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

Regulations are current to 2015-07-09 and last amended on 2015-06-13. Previous Versions

RELATED PROVISIONS

  • — SOR/97-12

    • 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

    • 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

    • 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

      • 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

    • 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

    • 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

    • 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

      • 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

    • 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

    • 13. For the purpose of paragraph 11(2)(a) of the Statutory Instruments Act, these Regulations apply before they are published in the Canada Gazette.

  • — SOR/2014-158, s. 14

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

      “submission”

      « présentation »

      “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.

      “supplement”

      « supplément »

      “supplement” means a supplement to a submission that is filed under section C.08.003 of the Food and Drug Regulations.

  • — 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.