Natural Health Products Regulations (SOR/2003-196)

89 If a natural health product has only one label, that label shall show all the statements, information and declarations required by these Regulations to be shown on both the inner and outer labels.

90 Every lot number required by these Regulations to be shown on a label of a natural health product shall be preceded by one of the following designations:

• (a) “Lot number”;

• (b) “Lot No.”;

• (c) “Lot”; or

• (d) “(L)”.

91 Every product number required by these Regulations to be shown on a label of a natural health product shall

• (a) in the case of a homeopathic medicine, be preceded by the designation “DIN-HM”; and

• (b) in any other case, be preceded by the designation “NPN”.

92 No reference, direct or indirect, to the Act, the Food and Drug Regulations or to these Regulations shall be made on any label of or in any advertisement for a natural health product unless the reference is specifically required by law.

• 93 (1) Subject to section 94, the inner and outer labels shall show the following information in respect of a natural health product:

  • (a) on the principal display panel,

    • (i) a brand name,

    • (ii) its product number,

    • (iii) its dosage form,

    • (iv) if it is sterile, the words “sterile” and “stérile”, and

    • (v) the net amount in the immediate container in terms of weight, measure or number; and

  • (b) on any panel,

    • (i) the name and address of the product licence holder,

    • (ii) if it is imported, the name and address of the importer,

    • (iii) the common name of each medicinal ingredient that it contains,

    • (iv) the proper name of each medicinal ingredient it contains, but only if the proper name is not the chemical name,

    • (v) a list by proper name, or by common name if the proper name is the chemical name, that sets out the quantity of each medicinal ingredient per dosage unit and, if any, the authorized potency of that medicinal ingredient,

    • (vi) its recommended use or purpose,

    • (vii) its recommended route of administration,

    • (viii) its recommended dose,

    • (ix) its recommended duration of use, if any,

    • (x) its risk information including any cautions, warnings, contra-indications or known adverse reactions associated with its use,

    • (xi) its recommended storage conditions, if any,

    • (xii) its lot number,

    • (xiii) its expiry date, and

    • (xiv) a description of the source material of each medicinal ingredient that it contains.

• (2) In addition to the requirements set out in subsection (1), the outer label shall show

  • (a) a qualitative list by common name, preceded by the words “non-medicinal ingredients”, of all non-medicinal ingredients of the natural health product; and

  • (b) if the natural health product contains mercury or any of its salts or derivatives as a non-medicinal ingredient, a statement that sets out the quantity of mercury contained in the natural health product.

Small Package Labelling

• 94 (1) The natural health product shall be labelled as follows if the immediate container is not large enough to accommodate an inner label that complies with the requirements of section 93:

  • (a) the inner label shall show the following in respect of the natural health product, namely,

    • (i) a brand name,

    • (ii) a qualitative list by proper name, or by common name if the proper name is the chemical name, that in descending order of quantity per dosage unit, sets out all medicinal ingredients that it contains,

    • (iii) its recommended dose,

    • (iv) its recommended duration of use, if any,

    • (v) its lot number,

    • (vi) its expiry date,

    • (vii) its product number,

    • (viii) if it is sterile, the words “sterile” and “stérile”,

    • (ix) the net amount in the immediate container in terms of weight, measure or number,

    • (x) its recommended use or purpose, and

    • (xi) if it does not have an outer label, a statement that refers the purchaser or consumer to the leaflet that is required in accordance with subsection (2); and

  • (b) the outer label, if any, shall be labelled as required under section 93.

• (2) If the natural health product does not have an outer label, the statements, information and declarations required to be shown on the outer label under section 93 shall be shown in a leaflet that is affixed or attached to the immediate container.

Security Packaging

• 95 (1) Subject to subsection (2), no person shall sell or import one or more of the following natural health products that is packaged unless it is contained in a security package:

  • (a) a mouthwash;

  • (b) a product to be inhaled, ingested or inserted into the body; or

  • (c) a product for ophthalmic use.

• (2) Subsection (1) does not apply to lozenges.

• (3) Subject to subsection (4), a statement or illustration that draws attention to the security feature of the security package referred to in subsection (1) shall be shown

  • (a) on the inner label; and

  • (b) if the security feature is a part of the outer package, on the outer label.

• (4) Subsection (3) does not apply if the security feature of a security package is self-evident and is an integral part of the immediate container.

Pressurized Containers

96 Sections A.01.061 to A.01.063 of the Food and Drug Regulations apply in respect of natural health products.

Cautionary Statements and Child Resistant Packages

97 Subsections C.01.001(2) to (4) and C.01.028(1), paragraphs C.01.028(2)(b) and (c), section C.01.029, subsection C.01.031(1), paragraphs C.01.031.2(1)(a) and (c) to (g), subsection C.01.031.2(2), and paragraphs C.01.031.2(3)(a) and (c) of the Food and Drug Regulations apply in respect of natural health products.

Medicinal Ingredient Representations

98 Section C.01.012 of the Food and Drug Regulations applies in respect of natural health products.

Inspectors

99 Sections A.01.022 to A.01.026 of the Food and Drug Regulations apply in respect of natural health products.

Imported Natural Health Products

100 Sections A.01.040 to A.01.044 of the Food and Drug Regulations apply in respect of natural health products.

Export Certificates

101 Section A.01.045 of the Food and Drug Regulations and Appendix III to those Regulations apply in respect of natural health products.

Sampling of Articles

102 Sections A.01.050 and A.01.051 of the Food and Drug Regulations apply in respect of natural health products.

Tablet Disintegration Times

103 Subsection C.01.015(1) and paragraphs C.01.015(2)(d) to (f) of the Food and Drug Regulations apply in respect of natural health products.

Sale of Natural Health Product for Emergency Treatment

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”;

• (b) the sale of a natural health product can only be authorized for human use;

• (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:

  • (c) the Minister has not, in respect of a natural health product, suspended the product licence under subsection 18(1) or section 19 of the Natural Health Products Regulations or cancelled the product licence under paragraph 20(b) of those Regulations;

• (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.

Public or Canadian Armed Forces Health Emergencies

• 103.15 (1) Sections C.11.002 and C.11.003 of the Food and Drug Regulations apply in respect of natural health products for which a product licence has not been issued.

• (2) If the Minister issues an authorization to sell a specified quantity of a natural health product under subsection C.11.003(1) of the Food and Drug Regulations, any quantities of the drug that are sold in accordance with the authorization cease to be considered to be natural health products as of the time of sale.

Exemptions

Advertising

103.2 A natural health product is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act.

Sale

103.3 A natural health product is exempt from subsection 3(2) of the Act with respect to its sale by a person where the natural health product is represented by label or is advertised by that person to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act.

Distribution of Natural Health Products as Samples

• 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.

• (2) An order referred to in subsection (1) may provide that the order be repeated at specified intervals during any period that does not exceed six months.

• (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;

  • (b) the expiry date of the natural health product falls on a day that is

    • (i) at least 30 days after the day on which it is distributed, if the expiry date consists of a day, month and year, or

    • (ii) in a month that follows the month in which it is distributed, if the expiry date consists only of a month and year;

  • (c) the natural health product meets the requirements of these Regulations.

• (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.

103.5 A person who, under subsection 103.4(1), receives an order for and distributes or causes to be distributed a natural health product as a sample shall

• (a) maintain records showing

  • (i) the name, address and description of each person to whom the natural health product was distributed,

  • (ii) the brand name, quantity and dosage form of the natural health product distributed, and

  • (iii) the date on which the natural health product was distributed; and

• (b) keep those records and all orders received for natural health products under subsection 103.4(1) for a period of not less than two years from the date on which the distribution referred to in the records was made.

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;

• (b) the expiry date of the natural health product falls on a day that is

  • (i) at least 30 days after the day on which it is distributed, if the expiry date consists of a day, month and year,

  • (ii) in a month that follows the month in which it is distributed, if the expiry date consists only of a month and year;

• (c) the natural health product meets the requirements of these Regulations.