Natural Health Products Regulations (SOR/2003-196)

10. (1) After reconsidering the application, the Minister shall issue or amend the product licence if the requirements of section 7 are met.

(2) If the Minister again refuses to issue or amend the product licence, the Minister shall send the applicant a final notice that sets out the reason for the refusal.

11. (1) If the licensee makes any of the following changes in respect of the natural health product, the licensee shall not sell any lot or batch of the natural health product affected by the change unless the product licence is amended accordingly:

• (a) a change to its recommended dose;

• (b) a change to its recommended duration of use;

• (c) the deletion or modification of risk information shown on any of its labels, including the deletion or modification of a caution, warning, contra-indication or known adverse reaction associated with its use;

• (d) a change of its recommended use or purpose;

• (e) a change of the source material of any of its medicinal ingredients;

• (f) changing any of its medicinal ingredients to or from being synthetically manufactured;

• (g) a change to the potency of any of its medicinal ingredients;

• (h) a change affecting its safety or efficacy that does not arise as a result of

  • (i) a change to the quantity of a medicinal ingredient per dosage unit,

  • (ii) the addition or substitution of a medicinal ingredient,

  • (iii) a change to its dosage form, or

  • (iv) a change to its recommended route of administration; or

• (i) one or more of the following changes to its specifications, namely,

  • (i) the removal of a test method set out in the specifications,

  • (ii) the modification of a test method set out in the specifications in a manner that widens the purity tolerances of the natural health product or the quantity, identity or potency tolerances of any of its medicinal ingredients, or

  • (iii) the modification of a test method set out in the specifications in a manner that renders it less precise, accurate, specific or sensitive.

(2) An application to amend a product licence shall be submitted to the Minister and shall contain the following information and documents:

• (a) the product number of the natural health product;

• (b) a statement identifying each change described in subsection (1) that has been made;

• (c) information demonstrating that the natural health product is safe and efficacious after the change;

• (d) the text of each label to be used in conjunction with the natural health product after the change, if the change is any of those described in paragraphs (1)(a) to (h); and

• (e) a copy of the revised specifications, if the change is any of those described in paragraph (1)(g) or (i).

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.