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

Regulations are current to 2021-05-04 and last amended on 2021-04-14. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2020-262, s. 1

    • 1 The portion of subsection C.01.014.6(3) of the Food and Drug RegulationsFootnote 1 before paragraph (a) is replaced by the following:

      • (3) The Minister may cancel the assignment of a drug identification number for a drug if, after he or she has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(a)(i) or (iii) to conduct an assessment of the drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health,

  • — SOR/2020-262, s. 2

    • 2 The portion of subsection C.01.050(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

      • (2) Le titulaire d’une autorisation relative à un produit thérapeutique délivrée à l’égard d’une drogue appartenant à l’une des catégories mentionnées au paragraphe (4) fournit au ministre les renseignements dont il a reçu communication ou a connaissance concernant tout risque grave de préjudice à la santé humaine et se rapportant à la sécurité de la drogue en ce qui concerne :

  • — SOR/2020-262, s. 3

      • 3 (1) Subsection C.01.052(1) of the Regulations is replaced by the following:

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

            • (a) 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

            • (b) 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 (a)(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 (a)(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, as defined in subsection C.01A.001(1), of the drug,

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

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

              • (iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (a)(ii) who is not 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 portion of subsection C.01.052(2) of the Regulations before paragraph (a) is replaced by the following:

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

  • — SOR/2020-262, s. 4

    • 4 Section C.01.053 of the Regulations is replaced by the following:

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

        • (a) 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;

        • (b) 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 (a)(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 (a)(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, as defined in subsection C.01A.001(1), of the drug,

            • (B) fabrication or packaging/labelling, as defined in 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 (a)(ii) who is not 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

        • (c) 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.

  • — SOR/2020-262, s. 5

    • 5 The portion of subsection C.08.006(3) of the Regulations before paragraph (a) is replaced by the following:

      • (3) The Minister may, by notice to a manufacturer, suspend for a definite or indefinite period a notice of compliance issued to that manufacturer in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions if, after the Minister has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(a)(iii) to conduct an assessment of the new drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health,

  • — SOR/2021-45, s. 3

    • 3 Section C.01A.005 of the Regulations is renumbered as subsection C.01A.005(1) and is amended by adding the following:

      • (2) In addition to the information and documents referred to in subsection (1), a person who submits an application for an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 to be carried out in respect of a category of drugs set out in Table II to that section that includes a COVID-19 drug may include a statement to that effect in the application.

  • — SOR/2021-45, s. 4

    • 4 Section C.01A.006 of the Regulations is amended by adding the following after subsection (1):

      • (1.1) In addition to the information and documents referred to in subsection (1), a person who submits an application to amend an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 to be carried out in respect of a category of drugs set out in Table II to that section that includes a COVID-19 drug may include a statement to that effect in the application.

  • — SOR/2021-45, s. 5

    • 5 Paragraph C.01A.007(2)(a) of the French version of the Regulations is replaced by the following:

      • a) qu’une inspection soit effectuée aux heures normales de bureau de tout bâtiment visé aux alinéas C.01A.005(1)g) ou h);

  • — SOR/2021-45, s. 6(1)

      • 6 (1) Subsection C.01A.008(1) of the Regulations is replaced by the following:

          • C.01A.008 (1) Subject to subsection (1.1) and section C.01A.010, the Minister shall, on receipt of the information and material referred to in sections C.01A.005 to C.01A.007, issue or amend an establishment licence.

          • (1.1) The Minister shall, in determining whether he or she has received the information and material referred to in sections C.01A.005 to C.01A.007 in relation to an application referred to in subsection C.01A.005(2) or C.01A.006(1.1) that contains the statement referred to in the applicable subsection, also take into consideration the public health need related to COVID-19.

  • — SOR/2021-45, s. 9

    • 9 The Regulations are amended by adding the following after section C.01A.012:

        • C.01A.012.1 (1) Despite subsection C.01A.008(4), the Minister may, at any time, including when issuing an establishment licence, impose terms and conditions on an establishment licence that is issued or amended under section C.01A.008 on the basis of an application referred to in subsection C.01A.005(2) or C.01A.006(1.1) that contains the statement referred to in the applicable subsection.

        • (2) For greater certainty, terms and conditions that may be imposed under subsection (1) are not limited to those that may be imposed under subsection C.01A.008(4).

      • C.01A.012.2 The Minister may, at any time, amend terms or conditions that are imposed on an establishment licence under subsection C.01A.012.1(1).

  • — SOR/2021-45, s. 10

    • 10 Paragraph C.01A.013(a) of the Regulations is replaced by the following:

      • (a) there is any change to the information referred to in any of paragraphs C.01A.005(1)(a), (b) and (e) to (i); or

  • — SOR/2021-45, s. 11

    • 11 The portion of section C.01A.017.1 of the Regulations before paragraph (a) is replaced by the following:

      • C.01A.017.1 The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if, after the Minister has, under section 21.31 of the Act, ordered the licensee to conduct an assessment in order to provide evidence establishing that the licensee’s buildings, equipment or practices and procedures, as the case may be, continue to meet the requirements referred to in paragraph C.01A.005(1)(l), subparagraph C.01A.005(1)(m)(ii) or (iii) or paragraph C.01A.005(1)(o),

  • — SOR/2021-45, s. 12

    • 12 Section C.02.019 of the Regulations is amended by adding the following after subsection (4):

      • (4.1) Subsections (1) and (2) do not apply to a distributor or importer of a COVID-19 drug if it is the subject of a written request made under section C.04.015.

