Food and Drug Regulations
C.08.014 (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
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