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

Assessments Ordered Under Section 21.31 of the Act

• C.01.052 (1) The Minister’s power to make an order under section 21.31 of the Act is subject to the following conditions:

  • (a) the order shall relate to a drug;

  • (b) the person to whom the order is made shall be the holder of one or more of the following therapeutic product authorizations in respect of the drug:

    • (i) a drug identification number that has been assigned under subsection C.01.014.2(1),

    • (ii) an establishment licence that has been issued under subsection C.01A.008(1), and

    • (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01; and

  • (c) the Minister shall have reasonable grounds to believe that

    • (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(i) or (iii), the benefits or risks of injury to health associated with the drug are significantly different than they were when the authorization was issued,

    • (ii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(ii) who is an importer, the manner in which one or more of the following activities is conducted may present a risk of injury to health associated with the drug:

      • (A) importation, within the meaning of subsection C.01A.001(1), of the drug,

      • (B) fabrication or packaging/labelling, within the meaning of subsection C.01A.001(1), of the drug outside Canada, or

      • (C) testing of the drug outside Canada, or

    • (iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(ii) other than an importer, the manner in which an activity that is authorized under the authorization is conducted may present a risk of injury to health associated with the drug.

• (2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act,

  • (a) provide the holder of the therapeutic product authorization with the results of the examination; and

  • (b) ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website.

Activities Ordered Under Section 21.32 of the Act

C.01.053 The Minister’s power to make an order under section 21.32 of the Act is subject to the following conditions:

• (a) the order shall relate to a drug;

• (b) the person to whom the order is made shall be the holder of one or more of the following therapeutic product authorizations in respect of the drug:

  • (i) a drug identification number that has been assigned under subsection C.01.014.2(1),

  • (ii) an establishment licence that has been issued under subsection C.01A.008(1), and

  • (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01;

• (c) the Minister shall have reasonable grounds to believe that

  • (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(i) or (iii), there are significant uncertainties relating to the benefits or harms associated with the drug,

  • (ii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(ii) who is an importer, the manner in which one or more of the following activities is conducted has introduced significant uncertainties relating to the benefits or harms associated with the drug:

    • (A) importation, within the meaning of subsection C.01A.001(1), of the drug,

    • (B) fabrication or packaging/labelling, within the meaning of subsection C.01A.001(1), of the drug outside Canada, or

    • (C) testing of the drug outside Canada,

  • (iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(ii) other than an importer, the manner in which an activity that is authorized under the authorization is conducted has introduced significant uncertainties relating to the benefits or harms associated with the drug,

  • (iv) the holder of the therapeutic product authorization is unable to provide the Minister with information that is sufficient to manage those uncertainties, and

  • (v) the applicable requirements of these Regulations, together with any terms and conditions that have been imposed on the authorization, do not allow for sufficient information to be obtained to manage those uncertainties; and

• (d) the Minister shall take into account the following matters:

  • (i) whether the activities that the holder of the therapeutic product authorization will be ordered to undertake are feasible, and

  • (ii) whether there are less burdensome ways of obtaining additional information about the drug’s effects on health or safety.

C.01.055 and C.01.056 [Repealed, SOR/82-524, s. 2]

Limits of Variability

• C.01.061 (1) Where the net amount of a drug in a package is not expressed on the label in terms of number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain an amount of the drug such that, when determined by that official method, the average of the net amounts of the drug in the 10 packages is not less than the net amount of the drug shown on the label.

• (2) Where the net amount of a drug in a package is expressed on the label in terms of the number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain a number of units such that, when determined by that official method,

  • (a) the average number of dosage units in the 10 packages is not less than the number of dosage units shown on the label;

  • (b) no package contains less than the number of dosage units shown on the label except as provided in the table; and

  • (c) where the drug is a controlled drug as defined in section G.01.001 or a narcotic as defined in the Narcotic Control Regulations, no package contains more than the number of dosage units shown on the label except as provided in the table to this section.

