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

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.

Disclosure of Information in Respect of Clinical Trials

• C.08.009.1 (1) In sections C.08.009.2 and C.08.009.3, information in respect of a clinical trial means information in respect of a clinical trial, within the meaning of section C.05.001, that is contained in a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for a new drug for human use filed under section C.08.002, C.08.002.01 or C.08.002.1 or in a supplement to any of those submissions filed under section C.08.003.

• (2) For greater certainty, the definition information in respect of a clinical trial includes information that is contained in a submission or supplement referred to in that definition and that is in respect of clinical testing involving human subjects in regards to which an application was filed under this Division before September 1, 2001.

• C.08.009.2 (1) Information in respect of a clinical trial that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the submission or supplement:

  • (a) the Minister issues a notice of compliance under section C.08.004 or C.08.004.01;

  • (b) in the case where the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) and the manufacturer does not amend the submission or supplement under subsection C.08.004(2) or C.08.004.01(2), the applicable period referred to in the relevant subsection expires;

  • (c) the Minister issues a notice to the manufacturer under paragraph C.08.004(3)(b) or C.08.004.01(3)(b).

• (2) Subsection (1) does not apply to information in respect of a clinical trial that

  • (a) was not used by the manufacturer in the submission or supplement to support the proposed conditions of use for the new drug or the purpose for which the new drug is recommended; or

  • (b) describes tests, methods or assays that are used exclusively by the manufacturer.

C.08.009.3 The Minister may disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, any information in respect of a clinical trial that has ceased to be confidential business information.

Sale of New Drug for Emergency Treatment

• C.08.010 (1) The Minister may issue a letter of authorization to a manufacturer of a new drug authorizing the sale of a specified quantity of the new drug for human or veterinary use to a practitioner, for use in the emergency treatment of an animal or a person under the care of that practitioner, if

  • (a) the practitioner provides the following information to the Minister:

    • (i) the name of the new drug and details concerning the medical emergency for which the new drug is required,

    • (ii) the quantity of the new drug that is required,

    • (iii) subject to subsection (2), the information in the possession of the practitioner in respect of the use, safety and efficacy of the new drug,

    • (iv) the name and the civic address of the person to whom the new drug is to be shipped, and

    • (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization;

  • (b) the practitioner agrees to

    • (i) provide a report to the manufacturer of the new drug and to the Minister describing the results obtained following the use of the new drug to address the medical emergency, including information respecting any adverse drug reactions observed by the practitioner, and

    • (ii) account to the Minister, on request, for all quantities of the new drug received;

  • (c) in the case of a new drug for human use, the person referred to in subparagraph (a)(iv) is a practitioner or a pharmacist; and

  • (d) in the case of a new drug for veterinary use, the person referred to in subparagraph (a)(iv) is a practitioner, a pharmacist or a person who may sell a medicated feed pursuant to section C.08.012.

• (2) Subparagraph (1)(a)(iii) does not apply if the following conditions are met:

  • (a) the sale of the new drug has been authorized under subsection (1) to address the same medical emergency on at least one previous occasion;

  • (b) the European Medicines Agency or the United States Food and Drug Administration has authorized the sale of the new drug without terms or conditions, for the same use in its jurisdiction; and

  • (c) the Minister has not cancelled the assignment of a drug identification number for the new drug under paragraph C.01.014.6(2)(b) or (c) or subsection C.01.014.6(3).

• (3) [Repealed, SOR/2021-271, s. 4]

• (4) The letter of authorization must contain the following information:

  • (a) the name of the practitioner to whom the new drug may be sold;

  • (b) the name and the civic address of the person to whom the new drug may be shipped;

  • (c) the name of the new drug and the medical emergency in respect of which it may be sold; and

  • (d) the quantity of the new drug that may be sold to the practitioner to address the medical emergency.

• (5) For the purposes of this section, the practitioner is not required to know the identity of the animal or the person under the care of that practitioner at the time the letter of authorization is issued.

• C.08.011 (1) Despite section C.08.002, the manufacturer may sell a new drug in accordance with a letter of authorization issued under subsection C.08.010(1).

• (2) In the case of the sale under subsection (1) of a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A and that was not imported under section C.08.011.2, an annual report identifying the total quantity of the new drug that was sold, including an estimate of the quantity sold in respect of each animal species for which the drug is intended, must be submitted to the Minister by the manufacturer, if the new drug was present in Canada at the time of sale, otherwise by the practitioner.

• (3) The sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations other than this section.

• (4) The annual report described in subsection (2) is for a period of one calendar year and must be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year during which the drug is first sold.

• C.08.011.1 (1) The Minister may issue a letter of authorization to the manufacturer of a new drug authorizing the holder of an establishment licence to import a specified quantity of the new drug for human or veterinary use, if the following conditions are met:

  • (a) the manufacturer provides the following information to the Minister:

    • (i) the name of the new drug and details concerning the medical emergency for which the new drug will be imported,

    • (ii) the quantity of the new drug to be imported,

    • (iii) the name of the holder of an establishment licence who will import the new drug,

    • (iv) the civic address of the facility where the new drug is to be stored in Canada, and

    • (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization;

  • (b) the establishment licence authorizes the importation of a new drug in the same category as the one to be imported; and

  • (c) the quantity that is to be imported does not exceed the amount that the Minister determines is likely to be required to address the medical emergency.

• (2) [Repealed, SOR/2021-271, s. 5]

• (3) The letter of authorization must contain the following information:

  • (a) the name of the new drug and the medical emergency in respect of which the letter is issued;

  • (b) the quantity of the new drug that may be imported to address the medical emergency;

  • (c) the name of the holder of an establishment licence who is authorized to import the new drug; and

  • (d) the civic address of the facility where the new drug is to be stored in Canada.