Food and Drug Regulations

C.01.019 (1) The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister an issue-related summary report.

(2) The report shall contain a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to the drug, as well as case reports of all or specified adverse drug reactions and serious adverse drug reactions to the drug that are known to the manufacturer in respect of the issue that the Minister directs the manufacturer to analyze in the report.

(3) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the report that is reasonable in the circumstances. The Minister may only specify a period that is less than 30 days if the Minister needs the information in the report to determine whether the drug poses a serious and imminent risk to human health.

(4) The manufacturer shall submit the report within the specified period.