Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2014-06-12 and last amended on 2008-06-01. Previous Versions

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 required under subsection (1) shall be the drug identification number.

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.