Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2016-06-06 and last amended on 2008-06-01. Previous Versions

Natural Health Products Regulations

SOR/2003-196

FOOD AND DRUGS ACT

Registration 2003-06-05

Natural Health Products Regulations

P.C. 2003-847 2003-06-05

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1)Footnote a of the Food and Drugs Act, hereby makes the annexed Natural Health Products Regulations.

Interpretation

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

    Act

    Act means the Food and Drugs Act. (Loi)

    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)

    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, up to and including which a natural health product maintains its purity and physical characteristics and its medicinal ingredients maintain their quantity per dosage unit and their potency, 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)

    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)

    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, 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. (produit de santé naturel)

    outer label

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

    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

  •  (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.

 
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