Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2019-06-20 and last amended on 2018-10-17. Previous Versions

PART 4Clinical Trials Involving Human Subjects (continued)

Suspension and Cancellation (continued)

 If the Minister cancels the authorization under paragraph 82(b), the Minister shall send the sponsor a notice that sets out the reason for the cancellation, the day on which the cancellation is effective and indicating whether the authorization is cancelled in its entirety or at a clinical trial site.

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.

  •  (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.

  • SOR/2018-69, s. 62

Small Package Labelling

  •  (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.

  • SOR/2018-69, s. 63
 
Date modified: