PLAs for NHPs that will benefit Canadians. NNHPD will accept Class I, II, and III applications that meet the following criteria:

• The product is intended to be sold or manufactured in Canada within 12 months of receiving authorization.

Amendments & Notifications

NNHPD prioritizes amendments and notifications that meet the below criteria.

Changes to an authorized NHP that is:

• already sold in Canada; or
• will be sold or manufactured in Canada within 12 months of the licence being amended, regardless of the nature of the change(s).

Manufacturing in Canada

You are required to provide site information for products that will be manufactured in Canada as per section 22 of the NHPR:

• new applications must include site information in the PLA if available at the time of filing.
  • Otherwise, you must provide it prior to the sale or manufacture of your licensed product.
• amendments for marketed products must include all site information in the Amendment Notification Form if it has not already been provided to NNHPD

Additional considerations:

• If the product is authorized and currently sold in Canada, its market status should be listed as "Active" in the Licensed Natural Health Products Database.
• Amendments prompted by a risk to the health and safety of Canadians will be prioritized. The Amendment and Notification Form includes a section to indicate whether the change is in response to a notice issued by NNHPD's Risk Management Division.

Refer to Appendix III for more information on application requirements.

Attestation requirements for submission

You must respond to attestation questions in the relevant form to confirm eligibility.

PLA form

You only need to obtain a product licence if you intend to sell or manufacture your product in Canada. The PLA form includes 2 questions in the Sales Intentions section to this effect:

• will this product be sold in Canada within 12 months of receiving authorization?
• will this product be manufactured in Canada within 12 months of receiving authorization?

Proceed as follows:

• If you intend to sell the product in Canada within 12 months of receiving authorization, answer "Yes" to the first question. Otherwise, answer "No".
• If you intend to manufacture the product in Canada within 12 months of receiving authorization, answer "Yes" to the second question. Otherwise, answer "No".
  • The application system will only finalize the form if you answered "Yes" to at least one of these questions.
• If your intentions change, you may complete and submit the application once you expect to sell and/or manufacture the product in Canada within the required timeframe.

Amendment and Notification Form (ANF)

The ANF includes the following attestation questions:

• is this product currently being sold in Canada?
• will this product be sold in Canada within 12 months of receiving a revised authorization?
• will this product be manufactured in Canada within 12 months of receiving a revised authorization?

To ensure Health Canada directs its resources toward products that benefit Canadians, we encourage you to discontinue your product licence if you have not sold or do not plan to sell or manufacture your product in Canada. If you discontinue the licence, you will not need to submit any amendments or notifications for that product licence.

The ANF does not prevent you from submitting amendments or notifications for products that you do not sell or manufacture (or intend to sell or manufacture) in Canada. However, if you choose to do so, we will not prioritize your application.

Applicant responsibilities

By selecting "Yes" to the attestation questions in either the PLA or ANF, you confirm your intent to notify NNHPD once the product becomes available for sale in Canada. The issuance letter reminds you of your obligation to:

• notify NNHPD when the product is being sold in Canada
• provide valid site information prior to commencing sale, as required under section 22 of the NHPR

Language of submission

Applications may be submitted in either of Canada's official languages (English or French).

The language you select at the time of submission for the product information presented on the PLA form should be used consistently throughout the entire submission process and, preferably, for any post-licensing applications. NNHPD will issue correspondence, including a regulatory decision in the language of the application.

Application classification and cover letter requirements

To facilitate processing and assessment of the PLA, and to ensure appropriate resource allocation, you must clearly identify the application class (Class I, II, or III) in both the PLA form and the cover letter (if required). You must base this classification on the definitions provided in the Application types and classes section.

A cover letter is required in the following situations:

• relevant company updates
• additional context relevant to the submission
• multiple PLA forms submitted (for kit applications)
• rationale for not fully attesting to a monograph or for omitting monograph statements
• verified form limitations confirmed through correspondence with NNHPD (for example: inability to select the correct class)

Cover letters are also useful for clarifying application details, particularly when technical limitations of the web-based forms or templates prevent accurate data entry. You may use the cover letter to:

• explain discrepancies
• provide context for unusual product features
• highlight supporting documents that may not be clearly linked in the submission

The cover letter may also include the Summary Report (if applicable).

We recommend that you include an overview of the submission contents (a table of contents).

Submission format

NNHPD does not accept scanned or PDF copies of the online PLA form. If you submit these formats, NNHPD will refuse the application. If you include scanned or PDF versions along with the online PLA form, NNHPD will disregard them during screening and review.

Refer to Appendix III for a detailed overview of application requirements by type and class.

