Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2014-12-08 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.