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

Regulations are current to 2019-06-20 and last amended on 2019-06-17. Previous Versions

RELATED PROVISIONS

  • — SOR/97-12, s. 66

    • 66 Packages of drugs that are labelled in accordance with Part C of the Food and Drug Regulations, as those Regulations read on December 31, 1996, are not required to comply with the labelling requirements in these Regulations until January 1, 1999.

  • — SOR/98-423, s. 10

    • 10 For the purposes of sections 11 to 13, Director has the same meaning as in section A.01.010 of the Food and Drugs Regulations.

  • — SOR/98-423, s. 11

    • 11 Despite sections 1 and 7 to 9, if a numbered certificate of registration has been issued in respect of a drug but a drug identification number has not been assigned under section C.01.014.2 of the Food and Drug Regulations, as amended by section 4 of these Regulations, or under section 12 of these Regulations, then section C.01.001A, paragraphs C.01.015(2)(b) and C.01.062(5)(b) and Division 10 and the schedule and the table to Division 10 of Part C of the Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, remain in force in respect of that drug until October 1, 1998, except to the extent that they require information that is not required by those provisions as amended by these Regulations.

  • — SOR/98-423, s. 12

      • 12 (1) Despite these Regulations and subject to subsection (3), if the conditions set out in subsection (2) are satisfied, the Director shall, until October 1, 1998, provide to a manufacturer or importer referred to in paragraph (2)( c),

        • (a) if the information referred to in section C.01.014.3 of the Food and Drug Regulations as amended by section 5 of these Regulations has not been submitted in respect of the drug, the document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations, as amended by section 4 of these Regulations; or

        • (b) in any other case,

          • (i) a drug identification number for the drug preceded by the letters “DIN”, or

          • (ii) where there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”.

      • (2) The conditions referred to in subsection (1) are:

        • (a) a numbered certificate of registration has been issued for the drug under subsection C.10.004(1) of the Food and Drug Regulations as it read before the coming into force of these Regulations;

        • (b) the numbered certificate of registration has not been cancelled under section C.10.008 of the Food and Drug Regulations as it read immediately before the coming into force of these Regulations; and

        • (c) prior to September 1, 1998, the manufacturer or importer has submitted to the Director

          • (i) the name of the drug for which a drug identification number is to be issued, and

          • (ii) the information referred to in subsection C.01.014.1(2) of the Food and Drug Regulations.

      • (3) If more than one numbered certificate of registration has been issued for a drug on the sole basis of a difference in colour, flavour or fragrance, a single drug identification number shall be assigned in respect of the drug.

  • — SOR/98-423, s. 13

    • 13 Despite section 4 of these Regulations and subject to section C.10.005 of the Food and Drug Regulations as that section read immediately before the coming into force of these Regulations, the Director may, until September 30, 1998, issue a numbered certificate of registration, if

      • (a) the manufacturer expressly requests that a numbered certificate of registration be issued for the drug; and

      • (b) its application was accepted by the Director for review before the coming into force of these Regulations.

  • — SOR/98-423, s. 14

    • 14 Despite section 2, a manufacturer may, until September 30, 2000, label a drug with the label that was in use on September 30, 1998.

  • — SOR/2001-203, s. 11

    • 11 An application concerning the sale of a drug for human use for the purposes of a clinical trial that is received under Division 8 of the Food and Drug Regulations before September 1, 2001 is subject to those Regulations and any procedures established under those Regulations as they read at the time the application was received.

  • — SOR/2003-11, s. 38

      • 38 (1) The following definitions apply in this section.

        former Regulations

        former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur)

        manufacturer

        manufacturer has the same meaning as in section A.01.010 of the Food and Drug Regulations. (fabricant)

        prepackaged product

        prepackaged product has the same meaning as in section B.01.001 of the Food and Drug Regulations. (produit préemballé)

      • (2) Despite sections 1 to 37 and subject to subsection (3), the former Regulations continue to apply to a prepackaged product that is labelled in accordance with the former Regulations until the day that is three years after the day on which these Regulations come into force, unless the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains

        • (a) a statement or claim set out in column 4 of any of items 15, 16 and 22 to 26 of the table following section B.01.513 of the Food and Drug Regulations, as enacted by section 20 of these Regulations;

        • (b) a statement or claim set out in column 1 of the table following section B.01.603 of the Food and Drug Regulations, as enacted by section 20 of these Regulations; or

        • (c) the expression “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

      • (3) In applying subsection (2) to a prepackaged product that is sold by a manufacturer who had gross revenues from sales in Canada of food of less than $1,000,000 for the 12-month period immediately prior to the day on which these Regulations come into force, the reference to “three years” in that subsection shall be read as a reference to “five years”.

