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

Regulations are current to 2022-11-16 and last amended on 2022-09-27. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2022-100, s. 1

    • 1 The Food and Drug RegulationsFootnote 1 are amended by adding the following after section A.01.045:

      • A.01.046 An exporter that issues a certificate referred to in paragraph 37(1)(c) of the Act in respect of a drug shall retain a copy of the certificate for five years after the day on which the drug is exported.

        • A.01.047 (1) For the purposes of paragraph 37(1)(d) of the Act, a drug that, by virtue of paragraph A.01.048(a), is required to be fabricated, packaged/labelled, tested, distributed or wholesaled in accordance with an establishment licence must be fabricated, packaged/labelled, tested, distributed or wholesaled by the holder of such a licence that has paid fees in connection with the licence in accordance with the Fees in Respect of Drugs and Medical Devices Order.

        • (2) Words and expressions used in this section have the same meaning as in subsection C.01A.001(1).

      • A.01.048 For the purposes of subsection 37(1.2) of the Act, the following provisions are prescribed in relation to drugs:

        • (a) the provisions of Division 1A of Part C;

        • (b) the provisions of Division 2 of Part C, except section C.02.003.2 and paragraphs C.02.009(5)(b), C.02.016(3)(b) and C.02.018(3)(c);

        • (c) sections C.03.001 to C.03.013; and

        • (d) the provisions of Division 4 of Part C, except

          • (i) sections C.04.003, C.04.019, C.04.020, C.04.054, C.04.055, C.04.080, C.04.082 to C.04.085 and C.04.091,

          • (ii) sections C.04.101 and C.04.102, paragraph C.04.117(c), sections C.04.118 to C.04.120, C.04.126 and C.04.127, paragraph C.04.128(a) and sections C.04.137, C.04.138, C.04.146, C.04.147, C.04.169, C.04.170, C.04.187 and C.04.190,

          • (iii) sections C.04.218 to C.04.220 and C.04.239 to C.04.241,

          • (iv) sections C.04.555, C.04.556, C.04.561, C.04.562, C.04.567, C.04.568, C.04.573, C.04.574, C.04.578, C.04.580, C.04.581, C.04.588, C.04.589, C.04.593, C.04.595 and C.04.596, and

          • (v) sections C.04.601, C.04.602, C.04.650 to C.04.656, C.04.676, C.04.677 and C.04.680 to C.04.683.

      Transhipments

      • A.01.049 For the purposes of paragraph 38(c) of the Act, all drugs must be in bond.

  • — SOR/2022-100, s. 2

    • 2 The Regulations are amended by adding the following after section C.01A.003:

      • C.01A.003.1 For the purposes of this Division and the provisions of Divisions 2 to 4 that are prescribed in paragraphs A.01.048(b) to (d),

        • (a) a reference to a distributor referred to in section C.01A.003 or a distributor referred to in paragraph C.01A.003(a) includes a reference to a distributor of an active ingredient that is intended for use outside Canada; and

        • (b) a reference to a distributor referred to in section C.01A.003 or a distributor referred to in paragraph C.01A.003(b) includes a reference to a distributor of a drug in dosage form that is intended for consumption or use outside Canada.

  • — SOR/2022-100, s. 3

    • 3 Paragraphs C.01A.004(1)(c) and (d) of the Regulations are replaced by the following:

      • (c) distribute as a distributor referred to in section C.01A.003 a drug other than

        • (i) an active pharmaceutical ingredient, or

        • (ii) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act; or

      • (d) wholesale a drug other than

        • (i) an active pharmaceutical ingredient, or

        • (ii) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act.

