Natural Health Products Regulations (SOR/2003-196)

• 18. (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.

19. 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.

20. 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).

21. If the Minister cancels a licence under paragraph 20(b), the Minister shall send the licensee a notice that sets out the reason for the cancellation and the day on which the cancellation is effective.

• 22. (1) Subject to subsection (2), the licensee shall provide the Minister with the following information prior to commencing the sale of the natural health product:

  • (a) in respect of each manufacturer, packager, labeller and importer of the natural health product

    • (i) the person’s name, address and telephone number, and if applicable, the person’s facsimile number and electronic mail address, and

    • (ii) if the person conducts the activity in Canada, the number assigned to the site licence issued in respect of that activity;

  • (b) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of each distributor of the natural health product;

  • (c) the address of each building in which the natural health product is manufactured, packaged or labelled;

  • (d) the address of each building in which the natural health product is stored for the purposes of importation or distribution; and

  • (e) if the natural health product is imported, evidence demonstrating 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.

• (2) If the natural health product is one in respect of which a drug identification number is assigned in accordance with subsection C.01.014.2 (1) of the Food and Drug Regulations and at the time the product licence is issued in respect of the natural health product it is already being sold, the licensee shall provide the information referred to in subsection (1) within 30 days after the day on which the product licence is issued.