Application forms

You must use 1 of 2 application forms, depending on the type of submission:

• new applications must be submitted using the web-based PLA form.
• post-licensing changes (amendments and notifications) for licensed NHPs must be submitted using the ANF.

You must use the most recent version of the PLA form or ANF. NNHPD does not accept submissions using outdated versions and will refuse them. In rare cases where you cannot use the forms, you should contact the Client Support Unit (nnhpd-dpsnso@hc-sc.gc.ca) for specific guidance.

Single application for multiple products

You may submit a single PLA in the following scenarios:

• multiple flavours, fragrances, or colours: if the only differences between products are the non-medicinal ingredients responsible for flavour, colour, or fragrance, they may be included in one application. All other product details (for example dosage form, claims, medicinal ingredients) must be identical.
• multiple net amounts: for example, a product sold in bottles of 90 or 180 capsules requires only one application.

Technical issues

For technical issues with the PLA or ANF form, contact the NHP Online Solution Team at nhp.initiative-psn@hc-sc.gc.ca as soon as possible.

If the issue remains unresolved at the time of submission:

• include a summary of the issue and the guidance provided by the NHP Online Solution Team in the cover letter.
• attach the relevant email correspondence to the application.

Animal Tissue Form requirements

When required, you must complete an Animal Tissue Form (ATF). An ATF may be necessary for the following types of ingredients:

• MIs
• NMIs
• ingredients used in processing (for example: not present in the final product)

A separate ATF must be provided for each:

• individual ingredient (medicinal, non-medicinal, or processing-related)
• type of process
• type of animal (for example: mammal, bird, or crustacean)

Letter of access

You may reference supporting information from another company's application(s) and/or licensed NHP using a letter of access. This letter authorizes NNHPD to access the specified information and must be:

• on official company letterhead of the company being referenced
• dated and signed by the Senior Official or an approved company contact of the referenced application
• addressed directly to the applicant or product licence holder (not to a third-party consultant)
• no older than three years

The letter must clearly state the:

• name of the company granting reference
• name of the company receiving reference
• product name and submission number of the referenced application
• NPN or Drug Identification Number–Homeopathic Medicine (DIN-HM), if applicable.

Designated Party Authorization forms

You must submit a Designated Party Authorization form (DPA) when the party submitting the application is a designated party acting on behalf of the Senior Official of the applicant company or product licence holder according to section 5(b) of the NHPR.

This authorization allows the contact person(s) to act on behalf of the applicant company or product licence holder for functions such as:

• submitting applications (for example: NPN applications, NHP-MFs, amendments, notifications)
• receiving and responding to Information Request Notices (IRNs)
• receiving and responding to regulatory notices (for example: safety concerns)
• submitting a request to withdraw the application or discontinue the product on behalf of the applicant or licensee

You must submit a DPA form once for each contact within a given company. You do not need to include the form with every application, as long as the authorization clearly allows the designated party to act on behalf of the Senior Official for multiple applications.

Acceptable signature formats are:

• hand-signed
• electronically signed
• docu-signed

Submitting a DPA form does not exempt you (or the product licence holder) from the responsibility to:

• maintain relevant records related to the PLA; and,
• ensure that the sale of your product complies with all applicable sections of the NHPR (once licensed), including record retention

To revoke a DPA, NNHPD requires a letter be sent via Connect in the new NHP applications conversation. The letter must be on company letterhead and signed by the Senior Official clearly indicating the end date of the DPA.

Label text

All PLAs must include corresponding label text that complies with the requirements outlined in sections 87-94 of the NHPR.

This requirement can be fulfilled in one of two ways:

• using the label text generator within the PLA form; or
• submitting the label separately in Word or PDF format

Monograph attestation requirements by application class

To meet all safety, efficacy, and/or quality requirements, you must either:

• attest to one or more NNHPD monographs from the Compendium of Monographs, (using the PLA form); and/or
• provide supporting evidence as outlined in Appendix II

Refer to Appendix V for more information on attesting to NNHPD monographs.

Class I applications

• You must fully attest to all parameters of a single monograph
• The PLA form will automatically validate most submitted information against the selected monograph
• If any validated parameter does not meet the monograph requirements, the form will display an error message, preventing finalization of the application

Class II applications

• You must select all applicable monographs on the PLA form to which you attest
• Upon receipt, NNHPD will verify the application against the selected monographs
• Deviations from monograph parameters will be assessed as outlined in the section on application types and classes
• Appendix V outlines specific cases where conditions of use may be omitted when combining monographs

Class III applications

• You must select all relevant monographs on the PLA form, if applicable
• Any non-compliant parameters must be clearly identified in the Summary Report or cover letter
• For each parameter not covered by a monograph, you must provide:
  • supporting evidence; or
  • a scientific rationale, as outlined in Appendix II.

