Food and Drug Regulations (C.R.C., c. 870)

C.03.316. (1) If a sponsor discontinues a study in its entirety or at a study site, the sponsor shall notify all qualified investigators of the discontinuance as soon as possible in writing, and include in the notice the reasons for the discontinuance and whether the study presented any risks to the health of study subjects or other persons.

(2) If the discontinuance is for reasons that would affect the health or safety of study subjects or other persons, the sponsor shall notify the Minister in writing within 15 days after the discontinuance, and include in the notice the reasons for the discontinuance and whether it will have an impact on any proposed or ongoing studies in respect of the study drug in Canada by the sponsor.

C.03.317. (1) The Minister shall suspend an authorization to sell or import a study drug, in its entirety or in respect of a study site, in any of the following circumstances:

• (a) information provided by the sponsor under section C.03.307, C.03.308 or C.03.313 proves to be inaccurate or incomplete;

• (b) the sponsor fails to provide the Minister with sufficient information to establish the safety of the study drug pursuant to a written request under section C.03.313, by the date specified in the request;

• (c) the sponsor fails to notify the Minister of an adverse reaction or file a report in respect of an adverse reaction in accordance with section C.03.314; or

• (d) the sponsor contravenes a provision of these Regulations or any provision of the Act in relation to the study drug.

(2) In determining whether to suspend an authorization in its entirety or in respect of a study site, the Minister shall consider whether the reason for the suspension affects the study in its entirety or affects only a certain study site.

(3) Before suspending an authorization, the Minister shall send the sponsor a notice that

• (a) specifies whether the suspension is of the study authorization in its entirety or in respect of a study site and sets out the reasons for the proposed suspension and the effective date;

• (b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and

• (c) gives the sponsor a reasonable opportunity to be heard in writing concerning the proposed suspension.

(4) Despite subsection (3), the Minister shall immediately suspend an authorization if she or he has reason to believe that it is necessary to do so to prevent injury to the health of a study subject or any other person.

(5) When the Minister suspends an authorization under subsection (4), the Minister must send the sponsor a notice that

• (a) sets out the reasons for the suspension;

• (b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and

• (c) gives the sponsor a reasonable opportunity to be heard in writing concerning the suspension.