Food and Drug Regulations

C.01.013 (1) Where the manufacturer of a drug is requested in writing by the Director 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) Where the Director is of the opinion that the evidence submitted by a manufacturer, pursuant to subsection (1), is not sufficient, he shall notify the manufacturer in writing that the evidence is not sufficient.

(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 Director 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.