Natural Health Products Regulations (SOR/2003-196)

Interpretation

• 1 (1) The following definitions apply in these Regulations.

  Act

  Act means the Food and Drugs Act. (Loi)

  added sulphites

  added sulphites means one or more of the food additives that are set out item 21, column 1, of table 2 of the Common Names for Ingredients and Components Document and are present in a natural health product as a result of being added to the product. (sulfites ajoutés)

  adverse reaction

  adverse reaction means a noxious and unintended response to a natural health product that occurs at any dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying an organic function. (réaction indésirable)

  brand name

  brand name means 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. (marque nominative)

  case report

  case report means a detailed record of all relevant data associated with the use of a natural health product in a subject. (fiche d’observation)

  Common Names for Ingredients and Components Document

  Common Names for Ingredients and Components Document means the document entitled Common Names for Ingredients and Components, prepared by the Canadian Food Inspection Agency and published on its website, as amended from time to time. (document sur les noms usuels d’ingrédients et de constituants)

  Compendium

  Compendium means the Compendium of Monographs published by the Department of Health and as amended from time to time. (Compendium)

  distributor

  distributor means a person who sells a natural health product to another person for the purpose of further sale by that other person. (distributeur)

  expiry date

  expiry date means the earlier of

  • (a) the date, expressed at minimum as a year and month, that is the end of the stability period determined under section 52; and

  • (b) the date, expressed at minimum as a year and month, after which the manufacturer recommends that the natural health product should not be used. (date limite d’utilisation)

  food allergen

  food allergen means any protein from any of the following foods, or any modified protein, including any protein fraction, that is derived from any of the following foods:

  • (a) almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts;

  • (b) peanuts;

  • (c) sesame seeds;

  • (d) wheat or triticale;

  • (e) eggs;

  • (f) milk;

  • (g) soybeans;

  • (h) crustaceans;

  • (i) molluscs;

  • (j) fish; or

  • (k) mustard seeds. (allergène alimentaire)

  food allergen source, gluten source and added sulphites statement

  food allergen source, gluten source and added sulphites statement means a statement appearing on the label of a natural health product that indicates the source of a food allergen or gluten that is present in the product or the presence in the product of added sulphites in a total amount of 10 p.p.m. or more. (mention des sources d’allergènes alimentaires ou de gluten et des sulfites ajoutés)

  gluten

  gluten means

  • (a) any gluten protein from the grain of any of the following cereals or from the grain of a hybridized strain that is created from at least one of the following cereals:

    • (i) barley,

    • (ii) oats,

    • (iii) rye,

    • (iv) triticale,

    • (v) wheat; or

  • (b) any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to in paragraph (a) or from the grain of a hybridized strain referred to in that paragraph. (gluten)

  immediate container

  immediate container means the container that is in direct contact with a natural health product. (contenant immédiat)

  importer

  importer means a person who imports a natural health product into Canada for the purpose of sale. (importateur)

  inner label

  inner label means the label on or affixed to an immediate container of a natural health product. (étiquette intérieure)

  List A

  List A means the document entitled List of Certain Natural Health Products for Distribution as Samples, dated March 2020 and published by the Government of Canada on its website. (Liste A)

  lot number

  lot number means any combination of letters, figures, or both, by which a natural health product can be traced in manufacture and identified in distribution. (numéro de lot)

  manufacturer

  manufacturer means 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 a patient, compounds a natural health product for the purpose of sale to that patient. (fabricant)

  natural health product

  natural health product means 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

  • (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.

  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. (produit de santé naturel)

  outer label

  outer label means the label on or affixed to the outside of a package, other than the immediate container, of a natural health product. (étiquette extérieure)

  point

  point means the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm. (point)

  principal display panel

  principal display panel has the same meaning as in the Consumer Packaging and Labelling Regulations. (espace principal)

  probiotic

  probiotic means a monoculture or mixed-culture of live micro-organisms that benefit the microbiota indigenous to humans. (probiotique)

  proper name

  proper name means, in respect of an ingredient of a natural health product, one of the following:

  • (a) if the ingredient is a vitamin, the name for that vitamin set out in item 3 of Schedule 1;

