Food and Drug Regulations

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.