Natural Health Products Management of Applications Policy: Appendices, glossary and acronyms

On this page

• Appendix I - Product classification information and resources
• Appendix II - Guidance and tools
• Appendix III - Application requirements by application type and class
• Appendix IV - Summary report for class III applications
• Appendix V - Attesting to NNHPD monographs
• Appendix VI - Service standards
• Appendix VII - Classification of amendment applications
• Appendix VIII - Post-licence changes and associated regulatory requirements
• Glossary
• Acronyms

Appendix I - Product classification information and resources

You must determine the appropriate product classification by consulting relevant resources and examples that address these interface scenarios.

For more information, refer to the table below outlining key resources related to product classification at different interfaces.

Appendix II - Guidance and tools

Use the available guidance and tools to meet your responsibilities across all stages of the product lifecycle — including before, during, and after submitting your PLA. These resources are intended to:

1. support more efficient application processing;
2. help reduce common deficiencies in submissions; and
3. promote compliance with the NHPR

Regulations

• Natural Health Products Regulations (NHPR)
• Supplementary Rules Respecting Nicotine Replacement Therapies Order
  • Refer also to the Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order

Natural Health Products Ingredients Database

The NHPID is a repository of medicinal and non-medicinal ingredients used in NHPs that can be selected in the PLA form or the ANF. It is a key component of the Natural Health Products Online System.

The NHPID provides access to a range of pre-cleared information, including:

• Single ingredient monographs
• Product monographs
• Controlled vocabulary, which covers standardized terms for, but not limited to:
  • Dosage forms
  • NMI purposes
  • Routes of administration
  • Test methods
  • Units of measurement

In addition, the NHPID may include information to help improve awareness and understanding of how to comply with regulatory requirements related to specific ingredients and their use in NHPs. The database also includes information on ingredients that are restricted or not permitted for use in NHPs.

The NHPID uses standardized terminology as outlined in the Natural Health Products Online System Standard Terminology Guide.

Compendium of Monographs

NNHPD has developed and published a Compendium of Monographs to help you support the safety, efficacy, and/or quality of an NHP as part of your PLA. The compendium is accessible through the NHPID, and each ingredient entry links to all relevant monographs.

• Compendium of Monographs
  • Refer also to the Compendium of Monographs guidance document
• Monograph combination guide

Safety and efficacy

The following documents outline NNHPD's approach to assessing evidence related to safety and efficacy of NHPs. They provide standards and considerations related, but not limited, to:

• Health claims
• Risk information
• Combining specific ingredients in NHP formulations

These resources are essential for ensuring that your NHPs meet regulatory requirements and are supported by appropriate evidence.

• Pathway for Licencing Natural Health Products Making Modern Health Claims
• Pathway for Licencing Natural Health Products Making Traditional Health Claims
• Schedule A and Section 3 to the Food and Drugs Act [Health Canada, 2010]
• Evidence for Homeopathic Medicines
• Monograph combination guide

Quality

The following documents are designed to help you ensure that your NHP is produced to a high standard of quality. They also outline how you can demonstrate compliance with the NHPR, specifically regarding the quality requirements.

• Quality of natural health products guide
• Finished Product Specifications
• Good manufacturing practices guide for natural health products (GUI-0158)

Labelling

On March 26, 2025, Health Canada published a Ministerial Order in the Canada Gazette, Part II that provides a temporary exemption from the new labelling requirements for certain NHPs.

This exemption applies to NHPs that are licensed on or after June 21, 2025, provided they continue to meet the previous labelling requirements outlined in the NHPR.

Key details include:

• The Ministerial Order came into force on June 21, 2025, the same day the new labelling provisions took effect.
• The exemption allows newly licensed NHPs to be labelled under the former regulations, as long as they are not sold to manufacturers or distributors.
• The Ministerial Order will be repealed on June 21, 2028, aligning with the end of the transition period for other NHPs.
• As a result, all NHPs must comply with the new labelling requirements by June 22, 2028.

The Guidance document: Labelling of Natural Health Products provides detailed instructions to help you comply with the new labelling requirements for NHPs, as outlined in Part 5 of the NHPR. It also includes information on security packaging requirements, which came into effect in 2022.

