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

Regulations are current to 2022-06-01 and last amended on 2022-03-02. Previous Versions

PART CDrugs (continued)

DIVISION 10Access to Drugs in Exceptional Circumstances (continued)

 Sections A.01.040, A.01.044 and C.01.004.1 do not apply in respect of the importation, under section C.10.006, of a designated drug by a person who holds an establishment licence.

  •  (1) Subject to sections C.10.009 and C.10.010, a sale of a designated drug that is imported under section C.10.006 is exempt from the following provisions:

    • (a) sections A.01.015, A.01.017 and A.01.051; and

    • (b) the provisions of Part C other than

      • (i) sections C.01.016, C.01.017, C.01.019 to C.01.020.1, C.01.040.3 to C.01.049.1 and C.01.051,

      • (ii) the provisions of Divisions 1A and 2, and

      • (iii) this section and sections C.10.009 to C.10.011.

  • (2) For greater certainty, for the purposes of section C.01.016, the manufacturer of a designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 in respect of the drug.

  • (3) Subsections (1) and (2) cease to apply in respect of the sale of a designated drug on its expiration date.

  •  (1) Section C.02.019 does not apply to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006.

  • (2) The licensee shall perform the finished product testing on a sample of the designated drug that is taken either

    • (a) after receipt of each lot or batch of the designated drug on their premises in Canada; or

    • (b) before receipt of each lot or batch of the designated drug on their premises in Canada if the following conditions are met:

      • (i) the licensee has evidence satisfactory to the Minister to demonstrate that lots or batches of the designated drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug, and

      • (ii) the designated drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

  • (3) In subsection (2), a reference to specifications is a reference to the specifications with which the designated drug is required to comply within the jurisdiction of the foreign regulatory authority referred to in paragraph C.10.006(1)(b).

  • (4) If the licensee receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, they shall visually inspect the lot or batch to confirm the identity of the product.

  • (5) Subsections (2) and (4) do not apply to the licensee if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and the following conditions are met:

    • (a) the address of the building is set out in their establishment licence; and

    • (b) they retain a copy of the batch certificate for each lot or batch of the designated drug that they receive for at least one year after the expiration date of the lot or batch.

  • (6) In this section, specifications has the same meaning as in section C.02.002.

  •  (1) A person who holds an establishment license and who imports a designated drug under section C.10.006 is required to comply with paragraphs C.02.020(1)(a), (b) and (d) in respect of the drug but is not required to maintain the records referred to in those paragraphs on their premises in Canada.

  • (2) The Minister may request that the licensee provide to the Minister any of the records referred to in paragraphs C.02.020(1)(a), (b) or (d) in respect of the designated drug.

  • (3) The licensee shall provide the requested records electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.

  •  (1) A person who holds an establishment licence shall not sell a designated drug that they imported under section C.10.006 unless they ensure that the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French and in a manner that permits the safe use of the drug.

  • (2) The licensee shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiration date of the designated drug that they imported.

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)

    human milk fortifier

    human milk fortifier has the same meaning as in section B.25.001; (fortifiant pour lait humain)

    human milk substitute

    human milk substitute has the same meaning as in section B.25.001; (succédané de lait humain)

    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
  • SOR/2021-57, s. 17
  •  (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) a human milk fortifier; or

    • (b) a human milk substitute intended solely for infants less than six months of age.

DIVISION 1Vitamins in Foods

  •  (1) In this Division, vitamin means any of the following vitamins:

    • (a) vitamin A;

    • (b) vitamin D;

    • (c) vitamin E;

    • (d) vitamin K;

    • (e) vitamin C;

    • (f) thiamin, thiamine or vitamin B1;

    • (g) riboflavin or vitamin B2;

    • (h) niacin;

    • (i) vitamin B6;

    • (j) folacin or folate;

    • (k) vitamin B12;

    • (l) pantothenic acid or pantothenate;

    • (m) biotin; and

    • (n) choline. (vitamine)

  • (2) For the purposes of this Division, no expression, other than an expression set out in subsection (1), shall be used to declare the vitamin content of a food.

  • (3) This Division applies only in respect of foods represented as containing a vitamin for use in human nutrition.

  • SOR/88-559, s. 32
  • SOR/2003-11, s. 28
  • SOR/2016-305, s. 63
  •  (1) For the purposes of these Regulations, the vitamin content of a food — other than a formulated liquid diet, human milk fortifier, human milk substitute or food represented as containing a human milk substitute — shall be determined

    • (a) in the case of vitamin A, in terms of the content of retinol and its derivatives and beta-carotene, calculated on the basis of micrograms of retinol activity equivalents (RAE) and expressed in micrograms on the basis of the following relationships:

      • (i) 1 RAE = 1 microgram of retinol, and

      • (ii) 1 RAE = 12 micrograms of beta-carotene;

    • (b) in the case of vitamin D, in terms of the content of cholecalciferol and ergocalciferol, expressed in micrograms;

    • (c) in the case of vitamin E, in terms of the content of d-alpha-tocopherol and dl-alpha-tocopherol and their derivatives, expressed in milligrams on the basis of the following relationships:

      • (i) one milligram d-alpha-tocopherol = one milligram vitamin E, and

      • (ii) one milligram dl-alpha-tocopherol = 0.74 milligram vitamin E;

    • (d) in the case of vitamin K, in terms of the content of phylloquinone and menaquinones, expressed in micrograms;

    • (e) in the case of vitamin C, in terms of the content of L-ascorbic acid and L-dehydroascorbic acid and their derivatives, calculated in milligram equivalents of L-ascorbic acid and expressed in milligrams;

    • (f) in the case of thiamin, thiamine or vitamin B1, and its derivatives, in terms of the content of thiamin, expressed in milligrams;

    • (g) in the case of riboflavin or vitamin B2 and its derivatives, in terms of the content of riboflavin, expressed in milligrams;

    • (h) in the case of niacin, in terms of the content of niacin and its derivatives, calculated in milligrams of nicotinic acid, plus the content of tryptophan, calculated in milligrams and divided by 60, with the total niacin equivalents (NE) expressed in milligrams;

    • (i) in the case of vitamin B6, in terms of the content of pyridoxine, pyridoxal and pyridoxamine and their derivatives, calculated in milligram equivalents of pyridoxine and expressed in milligrams;

    • (j) in the case of folate, in terms of the content of folic acid (pteroylmonoglutamic acid) and related compounds exhibiting the biological activity of folic acid, calculated and expressed in micrograms of dietary folate equivalents (DFE);

    • (k) in the case of vitamin B12, in terms of the content of cyanocobalamin and related compounds exhibiting the biological activity of cyanocobalamin, calculated in microgram equivalents of cyanocobalamin and expressed in micrograms;

    • (l) in the case of pantothenic acid or pantothenate, in terms of the content of d-pantothenic acid, expressed in milligrams;

    • (m) in the case of biotin, in terms of the content of biotin, expressed in micrograms; and

    • (n) in the case of choline, in terms of the content of choline, expressed in milligrams.

  • (2) For the purpose of paragraph (1)(h), the content of tryptophan may be calculated

    • (a) where the protein originates from a food that contains protein from more than one source or from a source other than milk, meat, poultry, fish or eggs, as constituting 1.1 per cent of the protein;

    • (b) where the protein originates from milk, meat, poultry or fish, as constituting 1.3 per cent of the protein; and

    • (c) where the protein originates from eggs, as constituting 1.5 per cent of the protein.

 
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