Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2016-04-12 and last amended on 2008-06-01. Previous Versions

Notification

  •  (1) If the licensee makes any of the changes described in subsection (2) in respect of the natural health product, the licensee shall, within 60 days after the day on which the change is made,

    • (a) notify the Minister of the change; and

    • (b) provide the Minister with the text of each label used in conjunction with the natural health product since the change, if the change is any of those described in paragraphs (2)(d) to (f).

  • (2) For the purposes of subsection (1), changes in respect of a natural health product are

    • (a) a change to any of the information submitted under paragraph 5(a) or (b);

    • (b) a change to any of the information provided under section 22;

    • (c) the addition or substitution of a non-medicinal ingredient, the addition or substitution of which does not affect its safety or efficacy;

    • (d) its sale under a brand name other than one submitted under paragraph 5(e);

    • (e) a change of the common or proper name of any of its medicinal ingredients; and

    • (f) the addition of risk information to any of its labels, including the addition of a caution, warning, contra-indication or known adverse reaction associated with its use.

Fundamental Change

 For greater certainty, if the licensee makes any of the following fundamental changes in respect of the natural health product, the licensee may not sell the natural health product affected by the change unless a product licence is issued in accordance with section 7 for the natural health product as changed:

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

  • (b) the addition or substitution of a medicinal ingredient;

  • (c) a change to its dosage form; or

  • (d) a change to its recommended route of administration.

Licence Contents

  •  (1) A product licence shall set out the following information:

    • (a) the name and address of the licensee;

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

    • (c) the dosage form that is authorized for the natural health product;

    • (d) the recommended route of administration that is authorized for the natural health product;

    • (e) the recommended dose that is authorized for the natural health product;

    • (f) the recommended duration of use, if any, that is authorized for the natural health product;

    • (g) in respect of each medicinal ingredient of the natural health product

      • (i) its authorized quantity per dosage unit,

      • (ii) its authorized potency, if any, and

      • (iii) its authorized source material;

    • (h) the recommended use or purpose that is authorized for the natural health product; and

    • (i) the date on which the licence was issued.

  • (2) Within 60 days after the day on which the product licence is issued, the licensee shall notify the Minister of any information set out on the licence that the licensee knows to be incorrect.

Additional Information or Samples

 If the information and documents submitted in respect of a product licence application under section 5 or an application for amendment under subsection 11(2) are insufficient to enable the Minister to determine whether the product licence should be issued or amended, as the case may be, the Minister may request that the applicant provide such additional information or samples of the natural health product as are necessary to make the determination.

Safety Information

 If the Minister has reasonable grounds to believe that a natural health product may no longer be safe when used under the recommended conditions of use, the Minister may request that the licensee provide the Minister, within 15 days after the day on which the request is received, with information and documents demonstrating that the natural health product is safe when used under the recommended conditions of use.

Direction to Stop Sale

  •  (1) The Minister may direct the licensee, manufacturer, importer and distributor to stop their sale of a natural health product if

    • (a) the licensee does not, within the required period, provide the Minister with the information and documents requested under section 16;

    • (b) the information and documents provided by the licensee in accordance with section 16 do not demonstrate that the natural health product is safe when used under the recommended conditions of use;

    • (c) in the case of a natural health product that is imported, the Minister has reasonable grounds to believe that the natural health product is not manufactured, packaged, labelled, imported, distributed or 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;

    • (d) in the case of a natural health product that is not imported, the Minister has reasonable grounds to believe that the natural health product is not manufactured, packaged, labelled, distributed or stored in accordance with the requirements set out in Part 3; or

    • (e) the Minister has reasonable grounds to believe that the natural health product is not packaged or labelled in accordance with the requirements set out in Part 5.

  • (2) The Minister shall lift a direction to stop the sale of a natural health product if the licensee provides the Minister with information and documents demonstrating that

    • (a) in the case of a direction to stop sale arising under either paragraph (1)(a) or (b), the natural health product is safe when used under the recommended conditions of use;

    • (b) in the case of a direction to stop sale arising under paragraph (1)(c), the natural health product is 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;

    • (c) in the case of a direction to stop sale arising under paragraph (1)(d), the natural health product is manufactured, packaged, labelled, distributed and stored in accordance with the requirements set out in Part 3;

    • (d) in the case of a direction to stop sale arising under paragraph (1)(e), the natural health product is packaged and labelled in accordance with the requirements of Part 5; or

    • (e) the situation giving rise to the direction to stop the sale of the natural health product did not exist.

Suspension and Cancellation

  •  (1) Subject to subsection (2), the Minister may suspend a product licence if the Minister has reasonable grounds to believe that

    • (a) the licensee has contravened these Regulations or any provision of the Act relating to the natural health product; or

    • (b) the licensee has made a false or misleading statement in the application submitted under section 5 or the application for amendment under subsection 11(2).

  • (2) Subject to section 19, the Minister shall not suspend a product licence unless

    • (a) the Minister has sent the licensee a notice that sets out the reason for the intended suspension; and

    • (b) the licensee has not, within 90 days after the day on which the notice referred to in paragraph (a) is received, provided the Minister with information or documents demonstrating that the licence should not be suspended on the grounds that

      • (i) the situation giving rise to the intended suspension did not exist, or

      • (ii) the situation giving rise to the intended suspension has been corrected.

 The Minister shall suspend a product licence before giving the licensee an opportunity to be heard if, as a result of any circumstance, the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer.

 If the Minister suspends a product licence under section 18 or 19, the Minister shall send the licensee a notice that sets out the reason for the suspension and the day on which the suspension is effective, and the Minister shall

  • (a) reinstate the licence if, within 90 days after the day on which the suspension is effective, the licensee provides the Minister with information or documents demonstrating that the situation giving rise to the suspension did not exist or that it has been corrected; or

  • (b) cancel the licence if, within 90 days after the day on which the suspension is effective, the licensee has not provided the Minister with the information or documents referred to in paragraph (a).

 
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