Food and Drug Regulations

C.01.014.12 (1) The Minister may request that the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug — or any person who holds an establishment licence in respect of a drug — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that

• (a) there is a shortage or risk of shortage of the drug;

• (b) the information is necessary to establish or assess

  • (i) the existence of a shortage or risk of shortage of the drug,

  • (ii) the reason for a shortage or risk of shortage of the drug,

  • (iii) the effects or potential effects on human health of a shortage of the drug, or

  • (iv) measures that could be taken to prevent or alleviate a shortage of the drug; and

• (c) the manufacturer or licensee will not provide the information without a legal obligation to do so.

(2) The manufacturer or licensee shall provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.