Natural Health Products Management of Applications Policy: Pre-submission process

On this page

• Determining whether a product is a natural health product
• Application types
• Application classes
• Before submitting a product licence application
• Master File
• Modifying the Natural Health Products Ingredients Database
• New company registration

Determining whether a product is a natural health product

As the applicant, you must confirm that your product meets the definition of an NHP as outlined in section 1(1) of the NHPR before you submit a product licence application (PLA).

To be classified as an NHP, a product must meet both the substance and function criteria.

Substance criteria

The product must contain, or be considered as, one or more of the following:

• medicinal ingredients (MIs) listed in Schedule 1 to the NHPR
• a homeopathic medicine
• a traditional medicine

Function criteria

The product must be represented for use in one or more of the following ways:

• diagnosing, treating, mitigating, or preventing a disease, disorder or abnormal physical state or its symptoms in humans
• restoring or correcting organic functions in humans
• modifying organic functions in humans

Understanding what is meant by "representation"

Health Canada interprets "representation" (explicit or implied) to include:

• indications of use or health claims
• any wording, image, symbol, or implication on product labels
• package inserts or advertisements (including websites)
• placement and location of sale

Product format

Product format can be a factor in the determination of whether a product is an NHP.

It is your responsibility, as the applicant, to determine the appropriate regulatory framework for your product.

Refer to Appendix I for resources to help determine whether your product falls under the NHPR.

If your product meets the definition of an NHP, you must obtain a product licence, that is Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) before it can legally be sold in Canada.

Proceeding with a product licence application

After reviewing all relevant resources, you may submit a PLA to NNHPD if you believe your product is an NHP and it meets the eligibility criteria.

NNHPD:

• does not issue classification decisions before receiving a submission
• makes regulatory classification decisions during the formal submission process
• will only respond to pre-submission inquiries that seek clarification on its guidance documents

Application types

NNHPD categorizes NHP licence applications by application type:

• traditional
• general (non-traditional)
• homeopathic (non-compendial)
• compendial

Refer to the glossary for definitions of each application type.

Application classes

NNHPD groups applications into 3 classes based on how NNHPD monographs are used.

An NNHPD monograph is a written summary describing specific elements of an ingredient or a combination of ingredients.

NNHPD has developed a Compendium of Monographs, which you can use to support the safety, efficacy, and/or quality of an NHP as part of your PLA.

Class I applications

Class I (compendial) applications must fully comply with all parameters outlined in an individual NNHPD monograph. The application must match the monograph exactly, without any modifications. You may reference only one NNHPD monograph per Class I application.

Monograph requirements

• Single-ingredient monographs: The application must match all parameters of the monograph exactly
• Multi-ingredient monographs: Each ingredient must meet the safety and quality parameters of the monograph. At least one ingredient must also meet the efficacy parameters, unless otherwise specified in the monograph.

Class II applications

Class II applications may include general (non-traditional) or traditional, and fall into the following categories:

• Applications supported entirely by 2 or more NNHPD monographs, with no deviations, except in specific cases:
  • there is no increased risk (for example: additive effects, over-medication, altered bioavailability and/or pharmacological activity) that cannot be mitigated by changes to the recommended conditions of use within the parameters of the monographs (for example: dosage, risk information, duration of use).
  • there is no reduction in efficacy (for example: conflicting therapeutic effects).
  • there are no incompatible recommended conditions of use (for example: contradictory claims, durations, and/or risk information).
• Applications supported entirely by an individual or by an acceptable combination of NNHPD monographs with minor deviations to one or more monograph statements, provided the changes maintain the original intent of the monograph (for example: using "statements to the effect of")
• Applications supported entirely by a combination of NNHPD monographs that include fruits and vegetables listed in the Canadian Nutrient File (CNF), prepared in a manner suitable for human consumption. These must:
  • exclude source materials listed as "refuse", that is, inedible parts
  • include a daily dose of up to 10 g of crude material or its crude equivalent for non-standardized extracts.
  • ensure the ingredient quantity aligns with typical consumption levels as per the CNF Database.

Refer to the Monograph combination guide for more details.

Class III applications

Class III applications may include:

• general (non-traditional)
• traditional
• homeopathic (non-compendial)

Class III applications fall outside the scope of Class I and II and require a full assessment of the product's safety, efficacy, and/or quality.