  • — SOR/2006-241, s. 2

    • 2 Section C.08.004.1 of the Food and Drug Regulations, as it read immediately before the coming into force of these Regulations, applies to a drug in respect of which a notice of compliance was issued before June 17, 2006.

  • — SOR/2007-302, s. 12

    • 12 Sections 1 to 6 and 11 of these Regulations do not apply to cheese that is made before these Regulations come into force.

  • — SOR/2013-74, s. 17

      • 17 (1) Every person who, on the day on which these Regulations come into force, fabricates, packages/labels, tests or imports an active pharmaceutical ingredient may continue to do so without an establishment licence if they submit an application for a licence under section C.01A.005 of the Food and Drug Regulations within three months after that day.

      • (2) Subsection (1) applies until the determination of the licence application under section C.01A.008 or C.01A.010 of the Food and Drug Regulations.

  • — SOR/2013-74, s. 18, as amended by SOR/2013-178, s. 125

    • 18 The Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, continue to apply in respect of whole blood and blood components until the day before the day on which subsection 3(2) of the Blood Regulations comes into force.

  • — SOR/2013-172, s. 12

    • 12 If, on the day on which these Regulations come into force, the Director has not yet issued a letter of authorization under subsection C.08.010(1) of the Food and Drug Regulations in response to a request that was made by a practitioner before that day, subsection C.08.010(1.1) of those Regulations, as enacted by section 11, applies in respect of the request.

  • — SOR/2013-172, s. 13

  • — SOR/2014-158, s. 14

    • 14 The following definitions apply in sections 15 to 32:

      submission

      submission means any of the following:

      • (a) a new drug submission that is filed under section C.08.002 of the Food and Drug Regulations;

      • (b) an extraordinary use new drug submission that is filed under section C.08.002.01 of those Regulations;

      • (c) an abbreviated new drug submission that is filed under section C.08.002.1 of those Regulations; or

      • (d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1 of those Regulations. (présentation)

      supplement

      supplement means a supplement to a submission that is filed under section C.08.003 of the Food and Drug Regulations. (supplément)

  • — SOR/2014-158, s. 15

    • 15 Subsection C.01.014.1(2) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to an application for a drug identification number that is made under subsection C.01.014.1(1) of those Regulations before the day on which section 1 comes into force.

  • — SOR/2014-158, s. 16

    • 16 Subsection C.08.002(2), subparagraph C.08.002.01(2)(b)(i) or paragraph C.08.002.1(2)(a) of the Food and Drug Regulations, as the case may be, as the applicable provision read immediately before the day on which section 1 comes into force, applies to a submission that is filed before the day on which section 1 comes into force.

  • — SOR/2014-158, s. 17

    • 17 Section C.08.003 of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to a supplement that is filed before the day on which section 1 comes into force.

  • — SOR/2014-158, s. 18

    • 18 If a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued for a drug in respect of an application referred to in section 15 or a submission referred to in section 16, section C.01.014.3 of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

  • — SOR/2014-158, s. 19

    • 19 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a submission referred to in section 16, paragraph C.08.002(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

  • — SOR/2014-158, s. 20

    • 20 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations, for a drug in respect of a supplement referred to in section 17, paragraph C.08.003(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

  • — SOR/2014-158, s. 21

    • 21 In sections 22 to 32, drug means a drug for human use in dosage form other than a drug that belongs to one of the following classes:

      • (a) prescription drugs; or

      • (b) drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner.

