Australia Therapeutic Goods Act 1989 s54B-54BA: Executive officers who know a listed offence or a civil penalty contravention by their company will occur, and can influence its conduct, must take all reasonable steps to prevent it or become personally liable

What does s54B-54BA require?

An executive officer of a body corporate (anyone concerned in or taking part in its management, director or not) commits an offence if the body commits an offence listed in section 54BA, the officer knew it would be committed, was in a position to influence the body's conduct in relation to it, and failed to take all reasonable steps to prevent it; the maximum penalty is the maximum a court could impose on an individual for the body's offence (with an uplift for section 41MN(10)). A parallel civil penalty applies where the body contravenes a civil penalty provision in the same circumstances (with a 5,000 penalty unit cap for section 41MNA(3)). The listed offences span standards, registration, conditions, adverse event notification, manufacturing, medical device, advertising, counterfeit and tampering provisions.