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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2019-06-06 and last amended on 2019-05-22. Previous Versions

PART CDrugs (continued)

DIVISION 10Access to Drugs in Exceptional Circumstances (continued)

  •  (1) A sale of a drug that is imported under subsection C.10.001(2) is exempt from the provisions of these Regulations only if the drug is sold, within the jurisdiction of a public health official who has notified the Minister as described in paragraph C.10.001(2)(a), for use in respect of the same urgent public health need for which it was imported.

  • (2) Any person who wholesales such a drug must hold an establishment licence to wholesale a drug in the same category and despite subsection (1), the following provisions apply in respect of the wholesale:

    • (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee;

    • (b) section C.02.006 as it applies to the storage of the drug by the licensee;

    • (c) subsection C.02.012(1);

    • (d) section C.02.013;

    • (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee;

    • (f) subsection C.02.022(1);

    • (g) section C.02.023; and

    • (h) subsection C.02.024(1).

  • SOR/2017-133, s. 2

 Every licensee who imports a drug under subsection C.10.001(2) must notify the Minister within 15 days after the day on which it is imported by providing the following information:

  • (a) the name, title and contact information of the person who imported the drug;

  • (b) the brand name of the drug;

  • (c) the medicinal ingredients, strength, dosage form, route of administration and the identifying code or number, if any assigned in the country in which the drug was authorized for sale;

  • (d) the name of the country from which the drug was imported; and

  • (e) the total quantity of the drug imported.

  • SOR/2017-133, s. 2
  •  (1) For the purposes of section 21.8 of the Act, the prescribed health care institutions that must provide information to the Minister about a serious adverse drug reaction that involves a drug imported under subsection C.10.001(2) are the health care institutions authorized by the laws of a province to provide acute care services.

  • (2) The following prescribed information about a serious adverse drug reaction must be provided to the Minister in writing within 30 days after the day on which the reaction is first documented:

    • (a) the name of the health care institution and the contact information of a representative of that institution;

    • (b) the name and identifying number or code of the drug that is suspected of causing the reaction; and

    • (c) a description of the serious adverse drug reaction.

  • SOR/2017-133, s. 2

PART DVitamins, Minerals and Amino Acids

  •  (1) In this Part,

    advertise

    advertise means to advertise to the general public; (faire de la publicité)

    brand name

    brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,

    • (a) that is assigned to the drug by its manufacturer,

    • (b) under which the drug is sold or advertised, and

    • (c) that is used to distinguish the drug; (marque nominative)

    common name

    common name means, with reference to a salt or derivative of a vitamin, the name in English or French by which the salt or derivative is

    • (a) commonly known, and

    • (b) designated in scientific or technical journals; (nom usuel)

    prepackaged product

    prepackaged product means any food that is contained in a package in the manner in which it is ordinarily sold to, or used or purchased by, a person; (produit préemballé)

    reasonable daily intake

    reasonable daily intake, in respect of a food named in an item in Column I of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne normale)

    recommended daily intake

    recommended daily intake[Repealed, SOR/2016-305, s. 61]

    Table of Daily Values

    Table of Daily Values has the same meaning as in subsection B.01.001(1); (Tableau des valeurs quotidiennes)

    Table of Reference Amounts

    Table of Reference Amounts has the same meaning as in subsection B.01.001(1); (Tableau des quantités de référence)

    testimonial

    testimonial, with respect to a food or drug that is represented as containing a vitamin, mineral nutrient or mineral, means any dramatized or undramatized pictorial, written or oral representation as to the result that is, has been or may be produced by the addition to a person’s diet of that vitamin, mineral nutrient or mineral, as the case may be; (témoignage)

    weighted recommended nutrient intake

    weighted recommended nutrient intake means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in Table II to Division 1 and Table II to Division 2. (apport nutritionnel recommandé pondéré)

  • (2) For the purposes of this Part, a serving of stated size of a food shall be

    • (a) based on the food as offered for sale;

    • (b) in either of the following cases, the net quantity of the food in the package:

      • (i) if the quantity of food in the package can reasonably be consumed by one person at a single eating occasion, or

      • (ii) if the package contains less than 200% of the reference amount for the food; and

    • (c) in all other cases, the amount indicated for the food according to the criteria set out in column 3A of the Table of Reference Amounts.

  • (3) A serving of stated size of a food shall be expressed as follows:

    • (a) in the case of a single-serving prepackaged product to which paragraph (2)(b) applies, per package and using the following units:

      • (i) in grams, if the net quantity of the food is shown on the label by weight or by count, and

      • (ii) in millilitres, if the net quantity of the food is shown on the label by volume; and

    • (b) in the case of a multiple-serving prepackaged product to which paragraph (2)(c) applies, according to the following units set out in column 3B of the Table of Reference Amounts and according to the manner set out in that column:

      • (i) the household measure that applies to the product, and

      • (ii) the metric measure that applies to the product.

  • SOR/88-559, s. 31
  • SOR/93-202, s. 31
  • SOR/96-259, s. 3
  • SOR/2003-11, s. 27
  • SOR/2016-305, s. 61
  •  (1) The daily value of a vitamin or mineral nutrient set out in column 1 of Part 2 of the Table of Daily Values is, in respect of a food, the quantity

    • (a) set out in column 2, if the food is intended solely for infants six months of age or older but less than one year of age;

    • (b) set out in column 3, if the food is intended for infants six months of age or older but less than one year of age or for children one year of age or older but less than four years of age, and

    • (c) set out in column 4, in any other case.

  • (2) Subsection (1) does not apply if the food is a human milk substitute intended solely for infants less than six months of age.

  • SOR/2016-305, s. 62
 
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