You are encouraged to consult the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products, which offers best practices for effective and compliant label design.

For reference, the previous, archived labelling guidance document can be found at: https://publications.gc.ca/collections/Collection/H164-24-2006E.pdf

You are also encouraged to consult the Guidelines for Consumer Advertising of Health Products.

Post-licensing

Compliance and enforcement policy for health products (POL-0001)

Appendix III - Application requirements by application type and class

Requirements	Application type							Notification
	Class I		Class II or III			Class III
	Compendial	Amendment	General	Traditional	Amendment	Homeopathic (with specific claims)	Amendment
Natural Health Product Licence Application form	✓	Not applicable	✓	✓	Not applicable	✓	Not applicable	Not applicable
Amendment and Notification Form	Not applicable	✓	Not applicable	Not applicable	✓	Not applicable	✓	✓
Label text	✓	If applicable to the proposed changes	✓	✓	If applicable to the proposed changes	✓	If applicable to the proposed changes	If applicable to the proposed changes
Summary Report (Evidence, Safety and/or Quality)	Not applicable	If applicable	Recommended (Class III)	Recommended (Class III)	Recommended (Class III)	Recommended	Recommended (if applicable)	Not applicable
Evidence	See Monograph attestation requirements	See Monograph attestation requirements	Monograph attestation or other evidence, as applicable. See Monograph attestation requirements	Monograph attestation or other evidence, as applicable. See Monograph attestation requirements	Monograph attestation or other evidence, as applicable. See Monograph attestation requirements	Monograph attestation or other evidence, as applicable. See Monograph attestation requirements	Monograph attestation or other evidence, as applicable. See Monograph attestation requirements	Not applicable
Animal Tissue Form (if applicable)	✓	✓	✓	✓	✓	✓	✓	✓
Finished Product Specifications	See Finished product specifications	See Finished product specifications	✓	✓	If applicable to the proposed changes	✓	If applicable to the proposed changes	Not applicable
✓ Required

Appendix IV - Summary report for class III applications

To strengthen the Summary Report, you should consider addressing the questions in the table below for each piece of evidence.

Note: The table provided is intended as an example. Other formats are acceptable, provided they clearly convey the expected information.

Appendix V - Attesting to NNHPD monographs

The table below outlines the required attestation(s) regarding safety, efficacy, and/or quality based on different submission scenarios.

Monograph parameters

When attesting to a monograph, the PLA must match the monograph content exactly or fall within its parameters. The following parameters of a monograph must be met upon attestation:

1. Proper name

   The proper name must be chosen from one of the options provided in the monograph.

2. Common name

   The common name must be chosen from one of the options provided in the monograph.

3. Source material

   The source material must be chosen from the options provided in the monograph. More than one source material is acceptable, provided that all source materials listed on the PLA form reflect the same dose and/or use or purpose on the referenced monograph.

4. Route of administration

   The route of administration must be chosen from the options provided in the monograph. Please see the NHPID Controlled Vocabulary for a description of the routes of administration.

5. Dosage form

   The dosage form must reflect the route of administration for the product and be chosen from the options provided in the monograph, where applicable, or as outlined in the Compendium of Monographs. Food-like dosage forms are not acceptable (for example, bars, chewing gums, beverages).

   Except when otherwise stated on a monograph, NNHPD monographs do not support modified formulations. Products formulated with the intent to alter the pharmacokinetics (absorption, distribution, metabolism or excretion) of one or all of its medicinal ingredients are not considered equivalent to products formulated and/or medicinal ingredients prepared with conventional dosage forms and/or methods. Examples include, but are not limited to:

   • Enhanced absorption (for example: liposomal, phytosomal formulations)
   • Modified release (for example: extended release, delayed release, time-release, sustained release)

   Modified formulation

   An NHP in a modified formulation (for example: liposomal, phytosomal) intended to improve the bioavailability and/or absorption of its medicinal ingredients is not considered equivalent to an NHP in a non-liposomal/phytosomal formulation or conventional dosage form. Therefore, applicants cannot attest to a monograph for the safety and efficacy of an ingredient unless the monograph specifically states that such formulations are acceptable.

   Products with modified release or any formulation with enhanced bioavailability must be submitted through the appropriate application type (for example, "General" application type) with specific evidence to support the corresponding formulation/dosage form. The cover letter must declare the modified formulation/preparation if not otherwise indicated in the PLA webform and the finished product specifications (FPS) form should include any relevant parameters.

6. Recommended use or purpose

   Claims have been identified for each monographed ingredient based on NNHPD's evaluation of the safety and efficacy data. As an applicant, you may choose one or more claims provided in the monograph.

   You must ensure that any conditions surrounding the claim (such as dose, source material, etc.) are met.

7. Dose

   The single and daily dose(s), as applicable, must fall within the range, or be equal to that, indicated in the monograph. The dose indicated in the monograph may be specific to:

   • Subpopulation
     • At least one subpopulation listed in the monograph should be selected.
   • Method of preparation
     • Must be chosen from the list of acceptable methods, if indicated.
     • Furthermore, to make a traditional use claim, the method of preparation must be one that was traditionally used. Refer to the Pathway for Licensing Natural Health Products Used as Traditional Medicines guidance document for a list of traditional methods of preparation.
   • Potency
     • When a monograph includes potency, it must be included in the PLA, unless otherwise specified.
     • The inclusion of a potency when not permitted by the monograph is not acceptable for attestation.
   • Frequency
     • The frequency must be the same as or fall within the range of the frequency in the monograph, when specified. When the monograph specifies a divided dose, the frequency must be more than once daily. If no frequency is specified, the applicant may select an appropriate frequency.
   • Directions of use
     • Where specified, all directions of use must be included in the PLA, as applicable.
8. Duration of use

   When the monograph includes a duration of use, it must be included in the PLA, as applicable.

9. Risk information

   When the monograph includes risk information, it must be included in the PLA, as applicable.

10. Non-medicinal ingredients

    Only non-medicinal ingredients listed in the NHPID may be used with an appropriate excipient purpose. Any applicable restrictions indicated in the database must be met.

    The presence of non-medicinal ingredients without conditions on the Cosmetic Ingredient Hotlist: Prohibited and Restricted Ingredients (the hotlist) indicates that there are potential safety issues with these ingredients. If the hotlist indicates that additional evidence is required for an ingredient or if an ingredient is listed with no specified conditions, it is not permitted in a Class I topical product. If the hotlist specifies certain conditions for an ingredient, or label requirements, it is the responsibility of the applicant to ensure that the ingredient meets the conditions outlined.

    Requirements for non-medicinal ingredients are outlined in the following documents:

    • Quality of Natural Health Products Guide,
    • Pathway for Licensing Natural Health Products Making Modern Health Claims,
    • Pathway for Licensing Natural Health Products Used as Traditional Medicines and
    • the Evidence for Homeopathic Medicines.

    Some monographs, such as the Aromatherapy – Essential Oils monograph, include additional restrictions for NMIs beyond those listed in the NHPID.

    Products containing or using an NMI beyond and/or outside of the restrictions outlined in the NHPID and/or monograph must be submitted with supporting evidence as Class III applications. For products containing NMIs which may contribute to the efficacy or to the total quantity of a medicinal ingredient (MI) or potency constituent, applicants should consider whether the NMIs may affect safety or efficacy of the product. The NNHPD may request clarification via IRN if a concern is identified that is not addressed by the applicant via cover letter or the inclusion of NMI quantities in the PLA.

    If an NMI combined with an MI is expected to have an effect on safety of efficacy, the NMI should either be declared as medicinal (and application class determined accordingly) or the application should be submitted as Class III for further assessment.

11. Storage conditions

    When the monograph includes storage conditions for the consumer, they must appear on the product label as per section 87 of the NHPR, in addition to any other storage conditions required for the product.

12. Specifications

    Note that certain monographs include additional specifications relevant to that ingredient or product. This information must be considered when establishing product specifications.

Attesting to multiple monographs

When attesting to more than one NNHPD monograph in support of safety and/or efficacy of a Class II or III product, monograph conditions of use (such as duration of use, risk information) must be omitted in the following situations:

• Sub-population-specific risk information is not required if the product is not indicated for that sub-population
  • For example: the risk statement "Ask a health care practitioner prior to use if you are pregnant or breastfeeding" is not required for a product indicated for an "adult male" sub-population.
• The risk information being omitted is considered less stringent and covered by the risk information required by another monograph attested to within the application:
  • For example: "Ask a health care practitioner prior to use if you are pregnant or breastfeeding" is considered less stringent and covered by "Do not use if you are pregnant or breastfeeding".
• The duration of use being omitted relates to the safety of the medicinal ingredient and is longer than the duration of use relating to safety required by another monograph attested to within the application.
  • For example: "Ask a health care practitioner for use beyond 4 weeks" relates to the safety of the medicinal ingredient and is longer than "Ask a health care practitioner for use beyond 1 week."

Applications omitting conditions of use in a Class II or III application within the situations described above must still attest to the monograph for all other monograph parameters that are met.

Appendix VI - Service standards

Appendix VII - Classification of amendment applications

This table clarifies application requirements and service standards. Use it to identify your amendment application class.

Appendix VIII - Post-licence changes and associated regulatory requirements

Each type of post-licensing change has distinct regulatory requirements. The table below outlines the different types of changes and their associated regulatory requirements.

Glossary

Adverse reaction (or known adverse reaction)

A noxious and unintended response to a natural health product that occurs at any dose used to test for the diagnosis, treatment or prevention of a disease or for modifying an organic function. Examples include flushing, nausea, diarrhea and constipation.

Applicant

The company in whose name the NHP application is submitted, and the product licence will be registered (the applicant will be referred to as the licensee or product licence holder once a licence has been granted or amended). For PLAs, the licensee (product licence holder)/applicant is not necessarily the company that fabricates the product (e.g., may be the distributor of the product or the importer).

Brand name

A name in English or French, whether or not it includes the name of a manufacturer, corporation, partnership or individual (a) that is used to distinguish the natural health product; and (b) under which a natural health product is sold or advertised. The brand name may or may not include a trade name.

Common name

For any medicinal or non-medicinal ingredient contained in an NHP, the name by which it is commonly known and is designated in a scientific or technical reference.

Compendial

An application type used on the PLA form for Class I products which meet all parameters of an individual NNHPD monograph.

Directions of use

How the product should be taken. This may include time of administration, or administration with respect to food or drink.

Discontinuation

An action taken by a product licence holder or by NNHPD to remove the active status of a NPN or DIN-HM.

Discontinued

A discontinued NPN is a once valid authorization issued by Health Canada for a natural health product, that has since been officially withdrawn and relinquished by the product's licence holder. The date of discontinuation is when the manufacturer last sold its NHP for distribution, not when it is last sold at retail.

Dosage form

The final physical form of the NHP which may be used by the consumer without requiring any further manufacturing.

Dose

The amount of finished product in dosage form used for the recommended purpose, including any directions of use. The dose is represented as the amount of dosage units, the frequency of use, and directions for use, if any, by a sub-population group.

Duration of use

The time frame in which an NHP can be consumed safely for its intended purpose.

Efficacy

The extent to which a specific intervention, procedure, regimen or service produces a beneficial result under ideal conditions.

Extract

A substance prepared by treating a plant or a plant material, an alga, a bacterium, a fungus, or non-human animal material with solvents or pressure to remove any constituents.

Finished product

A product that has undergone all stages of production, including packaging in its final container and labelling.

Finished product specifications

Quality standards for an NHP that contains the information described in section 44(2) of the NHPR which includes tests, references to analytical procedures and appropriate tolerance limits which are numerical limits, ranges or other criteria for the tests described. Specifications establish the criteria to which a finished product should conform in order to be considered acceptable for its intended use.

Frequency

How often the product is to be taken in a given time or time interval (e.g. 3 times daily).

General application

An application type used on the PLA form for products formally categorized as non-traditional applications and for all products which cannot be classified into the Compendial (Class I), Traditional, and Homeopathic application types.

