Australia Therapeutic Goods Act 1989 s42V-42W: Comply with tampering recall and public notification requirements, and do not supply or export goods of a kind or batch subject to a tampering recall without the Secretary's written consent

What does s42V-42W require?

Where the Secretary believes a kind or batch of goods that a person supplies has been, is, or may be affected by actual or potential tampering, the Secretary can require that person, within set periods, to recall the goods it supplied or to warn the public or a named class of people about the actual or possible tampering; requirements are published and may be imposed whether or not the person notified under section 42T. Failure is an offence tiered by harm and a civil penalty (section 42VA), with possible court relief (section 42VB). Supplying in Australia, or exporting, goods of a kind or batch under a tampering recall requirement (imposed on that person or another), knowing or reckless as to that, without the Secretary's written consent is an offence (12 months or 1,000 penalty units); export consent is given only in exceptional circumstances.