  Item	Column I	Column II
  	Labelled Number of Dosage Units Per Package	Permitted Variation from the Labelled Number
  1	50 or less	0
  2	More than 50, but less than 101	1
  3	101 or more	the greater of one unit or 0.75% of the labelled number, rounded up to the next whole number

• C.01.062 (1) Subject to subsections (2) to (5), no manufacturer shall sell a drug in dosage form where the amount of any medicinal ingredient therein, determined using an acceptable method, is

  • (a) less than 90.0 per cent of the amount of the medicinal ingredient shown on the label; or

  • (b) more than 110.0 per cent of the amount of the medicinal ingredient shown on the label.

• (2) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a volatile substance of botanical origin or its synthetic equivalent, the amount of that ingredient, determined using an acceptable method, shall be

  • (a) not less than 85.0 per cent of the amount of the medicinal ingredient shown on the label; and

  • (b) not more than 120.0 per cent of the amount of the medicinal ingredient shown on the label.

• (3) Subject to subsection (5), where a drug in capsule form contains a medicinal ingredient that is a vitamin in a fish-liver oil, no variation from the amount of the medicinal ingredient as shown on the label, determined using an acceptable method, is permitted other than that which is in accordance with the variation for that fish-liver oil as stated in any publication whose name is referred to in Schedule B to the Act.

• (4) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a vitamin, no variation from the amount of the medicinal ingredient shown on the label, determined using an acceptable method, is permitted other than the variation set out in column III or IV of an item of the table to this section opposite the vitamin set out in column I of that item for the amount of vitamin set out in column II of that item.

• (5) Subsections (1) to (4) do not apply in respect of

  • (a) a drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01;

  • (b) [Repealed, SOR/98-423, s. 8]

  • (c) a drug for which a standard is contained in any publication whose name is referred to in Schedule B to the Act;

  • (d) a drug described in Schedule C or D to the Act or Division 6 of Part C of these Regulations; or

  • (e) a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and in respect of which

    • (i) the conditions of pharmaceutical production and quality control are suitable for controlling the identity, quality, purity, stability, safety, strength and potency of the drug,

    • (ii) all labels to be used in connection with the drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, make proper claims in respect of the drug,

    • (iii) the drug can, without undue foreseeable risk to humans, be used for the purposes and under the conditions of use recommended by the manufacturer, and

    • (iv) the drug is effective for the purposes and under the conditions of use recommended by the manufacturer.

  Item	Column I	Column II	Column III	Column IV
  	Vitamin	Recommended daily dose	Limits of variation when the recommended daily dose shown on label is equal to or less then amount set out in column II	Limits of variation when the recommended daily dose shown on label is greater than amount set out in column II
  1	vitamin A (or as B-carotene)	10 000 I.U.	90.0 - 165.0 %	90.0 - 115.0 %
  2	thiamine	4.5 mg	90.0 - 145.0 %	90.0 - 125.0 %
  3	riboflavin	7.5 mg	90.0 - 125.0 %	90.0 - 125.0 %
  4	niacin or niacinamide	45 mg	90.0 - 125.0 %	90.0 - 125.0 %
  5	pyridoxine	3 mg	90.0 - 125.0 %	90.0 - 125.0 %
  6	d-pantothenic acid	15 mg	90.0 - 135.0 %	90.0 - 125.0 %
  7	folic acid	0.4 mg	90.0 - 135.0 %	90.0 - 115.0 %
  8	vitamin B12	14 µg	90.0 - 135.0 %	90.0 - 125.0 %
  9	vitamin C	150 I.U.	90.0 - 145.0 %	90.0 - 125.0 %
  10	vitamin D	400 I.U.	90.0 - 145.0 %	90.0 - 115.0 %
  11	vitamin E	25 I.U.	90.0 - 125.0 %	90.0 - 125.0 %
  12	vitamin K	0.0 mg		90.0 - 115.0 %
  13	biotin	0.0 mg		90.0 - 135.0 %