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

Regulations are current to 2020-09-09 and last amended on 2020-07-01. 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

  •  (1) The Minister may issue a letter of authorization authorizing the sale of a quantity of a new drug for human or veterinary use to a practitioner named in the letter of authorization for use in the emergency treatment of a patient under the care of that practitioner, if

    • (a) the practitioner has supplied to the Minister information concerning

      • (i) the medical emergency for which the drug is required,

      • (ii) the data in the possession of the practitioner with respect to the use, safety and efficacy of that drug,

      • (iii) the names of all institutions in which the drug is to be used, and

      • (iv) such other data as the Minister may require; and

    • (b) the practitioner has agreed to

      • (i) report to the manufacturer of the new drug and to the Minister on the results of the use of the drug in the medical emergency, including information respecting any adverse reactions encountered, and

      • (ii) account to the Minister on request for all quantities of the drug received by him.

  • (1.1) The Minister shall not issue a letter of authorization under subsection (1) for a new drug that is or that contains a restricted drug as defined in section J.01.001.

  • (2) The Minister shall, in any letter of authorization issued pursuant to subsection (1), state

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

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

    • (c) the quantity of the new drug that may be sold to that practitioner for that emergency.

  • SOR/2013-172, s. 11
  • SOR/2018-69, ss. 31(E), 32(F)
  •  (1) Notwithstanding section C.08.002, a manufacturer may sell to a practitioner named in a letter of authorization issued pursuant to section C.08.010, a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.

  • (2) A sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations.

Sale of Medicated Feeds

  •  (1) Notwithstanding anything in this Division, a person may sell, pursuant to a written prescription of a veterinary practitioner, a medicated feed if

    • (a) as regards the drug or drugs used as the medicating ingredient of the medicated feed,

      • (i) the Minister has assigned a drug identification number pursuant to section C.01.014.2, or

      • (ii) the sale is permitted by section C.08.005, C.08.011 or C.08.013;

    • (b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription;

    • (c) the medicated feed is for therapeutic purposes only; and

    • (d) the written prescription contains the following information:

      • (i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed,

      • (ii) the species, production type and age or weight of the animals to be treated with the medicated feed,

      • (iii) the type and amount of medicated feed to be mixed,

      • (iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients,

      • (v) any special mixing instructions, and

      • (vi) labelling instructions including

        • (A) feeding instructions,

        • (B) a warning statement respecting the withdrawal period to be observed following the use of the medicated feed, and

        • (C) where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed.

  • (2) For the purpose of this section, medicated feed has the same meaning as in the Feeds Regulations.

  • SOR/80-741, s. 1
  • SOR/92-130, s. 1
  • SOR/93-202, s. 27
  • SOR/2018-69, s. 27

Experimental Studies

Conditions of Sale
  •  (1) Notwithstanding anything in this Division, a person may sell a new drug proposed for use in animals to an experimental studies investigator in a quantity specified by the Minister for the purpose of conducting an experimental study in animals if

    • (a) the experimental studies investigator has been issued an experimental studies certificate pursuant to subsection C.08.015(1) and the certificate has not been suspended or cancelled pursuant to section C.08.018; and

    • (b) the drug is labelled in accordance with subsection C.08.016(1).

  • (2) For the purposes of this section and sections C.08.014 to C.08.018,

    experimental studies certificate

    experimental studies certificate means a certificate issued pursuant to subsection C.08.015(1); (certificat d’études expérimentales)

    experimental studies investigator

    experimental studies investigator means a person named as the investigator in an experimental studies certificate; (expert en études expérimentales)

    experimental study

    experimental study means a limited test of a new drug in animals carried out by an experimental studies investigator. (étude expérimentale)

  • SOR/81-333, s. 1
  • SOR/2018-69, s. 27
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