Health claim

See "Recommended use or purpose".

Homeopathic application

An application type used on the PLA form for products categorized as homeopathic medicines (See "Homeopathic medicine").

Homeopathic medicine

To be considered a homeopathic medicine, a product must meet two criteria. It must be:

1. Manufactured from, or contain as medicinal ingredients, only substances referenced in a homeopathic monograph in one of the following homeopathic pharmacopoeias, as they are amended from time to time:
   • Homeopathic Pharmacopeia of the United States (HPUS)
   • Homöopathische Arzneibuch (HAB) or German Homeopathic Pharmacopoeia
   • Pharmacopée française or French Pharmacopoeia (PhF)
   • European Pharmacopoeia (Ph.Eur.)
   • Encyclopedia of Homeopathic Pharmacopoeia (EHP)
2. Prepared in accordance with the methods outlined in one of the homeopathic pharmacopoeias listed above, as they are amended from time to time.

Importer

A person who imports a natural health product into Canada, for the purpose of sale. This would include bulk natural health products.

Ingredient

A single substance that is a component part of any product formulation.

Kit

A kit is defined as a package containing more than one NHP or a combination of one or more NHPs and one or more foods, cosmetics or medical devices that is intended to have a combined benefit (for example: overarching claims or brand name).

Label

Includes any legend, word or mark attached to, included in, belonging to or accompanying an NHP. Products must be labelled in both official languages.

Refer to Part 5 of the NHPR and the Guidance document: Labelling of natural health products.

Licensee

See "Applicant".

Manufacturer

A person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of the patient, compounds a natural health product for the purpose of sale to that patient.

Master File

An NHP Master File may be submitted, when a company would like to submit confidential information on behalf of another company (e.g. supplier submitting confidential manufacturing information on behalf of a manufacturer).

Medicinal ingredient

Any substance set out in Schedule 1 of the NHPR that is intended to provide pharmacological activity or other direct effect in: (a) the diagnosis, treatment, mitigation, or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; or (b) restoring or correcting organic functions in humans; or (c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Merger/Acquisition

A legal consolidation in which one company may absorb another and assume its assets, licences and liabilities.

Natural Health Product

A substance set out in Schedule 1 of the Regulations or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for use in: (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; (b) restoring or correcting organic functions in humans; or (c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

However, a natural health product does not include a substance set out in Schedule 2 of the Regulations or any combination of substances that includes a substance set out in Schedule 2.

NNHPD monograph

A written description of particular elements on an identified ingredient or product. The Compendium of Monographs is comprised of single and product monographs to be used to support the safety and efficacy of the medicinal ingredient(s). Single ingredient monographs indicate only one medicinal ingredient, while product monographs indicate multiple ingredients or describe the conditions of use for a product category.

Non-medicinal ingredient

A non-medicinal ingredient is defined as any substance that is added to a product to confer suitable consistency or form to the medicinal ingredients (suitable as per dosage form and route of administration).

Non-medicinal ingredients:

• should not exhibit pharmacological effects;
• should not have any effect contradictory to the product's recommended purpose;
• should not exceed the minimum concentration required for the formulation;
• should not adversely affect the bioavailability, pharmacological activity, or safety of the medicinal ingredients; and
• should be safe.

Non-traditional

Products that make modern health claims based on the sum total of knowledge, skills, and practices based on theories, beliefs, and experiences indigenous to a specific culture, used in the maintenance of health, as well as prevention, diagnosis, improvement, or treatment of physical and mental illness.

NPN/DIN-HM

A Natural Product Number (NPN) is an eight (8) digit numerical code assigned to each natural health product approved to be marketed under the NHPR. The Drug Identification Number for Homeopathic Medicines (DIN- HM) is an eight (8) digit numerical code assigned to each homeopathic medicine approved to be marketed under the NHPR.

Potency

The amount per dosage unit of the standardized component that further characterizes the quantity of the ingredient. Potency may reflect the active constituent, a marker compound or the "activity" of the medicinal ingredient.

Product licence holder

See "Applicant".

