Licensed Natural Health Products Database (LNHPD) - Terminology Guide

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

March 2017, Version 1.1

The purpose of the following guide is to provide definitions for a number of key terms found in the LNHPD.

Note - The terms found in this document are not organized in alphabetical order.

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Term / Definition

Natural Health Product ( NHP)

A substance set out in Schedule 1 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:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
  2. restoring or correcting organic functions in humans; or
  3. 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, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.

Product / 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.

Medicinal Ingredient

Any substance set out in Schedule 1 of the Natural Health Products Regulations that is intended to furnish pharmacological activity or other direct effect in:

  1. the diagnosis, treatment, mitigation, or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; or
  2. restoring or correcting organic functions in humans; or
  3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
Non-Medicinal Ingredient

Any substance added to a NHP formulation to confer suitable consistency or form to the medicinal ingredients. In a manner consistent with existing regulations for conventional pharmaceuticals, non-medicinal ingredients should not exhibit any pharmacological effects of their own, should not exceed the minimum concentration required for the formulation, and should be safe in the amounts used. The presence of a non-medicinal ingredient must not adversely affect the bioavailability, pharmacological activity or safety of the medicinal ingredients. As well, non-medicinal ingredients must not interfere with assays and tests for the medicinal ingredients and, when present, antimicrobial preservative effectiveness. Non-medicinal ingredients should be the least toxic available that are appropriate to the formulation.

Non-medicinal ingredients can include, but are not limited to, diluents, binders, lubricants, disintegrators, colouring agents, fragrances and flavours that are necessary for the formulation of the dosage form. Non-medicinal ingredient purposes such as surfactants, which are only applicable to topical products, are also indicated. Antimicrobial preservatives and antioxidants will be considered as non-medicinal ingredients but should not be used as alternatives to Good Manufacturing Practices.

Dosage Form

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

Recommended Use or Purpose / Health claim

A statement that indicates the intended beneficial effect of an NHP when used in accordance with the recommended conditions of use. The term "recommended use or purpose" is often used interchangeably with "health claim" or "indications for use".

NPN / DIN-HM

Natural Product Number (NPN) is an eight (8) digit numerical code assigned to each natural health product approved to be marketed under the Natural Health Products Regulations. A Homeopathic Medicine Number (DIN-HM) is an eight (8) digit numerical code assigned to each homeopathic medicine approved to be marketed under the Natural Health Products Regulations.

Quantity per dosage Unit

The amount of medicinal ingredient(s) per dosage unit. It is always required for a product, as it is the amount of medicinal ingredient in the product.

Potency

The amount per dosage unit of the standardized component(s) which further characterizes the quantity of the ingredient. It is required only when a claim on the potency is to be on the label, or it is required for a specific product (i.e. when literature supports the product with that standardized component). In the Supplementary Good Manufacturing Practices for Homeopathic Medicines, potency refers to the degree of dilution of a homeopathic medicine.

Date of Licensing

The date the product licence was issued by the NNHPD.

Revised Date of Licensing

The date the product licence was revised due to an amendment or notification.

Licensee

A person who is issued a licence by the Natural and Non-prescription Health Products Directorate (NNHPD).

Active

The product has been licensed with a valid NPN or DIN-HM.

Discontinued

The product had a valid NPN, but the licence holder has withdrawn the product from sale and relinquished its NPN, i.e., the product/NPN has been invalidated by the licence holder themselves.

Stop Sale

The NPN remains valid and the product is still available for sale at retail, but is not to be sold at wholesale.

Suspended

The NPN remains valid, but the product should no longer be sold at retail or wholesale.

Cancelled

The NPN is no longer valid.

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