Regulations Amending the Natural Health Products Regulations (Distribution of Natural Health Products as Samples): SOR/2020-75

Canada Gazette, Part II, Volume 154, Number 9

Registration

SOR/2020-75 April 7, 2020

FOOD AND DRUGS ACT

P.C. 2020-229 April 3, 2020

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) ^{footnote a} of the Food and Drugs Act ^{footnote b}, makes the annexed Regulations Amending the Natural Health Products Regulations (Distribution of Natural Health Products as Samples).

Regulations Amending the Natural Health Products Regulations (Distribution of Natural Health Products as Samples)

Amendments

1 Subsection 1(1) of the Natural Health Products Regulations ^{footnote 1} is amended by adding the following in alphabetical order:

List A means the document entitled List of Certain Natural Health Products for Distribution as Samples, dated March 2020 and published by the Government of Canada on its website. (Liste A)

2 The Regulations are amended by adding the following after section 103.3:

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.

Coming into Force

3 These Regulations come into force on the day on which section 57 of the Canada–United States–Mexico Implementation Act, chapter 1 of the Statutes of Canada, 2020, comes into force, but if they are registered after that day, they come into force on the day on which they are registered.

N.B. The Regulatory Impact Analysis Statement for these Regulations appears following SOR/2020-74, Regulations Amending the Food and Drug Regulations (Distribution of Drugs as Samples).