Natural Health Products Regulations (SOR/2003-196)

Sixty-Day Disposition

• 6 (1) Subject to subsection (2), the Minister shall dispose of an application submitted under section 5 within 60 days after the day on which it is submitted if, in support of the application, the only information submitted by the applicant under paragraph 5(g) is that which is

  • (a) in the case of an application respecting a natural health product that has only one medicinal ingredient, contained in a monograph for that medicinal ingredient in the Compendium; and

  • (b) in the case of an application respecting a natural health product that has more than one medicinal ingredient, contained in a monograph for that combination of medicinal ingredients in the Compendium.

• (2) If the Minister requests that additional information or samples be submitted under section 15, the 60-day period referred to in subsection (1) does not include the number of days beginning on the day on which the request is made and ending on the day on which the additional information or samples are received.

• (3) For the purposes of this section, the Minister disposes of an application on the earlier of the day on which

  • (a) the licence is issued in accordance with section 7; and

  • (b) the applicant is sent a notice under subsection 9(1).

Issuance and Amendment

7 The Minister shall issue or amend a product licence if

• (a) the applicant submits an application to the Minister that is in accordance with section 5 or subsection 11(2), as the case may be;

• (b) the applicant submits to the Minister all additional information or samples requested under section 15;

• (c) the applicant does not make a false or misleading statement in the application; and

• (d) the issuance or amendment of the licence, as the case may be, is not likely to result in injury to the health of a purchaser or consumer.

Product Number

• 8 (1) The Minister shall assign a product number to each natural health product in respect of which a product licence is issued.

• (2) In the case of a natural health product that is a drug for which a drug identification number is assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations, the product number assigned under subsection (1) shall be the drug identification number.

Refusal to Issue or Amend

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

• (2) The notice shall indicate that the applicant may, within 30 days after the date of the notice, 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.

• 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.

Amendment

• 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).

Notification

• 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.

Fundamental Change

13 For greater certainty, if the licensee makes any of the following fundamental changes in respect of the natural health product, the licensee shall not sell the natural health product affected by the change unless a product licence is issued in accordance with section 7 for the natural health product as changed:

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

• (b) the addition or substitution of a medicinal ingredient;

• (c) a change to its dosage form; or

• (d) a change to its recommended route of administration.

Licence Contents

• 14 (1) A product licence shall set out the following information:

  • (a) the name and address of the licensee;

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

  • (c) the dosage form that is authorized for the natural health product;

  • (d) the recommended route of administration that is authorized for the natural health product;

  • (e) the recommended dose that is authorized for the natural health product;

  • (f) the recommended duration of use, if any, that is authorized for the natural health product;

  • (g) in respect of each medicinal ingredient of the natural health product

    • (i) its authorized quantity per dosage unit,

    • (ii) its authorized potency, if any, and

    • (iii) its authorized source material;

  • (h) the recommended use or purpose that is authorized for the natural health product; and

  • (i) the date on which the licence was issued.

• (2) Within 60 days after the day on which the product licence is issued, the licensee shall notify the Minister of any information set out on the licence that the licensee knows to be incorrect.

Additional Information or Samples

15 If the information and documents submitted in respect of a product licence application under section 5 or an application for amendment under subsection 11(2) are insufficient to enable the Minister to determine whether the product licence should be issued or amended, as the case may be, the Minister may request that the applicant provide such additional information or samples of the natural health product as are necessary to make the determination.

Safety Information

16 If the Minister has reasonable grounds to believe that a natural health product may no longer be safe when used under the recommended conditions of use, the Minister may request that the licensee provide the Minister, within 15 days after the day on which the request is received, with information and documents demonstrating that the natural health product is safe when used under the recommended conditions of use.

