Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2020-07-28 and last amended on 2020-07-01. Previous Versions

PART 5General (continued)

Labelling and Packaging (continued)

Security Packaging

  •  (1) Subject to subsection (2), no person shall sell or import a natural health product that is packaged unless the natural health product is contained in a security package.

  • (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

 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

 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

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

Inspectors

 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

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

  • SOR/2018-69, s. 64

Export Certificates

 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

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

Tablet Disintegration Times

 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

 Sections C.08.010 and C.08.011 of the Food and Drug Regulations apply in respect of natural health products except that

  • SOR/2004-119, s. 1

Exemptions

Advertising

 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 to the Act.

  • SOR/2007-288, s. 2

Sale

 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 to the Act.

  • SOR/2007-288, s. 2

Distribution of Natural Health Products as Samples

  •  (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.

  • SOR/2020-75, s. 2

 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.

  • SOR/2020-75, s. 2

 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:

  • SOR/2020-75, s. 2

PART 6Amendments, Transitional Provisions and Coming into Force

Amendments

Food and Drug Regulations

 [Amendment]

 [Amendment]

 [Amendment]

 [Amendment]

Transitional Provisions

  •  (1) Subject to section 110, a person may, without complying with these Regulations, sell a drug to which these Regulations apply that is assigned a drug identification number in accordance with section C.01.014.2(1) of the Food and Drug Regulations, until the earlier of

    • (a) the day on which an application for a product licence in respect of the drug is disposed of or withdrawn, and

    • (b) December 31, 2009.

  • (2) A person who sells a drug under subsection (1) shall conduct that sale in accordance with the requirements of the Food and Drug Regulations.

 An application for a product licence that is made in respect of a drug referred to in subsection 108(1) on or before December 31, 2009 is not required to contain the information referred to in paragraph 5(g).

 A sale or importation of a drug to which these Regulations apply that, before January 1, 2004, is authorized for the purposes of a clinical trial under Division 5 of Part C of the Food and Drug Regulations shall continue to be regulated under that Division.

 
Date modified: