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Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2019-08-28 and last amended on 2018-10-17. Previous Versions

Application (continued)

 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.

  • SOR/2018-69, s. 43(E)

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.

  •  (1) After reconsidering the application, the Minister shall issue or amend the product licence if the requirements of section 7 are met.

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

Amendment

  •  (1) If the licensee makes any of the following changes in respect of the natural health product, the licensee shall not sell any lot or batch of the natural health product affected by the change unless the product licence is amended accordingly:

    • (a) a change to its recommended dose;

    • (b) a change to its recommended duration of use;

    • (c) the deletion or modification of risk information shown on any of its labels, including the deletion or modification of a caution, warning, contra-indication or known adverse reaction associated with its use;

    • (d) a change of its recommended use or purpose;

    • (e) a change of the source material of any of its medicinal ingredients;

    • (f) changing any of its medicinal ingredients to or from being synthetically manufactured;

    • (g) a change to the potency of any of its medicinal ingredients;

    • (h) a change affecting its safety or efficacy that does not arise as a result of

      • (i) a change to the quantity of a medicinal ingredient per dosage unit,

      • (ii) the addition or substitution of a medicinal ingredient,

      • (iii) a change to its dosage form, or

      • (iv) a change to its recommended route of administration; or

    • (i) one or more of the following changes to its specifications, namely,

      • (i) the removal of a test method set out in the specifications,

      • (ii) the modification of a test method set out in the specifications in a manner that widens the purity tolerances of the natural health product or the quantity, identity or potency tolerances of any of its medicinal ingredients, or

      • (iii) the modification of a test method set out in the specifications in a manner that renders it less precise, accurate, specific or sensitive.

  • (2) An application to amend a product licence shall be submitted to the Minister and shall contain the following information and documents:

    • (a) the product number of the natural health product;

    • (b) a statement identifying each change described in subsection (1) that has been made;

    • (c) information demonstrating that the natural health product is safe and efficacious after the change;

    • (d) the text of each label to be used in conjunction with the natural health product after the change, if the change is any of those described in paragraphs (1)(a) to (h); and

    • (e) a copy of the revised specifications, if the change is any of those described in paragraph (1)(g) or (i).

 
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