Products containing nanomaterial ingredients must be submitted as a Class III application, unless nanomaterial ingredients specification details are included in monographs. Any manufacturing process that may affect the safety or efficacy of ingredients, such as those involving novel technologies (for example: nanotechnology), must be supported by appropriate evidence under the Class III application stream. For information on nanomaterials, refer to the Policy Statement on Health Canada's Working Definition for Nanomaterial.

Summary report for class III applications

NNHPD strongly encourages you to include a summary report in all Class III applications, especially for complex submissions such as those involving multiple extrapolations. Including a summary report helps guide and streamline the assessment process and may reduce review timelines.

In general, the summary report should:

• demonstrate how each piece of submitted information supports the recommended conditions of use for the NHP
• reflect the totality of available evidence relevant to the product
• provide context for any apparent gaps or uncertainties related to the product's safety, efficacy, and/or quality

For products with multiple MIs and/or multiple claims, it is helpful to clearly link each piece of evidence to the specific ingredient(s) or claim(s).

Where applicable, the report should explain how the evidence:

• relates to the ingredient's form (for example: source material) or preparation (for example: extraction method)
• supports the product's recommended conditions of use (for example: dosage information)

Additional resources

For more detailed guidance on summary reports, refer to:

• Appendix IV – Example of a summary report
• Pathway for Licensing Natural Health Products Making Modern Health Claims
• Evidence for Homeopathic Medicines
• Pathway for Licensing Natural Health Products Used as Traditional Medicines

Finished product specifications and attestation requirements

When you submit a Class I application, you attest that your product meets the specifications outlined in both the relevant NNHPD monograph and the Quality of Natural Health Products Guide.

It is your responsibility to ensure you are familiar with all applicable regulatory requirements when providing this attestation.

You do not need to submit finished product specifications (FPS) with Class I PLAs or Class I amendment applications; however, FPS must:

• be established in accordance with the requirements described in the Quality of Natural Health Products Guide
• remain in compliance with the requirements described in the Quality of Natural Health Products Guide; and
• be provided to Health Canada upon request

Kit applications

A kit is defined as a package that includes either multiple NHPs, or a combination of one or more NHPs with foods, non-prescription drugs, cosmetics, or medical devices. The kit is intended to deliver a combined benefit, such as unified branding or overarching health claims.

NNHPD requires that the MIs and NMIs for each component (that is, each product within the kit) be listed separately for kit applications. You meet this requirement by submitting individual PLA forms (one PLA form for each component of the kit).

Each PLA form must:

• include the same recommended conditions of use across all components
• indicate that the application is for a kit by checking the "This application is for a kit" box on the PLA form

Additionally, you must:

• specify the number of PLA forms included in the kit in the cover letter

Site information

In accordance with section 22 of the NHPR, you must provide site information for each manufacturer, packager, labeller, importer, distributor, and/or storage facility prior to the sale of the NHP.

Where available, the following details must be included in the PLA form under Part 3 – Site Information:

• company name
• address
• site licence number (for Canadian sites)

An NHP cannot be sold in Canada until:

• an NPN or DIN-HM is issued, and
• complete site information has been provided to NNHPD.

For questions regarding the site licensing process, contact Health Canada's Regulatory Operations and Enforcement Branch at: hpcd.nhp.sl-dcps.psn.le@hc-sc.gc.ca

Submitting your application

Once you submit an application, NNHPD does not accept unsolicited changes or additional information, except for updates to contact information.

If you wish to make changes to a submitted PLA, you must withdraw the original application and submit a new one with the revised information.

Electronic submission requirements

NNHPD only accepts applications submitted electronically. The current method for electronic submission is via Canada Post's secure email service, Connect.

To use Connect, you must be enrolled as a Trading Partner. For details, refer to the guidance on Electronically contacting the Natural and Non-prescription Health Products Directorate.

In rare cases where the PLA or ANF forms cannot be used, contact the Client Support Unit (nnhpd-dpsnso@hc-sc.gc.ca) who will provide additional guidance.

Submission instructions

All NHP applications must be submitted to the following Connect account:

nhpsn.epostel.applications

NNHPD uses this account to initiate company-specific conversation threads. All new applications, amendments, and notifications must be submitted to this account.

High volume submission notification

You are expected to notify NNHPD in advance if you plan to submit a large volume of applications over a short period of time (for example: more than 20 applications per week). This applies to all application classes, including amendments and notifications.

Early notification allows NNHPD to work with you to develop a submission plan that supports timely processing and assessment in alignment with service standards.