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

Regulations are current to 2023-11-14 and last amended on 2022-12-08. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2023-18, s. 1

    • 1 Subsection C.01.020.1(2) of the Food and Drug RegulationsFootnote 1 is amended by adding the following after paragraph (c):

      • (c.1) in the case of a drug whose sale has been authorized under subsection C.11.003(1), its identifying name, code, number or mark;

  • — SOR/2023-18, s. 2

      • 2 (1) The portion of subsection C.10.001(1) of the Regulations before the first definition is replaced by the following:

          • C.10.001 (1) The following definitions apply in this section and in section C.10.002.

      • (2) Paragraph (d) of the definition public health official in subsection C.10.001(1) of the Regulations is replaced by the following:

        • (d) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique)

      • (3) Paragraph C.10.001(2)(b) of the French version of the Regulations is replaced by the following:

        • b) la vente de la drogue est autorisée par une autorité réglementaire étrangère relevant des États-Unis, de la Suisse ou de l’Union européenne pour être utilisée pour le même usage ou aux mêmes fins que ceux visés au sous-alinéa a)(ii);

  • — SOR/2023-18, s. 3

      • 3 (1) Paragraph C.10.003(b) of the French version of the Regulations is replaced by the following:

        • b) la marque nominative de la drogue;

      • (2) Paragraph C.10.003(c) of the Regulations is replaced by the following:

        • (c) the medicinal ingredients, strength, dosage form and route of administration of the drug and any identifying code or number assigned to it in the country in which it was authorized for sale;

  • — SOR/2023-18, s. 4

    • 4 The Regulations are amended by adding the following after section C.10.011:

      DIVISION 11Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling

        • C.11.001 (1) The following definitions apply in this Division.

          foreign regulatory authority

          foreign regulatory authority has the same meaning as in subsection C.10.001(1). (autorité réglementaire étrangère)

          initial public health official

          initial public health official means the public health official named in an authorization issued under subsection C.11.003(1). (responsable de la santé publique initial)

          public health official

          public health official means

          • (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act;

          • (b) the Chief Medical Officer of Health, or equivalent, of a province;

          • (c) the Medical Officer of Health, or equivalent, of a municipality;

          • (d) the Surgeon General of the Canadian Armed Forces; or

          • (e) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique)

          subsequent public health official

          subsequent public health official means any public health official, other than the initial public health official, who obtains the quantity of a drug, or a portion of the quantity, that is specified in an authorization issued under subsection C.11.003(1). (responsable de la santé publique subséquent)

        • (2) This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, including drugs that have ceased to be considered to be natural health products by virtue of subsection 103.15(2) of the Natural Health Products Regulations.

        • C.11.002 (1) In order to address an actual, imminent or potential emergency, event or incident affecting public health or the health of members of the Canadian Armed Forces, a public health official may, on application to the Minister, obtain an authorization that permits a drug manufacturer to sell a specified quantity of a drug to the public health official, for immediate use or stockpiling or both.

        • (2) The application must

          • (a) set out the name of the public health official and include information setting out how they may be contacted at any time;

          • (b) set out the name of the manufacturer and include information setting out how they may be contacted at any time;

          • (c) describe the emergency, event or incident;

          • (d) state whether the drug is for immediate use or stockpiling or both;

          • (e) describe the use of the drug that is intended to address the emergency, event or incident;

          • (f) set out the civic address of the place to which the drug is to be shipped by the manufacturer;

          • (g) set out the following information about the drug:

            • (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark,

            • (ii) its medicinal ingredients,

            • (iii) its strength,

            • (iv) its dosage form,

            • (v) the recommended dosage for the use described under paragraph (e),

            • (vi) its recommended route of administration,

            • (vii) the indications that have been approved by any foreign regulatory authority, if applicable,

            • (viii) its contraindications,

            • (ix) a summary of its safety profile, and

            • (x) the recommended storage conditions for the drug;

          • (h) specify the quantity of the drug required to address the emergency, event or incident;

          • (i) include a statement by the public health official, accompanied by supporting information or documents, attesting that

            • (i) there is an actual, imminent or potential emergency, event or incident affecting public health or the health of the members of the Canadian Armed Forces that is likely to result, in humans, in a serious or life-threatening disease, disorder or abnormal physical state,

            • (ii) immediate action is or would likely be required to diagnose, treat, mitigate or prevent the disease, disorder or abnormal physical state or its symptoms,

            • (iii) conventional therapies, if any, have failed, are unsuitable or are unavailable in Canada at the time the application is made, and

            • (iv) the known and potential benefits associated with the use of the drug described under paragraph (e) outweigh the known and potential risks associated with that use;

          • (j) include any information or document available to the public health official concerning the safety, efficacy and quality of the drug in respect of the use described under paragraph (e), including information published in a medical or scientific journal; and

          • (k) set out the following information, if known by the public health official:

            • (i) the names of the foreign regulatory authorities that have authorized the sale of the drug in their jurisdictions for the same use as that described under paragraph (e),

            • (ii) the names of the foreign regulatory authorities that have received an application for authorization to sell the drug in their jurisdictions for the use described under paragraph (e) but that have not yet made a decision in respect of that application at the time the public health official makes the application under subsection (1), and

            • (iii) the names of the foreign regulatory authorities that have refused to authorize the sale of the drug in their jurisdictions for any use, as well as the reason for the refusal.

        • (3) The public health official must provide the Minister with any additional information or document that the Minister determines is necessary for the purpose of reviewing the application, by the date specified by the Minister.

        • C.11.003 (1) The Minister may, after review of the application, issue an authorization to a manufacturer authorizing the sale of a specified quantity of the drug to the public health official for the use described in the application.

        • (2) In reviewing the application, the Minister must consider whether there is an alternative mechanism that would address the emergency, event or incident.

        • (3) The authorization must

          • (a) set out the date of issue;

          • (b) set out the name and contact information of the public health official;

          • (c) set out the name and contact information of the manufacturer;

          • (d) describe the emergency, event or incident;

          • (e) state whether the drug is for immediate use or stockpiling or both;

          • (f) describe the use for which the sale of the drug is authorized in order to address the emergency, event or incident;

          • (g) set out the civic address of the place to which the drug is to be shipped by the manufacturer;

          • (h) set out the following information about the drug:

            • (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark,

            • (ii) its medicinal ingredients,

            • (iii) its strength,

            • (iv) its dosage form,

            • (v) its recommended dosage and route of administration, and

            • (vi) its recommended storage conditions; and

          • (i) specify the quantity of the drug that may be sold.

      • C.11.004 The initial public health official must notify the Minister, in writing, of any change to the information provided under paragraph C.11.002(2)(g), subparagraph C.11.002(2)(i)(iv), paragraph C.11.002(2)(j) or subsection C.11.002(3), within 30 days after the day on which they become aware of the change.

        • C.11.005 (1) Subject to subsection C.11.008(2), these Regulations, other than sections A.01.010, A.01.014 and A.01.045, subsections C.01.001(1) and (1.1) and this Division, do not apply to a drug that is sold in accordance with an authorization.

        • (2) In the case of a drug described in Schedule C or D of the Act, a drug that is sold in accordance with an authorization is exempt from the application of section 12 of the Act.

        • C.11.006 (1) The initial public health official must ensure that the drug bears a label or is accompanied by a document that clearly sets out the following information in English and French:

          • (a) the name and civic address of the drug’s manufacturer;

          • (b) a statement that the Minister has authorized the sale of the drug to address the emergency, event or incident described in the authorization;

          • (c) a statement that the drug is to be used only for the use described in the authorization;

          • (d) the drug’s brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark;

          • (e) the drug’s medicinal ingredients;

          • (f) the drug’s strength;

          • (g) the drug’s dosage form;

          • (h) the drug’s recommended dosage and route of administration;

          • (i) the drug’s lot number, if known;

          • (j) all warnings and precautions in respect of the use of the drug, if any;

          • (k) the drug’s expiration date, or, if there is no expiration date, the stability testing date or the date on which the drug should be retested, as specified by the manufacturer;

          • (l) the drug’s recommended storage conditions; and

          • (m) the net contents of the drug’s container, in terms of the weight, volume, size or number of units of the drug in the container.

        • (2) Any subsequent public health official must ensure that the drug bears the label or is accompanied by the document.

        • (3) If the initial public health official becomes aware of a change to any of the information referred to in paragraph (1)(a), (h), (j), (k) or (l), they must

          • (a) ensure that the information on the drug’s label or in the accompanying document is updated; and

          • (b) notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug.

        • (4) If the person notified under paragraph (3)(b) is a subsequent public health official, they must notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug.

        • (5) Any person who is notified under paragraph (3)(b) or subsection (4) must ensure that the updated information accompanies, in writing, any quantity of the drug that remains in their possession.

        • C.11.007 (1) In addition to the information required under subsection C.11.006(1), the initial public health official or any subsequent public health official, as the case may be, must make the following information available to the following persons, in writing, in English and French:

          • (a) to the persons to whom the drug is administered and the persons who administer the drug, the known and potential benefits and risks associated with the use for which the sale of the drug is authorized, the recommended duration of use, if any, of the drug and instructions on how to report serious adverse drug reactions; and

          • (b) to the persons who administer the drug, the information referred to in paragraphs C.11.002(2)(a), (b) and (e) and subparagraphs C.11.002(2)(g)(v), (vii) and (viii), if that information is not set out on the drug’s label or accompanying document.

        • (2) If the initial public health official becomes aware of a change to any of the information referred to in subsection (1), they must, in writing and without delay, notify the relevant persons of the change.

        • C.11.008 (1) If the initial public health official is a person referred to in paragraph (d) of the definition public health official in subsection C.11.001(1), they must submit a written report to the Minister in respect of any serious adverse drug reaction to the drug, and include in the report the information referred to in paragraphs C.01.020.1(2)(b) to (l), no later than the 30th day after the day on which they become aware of the reaction.

        • (2) If the initial public health official is a person referred to in any of paragraphs (a) to (c) or (e) of the definition public health official in subsection C.11.001(1), the written report is not required and section C.01.020.1 applies in respect of the provision of information relating to serious adverse drug reactions.

        • C.11.009 (1) The initial public health official must monitor the response to the drug in the emergency, event or incident — including monitoring information they receive relating to serious adverse drug reactions — and must take reasonable steps to obtain information on that response.

        • (2) The initial public health official must, on request of the Minister, submit a written report to the Minister on the monitoring of the response to the drug in the emergency, event or incident during the time period specified by the Minister, as well as on any corrective measures taken as a result of the monitoring.

        • C.11.010 (1) The initial public health official must maintain all information about the sale and use of the drug in a way that allows them to submit the information, notices and reports referred to in sections C.11.004 and C.11.008 and subsection C.11.009(2).

        • (2) The initial public health official and any subsequent public health official must maintain all information about the sale and use of the drug in a way that allows them to communicate with persons to whom the drug has been administered if the health of those persons may be endangered by its use.

      • C.11.011 The initial public health official or any subsequent public health official, as the case may be, must retain the information, notices and reports referred to in sections C.11.004 and C.11.008, subsection C.11.009(2) and section C.11.010, as applicable, for 15 years after the end of the period to which the information, notices and reports relate.

      • C.11.012 The initial public health official must account to the Minister for any unused quantity of stockpiled drug remaining in their possession at the end of the preceding calendar year by the January 30 that follows the first full calendar year during which the drug is stockpiled and then by January 30 of each subsequent year.

        • C.11.013 (1) The Minister may cancel an authorization if the Minister has reasonable grounds to believe that the drug presents a serious or imminent risk of injury to human health.

        • (2) If the Minister cancels an authorization, the initial public health official must, without delay, notify of the cancellation any person to whom they have directly distributed any quantity of the drug.

        • (3) These Regulations apply to any unused quantity of the drug as of the day on which the cancellation takes effect.

        • C.11.014 (1) The Minister may issue an authorization that permits an initial public health official who is a person referred to in paragraph (a), (d) or (e) of the definition public health official in subsection C.11.001(1) to sell a specified quantity of a stockpiled drug to a practitioner for use in the emergency treatment of a person under the care of that practitioner, if

          • (a) the manufacturer of the drug has been issued a letter of authorization under subsection C.08.010(1) that authorizes the sale of a specified quantity of the drug to that practitioner for the emergency treatment of that person; and

          • (b) the use of the drug specified in the letter of authorization is the same as the use described in the authorization issued to the manufacturer under subsection C.11.003(1).

        • (2) This Division, other than this section, does not apply to a drug sold in accordance with an authorization issued under subsection (1).


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