Food and Drug Regulations

C.08.008 No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister

• (a) on request, reports of all records respecting the information described in paragraphs C.08.007(a) to (c);

• (b) immediately on receipt by the manufacturer, reports of all records respecting the information described in paragraphs C.08.007(d) to (f); and

• (c) within 15 days after the receipt by the manufacturer of information referred to in paragraphs C.08.007(g) and (h), a report on the information received.