Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2019-06-20 and last amended on 2018-10-17. Previous Versions

PART 1Product Licences (continued)

Suspension and Cancellation (continued)

 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.

Site Information

  •  (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.

  • SOR/2018-69, s. 46(F)

Records

  •  (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

  •  (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

 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

 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

  •  (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

    • (a) during the period of any suspension of the licence under section 39 or 40; or

    • (b) after cancellation of the licence under paragraph 41(b).

Licence Application

 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 demonstrating that they comply with the requirements set out in Part 3.

Issuance and Amendment

  •  (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

  •  (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) 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.

 
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