  • — SOR/2014-158, s. 22

    • 22 Section A.01.016 of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of a drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

  • — SOR/2014-158, s. 23

    • 23 Section A.01.017 of the Food and Drug Regulations, as enacted by section 2, and section C.01.004.01 of those Regulations, as enacted by subsection 4(1), do not apply in respect of a drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

  • — SOR/2014-158, s. 24

    • 24 Paragraph C.01.014.1(2)(m) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to an application for a drug identification number in respect of a drug that is made under subsection C.01.014.1(1) of those Regulations during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

  • — SOR/2014-158, s. 25

    • 25 Paragraph C.08.002(2)(j) of the Food and Drug Regulations, as it read immediately before the day on which section 1 comes into force, applies to a submission in respect of a drug that is filed during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

  • — SOR/2014-158, s. 26

    • 26 If a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued for a drug in respect of an application referred to in section 24 or a submission referred to in section 25, section C.01.014.3 of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

  • — SOR/2014-158, s. 27

    • 27 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a submission referred to in section 25, paragraph C.08.002(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

  • — SOR/2014-158, s. 28

    • 28 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug in respect of a supplement that is filed during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force, paragraph C.08.003(1)(d) of those Regulations, as it read immediately before the day on which section 1 comes into force, applies in respect of the drug.

  • — SOR/2014-158, s. 29

    • 29 Paragraphs C.01.014.1(2)(m.1) and (o) of the Food and Drug Regulations, as enacted by subsection 7(3), do not apply to an application referred to in section 24.

  • — SOR/2014-158, s. 30

    • 30 Paragraphs C.08.002(2)(j.1) and (o) of the Food and Drug Regulations, as enacted by subsections 10(3) and (5) respectively, do not apply to a submission referred to in section 25.

  • — SOR/2014-158, s. 31

    • 31 If a notice of compliance is issued under section C.08.004 or C.08.004.01 of the Food and Drug Regulations for a drug, paragraph C.08.003(2)(g.1) of those Regulations, as enacted by subsection 13(3), does not apply in respect of the drug during the period that begins on the day on which section 1 comes into force and that ends immediately before the day on which section 3 comes into force.

  • — SOR/2014-158, s. 32

    • 32 Subsection C.08.003(3.1) of the Food and Drug Regulations, as enacted by subsection 13(4), does not apply to a supplement referred to in section 28.

  • — SOR/2016-74, s. 17

      • 17 (1) In this section,

        former Regulations

        former Regulations means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force. (règlement antérieur)

        saccharin sweetener

        saccharin sweetener means a saccharin sweetener as defined in subsection E.01.001(1) of the former Regulations. (édulcorant à la saccharine)

      • (2) Despite sections 11 to 16, if, on the day immediately before the day on which these Regulations come into force, a saccharin sweetener was sold in accordance with Part E of the former Regulations, the sale of the sweetener may continue in accordance with Part E of the former Regulations for a period of one year beginning on the day on which these Regulations come into force.

  • — SOR/2016-305, s. 76

      • 76 (1) The following definitions apply in this section.

        former Regulations

        former Regulations means the provisions of the Food and Drug Regulations that are amended or repealed by these Regulations — other than those that are amended or repealed by any of sections 12 or 49 to 56 — as they read immediately before the day on which these Regulations come into force. (règlement antérieur)

        prepackaged product

        prepackaged product has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. (produit préemballé)

      • (2) Despite these Regulations, a prepackaged product may be labelled in accordance with the former Regulations or these Regulations until the day that is five years after the day on which these Regulations come into force.

  • — SOR/2017-76, s. 11

      • 11 (1) In this section, fabricate, package/label, import and active pharmaceutical ingredient have the same meaning as in subsection C.01A.001(1) of the Food and Drug Regulations.

      • (2) Every person who, on or before the day on which section 7, subsections 8(1) and (3) and section 9 of these Regulations come into force, fabricates, packages/labels, tests or imports an active pharmaceutical ingredient for veterinary use may continue to do so without an establishment licence if they submit an application for a licence under section C.01A.005 of the Food and Drug Regulations within 14 months after that day.

      • (3) Subsection (2) applies until the determination of the licence application is made under section C.01A.008 or C.01A.010 of the Food and Drug Regulations.

