Food and Drug Regulations (C.R.C., c. 870)

C.01A.013 Every person who holds an establishment licence shall notify the Minister in writing within 15 days after

• (a) there is any change to the information referred to in any of paragraphs C.01A.005(1)(a), (b) and (e) to (i); or

• (b) an event occurs that results in their being in contravention of any of the applicable requirements set out in Divisions 2 to 4, if the event may affect the quality, safety or efficacy of a drug that they fabricate, package/label, test in accordance with the requirements set out in Division 2 or store, including during transportation.