Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2014-10-15 and last amended on 2008-06-01. Previous Versions

PART 5GENERAL

Electronic Signatures

 Any signature that is required by these Regulations to be shown on a record or document may be an electronic reproduction of the required signature.

Electronic Records

 Any record that is required to be maintained by these Regulations may be maintained in any electronic format from which a printed copy of the record can be produced.

Labelling and Packaging

General

  •  (1) No person shall sell a natural health product unless it is labelled and packaged in accordance with these Regulations.

  • (2) Despite subsection (1), a person may sell a natural health product that is not labelled and packaged in accordance with these Regulations if the sale is to a manufacturer or distributor.

  •  (1) Subject to subsection (2), when required by these Regulations to be shown on a label, the following information respecting a natural health product shall be in both English and French:

    • (a) any of the information referred to in paragraphs (a) to (f) of the definition “recommended conditions of use” in subsection 1(1);

    • (b) the common name and proper name of each medicinal ingredient and each non-medicinal ingredient that it contains;

    • (c) a description of the source material of a medicinal ingredient; and

    • (d) its storage conditions.

  • (2) The common name or proper name of a medicinal ingredient or non-medicinal ingredient shall be shown in any other language if the name does not have an English or French equivalent.

 The statements, information and declarations required by these Regulations to be shown on a label of a natural health product shall be

  • (a) clearly and prominently displayed; and

  • (b) readily discernible to the purchaser or consumer of the natural health product under the customary conditions of purchase and use.

 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.

 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)”.

 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”.

 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.