Natural Health Products Regulations — 1
lished by the Government of Canada on its website. ( Liste A ) 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 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 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 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 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 has the same meaning as in the Consumer Packaging and Labelling Regulations . ( espace principal ) probiotic means a monoculture or mixed-culture of live micro-organisms that benefit the microbiota indigenous to humans. ( probiotique ) 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 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 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 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 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 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