Food and Drug Regulations

C.01.013 (1) Where the manufacturer of a drug is requested in writing by the Minister to submit on or before a specified day evidence with respect to a drug, the manufacturer shall make no further sales of that drug after that day unless he has submitted the evidence requested.

(2) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a drug is not sufficient, he shall make no further sales of that drug unless he submits further evidence and is notified in writing by the Minister that that further evidence is sufficient.

(4) A reference in this section to evidence with respect to a drug means evidence to establish the safety of the drug under the conditions of use recommended and the effectiveness of the drug for the purposes recommended.