C.05.006. (1) Subject to subsection (3), a sponsor may sell or import a drug, other than a drug described in subsection (2), for the purposes of a clinical trial if
(a) the sponsor has submitted to the Minister an application in accordance with section C.05.005;
(b) the Minister does not, within 30 days after the date of receipt of the application, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug for any of the following reasons:
(i) that the information and documents in respect of the application
(A) were not provided in accordance with these Regulations, or
(B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or
(ii) that based on an assessment of the application, an assessment of any information submitted under section C.05.009 or a review of any other information, 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, or
(C) the objectives of the clinical trial will not be achieved;
(c) for each clinical trial site, the sponsor has obtained the approval of the research ethics board in respect of the protocol referred to in paragraph C.05.005(a) and in respect of an informed consent form that contains the statement referred to in paragraph C.05.005(b); and
(d) before the sale or importation of the drug at a clinical trial site, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h), if it was not submitted in respect of that clinical trial site at the time of submitting the application.
(2) Subject to subsection (3), a sponsor may sell or import a drug for the purposes of a clinical trial in respect of
(a) a new drug that has been issued a notice of compliance under subsection C.08.004(1), if the clinical trial is in respect of a purpose or condition of use for which the notice of compliance was issued; or
(b) a drug, other than a new drug, that has been assigned a drug identification number under subsection C.01.014.2(1), if the clinical trial is in respect of a use or purpose for which the drug identification number was assigned.
(3) A sponsor may not sell or import a drug for the purposes of a clinical trial
(a) during the period of any suspension made under section C.05.016 or C.05.017; or
(b) after a cancellation made under section C.05.016 or C.05.017.
- SOR/2001-203, s. 4;
- SOR/2012-16, s. 3(F).
C.05.007. If the sale or importation of a drug is authorized under this Division, the sponsor may make one or more of the following changes if the sponsor notifies the Minister in writing within 15 days after the date of the change:
(a) a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008; and
(b) a change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008.
- SOR/2001-203, s. 4;
- SOR/2012-16, s. 4(F).
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