Food and Drug Regulations

C.05.016 (1) Subject to subsection (2), the Minister shall suspend the authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that

• (a) the sponsor has contravened these Regulations or any provisions of the Act relating to the drug;

• (b) any information submitted in respect of the drug or clinical trial is false or misleading;

• (c) the sponsor has failed to comply with good clinical practices; or

• (d) the sponsor has failed to provide

  • (i) information or samples of the drug as required under section C.05.009 or C.05.013, or

  • (ii) information or a report under section C.05.014.

(2) Subject to section C.05.017, the Minister shall not suspend an authorization referred to in subsection (1) unless

• (a) the Minister has sent to the sponsor a written notice of the intention to suspend the authorization that indicates whether the authorization is to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension;

• (b) the sponsor has not, within 30 days after receipt of the notice referred to in paragraph (a), provided the Minister with information or documents that demonstrate that the authorization should not be suspended on the grounds that

  • (i) the situation giving rise to the intended suspension did not exist, or

  • (ii) the situation giving rise to the intended suspension has been corrected; and

• (c) the Minister has provided the sponsor with the opportunity to be heard in paragraph (b).

(3) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.

(4) If the Minister has suspended an authorization under subsection (1), the Minister shall

• (a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension has been corrected; or

• (b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).