Administration of unregistered or unlisted therapeutic goods

The (Commonwealth) Therapeutic Goods Act, 1989 (the Act) and associated regulations establishes a uniform, national system of regulatory controls to ensure the quality, safety, efficacy and timely availability of therapeutic goods for human use in Australia. Under the Act, therapeutic goods for human use that are imported into, supplied in, or exported from Australia must be included in the Australian Register of Therapeutic Goods (ARTG). Persons in breach of the above provisions under the Act could face civil or criminal penalties of up to five years imprisonment and/or up to $720,000 for each offence for an individual or $3.6 million for a corporation.
 
Additionally, the supply or administration of imported medicines, including injectable botulinum toxin, hyaluronic acid dermal fillers and injectable local anaesthetics, which are not registered for use in Australia in the Australian Register of Therapeutic Goods is also an offence under the NSW Poisons and Therapeutic Goods Act that may attract a penalty of up to $2,200 for each offence.
 

Administration and supply of injectable botulinum toxin or hyaluronic acid dermal fillers by unauthorised persons

The administration of botulinum toxin, hyaluronic acid dermal fillers, injections or local anaesthetics and other prescription only medications by persons who are not medical practitioners or nurse practitioners, or administering these prescription only medications under the direct supervision of such a practitioner is an offence under the Poisons and Therapeutic Goods Act attracting a penalty of up to $1,650 or imprisonment of up to 6 months, or both, for each offence.  In the case of some prescription only medications the penalties may be up to $2,200 or imprisonment of up to two years, or both, for each offence.
 
Page Updated: Tuesday 12 July 2016