Advanced Search

• 1 (1) The following definitions apply in these Regulations.

  added sulphites

  added sulphites  means one or more of the food additives that are set out item 21, column 1, of table 2 of the Common Names for Ingredients and Components Document and are present in a natural health product as a result of being added to the product. (sulfites ajoutés)

  Common Names for Ingredients and Components Document

  Common Names for Ingredients and Components Document  means the document entitled Common Names for Ingredients and Components, prepared by the Canadian Food Inspection Agency and published on its website, as amended from time to time. (document sur les noms usuels d’ingrédients et de constituants)

  Compendium

  Compendium  means the Compendium of Monographs published by the Department of Health and as amended from time to time. (Compendium)

  expiry date

  expiry date  means the earlier of

  • (a) the date, expressed at minimum as a year and month, that is the end of the stability period determined under section 52; and

  • (b) the date, expressed at minimum as a year and month, after which the manufacturer recommends that the natural health product should not be used. (date limite d’utilisation)

  List A

  List A  means the document entitled List of Certain Natural Health Products for Distribution as Samples, dated March 2020 and published by the Government of Canada on its website. (Liste A)

  point

  point  means the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm. (point)

  principal display panel

  principal display panel  has the same meaning as in the Consumer Packaging and Labelling Regulations. (espace principal)

[...]

103.1 Section C.08.010 and subsections C.08.011(1) and (3) of the Food and Drug Regulations apply in respect of natural health products with the following modifications:

• (a) a reference to “new drug” is to be read as a reference to “natural health product”;

• [...]

• (c) in subparagraph C.08.010(1)(b)(i), the reference to “adverse drug reactions” is to be read as a reference to “adverse reactions”;

• (d) paragraph C.08.010(2)(c) is to be read as follows:

  [...]

• (e) in subsection C.08.011(1), the reference to “section C.08.002” is to be read as a reference to “subsection 4(1) of the Natural Health Products Regulations”; and

• (f) in subsection C.08.011(3), the reference to “these Regulations” is to be read as a reference to the Natural Health Products Regulations.

[...]

• 103.4 (1) If a practitioner or pharmacist has signed an order specifying the proper name or common name, the brand name and the quantity of a natural health product, the person who receives the order may distribute or cause to be distributed the natural health product, in dosage form, as a sample to that practitioner or pharmacist if the natural health product meets the requirements of these Regulations.

• [...]

• (3) Despite subsection (1), a person may distribute or cause to be distributed a natural health product, in dosage form, as a sample to a practitioner or pharmacist without a signed order if that natural health product has a localized effect and is for administration either in the oral cavity or on the skin, or is a throat lozenge, and if all of the following conditions are met:

  • (a) the natural health product is part of a class of natural health products that is set out in column 1 of List A and contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the natural health product is consistent with the descriptive information set out in columns 4 to 6;

• (4) For the purposes of this section, practitioner and pharmacist have the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations.

[...]

• 79 (1) If the sponsor discontinues a clinical trial in its entirety or at a clinical trial site, the sponsor shall

  • [...]

  • (c) as soon as possible, notify all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and

  • (d) in respect of each discontinued clinical trial site, stop the sale or importation of the natural health product as of the day of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the natural health product that have been sold.

103.6 A person may distribute or cause to be distributed a natural health product, in dosage form, as a sample to any consumer that is 18 years of age or older if that natural health product has a localized effect and is for administration either in the oral cavity or on the skin, or is a throat lozenge, and if all of the following conditions are met:

• (a) the natural health product is part of a class of natural health products that is set out in column 1 of List A and contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the natural health product is consistent with the descriptive information set out in columns 4 to 6;

[...]