  • — SOR/2017-259, s. 24

    • 24 In sections 25 and 26, drug means a drug that is listed in Schedule C to the Food and Drugs Act, that is in dosage form and that was available for sale in Canada before the day on which these Regulations come into force.

  • — SOR/2017-259, s. 25

      • 25 (1) Despite these Regulations, if the labels of a drug display information in accordance with one of the following provisions of the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force, that provision continues to apply in respect of the drug:

        • (a) subsection C.03.202(1);

        • (b) subsection C.03.203(1); or

        • (c) section C.03.208.

      • (2) Subsection (1) ceases to apply in respect of a drug

        • (a) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force,

          • (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 24 months after the day on which the final decision on the application is made, and

          • (ii) in the case of any other drug, 12 months after the day on which the final decision on the application is made; and

        • (b) if an application for a drug identification number for the drug is not made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force,

          • (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 30 months after the day on which these Regulations come into force, and

          • (ii) in the case of any other drug, 18 months after the day on which these Regulations come into force.

  • — SOR/2017-259, s. 26

      • 26 (1) Despite these Regulations, subsection C.01.014(2) of the Food and Drug Regulations, as it read immediately before the day on which these Regulations come into force, continues to apply in respect of a drug.

      • (2) Subsection (1) ceases to apply in respect of a drug

        • (a) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force and a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations is issued in respect of the drug, on the day on which the document is issued;

        • (b) if an application for a drug identification number for the drug is made under subsection C.01.014.1(1) of the Food and Drug Regulations within six months after the day on which these Regulations come into force and the final decision on the application is a refusal to issue a document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations in respect of the drug,

          • (i) in the case of a kit as defined in section C.03.205 of the Food and Drug Regulations, 24 months after the day on which the final decision is made, and

          • (ii) in the case of any other drug, 12 months after the day on which the final decision is made; and

        • (c) in the cases referred to in paragraph 25(2)(b), at the end of the period referred to in subparagraph 25(2)(b)(i) or (ii), as the case may be.

  • — SOR/2019-62, s. 4

    • 4 In sections 5 and 6, information in respect of a clinical trial has the same meaning as in section C.08.009.1 of the Food and Drug Regulations.

  • — SOR/2019-62, s. 5

    • 5 Despite subsection C.08.009.2(1) of the Food and Drug Regulations, information in respect of a clinical trial that is confidential business information and that is contained in a submission or supplement with respect to which one of the following circumstances occurred before the day on which these Regulations come into force ceases to be confidential business information on the day on which these Regulations come into force:

      • (a) the Minister issued a notice of compliance under section C.08.004 or C.08.004.01 of the Food and Drug Regulations;

      • (b) the Minister, after having notified the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) of the Food and Drug Regulations that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations, issued a notice to the manufacturer, in view of the omission by the manufacturer to amend the submission or supplement, that indicated that the submission or supplement was considered to have been withdrawn;

      • (c) the Minister notified the manufacturer under paragraph C.08.004(3)(b) or C.08.004.01(3)(b) of the Food and Drug Regulations that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of those Regulations.

  • — SOR/2019-62, s. 6

      • 6 (1) This section applies to information in respect of a clinical trial that is confidential business information and that is contained in a submission or supplement

        • (a) that was filed within 90 days before the day on which these Regulations come into force; and

        • (b) with respect to which the Minister notified the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(b) of the Food and Drug Regulations before the day on which these Regulations come into force that the submission or supplement did not comply with section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1 of the Food and Drug Regulations.

      • (2) Despite subsection C.08.009.2(1) of the Food and Drug Regulations, information in respect of a clinical trial that is contained in a submission or supplement ceases to be confidential business information upon the expiry of whichever of the following periods applies if the manufacturer does not amend the submission or supplement within that period:

        • (a) 90 days after the day on which these Regulations come into force; or

        • (b) any longer period specified by the Minister.

  • — SOR/2019-62, s. 7

  • — SOR/2019-98, s. 6

    • 6 Despite these Regulations, beer may, until December 13, 2022, be sold in accordance with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force.

  • — SOR/2019-217, s. 2

    • 2 Despite these Regulations, vodka may, until December 13, 2022, be sold in accordance with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force.

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