Natural Health Products Regulations

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 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.