Natural Health Products Regulations (SOR/2003-196)

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.

PART 6Amendments, Transitional Provisions and Coming into Force

Amendments

Food and Drug Regulations

104 [Amendment]

105 [Amendment]

106 [Amendment]

107 [Amendment]

Transitional Provisions

• 108 (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.

109 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).

110 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.

111 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.

112 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.

• 113 (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.

• 114 (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.

115 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

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

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