  • (b) 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

  • (c) if the ingredient is other than one described in paragraphs (a) or (b), the chemical name of the ingredient. (nom propre)

  recommended conditions of use

  recommended conditions of use means, in respect of a natural health product,

  • (a) its recommended use or purpose;

  • (b) its dosage form;

  • (c) its recommended route of administration;

  • (d) its recommended dose;

  • (e) its recommended duration of use, if any; and

  • (f) its risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with its use. (conditions d’utilisation recommandées)

  security package

  security package means a package having a security feature that provides reasonable assurance to consumers that the package has not been opened prior to purchase. (emballage de sécurité)

  serious adverse reaction

  serious adverse reaction means a noxious and unintended response to a natural health product that occurs at any dose and that requires in-patient hospitalization or a prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave)

  serious unexpected adverse reaction

  serious unexpected adverse reaction means a serious adverse reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the natural health product. (réaction indésirable grave et imprévue)

  specifications

  specifications means a description of a natural health product that contains the information described in subsection 44(2). (spécifications)

• (2) Subject to subsection (3), the words and expressions used in the provisions of the Food and Drug Regulations that are incorporated by reference by these Regulations shall have the meanings assigned to them by these Regulations, but if no meanings are assigned, they shall have any meaning assigned to them by the Food and Drug Regulations.

• (3) The word manufacturer in the provisions of the Food and Drug Regulations that are incorporated by reference by these Regulations shall have the meaning assigned to it by the Food and Drug Regulations.

Application

• 2 (1) These Regulations apply to

  • (a) the sale of natural health products;

  • (b) the manufacture, packaging, labelling and importation for sale of natural health products;

  • (c) the distribution of natural health products; and

  • (d) the storage of natural health products for the purposes of any of the activities referred to in paragraphs (b) and (c).

• (2) For the purposes of these Regulations, a substance or combination of substances or a traditional medicine is not considered to be a natural health product if its sale, under the Food and Drug Regulations, is required to be pursuant to a prescription when it is sold other than in accordance with section C.01.043 of those Regulations.

3 Except where otherwise indicated in these Regulations, the provisions of the Food and Drug Regulations do not apply to natural health products.

PART 1Product Licences

Prohibition

• 4 (1) Subject to subsections (2) and (3), no person shall sell a natural health product unless a product licence is issued in respect of the natural health product.

• (2) No product licence holder, manufacturer, importer or distributor of a natural health product for which a product licence is issued shall sell the natural health product during any period that the sale of that natural health product is directed to be stopped under section 17.

• (3) No person shall sell a natural health product for which a product licence is issued

  • (a) during the period of any suspension of the licence under section 18 or 19; or

  • (b) after cancellation of the licence under paragraph 20(b).

Licence Application

5 An application for a product licence shall be submitted to the Minister and shall contain the following information and documents:

• (a) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant;

• (b) if the address submitted under paragraph (a) is not a Canadian address, the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant’s representative in Canada to whom notices may be sent;

• (c) for each medicinal ingredient of the natural health product,

  • (i) its proper name and its common name,

  • (ii) its quantity per dosage unit,

  • (iii) its potency, if a representation relating to its potency is to be shown on any label of the natural health product,

  • (iv) a description of its source material, and

  • (v) a statement indicating whether it is synthetically manufactured;

• (d) a qualitative list of the non-medicinal ingredients that are proposed for the natural health product and for each ingredient listed, a statement that indicates the purpose of the ingredient;

• (e) each brand name under which the natural health product is proposed to be sold;

• (f) the recommended conditions of use for the natural health product;

• (g) information that demonstrates the safety and efficacy of the natural health product when it is used in accordance with the recommended conditions of use;

• (h) the text of each label that is proposed to be used in conjunction with the natural health product;

• (i) a copy of the specifications to which the natural health product will comply; and

• (j) one of the following attestations, namely,

  • (i) if the natural health product is imported, an attestation by the applicant that the natural health product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3, or

  • (ii) if the natural health product is not imported, an attestation by the applicant that the natural health product will be manufactured, packaged, labelled, distributed and stored in accordance with requirements set out in Part 3.