Food and Drug Regulations

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(a), (b), and (e) to (i); or

• (b) an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them.