Natural Health Products Regulations (SOR/2003-196)

12 (1) If the licensee makes any of the changes described in subsection (2) in respect of the natural health product, the licensee shall, within 60 days after the day on which the change is made,

• (a) notify the Minister of the change; and

• (b) provide the Minister with the text of each label used in conjunction with the natural health product since the change, if the change is any of those described in paragraphs (2)(d) to (f).

(2) For the purposes of subsection (1), changes in respect of a natural health product are

• (a) a change to any of the information submitted under paragraph 5(a) or (b);

• (b) a change to any of the information provided under section 22;

• (c) the addition or substitution of a non-medicinal ingredient, the addition or substitution of which does not affect its safety or efficacy;

• (d) its sale under a brand name other than one submitted under paragraph 5(e);

• (e) a change of the common or proper name of any of its medicinal ingredients; and

• (f) the addition of risk information to any of its labels, including the addition of a caution, warning, contra-indication or known adverse reaction associated with its use.