  • — SOR/2022-100, s. 4

      • 4 (1) Paragraphs C.01A.008(2)(a) and (b) of the Regulations are replaced by the following:

        • (a) each activity set out in Table I to this section that is authorized and the category of drugs set out in Table II to this section for which each activity is authorized, specifying for each activity and category whether sterile dosage forms are authorized;

        • (b) the address of each building in Canada at which a category of drugs set out in Table II to this section is authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, specifying for each building which of those activities and for which category of drugs, and whether sterile dosage forms of the category are authorized; and

      • (2) Subparagraph C.01A.008(2)(c)(ii) of the Regulations is replaced by the following:

        • (ii) the address of each building at which the drug is authorized to be fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drugs set out in Table II to this section that are authorized, and whether sterile dosage forms are authorized.

      • (3) Item 4 of Table I to section C.01A.008 of the Regulations is replaced by the following:

        ItemActivities
        4Distribute as a distributor referred to in paragraph C.01A.003(a) an active ingredient other than
        • (a) an active pharmaceutical ingredient; or

        • (b) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act

      • (4) Item 7 of Table I to section C.01A.008 of the Regulations is replaced by the following:

        ItemActivities
        7Wholesale a drug other than
        • (a) an active pharmaceutical ingredient; or

        • (b) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act

  • — SOR/2022-100, s. 5

    • 5 The Regulations are amended by adding the following after section C.02.002.1:

      • C.02.002.2 In this Division,

        • (a) a reference to specifications is — in respect of a drug intended for consumption or use outside Canada, the raw material used in such a drug or the packaging material for such a drug — a reference to the specifications with which the drug, raw material or packaging material is required to comply in the country in which the drug is intended to be consumed or used; and

        • (b) the definition expiration date in subsection C.01.001(1) does not apply in respect of a drug intended for consumption or use outside Canada.

  • — SOR/2022-100, s. 6

    • 6 The form in Appendix III to the Regulations is amended by replacing “(Under the Food and Drugs Act* — R.S.C. 1970, c. F-27)” with the following:

      (Under section 37 of the Food and Drugs Act)

  • — SOR/2022-100, s. 7

    • 7 Appendix III to the Regulations is amended by replacing the portion of the form after “and marked in distinct overprinting with the word “Export”” and before “Dated at” with the following:

      • 1 is manufactured or prepared in Canada,

      • 2 is not manufactured or sold for consumption or use in Canada, and

      • 3 the packages and the contents of those packages do not contravene any known requirement of the law of (name of country or countries) to which it is or is about to be consigned.

  • — SOR/2022-100, s. 8

    • 8 The form in Appendix III to the Regulations is amended by replacing “19   .” with “20   .”.

  • — SOR/2022-100, s. 9

  • — SOR/2022-100, s. 10

      • 10 (1) Unless the context requires otherwise, words and expressions used in this section have the same meaning as in subsection C.01A.001(1) of the Food and Drug Regulations.

      • (2) Subject to subsection (3), during the three-month period that begins on the day on which these Regulations come into force, a drug that has, until that day, been exempt, under subsection 37(1) of the Act, from the provisions prescribed in section A.01.048 of the Food and Drug Regulations and that continues to meet the conditions set out in subsection 37(1)

        • (a) may, despite section C.01A.004 of those Regulations, continue to be fabricated, packaged/labelled, tested, distributed or wholesaled by a person that conducted the activity before that day and that does not hold an establishment licence that authorizes the activity in respect of the drug; and

        • (b) is exempt from the provisions of Divisions 2 to 4 of Part C of those Regulations that are prescribed in section A.01.048.

      • (3) If, before the end of the three-month period, a person referred to in paragraph (2)(a) submits — in accordance with section C.01A.005 or C.01A.006 of the Food and Drug Regulations — an application for, or to amend, an establishment licence to authorize the activity that they have been conducting in respect of the drug, the person is, in respect of the activity, exempt from the requirement to hold an establishment licence and from the provisions referred to in paragraph (2)(b) until the Minister of Health

        • (a) issues the licence or amends it to authorize the activity; or

        • (b) notifies the person, after giving them the opportunity to be heard, that the licence will not be issued or amended.

      • (4) The exemptions referred to in subsection (3) cease to apply if the person withdraws the application.

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