Food and Drug Regulations
C.05.013 (1) The Minister shall require a sponsor to submit, within two days after receipt of the request, information concerning the drug or the clinical trial, or samples of the drug, if the Minister has reasonable grounds to believe that
(a) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person;
(b) the clinical trial is contrary to the best interests of a clinical trial subject;
(c) the objectives of the clinical trial will not be achieved;
(d) a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or
(e) information submitted in respect of the drug or the clinical trial is false or misleading.
(2) The Minister may require the sponsor to submit, within seven days after receipt of the request, any information or records kept under section C.05.012, or samples of the drug, in order to assess the safety of the drug or the health of clinical trial subjects or other persons.
- SOR/2001-203, s. 4.
- Date modified: