Food and Drug Regulations
C.08.018 (1) If the Minister determines that it is necessary in order to safeguard animal health or public health or to promote public safety, he or she may suspend for a definite or indefinite period or cancel an experimental studies certificate.
(2) Without limiting the generality of subsection (1), the Minister 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
- SOR/2018-69, ss. 26, 27
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