Direction to Stop Sale

• 17 (1) The Minister may direct the licensee, manufacturer, importer and distributor to stop their sale of a natural health product if

  • (a) the licensee does not, within the required period, provide the Minister with the information and documents requested under section 16;

  • (b) the information and documents provided by the licensee in accordance with section 16 do not demonstrate that the natural health product is safe when used under the recommended conditions of use;

  • (c) in the case of a natural health product that is imported, the Minister has reasonable grounds to believe that the natural health product is not manufactured, packaged, labelled, imported, distributed or stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3;

  • (d) in the case of a natural health product that is not imported, the Minister has reasonable grounds to believe that the natural health product is not manufactured, packaged, labelled, distributed or stored in accordance with the requirements set out in Part 3; or

  • (e) the Minister has reasonable grounds to believe that the natural health product is not packaged or labelled in accordance with the requirements set out in Part 5.

• (2) The Minister shall lift a direction to stop the sale of a natural health product if the licensee provides the Minister with information and documents demonstrating that

  • (a) in the case of a direction to stop sale arising under either paragraph (1)(a) or (b), the natural health product is safe when used under the recommended conditions of use;

  • (b) in the case of a direction to stop sale arising under paragraph (1)(c), the natural health product is manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3;

  • (c) in the case of a direction to stop sale arising under paragraph (1)(d), the natural health product is manufactured, packaged, labelled, distributed and stored in accordance with the requirements set out in Part 3;

  • (d) in the case of a direction to stop sale arising under paragraph (1)(e), the natural health product is packaged and labelled in accordance with the requirements of Part 5; or

  • (e) the situation giving rise to the direction to stop the sale of the natural health product did not exist.

Suspension and Cancellation

• 18 (1) Subject to subsection (2), the Minister may suspend a product licence if the Minister has reasonable grounds to believe that

  • (a) the licensee has contravened these Regulations or any provision of the Act relating to the natural health product; or

  • (b) the licensee has made a false or misleading statement in the application submitted under section 5 or the application for amendment under subsection 11(2).

• (2) Subject to section 19, the Minister shall not suspend a product licence unless

  • (a) the Minister has sent the licensee a notice that sets out the reason for the intended suspension; and

  • (b) the licensee has not, within 90 days after the date of the notice referred to in paragraph (a), provided the Minister with information or documents demonstrating that the licence should not be suspended on the grounds that

    • (i) the situation giving rise to the intended suspension did not exist, or

    • (ii) the situation giving rise to the intended suspension has been corrected.

19 The Minister shall suspend a product licence before giving the licensee an opportunity to be heard if, as a result of any circumstance, the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer.

20 If the Minister suspends a product licence under section 18 or 19, the Minister shall send the licensee a notice that sets out the reason for the suspension and the day on which the suspension is effective, and the Minister shall

• (a) reinstate the licence if, within 90 days after the day on which the suspension is effective, the licensee provides the Minister with information or documents demonstrating that the situation giving rise to the suspension did not exist or that it has been corrected; or

• (b) cancel the licence if, within 90 days after the day on which the suspension is effective, the licensee has not provided the Minister with the information or documents referred to in paragraph (a).

21 If the Minister cancels a licence under paragraph 20(b), the Minister shall send the licensee a notice that sets out the reason for the cancellation and the day on which the cancellation is effective.

Site Information

• 22 (1) Subject to subsection (2), the licensee shall provide the Minister with the following information prior to commencing the sale of the natural health product:

  • (a) in respect of each manufacturer, packager, labeller and importer of the natural health product

    • (i) the person’s name, address and telephone number, and if applicable, the person’s facsimile number and electronic mail address, and

    • (ii) if the person conducts the activity in Canada, the number assigned to the site licence issued in respect of that activity;

  • (b) the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of each distributor of the natural health product;

  • (c) the address of each building in which the natural health product is manufactured, packaged or labelled;

  • (d) the address of each building in which the natural health product is stored for the purposes of importation or distribution; and

  • (e) if the natural health product is imported, evidence establishing that the natural health product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements set out in Part 3 or in accordance with requirements that are equivalent to those set out in Part 3.

• (2) If the natural health product is one in respect of which a drug identification number is assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations and at the time the product licence is issued in respect of the natural health product it is already being sold, the licensee shall provide the information referred to in subsection (1) within 30 days after the day on which the product licence is issued.