Class III applications include, but are not limited to, the following scenarios:

• applications for products with an ingredient, claim, or condition of use not supported by an NNHPD monograph
• applications for products with modified formulations (for example: liposomal, phytosomal, etc.) intended to improve the bioavailability and/or absorption of its medicinal ingredients
• applications referencing a Master File or previously submitted evidence to support safety and/or efficacy
• applications that partially reference monograph information but exceed the parameters outlined in the monograph (for example: dosage forms or routes of administration not specified in the monograph)
• applications for homeopathic products with specific claims. Refer to the Evidence for Homeopathic Medicines Guidance
• applications supported entirely by NNHPD monographs but involving ingredient combinations that may require additional safety and/or efficacy assessment. These include combinations with lower certainty or increased risk, such as:
  • stimulant laxatives combined with diuretics
  • weight management ingredients/claims combined with diuretics
  • products with combined hormonal effects

Refer to the Monograph combination guide for further guidance.

Position on "statements to the effect of"

The use of "statements to the effect of" is not permitted in Class I applications. However, such statements remain acceptable in Class II and III applications. Any application that includes statements deviating from the exact wording provided in monographs must be submitted as a Class II or III application.

Before submitting a product licence application

This section outlines key information and instructions that must be reviewed and followed before submitting a PLA to NNHPD.

Failure to follow one or more of these requirements may jeopardize the application and could result in its refusal.

Refer to Appendix II for key guidance and supporting documents.

Pre-submission meeting

A pre-submission meeting gives you an opportunity to discuss the evidence required to support a Class III application. These meetings aim to:

• help NNHPD staff become familiar with the proposed application before it is submitted, and provide a forum to discuss supporting evidence to facilitate the review process
• establish which studies or scientific data you intend to use to support the safety and/or efficacy of the NHP, and assess the adequacy and appropriateness of proposed controls
• allow you to discuss application details with NNHPD and receive feedback on potential concerns based on current regulatory requirements and experience
• help NNHPD manage resources and expertise in accordance with the anticipated application workload

A pre-submission meeting is recommended for NHPs for which there is uncertainty (for example: limited or no history of authorizations under the given conditions of use), such as:

• MIs not previously licensed
• unfamiliar or unlicensed combinations of MIs
• recommended conditions of use that have not yet been assessed or licensed
• a dosage form that has not been assessed or has not been licensed for a particular MI

Meeting minutes for pre-submission meetings

You are responsible for taking minutes during a pre-submission meeting. You are expected to submit these minutes to NNHPD within 14 calendar days of the meeting for review and confirmation.

How to request a pre-submission meeting

To request a pre-submission meeting, contact the NNHPD Client Support Unit at nnhpd-dpsnso@hc-sc.gc.ca.

You must submit your request at least 30 calendar days before the proposed meeting date. The request should include the following information:

• purpose of the meeting
• brief description of the product (for example: indicate if it is a combination product such as an NHP with a medical device)
• specific questions you wish to discuss
• international status of the product (for example: whether it has been authorized in another jurisdiction)
• 3 proposed meeting dates

Meeting prioritization and format

NNHPD prioritizes meeting requests that:

• impact the filing of an application (see eligibility criteria for product licence applications)
• relate to an existing licence

If NNHPD determines that your questions can be addressed more efficiently in writing, a written response will be sent to you, along with the rationale. If the response does not sufficiently address your concerns, you may request a meeting.

NNHPD will make every effort to schedule the meeting on one of the proposed dates, depending on the availability of subject matter experts. However, due to file complexity or competing priorities, alternative dates may be proposed.

Pre-submission meeting information package

You must submit a pre-submission meeting information package to NNHPD at least 14 calendar days before the scheduled meeting date. The package must include the following:

• cover letter
• agenda for the meeting
• list of participants, including their titles and roles
• list of specific issues or questions you wish to discuss
• summary of the product being presented
• detailed list of:
  • MIs and their quantities
  • non-medicinal ingredients (NMIs), including their purposes and quantities
  • recommended conditions of use, including the health claim(s) for which authorization is sought
• overview of the product's market history, including its regulatory status in foreign jurisdictions (if applicable)
• summary of safety and efficacy data supporting the NHP

Master File

The manufacturer of an ingredient or raw material, known as the NHP Master File (NHP-MF) holder, may submit proprietary information directly to NNHPD without sharing it with the product licence applicant.

The NHP-MF holder (Senior Official) may issue a letter of access that allows one or more applicants to cross-reference the confidential file.

The NHP-MF is a confidential document and may only be accessed by Health Canada officials.

Submitting a Master File

The NHP-MF holder may submit unpublished evidence (for example: proprietary data not publicly available) to NNHPD to support product assessment.

Required information for NHP-MF submission:

• ingredient or product name
• company name and address
• Senior Official's information
• contact person's information
• Designated Party Authorization

Secure submission

NNHPD recommends submitting NHP-MFs via Connect (formerly known as ePost Connect), due to security limitations with regular email.

Refer to the section on submitting an application for details on using Connect.

Processing a Master File

Upon receipt of an NHP-MF, NNHPD will:

• assign an MF number
• send an acknowledgment letter to the NHP-MF holder

Although there is no service standard for processing NHP-MFs, NNHPD aims to assign an MF number within 30 calendar days of receipt.

During the product assessment process, the NHP-MF holder may receive an Information Request Notice (IRN) if clarification or additional information is needed.

NNHPD communicates the final regulatory decision on a PLA (that is, whether it issues a product licence or refuses the application) only to the PLA applicant.

Referencing a Master File

To protect the proprietary nature of the files and to confirm access, you, as the applicant, must include a letter of access from the NHP-MF holder as part of your PLA to reference information contained in an NHP-MF.

This letter must:

• be on the official company letterhead of the NHP-MF holder
• be dated and signed by the Senior Official of the NHP-MF holder company
• grant reference directly to the applicant (not to a manufacturer or consultant)
• must be no older than 3 years
• include:
  • name and address of the company being granted access
  • name of the product referencing the NHP-MF
  • assigned MF number

Option to provide a general authorization

The NHP-MF holder may also authorize a company to reference some or all of their NHP-MFs. In these cases, a single general letter of access may be used, and individual letters for each application are not required.

Consequences of a missing authorization

If you do not provide a valid letter of access, NNHPD cannot assess the NHP-MF in conjunction with the PLA that references it. This may lead to the refusal of the application referencing the NHP-MF due to insufficient information to support the product's safety, efficacy and/or quality.

Modifying the Natural Health Products Ingredients Database

You must confirm that all proposed ingredients and sub-ingredients, including each ingredient's purpose, if applicable, are listed in the Natural Health Products Ingredients Database (NHPID) with the correct conditions of use before submitting a PLA.

If you wish to include an ingredient, sub-ingredient, or ingredient purpose that is not listed in the NHPID, you must submit a formal modification request.

Refer to Appendix II for more information on the NHPID.

Evidence requirements

Requests to modify the NHPID must be supported by credible, verifiable, and objective information aligned with applicable regulations, definitions, guidance, and policies.

Acceptable sources include:

• pharmacopoeias
• peer-reviewed journal articles
• books by reputable, established authors
• foreign government or regulatory authority documents, evaluations, and websites

Submission process

To request a modification to the NHPID, you must:

1. Complete the NHPID Request Form
2. Provide sufficient supporting evidence for:
   • MI identity and function
   • NMI purpose
   • any other requested modification

You are responsible for ensuring that all necessary evidence is provided, which may go beyond what's expected in the form.

Additional information

NNHPD may request further details to ensure ingredients are appropriately displayed in the NHPID and aligned with the Natural Health Products Online System Standard Terminology Guide.

This helps improve submission quality and ensures consistency in:

• PLA forms
• amendment and notification forms (ANFs)
• product labels (in accordance with the NHPR)

Processing timeline

Requests are generally processed in the order received, but may be prioritized based on:

• complexity
• volume of requests
• urgency related to an upcoming submission

All modifications must be completed before submitting a new application or an amendment.

Updates

• Changes made to the NHPID are listed in the "What's New in the NHPID" section after each update cycle.
• The NHPID is updated monthly, typically on the last Friday of each month.
• NNHPD will only contact requesters if clarification is needed or if the submitted information is insufficient.
• NNHPD does not notify applicants individually when an ingredient has been added to the NHPID.

New Company Registration

A new applicant must register their company with NNHPD before submitting their first PLA. This step is essential to:

• enabling access to the web-based PLA form
• ensuring traceability of applications

NNHPD will issue a unique 5-digit company code upon registration. You must include this code in all future applications to ensure proper processing.

How to register

You must complete the New Company Registration Form to register a company and obtain a company code.

Locating an existing company code

If you already have a company code, you can find it on NNHPD correspondence documents, such as:

• issuance letters
• IRNs
• notices of refusal