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Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2022-06-20 and last amended on 2022-02-11. 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, 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)

    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, 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.

  • SOR/2018-69, s. 42(F)

 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

  •  (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

 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.

Sixty-Day Disposition

  •  (1) Subject to subsection (2), the Minister shall dispose of an application submitted under section 5 within 60 days after the day on which it is submitted if, in support of the application, the only information submitted by the applicant under paragraph 5(g) is that which is

    • (a) in the case of an application respecting a natural health product that has only one medicinal ingredient, contained in a monograph for that medicinal ingredient in the Compendium; and

    • (b) in the case of an application respecting a natural health product that has more than one medicinal ingredient, contained in a monograph for that combination of medicinal ingredients in the Compendium.

  • (2) If the Minister requests that additional information or samples be submitted under section 15, the 60-day period referred to in subsection (1) does not include the number of days beginning on the day on which the request is made and ending on the day on which the additional information or samples are received.

  • (3) For the purposes of this section, the Minister disposes of an application on the earlier of the day on which

    • (a) the licence is issued in accordance with section 7; and

    • (b) the applicant is sent a notice under subsection 9(1).

Issuance and Amendment

 The Minister shall issue or amend a product licence if

  • (a) the applicant submits an application to the Minister that is in accordance with section 5 or subsection 11(2), as the case may be;

  • (b) the applicant submits to the Minister all additional information or samples requested under section 15;

  • (c) the applicant does not make a false or misleading statement in the application; and

  • (d) the issuance or amendment of the licence, as the case may be, is not likely to result in injury to the health of a purchaser or consumer.

Product Number

  •  (1) The Minister shall assign a product number to each natural health product in respect of which a product licence is issued.

  • (2) In the case of a natural health product that is a drug for which a drug identification number is assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations, the product number assigned under subsection (1) shall be the drug identification number.

  • SOR/2018-69, s. 44(E)

Refusal to Issue or Amend

  •  (1) If the Minister refuses to issue or amend a product licence, the Minister shall send the applicant a notice that sets out the reason for the refusal.

  • (2) Within 30 days after the day on which the notice is sent, the applicant may make a request that the Minister reconsider the application.

  • (3) If the applicant makes a request in accordance with subsection (2), the Minister shall

    • (a) give the applicant an opportunity to be heard in respect of the application; and

    • (b) reconsider the application after giving the applicant that opportunity.

 
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