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.
- SOR/2021-199, s. 3
- Date modified: