C.08.015. (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.
C.08.016. (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
C.08.017. 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.
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