Proper name

In respect of an ingredient of an NHP, a proper name refers to one of the following:

• if the ingredient is a vitamin, the name for that vitamin set out in item 3 of Schedule 1;
• if the ingredient is a plant or a plant material, an alga, a bacterium, a fungus, a non-human animal material or a probiotic, the Latin nomenclature of its genus and, if any, its specific epithet; and
• if the ingredient is other than one described in paragraphs (a) or (b), the chemical name of the ingredient.

Quantity

The amount of medicinal ingredient(s) per dosage unit.

Quantity crude equivalent

The amount of crude dried or fresh material (amount of original material) from which the ingredient was extracted (per dosage unit).

Recommended conditions of use

As defined in section 1(1) of the NHPR, 'conditions of use' or 'recommended conditions of use' for a natural health product include:

• its recommended use or purpose;
• its dosage form;
• its recommended route of administration;
• its recommended dose;
• its recommended duration of use, if any; and
• its risk information, including any cautions, warnings, contraindications or known adverse reactions associated with its use.

Recommended use or purpose

A statement that indicates the intended beneficial effect of an NHP when used according to the recommended dose, duration of use and route of administration listed on the label.

Regulatory decision

In the context of this document, a regulatory decision refers to the assessment of a product licence application, including post-licensing applications, resulting in the issuance of a product licence or notice of refusal.

Risk information

Any cautions and warnings, adverse reactions and contraindications associated with the use of the NHP.

Risk Management Plan (RMP)

A document that describes a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks related to drug products, and the assessment of the effectiveness of those interventions (adopted from the European Medicines Agency definition of a Risk Management System).

Route of administration

The method by which the NHP is to be delivered to the body. Routes of administration include, but are not limited to: oral, buccal, dental, nasal and topical.

Safety

The ability for a natural health product to produce a beneficial health outcome, outweighing the risk associated with using it, in humans, according to the recommended conditions of use.

Senior Official

The principal contact person for the licensee (product licence holder)/applicant, to whom regulatory mail is sent. This is not the contact person for product application-specific questions, but the person who will represent the company.

Site

A place of or for an activity specified under the NHPR.

Source material

The substance from which the medicinal ingredient as defined in Schedule 1 of the NHPR was prepared or derived. There may be multiple sources for a medicinal ingredient.

Specifications

A description of an NHP that contains the information described in section 44(2) of the NHPR.

Submission coordinator

The regulatory project officer assigned to coordinate a PLA through the assessment process. In order to contact the submission coordinator, applicants should follow the instructions provided in the IRN communication.

Submission number

The six-digit processing number assigned to an individual application, including post-licensing applications. The submission number should be referenced in all correspondence and enquiries referring to the product application.

Sub-population group

The group to which the NHP is targeted (may be more than one) that may require different dosing from the standard. For example, most NHPs are for adults, but seniors or children may take them at different doses.

Traditional application

An application type used on the PLA form for products categorized as traditional medicines (See "Traditional medicine").

Traditional medicine

A medicine based on the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness. This definition is one modified from the World Health Organization Traditional Medicine Program, recognizing traditional medicines at their core as ancient medical practice that existed in human societies before the application of modern science to health and that have evolved to reflect different philosophical backgrounds and cultural origins.

Transfer

An authorized/acknowledged reassignment of active produce licences from one product licence holder to another.

Withdrawal

An action taken by the applicant to remove an application from the application review process.

Acronyms

ANF

Amendments and Notification Form

ATF

Animal Tissue Form

DIN-HM

Drug Identification Number-Homeopathic Medicine

DPA

Designated Party Authorization

FPS

Finished Product Specifications

IRN

Information Request Notice

LNHPD

Licensed Natural Health Products Database

MI

Medicinal ingredient

NHPID

Natural Health Products Ingredients Database

NHP-MF

Natural Health Product Master File

NHPR

Natural Health Products Regulations

NHP

Natural Health Products

NNHPD

Natural and Non-prescription Health Products Directorate

NPN

Natural Product Number

PLA

Product Licence Application

RMP

Risk Management Plan

ROEB

Regulatory Operations and Enforcement Branch

SEAR

Safety and Efficacy Assessment Report