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Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2019-11-19 and last amended on 2018-10-17. Previous Versions

PART 2Site Licences (continued)

Refusal to Issue or Amend (continued)

  •  (1) After reconsidering the application, the Minister shall issue or amend the site licence if the requirements of subsection 29(1) are met.

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

Amendment

  •  (1) A licensee shall not conduct any of the following activities unless the site licence is amended accordingly:

    • (a) conduct any activity for a which a site licence is required that the licensee is not already authorized to conduct;

    • (b) if the licensee is authorized to manufacture, package or label a natural health product, conduct that activity in a building in which they are not authorized to do so;

    • (c) if the licensee is authorized to import a natural health product, store a natural health product in a building in which they are not authorized to do so; or

    • (d) if the licensee is authorized to conduct an activity, but not already authorized to conduct it in respect of a natural health product in sterile dosage form, conduct the activity in respect of a natural health product in that form.

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

    • (a) the licence number;

    • (b) a statement that specifies each activity referred to in subsection (1) that the licensee is proposing to conduct; and

    • (c) a report from a quality assurance person demonstrating that the buildings, equipment, practices and procedures used in respect of each activity conducted by the licensee will remain in compliance with the requirements set out in Part 3.

  • SOR/2018-69, s. 47(E)

Notification

 If the licensee makes any of the following changes, the licensee shall notify the Minister of the change within 60 days after the day on which the change is made:

  • (a) a change to the information submitted under paragraph 28(a); and

  • (b) a change that substantially alters any building, equipment, practice or procedure in respect of which a report from a quality assurance person was submitted under paragraph 28(f).

Licence Contents

 A site licence shall set out the following information:

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

  • (b) the site licence number;

  • (c) each activity that the licensee is authorized to conduct and a statement indicating whether the activity is authorized to be conducted in respect of a natural health product in sterile dosage form;

  • (d) if the licensee is authorized to manufacture, package or label a natural health product, the address of each building in which the licensee is authorized to conduct that activity; and

  • (e) if the licensee is authorized to import a natural health product, the address of each building in which the licensee is authorized to store that natural health product.

Expiry

  •  (1) A site licence expires on the first anniversary of the day on which it was issued unless it is renewed in accordance with section 36.

  • (2) A site licence that is renewed in accordance with section 36 expires on the day on which the renewal period ends unless the licence is further renewed in accordance with section 36.

Renewal

  •  (1) The Minister shall renew a site licence if

    • (a) the licensee submits a request to renew the licence to the Minister no later than 30 days before the day on which the licence expires;

    • (b) the licensee provides the Minister with all additional information requested under section 37; and

    • (c) the renewal of the licence is not likely to result in injury to the health of a purchaser or consumer.

  • (2) If the Minister renews a site licence, the Minister shall renew it for a period of

    • (a) one year, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of less than three years;

    • (b) two years, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of at least three years but less than nine years; or

    • (c) three years, if on the next anniversary of the day on which the licence was issued, the licensee will have held the licence for a period of nine years or more.

  • (3) A site licence renewal becomes effective on the day after the anniversary of the day on which the licence was issued.

Additional Information

 If the information and documents submitted in respect of an application under section 28, an application for amendment under subsection 32(2) or a request for renewal under section 36 are insufficient to enable the Minister to determine whether the licence should be issued, amended or renewed, as the case may be, the Minister may request that the applicant provide the Minister with such additional information as is necessary to make the determination.

Relinquishment of Authorization

  •  (1) A licensee may, by amendment of the site licence, relinquish any part of the authorization given to the licensee under this Part.

  • (2) An application to amend the site licence for the purposes of subsection (1) shall be submitted to the Minister and shall contain the following information and documents:

    • (a) a document, signed and dated by the licensee, that sets out the site licence number and that specifies each activity or, by address, each building, in respect of which the authorization is requested to be relinquished; and

    • (b) an attestation, signed and dated by a quality assurance person, stating that after the relinquishment, the buildings, equipment, practices and procedures used in respect of each activity conducted by the licensee will remain in compliance with the requirements set out in Part 3.

  • (3) The Minister shall amend the site licence as requested by the licensee in paragraph (2)(a) if the licensee provides the Minister with an application that is in accordance with subsection (2).

Suspension and Cancellation

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

    • (a) the licensee has contravened any provision of the Act or these Regulations; or

    • (b) the licensee has made a false or misleading statement in the application submitted under section 28 or the application for amendment under subsection 32(2).

  • (2) Subject to section 40, the Minister shall not suspend a site 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 site 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 site licence under section 39 or 40, the Minister shall send the licensee a notice that sets out the reason for 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).

 If the Minister cancels a licence under paragraph 41(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.

PART 3Good Manufacturing Practices

Prohibition

  •  (1) Subject to subsection (2), no person shall sell a natural health product unless it is manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with this Part.

  • (2) A person may sell a natural health product that is manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with requirements that are equivalent to those set out in this Part if the natural health product is imported.

 
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