PART CDrugs (continued)
DIVISION 8 (continued)
Sale of New Drug for Emergency Treatment (continued)
- SOR/2020-212, s. 1(F)
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);
(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, in the form established by 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.
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 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
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)
- SOR/81-333, s. 1
- SOR/2018-69, s. 27
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.
- SOR/81-333, s. 1
- SOR/93-202, s. 28
- SOR/2018-69, s. 27
C.08.015 (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Minister has determined 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 Minister 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) If, on receipt of the information and material submitted under section C.08.014, the Minister is not satisfied that the requirements of paragraphs (1)(a), (b) and (c) have been met, he or she shall refuse to issue an experimental studies certificate.
- SOR/81-333, s. 1
- SOR/2018-69, ss. 25, 27
- SOR/2022-197, s. 9
- Date modified: