Summary

Amends the Therapeutic Goods Act 1989 to: require mandatory reporting of adverse events involving medical devices; provide a marketing approval pathway for biologicals that are for export only; remove merits review rights for a decision by the secretary to require a person to provide information or documents under the Act; enable the secretary to extend the period for a person to pay the amount stated in an infringement notice, and require a person to provide information or documents that are relevant to a contravention of the Act; extend the period for which seized goods can be held; provide that therapeutic goods advertising is excluded from advertising restrictions for certain health professionals or to persons purchasing goods on behalf of governments, registered charities or health facilities; enable the secretary to withdraw approval for the use of a restricted representation in an advertisement about therapeutic goods; enable the secretary to approve the importation or supply of substitute overseas prescription medicine that has been previously approved within Australia; provide that the secretary is not required to observe any requirements of the natural justice hearing rule when releasing therapeutic goods information; provide that sponsors of reportable medicines that are in shortage must provide updated information to the secretary; and make technical amendments.