  • — SOR/2021-45, s. 15

    • 15 The Regulations are amended by adding the following after section C.08.003:

        • C.08.003.01 (1) The following definitions apply in this section.

          submission

          submission means

          • (a) a new drug submission that is filed under section C.08.002;

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

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

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

          supplement

          supplement means a supplement to a submission that is filed under section C.08.003. (supplément)

        • (2) Despite sections C.08.002, C.08.002.01, C.08.002.1 and C.08.003 and subject to subsection (3), the manufacturer of a new drug is not permitted to file a submission or supplement for the new drug on the basis of a direct or indirect comparison to any new drug in respect of which an authorization was issued under the ISAD Interim Order.

        • (3) Subsection (2) does not prevent the manufacturer of a new drug from filing a submission or supplement for the new drug on the basis of a direct or indirect comparison to another new drug in respect of which an authorization was issued under the ISAD Interim Order if

          • (a) a notice of compliance is issued under section C.08.004 or C.08.004.01 in respect of a submission or supplement for that other new drug; and

          • (b) the comparison is in respect of the matters that were approved by the notice of compliance.

  • — SOR/2021-45, s. 16

    • 16 Section C.08.004.1 of the Regulations is amended by adding the following after subsection (1):

      • (1.1) For the purposes of the definition innovative drug in subsection (1), a medicinal ingredient is not considered to be approved in a drug by reason of the Minister having issued or amended an authorization under the ISAD Interim Order in respect of a COVID-19 drug that contains the medicinal ingredient.

  • — SOR/2021-45, s. 17

    • 17 The Regulations are amended by adding the following after section C.08.009:

      Pre-positioning of Designated COVID-19 Drugs
      • C.08.009.01 The following definitions apply in sections C.08.009.03 to C.08.009.05.

        Chief Public Health Officer

        Chief Public Health Officer means the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act. (administrateur en chef de la santé publique)

        foreign regulatory authority

        foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)

      • C.08.009.02 Sections C.08.009.03 to C.08.009.05 apply in respect of a designated COVID-19 drug if the following conditions are met:

        • (a) a notice of compliance has not been issued under section C.08.004 or C.08.004.01 in respect of the designated COVID-19 drug; and

        • (b) Her Majesty in right of Canada has entered into a contract for the procurement of the designated COVID-19 drug.

        • C.08.009.03 (1) The holder of an establishment licence may import a designated COVID-19 drug if the following conditions are met:

          • (a) the Chief Public Health Officer provides the Minister with

            • (i) information indicating that

              • (A) the designated COVID-19 drug is the subject of a new drug submission that was filed under section C.08.002, or

              • (B) an application has been submitted to a foreign regulatory authority to authorize the sale of the designated COVID-19 drug,

            • (ii) the name of the designated COVID-19 drug and a description of it,

            • (iii) the name and contact information of the designated COVID-19 drug’s manufacturer,

            • (iv) information specifying the quantity of the designated COVID-19 drug to be imported,

            • (v) the name and contact information of any holder of an establishment licence who is proposed to be an importer of the designated COVID-19 drug, and

            • (vi) the civic address of the place where the designated COVID-19 drug will be stored after importation;

          • (b) the holder provides the Minister with

            • (i) the name and contact information of each fabricator, packager/labeller and tester of the designated COVID-19 drug and the civic address of each building at which the designated COVID-19 drug will be fabricated, packaged/labelled or tested, specifying for each building

              • (A) the activities referred to in Table I to section C.01A.008 that apply to the designated COVID-19 drug,

              • (B) the categories referred to in Table II to that section that apply to the designated COVID-19 drug, and

              • (C) for each category, the dosage form classes, if any, and whether the designated COVID-19 drug will be in a sterile form, and

            • (ii) a certificate from an inspector indicating that each fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4 or, alternatively, other evidence establishing that those requirements are met; and

          • (c) the holder is one of those specified in the information that the Chief Public Health Officer provides under subparagraph (a)(v).

        • (2) Paragraph (1)(b) does not apply to the holder of an establishment licence in respect of a building referred to in subparagraph (1)(b)(i) if

          • (a) the building is listed in the licence; and

          • (b) the information referred to in clauses (1)(b)(i)(A) to (C) that the holder submitted in respect of the building in their application for the licence under section C.01A.005 or in an application to amend the licence under section C.01A.006, has not changed.

        • (3) If the conditions set out in subsection (1) are met, the Minister shall send a letter to the Chief Public Health Officer to that effect.

