Food and Drug Regulations

C.01.016 (1) No manufacturer shall sell a drug unless the manufacturer, with respect to any adverse drug reaction or any serious adverse drug reaction known to the manufacturer that occurs after this section comes into force, furnishes to the Director

• (a) a report of all information in respect of any serious adverse drug reaction that has occurred in Canada with respect to the drug, within 15 days after receiving the information; and

• (b) a report of all information in respect of any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug, within 15 days after receiving the information.

(2) The manufacturer shall, on an annual basis and whenever requested to do so by the Director, conduct a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to a drug referred to in subsection (1) and prepare a summary report in respect of the reports received during the previous twelve months or received during such period of time as the Director may specify.

(3) Where, after reviewing any report furnished pursuant to subsection (1) and any available safety data relating to the drug, the Director considers that the drug may not be safe when used under the recommended conditions of use, the Director may, for the purpose of assessing the safety of the drug, request in writing, that the manufacturer submit

• (a) case reports of all adverse drug reactions and serious adverse drug reactions to that drug that are known to the manufacturer; and

• (b) a summary report prepared pursuant to subsection (2).

(4) The manufacturer shall submit the case reports and summary report referred to in subsection (3) within 30 days after receiving the request from the Director.