Natural Health Products Regulations (SOR/2003-196)

• 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.

• 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 that is not one in which the conduct of that activity is authorized;

  • (c) if the licensee is authorized to import a natural health product, store a natural health product in a building that is not one in which the storage is authorized; 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.

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).

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.