      • C.08.009.04 Sections A.01.040 and C.01.004.1, subsection C.01A.004(1), section C.01A.006 and Divisions 2 to 4, other than the following provisions, do not apply in respect of the importation, under section C.08.009.03, of a designated COVID-19 drug by the holder of an establishment licence:

        • (a) sections C.02.003.1, C.02.004 and C.02.006, as they apply to the storage of the designated COVID-19 drug by the holder;

        • (b) subsection C.02.012(1);

        • (c) sections C.02.013 and C.02.014;

        • (d) section C.02.015, as it applies to the storage and transportation of the designated COVID-19 drug by the holder;

        • (e) subsection C.02.021(1), as it applies to the storage of the designated COVID-19 drug by the holder;

        • (f) subsection C.02.022(1);

        • (g) section C.02.023;

        • (h) subsection C.02.024(1);

        • (i) section C.03.013; and

        • (j) section C.04.001.1, as it applies to the storage of the designated COVID-19 drug by the holder.

      • C.08.009.05 Despite anything in these Regulations, the holder of an establishment licence may distribute a designated COVID-19 drug that they have imported under section C.08.009.03 if the following conditions are met:

        • (a) the Chief Public Health Officer provides the Minister with the name of the designated COVID-19 drug and the civic address of the place where it will be stored after the distribution; and

        • (b) the designated COVID-19 drug is distributed to a person who will store it at that place.

  • — SOR/2021-45, s. 20

    • 20 The Food and Drug Regulations — other than the following provisions — do not apply to a new drug in respect of which an authorization was issued to the manufacturer of the new drug if, immediately before the day on which this section comes into force, the authorization was neither suspended nor revoked:

      • (a) sections A.01.014, A.01.015, A.01.022 to A.01.043, A.01.050, A.01.051 and A.01.060.1 to A.01.068;

      • (b) sections C.01.004 to C.01.011, C.01.014.9, C.01.014.10, C.01.017 and C.01.019, subsection C.01.020(1) and sections C.01.020.1, C.01.040.3 to C.01.053, C.01.064 to C.01.069 and C.01.401;

      • (c) the provisions of Divisions 1A and 2 of Part C;

      • (d) sections C.03.202, C.03.203 and C.03.206 to C.03.209; and

      • (e) sections C.04.013 to C.04.016, C.04.019 and C.04.020.

  • — SOR/2021-45, s. 21

      • 21 (1) The drug identification number that was assigned under subsection 7(1) of the ISAD Interim Order in relation to a new drug that is referred to in section 20 continues to be assigned for the distinct combination of dosage form, strength and route of administration of the new drug.

      • (2) A reference in Divisions 1 and 1A of Part C of the Food and Drug Regulations — other than in sections C.01.050, C.01.052, C.01.053 and C.01A.003 — to a drug identification number is deemed to include a reference to the drug identification number that is referred to in subsection (1).

      • (3) A reference in section C.01A.003 of the Food and Drug Regulations to a distributor who holds a drug identification number is deemed to include a reference to the manufacturer who is referred to in section 20.

  • — SOR/2021-45, s. 22

    • 22 The manufacturer who is referred to in section 20 shall, within 15 days after the day on which the new drug is first sold in Canada, notify the Minister, in writing, of the date of that first sale, unless the manufacturer has already done so under section 8 of the ISAD Interim Order.

  • — SOR/2021-45, s. 23

    • 23 The manufacturer who is referred to in section 20 shall, within 15 days after the day on which the manufacturer permanently discontinues the sale in Canada of the new drug, notify the Minister, in writing, of the date on which the sale was permanently discontinued, unless the manufacturer has already done so under section 9 of the ISAD Interim order.

  • — SOR/2021-45, s. 24

    • 24 Despite the definition drug in section C.01.014.8 of the Food and Drug Regulations, sections C.01.014.9 and C.01.014.10 of those Regulations apply, with any necessary modifications, to the manufacturer who is referred to in section 20 in respect of the new drug.

  • — SOR/2021-45, s. 25

      • 25 (1) Subject to subsection (2), sections 20 to 24 cease to apply to a new drug that is referred to in section 20 90 days after the day on which this section comes into force.

      • (2) If the manufacturer who is referred to in section 20 files, for the new drug, a new drug submission under section C.08.002 of the Food and Drug Regulations or a supplement, within the period referred to in subsection (1) or has filed such a submission or supplement before the day on which this section comes into force, sections 20 to 24 cease to apply to the new drug when one of the circumstances referred to in paragraphs 19(3)(a) to (c) occurs.

  • — SOR/2021-45, s. 27(2)

      • 27 (2) Any terms and conditions of an establishment licence that are imposed by the Minister under the ISAD Interim Order are deemed to be imposed by the Minister under section C.01A.012.1 of the Food and Drug Regulations.

  • — SOR/2021-45, s. 29

    • 29 Information and material in respect of a designated COVID-19 drug that were provided under paragraphs 28(1)(a) and (b) or 30(a) of the ISAD Interim Order are deemed to have been provided under, as the case may be, paragraphs C.08.009.03(1)(a) and (b) or C.08.009.05(a) of the Food and Drug Regulations.

  • — SOR/2021-45, s. 30

    • 30 Section C.08.009.05 of the Food and Drug Regulations applies, with any necessary modifications, in respect of a designated COVID-19 drug that was imported under section 28 of the ISAD Interim Order.

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