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Canada – Division 5 – Drugs for Clinical Trials

(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 tria 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.

Notification

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.

Amendment

C.05.008.
(1) Subject to subsections (4) and (5), when the sale or importation of a drug is authorized under this Division and the sponsor proposes to make an amendment referred to in subsection (2), the sponsor may sell or import the drug for the purposes of the clinical trial in accordance with the amended authorization, if the following conditions are met:

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