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

Regulations are current to 2016-11-21 and last amended on 2016-10-31. Previous Versions

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 Director 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.

Experimental Studies Certificate

  •  (1) For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Director, 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 Director 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 Director 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 Director requests and where such samples or information are not submitted, the Director may refuse to issue an experimental studies certificate.

  • SOR/81-333, s. 1;
  • SOR/93-202, s. 28.
  •  (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is satisfied that

    • (a) the applicant is qualified as an experimental studies investigator for the purposes of the proposed experimental study,

    • (b) the facilities for the conduct of the experimental study are adequate for the purposes of the proposed experimental study, and

    • (c) the proposed experimental study can be conducted without undue foreseeable risk to humans or animals,

    the Director shall issue an experimental studies certificate for the purposes of the proposed experimental study and shall specify therein the quantity of the new drug that may be sold to the experimental studies investigator.

  • (2) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is not satisfied that the requirements of paragraphs (1)(a), (b) and (c) have been met, he shall refuse to issue an experimental studies certificate.

  • SOR/81-333, s. 1.

Labelling

  •  (1) The label of a new drug that is sold pursuant to section C.08.013 shall show

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

    • (b) a warning statement to the effect that the drug is for use only in an experimental study in animals;

    • (c) the lot number of the drug;

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

    • (e) the name of the person to whom the drug has been supplied.

  • (2) Sections C.01.004, C.01.005 and C.01.014 do not apply to a drug that is sold pursuant to section C.08.013 and labelled in accordance with subsection (1).

  • SOR/81-333, s. 1;
  • SOR/88-378, s. 2;
  • SOR/93-202, s. 29.

Conditions of Experimental Study

 An experimental studies investigator shall

  • (a) use the new drug only in accordance with the outline of the experimental study;

  • (b) report immediately to the Director all serious adverse drug reactions associated with the use of the new drug;

  • (c) report promptly to the Director, on request, the results of the experimental study;

  • (d) return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;

  • (e) maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Director;

  • (f) report promptly to the Director any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014(2); and

  • (g) account to the Director, on request, for all quantities of the new drug received by him.

  • SOR/81-333, s. 1;
  • SOR/2001-203, s. 10.

Suspension or Cancellation of Experimental Studies Certificate

  •  (1) Where the Director is of the opinion that it is necessary in order to safeguard animal health or public health or to promote public safety, he may suspend for a definite or indefinite period or cancel an experimental studies certificate.

  • (2) Without limiting the generality of subsection (1), the Director may suspend or cancel an experimental studies certificate if

    • (a) the information and material submitted pursuant to section C.08.014 contains an untrue statement or contains any omission concerning the properties of the drug that were known or ought reasonably to have been known to the manufacturer or the experimental studies investigator;

    • (b) the labelling of the new drug is, at any time, false, misleading, deceptive or incomplete;

    • (c) the qualifications of the experimental studies investigator prove to be inadequate;

    • (d) there is evidence that the experimental studies investigator has not complied with the conditions referred to in section C.08.017; or

    • (e) an action of the manufacturer in respect of the new drug has resulted in his conviction for a violation of section C.08.002.

  • SOR/81-333, s. 1.

DIVISION 9

Non-prescription Drugs

 This Division does not apply to

  • SOR/84-145, s. 4.
 
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