Natural Health Products Regulations (SOR/2003-196)

Records

• 23 (1) Every licensee who sells a natural health product shall maintain the following records:

  • (a) a list of all ingredients contained in each lot or batch of the natural health product that has been made available for sale; and

  • (b) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale.

• (2) The records shall be maintained by the licensee for a period of one year following the expiry date of the natural health product to which that record relates.

Reaction Reporting

• 24 (1) A licensee shall provide the Minister with

  • (a) a case report for each serious adverse reaction to the natural health product that occurs inside Canada, within 15 days after the day on which the licensee becomes aware of the reaction; and

  • (b) a case report for each serious unexpected adverse reaction to the natural health product that occurs inside or outside Canada, within 15 days after the day on which the licensee becomes aware of the reaction.

• (2) A licensee who sells a natural health product shall annually prepare and maintain a summary report that contains a concise and critical analysis of

  • (a) all adverse reactions to the natural health product that have occurred inside Canada; and

  • (b) all reactions for which a case report is required to be provided under subsection (1), that have occurred

    • (i) during the previous 12 months, and

    • (ii) at a dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying organic functions in humans.

• (3) If after reviewing a case report provided under subsection (1) or after reviewing any other safety data relating to the natural health product, the Minister has reasonable grounds to believe that the natural health product may no longer be safe when used under the recommended conditions of use, the Minister may request that, within 30 days after the day on which the request is received, the licensee

  • (a) provide to the Minister a copy of any summary report prepared under subsection (2); or

  • (b) prepare and provide to the Minister an interim summary report containing a concise and critical analysis of

    • (i) all adverse reactions to the natural health product that have occurred inside Canada, and

    • (ii) all reactions for which a case report is required to be provided under subsection (1), that have occurred

      • (A) since the date of the most recent summary report prepared under subsection (2), and

      • (B) at a dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying organic functions in humans.

Recall Reporting

25 Every licensee who commences a recall of a natural health product shall provide the Minister with the information referred to in section 62 within three days after the day on which the recall is commenced.

PART 2Site Licences

Application

26 This Part does not apply to any activity that is conducted in respect of a natural health product solely for the purposes of a clinical trial as defined in section 63.

Prohibition

• 27 (1) Subject to subsection (2), no person shall manufacture, package, label or import a natural health product for sale unless

  • (a) the person holds a site licence issued in respect of the activity; and

  • (b) the person conducts the activity in accordance with the requirements set out in Part 3.

• (2) No person who holds a site licence shall manufacture, package, label or import a natural health product for sale during the period of any suspension of the licence under section 39 or 40.

Licence Application

28 An application for a site 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) a statement specifying which one or more of the activities of manufacturing, packaging, labelling or importing the applicant is proposing to conduct;

• (c) if the applicant is proposing to manufacture, package or label a natural health product, the address of each building in which each activity is proposed to be conducted;

• (d) if the applicant is proposing to import a natural health product, the address of each building in which that natural health product is proposed to be stored;

• (e) for each activity specified under paragraph (b), a statement indicating whether or not the applicant is proposing to conduct the activity in respect of a natural health product in sterile dosage form; and

• (f) in respect of the buildings, equipment, practices and procedures used to conduct each activity specified under paragraph (b), a report from a quality assurance person establishing that they comply with the requirements set out in Part 3.

Issuance and Amendment

• 29 (1) The Minister shall issue or amend a site licence if

  • (a) the applicant submits an application to the Minister that is in accordance with section 28 or subsection 32(2), as the case may be;

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

  • (c) the applicant does not make a false or misleading statement in the application.

• (2) If the Minister issues a site licence, the Minister shall assign that licence a site licence number.

Refusal to Issue or Amend

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

• (2) The notice shall indicate that the applicant may, within 30 days after the date of the notice, 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.

• 31 (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

• 32 (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 establishing 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.

Notification

33 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

34 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

• 35 (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

• 36 (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

37 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

• 38 (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

• 39 (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 date of the notice referred to in paragraph (a), 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.

40 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.

41 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).

42 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.