Natural Health Products Regulations (SOR/2003-196)

• 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

  • (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).

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

• 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.

• 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) 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.