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Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2019-08-28 and last amended on 2018-10-17. 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

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.

 Until December 31, 2009, a person may sell a lot or batch of a drug referred to in section 108 that is not labelled or packaged in accordance with the requirements of Part 5 if the lot or batch is packaged in accordance with the requirements of the Food and Drug Regulations.

 If during the period beginning on January 1, 2004 and ending on December 31, 2005, the information referred to in section 22 is not available to the licensee prior to commencing the sale of the natural health product or within 30 days after the day on which the license is issued in respect of the natural health product, as the case may be, the licensee shall provide the information to the Minister immediately after it is available to the licensee.

  •  (1) A person who, before January 1, 2004, manufactures, packages, labels or imports for sale a drug to which these Regulations apply may continue to conduct the activity in respect of that drug without complying with the requirements of Parts 2 and 3, until the earlier of

    • (a) the day on which that person’s application for a site licence to conduct that activity in respect of the drug is disposed of or withdrawn, and

    • (b) December 31, 2005.

  • (2) A person who conducts an activity under subsection (1) shall conduct that activity in accordance with the requirements of the Food and Drug Regulations.

  •  (1) A person who, before January 1, 2004, distributes a drug to which these Regulations apply may continue to conduct the activity in respect of that drug without complying with the requirements of Part 3 until December 31, 2005.

  • (2) A person who conducts an activity under subsection (1) shall conduct that activity in accordance with the requirements of Division 2 of Part C of the Food and Drug Regulations.

 A person may sell a lot or batch of a drug referred to in section 108 that is not manufactured, packaged, labelled, imported, distributed or stored, as the case may be, in accordance with the requirements of Part 3 if

  • (a) the lot or batch is manufactured, packaged and labelled before January 1, 2006; and

  • (b) any manufacturing, packaging, labelling, importation, distribution or storage of the lot or batch that is not conducted in accordance with the requirements of Part 3 is conducted in accordance with the requirements of Division 2 of Part C of the Food and Drug Regulations.

Coming into Force

  •  (1) Except for section 6, these Regulations come into force on January 1, 2004.

  • (2) Section 6 comes into force on July 1, 2004.

 
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