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

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.

• C.08.011.2 (1) Despite subsection C.01A.004(1), the holder of an establishment licence may import a new drug in accordance with a letter issued under subsection C.08.011.1(1).

• (2) Section C.01A.006 and Divisions 2 to 4, except for the following provisions, do not apply to the importation of a new drug referred to in the letter of authorization:

  • (a) sections C.02.003.1 and C.02.004, as they apply to the storage of the new drug by the holder of an establishment licence;

  • (b) section C.02.006, as it applies to the storage of the new drug by the holder of an establishment licence;

  • (c) subsection C.02.012(1);

  • (c.1) section C.02.012.1, as it applies to the storage of the new drug by the holder of an establishment licence;

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

  • (e) section C.02.015, as it applies to the storage and transportation of the new drug by the holder of an establishment licence;

  • (f) subsection C.02.021(1), as it applies to the storage of the new drug by the holder of an establishment licence;

  • (g) subsection C.02.022(1);

  • (h) section C.02.023;

  • (i) subsection C.02.024(1);

  • (j) section C.03.013; and

  • (k) section C.04.001.1, as it applies to the storage of the new drug by the holder of an establishment licence.

• C.08.011.3 (1) Despite section C.08.002, the holder of an establishment licence who imports a new drug under section C.08.011.2 may distribute a new drug in accordance with a letter of authorization issued under subsection C.08.010(1).

• (2) The holder of an establishment licence who distributes to a practitioner, in accordance with subsection (1), a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A must submit to the Minister an annual report identifying the total quantity of the new drug that was distributed, including an estimate of the quantity distributed in respect of each animal species for which the drug is intended.

• (3) The distribution 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 distributed.

Sale of Medicated Feeds

• C.08.012 (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 purposes of this section, medicated feed has the same meaning as in the Feeds Regulations, 2024.

Experimental Studies

Conditions of Sale

• C.08.013 (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)

Experimental Studies Certificate

• C.08.014 (1) For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Minister, in writing, the following information and material:

  • (a) the brand name of the new drug or the identifying name or code proposed for the new drug;

  • (b) the objectives and an outline of the proposed experimental study of the new drug;

  • (c) the species, number and production type of animals in respect of which the new drug is to be administered;

  • (d) the name and address of the manufacturer of the new drug;

  • (e) the address of the premises in which the experimental study is to be conducted;

  • (f) a description of the facilities to be used to conduct the experimental study;

  • (g) the name, address and qualifications of the proposed experimental studies investigator;

  • (h) the chemical structure, if known, and the relevant compositional characteristics of the new drug;

  • (i) the proposed quantity of the new drug to be used for the experimental study;

  • (j) the results of any toxicological or pharmacological studies that may have been conducted with the new drug;

  • (k) the written agreement referred to in subsection (2); and

  • (l) such other information and material as the Minister may require.

• (2) Where a food-producing animal is involved in an experimental study, the applicant referred to in subsection (1) shall, for the purposes of obtaining an experimental studies certificate, obtain from the owner of the animals, or from a person authorized by the owner, a written agreement not to sell the animal or any products from it without prior authorization from the experimental studies investigator.

• (3) The Minister may request the manufacturer of a new drug to submit to him samples of the new drug or of any ingredient of the drug and, in satisfactory form and manner, any other information that the Minister requests and where such samples or information are not submitted, the Minister may refuse to issue an experimental studies certificate.