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

Regulations are current to 2020-10-05 and last amended on 2020-09-28. Previous Versions

PART CDrugs (continued)

DIVISION 8 (continued)

Disclosure of Information in Respect of Clinical Trials

  •  (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.

  • SOR/2019-62, s. 3
  •  (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.

  • SOR/2019-62, s. 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.

  • SOR/2019-62, s. 3

Sale of New Drug for Emergency Treatment

[SOR/2020-212, s. 1(F)]
  •  (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 practioner, 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) The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001.

  • (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.

  • SOR/2013-172, s. 11
  • SOR/2018-69, ss. 31(E), 32(F)
  • SOR/2020-212, s. 2
  •  (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, in the form established by 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.

  • SOR/2020-212, s. 2
  •  (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 concerning

      • (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) The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001.

  • (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.

  • SOR/2020-212, s. 2
 
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